ISO 9001 Quality Management System

ISO 9001 Standard - ISO 9001:2008 Standards

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Assessment to ISO 9001 Standards

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Assessment to ISO 9001 Standards
Once all the requirements of ISO 9001 have been met, it is time for an external audit. This should be carried out by a third party, accredited certification body. In the UK, the body should be accredited by UKAS. The chosen certification body will review the quality manuals and procedures. This process involves looking at the companys evaluation of quality and ascertains if targets set for the management program are measurable and achievable. This is followed at a later date by a full on-site audit to ensure that working practices observe the procedures and stated objectives and that appropriate records are kept.
After a successful audit, a certificate of registration to ISO 9001 will be issued. There will then be surveillance visits (usually once or twice a year) to ensure that the system continues to work.

Environmental Management Programmes

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ISO 14001 Section 4.3.4, Environmental Management Program(s), requires that organizations establish and maintain one or more environmental management programs for achieving their objectives. The environmental management program is a key element to the success of an EMS. Properly designed and implemented, environmental management programs should achieve the objectives and, consequently, improve your organization’s environmental performance.
According to ISO 14001 Section 4.3.4 the environmental management program must:
1. address each environmental objective and target
2. designate the personnel responsible for achieving targets at each relevant function and level of the
organization
3. provide an “action plan” describing how each environmental target will be achieved
4. establish a time-frame or a schedule for achieving each target.
An environmental management program is an action plan or a series of action plans to achieve an environmental objective.

EMS Documentation

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ISO 14001 Section 4.4.4, EMS Documentation, requires that organizations “. . . establish and maintain information, in paper or electronic form, to: 1. describe the core elements of the management system and their interaction; 2. provide direction to related documentation.”
ISO 14001 Section 4.4.5, Document Control, requires that organizations establish and maintain procedures to control all documents required by ISO 14001. The purpose of these document control procedures is to ensure that organizations create and maintain documents sufficient to implementing an EMS.
The procedure must ensure that:
• EMS documents can be located
• EMS documents are legible, dated (with dates of revisions) and readily identifiable
• EMS documents are maintained in an orderly manner and retained for a specified period
• EMS documents are periodically reviewed, revised as necessary, and approved for adequacy by authorized personnel
• The current versions of relevant documents are available at all locations where they are necessary
• Obsolete documents are promptly removed from all distribution points
• Any obsolete documents retained for legal and/or knowledge preservation purposes must be identified as such.
ISO 14001 Section 4.3.5 also requires that organizations establish procedures and designate responsibilities and
authority regarding the creation and modification of EMS documents.

Implementing ISO 9000 Quality Management System

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Implementation of ISO 9000 affects the entire organization right from the start. If pursued with total dedication, it results in ‘cultural transition’ to an atmosphere of continuous improvement.The process of implementing ISO 9000 depends on:???? The sophistication of your existing quality program,???? The size of your organization, and???? The complexity of your process.The 14 essential steps, briefly described below, are to be followed through in order to implement ISO 9000 quality management system successfully.Step 1: Top management commitmentStep 2: Establish implementation teamStep 3. Start ISO 9000 awareness programsStep 4: Provide TrainingStep 5. Conduct initial status surveyStep 6: Create a documented implementation planStep 7. Develop quality management system documentationStep 8: Document controlStep 9. ImplementationStep 10. Internal quality auditStep 11. Management reviewStep 12. Pre-assessment auditStep 13. Certification and registrationStep 14: Continual ImprovementStep 1: Top Management CommitmentThe top management (managing director or chief executive) should demonstrate a commitment and a determination to implement an ISO 9000 quality management system in the organization. Without top management commitment, no quality initiative can succeed. Top management must be convinced that registration and certification will enable the organization to demonstrate to its customers a visible commitment to quality. It should realize that a quality management system would improve overallbusiness efficiency by elimination of wasteful duplication in management system.The top management should provide evidence of its commitment to the development and implementation of the quality management system and continually improve its effectiveness by:a. Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,b. Defining the organization’s quality policy and make this known to every employee,c. Ensuring that quality objectives are established at all levels and functions,d. Ensuring the availability of resources required for the development andimplementation of the quality management system,e. Appointing a management representative to coordinate quality management system activities, and Conducting management review.The top management should also consider actions such as:1. Leading the organization by example,2. Participating in improvement projects,3. Creating an environment that encourages the involvement of people.This type of top management commitment may be driven by:1. Direct marketplace pressure: requirements of crucial customers or parentconglomerates.2. Indirect marketplace pressure: increased quality levels and visibility among competitors.3. Growth ambitions: desire to exploit market opportunities.4. Personal belief in the value of quality as a goal and quality management systems as a means of reaching that goal.The top management should identify the goals to be achieved through the quality management system. Typical goals may be:• Be more efficient and profitable• Produce products and services that consistently meet customers’ needs andexpectations• Achieve customers satisfaction• Increase market share• Improve communications and morale in the organization• Reduce costs and liabilities• Increase confidence in the production systemStep 2. Establish Implementation TeamISO 9000 is implemented by people. The first phase of implementation calls for the commitment of top management – the CEO and perhaps a handful of other key people.The next step is to establish implementation team and appoint a ManagementRepresentative (MR) as its coordinator to plan and oversee implementation. Its members should include representatives of all functions of the organization -Marketing, Design and development, Planning, Production, Quality control, etc.In the context of the standard, the MR is the person within the Organization who acts as interface between organization management and the ISO 9000 registrar. His role is, in fact, much broader than that. The MR should also act as the organization’s “quality management system champion,” and must be a person with:
1. Total backing from the CEO,2. Genuine and passionate commitment to quality in general and the ISO 9000 qualitymanagement system in particular,3. The dignity – resulting from rank, seniority, or both – to influence managers and others of all levels and functions,4. Detailed knowledge of quality methods in general and ISO 9000 in particular.The members of the implementation team should also be trained on ISO 9000 quality management systems by a professional training organization.
Step 3. Start ISO 9000 Awareness ProgramsISO 9000 awareness programs should be conducted to communicate to theemployees the aim of the ISO 9000 quality management system; the advantage it offers to employees, customers and the organization; how it will work; and their roles and responsibilities within the system. Suppliers of materials and components should also participate in these programs.The awareness program should emphasize the benefits that the organization expects to realize through its ISO 9000 quality management system. The program should also stress the higher levels of participation and self-direction that the quality management system renders to employees. Such a focus will go far to enlist employee support and commitment.The programs could be run either by the implementation team or by experts hired to talk to different levels of employees.Step 4. Provide TrainingSince the ISO 9000 quality management system affects all the areas and all personnel in the organization, training programs should be structured for different categories of employees – senior managers, middle-level managers, supervisors and workers. The ISO 9000 implementation plan should make provision for this training. The training should cover the basic concepts of quality management systems and the standard and their overall impact on the strategic goals of the organization, the changed processes, and the likely work culture implications of the system. In addition, initial training mayalso be necessary on writing quality manuals, procedures and work instruction; auditing principles; techniques of laboratory management; calibration; testing procedures, etc.When in-house capacity to carry out such training is not available, it may be necessary to participate in external training courses run by professional training organizations.Alternatively, an external training institution could be invited to conduct in-house training courses.
Step 5. Conduct Initial Status SurveyISO 9000 does not require duplication of effort or redundant system. The goal of ISO 9000 is to create a quality management system that conforms to the standard. This does not preclude incorporating, adapting, and adding onto quality programs already in place. So the next step in the implementation process is to compare the organization’s existing quality management system, if there is one — with the requirements of thestandard (ISO 9001:2008).For this purpose, an organization flow chart showing how information actually flows (not what should be done) from order placement by the customer to delivery to this customer should be drawn up. From this over-all flow chart, a flow chart of activities in each department should be prepared.With the aid of the flow charts, a record of existing quality management system should be established. A significant number of written procedures may already be in place.Unless they are very much out of date, these documents should not be discarded.Rather, they should be incorporated into the new quality management system.Documents requiring modification or elaboration should be identified and listed. Thisexercise is some times referred to as ” gap analysis”. During these review processes,wide consultation with executives and representatives of various unions andassociations within the organization is required to enlist their active cooperation.In the review process, documents should be collected, studied and registered for further use, possibly after they have been revised. Before developing new quality management system documentation, you need to consider with which quality requirements or department you should start. The best is to select an area where processes are fairly well organized, running effectively and functioning satisfactorily.The basic approach is to determine and record how a process is currently carried out.We can do this by identifying the people involved and obtaining information from them during individual interviews. Unfortunately, it often happens that different people will give different, contradicting versions of a process. Each one may refer to oral instructions that are not accurate or clear. This is why the facts are often not described correctly the first time around, and have to be revised several times.Once it has been agreed how to describe the current process, this process has to be adapted, supplemented and implemented according to the requirements of the quality standard (ISO 9001:2008). This requires organizational arrangements, the drawing up of additional documents and possible removal of existing documentation (e.g. procedures, inspection/test plans, inspection/test instructions) and records (e.g.inspection/test reports, inspection/test certificates).In introducing a quality management system, the emphasis is on the improvement of the existing processes or the re-organization of processes.In general, the steps to follow are the following:Ascertain and establish the following:What is the present operation/process? What already exists?
Analyze the relevant sections of the quality standard – ISO 9001:2000:What is actually required? If necessary, supplement and change operational arrangements in accordance with the standard, develop documents and records, and describe operations/processes:What is the desired operation/process?Figure 1: Steps in introducing a quality management systemThe above gap analysis can be done internally, if the knowledge level is there. Or aformal pre-assessment can be obtained from any one of a large number of ISO 9000consulting, implementing, and registration firms.Step 6. Create a Documented Implementation PlanOnce the organization has obtained a clear picture of how its quality management system compares with the ISO 9001:2008 standard, all non-conformances must be addressed with a documented implementation plan. Usually, the plan calls for identifying and describing processes to make the organization’s quality management system fully in compliance with the standard.The implementation plan should be thorough and specific, detailing:???? Quality documentation to be developed???? Objective of the system???? Pertinent ISO 9001:2008 section???? Person or team responsible???? Approval required???? Training required???? Resources required???? Estimated completion dateThese elements should be organized into a detailed chart, to be reviewed andapproved. The plan should define the responsibilities of different departments and personnel and set target dates for the completion of activities. Once approved, the Management Representative should control, review and update the plan as the implementation process proceeds.Typical implementation action plan is shown in Figure 2. Use ISO 10005:1995 for guidance in quality planning
Step 7. Develop Quality Management System DocumentationDocumentation is the most common area of non-conformance among organizations wishing to implement ISO 9000 quality management systems. As one company pointed out: “When we started our implementation, we found that documentation was inadequate. Even absent, in some areas. Take calibration. Obviously it’s necessary, and obviously we do it, but it wasn’t being documented. Another area was inspection and testing. We inspect and test practically every item that leaves here, but our documentation was inadequate”.Documentation of the quality management system should include:???? Documented statements of a quality policy and quality objectives,???? A quality manual,???? Documented procedures and records required by the standard ISO 9001:2008, and???? Documents needed by the organization to ensure the effective planning, operation and control of its processes.Quality documentation is generally prepared in the three levels indicated in the box that follows. Use ISO 10013:1995 for guidance in quality documentation.
In small companies, the above levels of documentation could be presented in one manual; otherwise, separate manuals should be prepared.A list of the documents to be prepared should be drawn up and the responsibility for writing the documents should be assigned to the persons concerned in various functional departments. They should be advised to prepare the drafts within a specific time frame.Step 8: Document ControlOnce the necessary quality management system documentation has been generated, a documented system must be created to control it. Control is simply a means of managing the creation, approval, distribution, revision, storage, and disposal of the various types of documentation. Document control systems should be as simple and as easy to operate as possible — sufficient to meet ISO 9001:2008 requirements and that is all.Document control should include:???? Approval for adequacy by authorized person (s) before issue,???? Review, updating and re-approval of documents by authorized person (s),???? Identification of changes and of the revision status of documents,???? Availability of relevant versions of documents at points of use,???? Identification and control of documents of external origin,???? Assurance of legibility and identifability of documents, and???? Prevention of unintended use of obsolete documents.The principle of ISO 9000 document control is that employees should have access to the documentation and records needed to fulfil their responsibilities.Step 9. ImplementationIt is good practice to implement the quality management system being documented as the documentation is developed, although this may be more effective in larger firms. In smaller companies, the quality management system is often implemented all at once throughout the organization. Where phased implementation takes place, the effectiveness of the system in selected areas can be evaluated.It would be a good idea initially to evaluate areas where the chances of a positive evaluation are high, to maintain the confidence of both management and staff in the merits of implementing the quality management system.The implementation progress should be monitored to ensure that the qualitymanagement system is effective and conforms to the standard. These activities include internal quality audit, formal corrective action and management review.Step 10. Internal Quality AuditAs the system is being installed, its effectiveness should be checked by regular internal quality audits. Internal quality audits are conducted to verify that the installed quality management system:
???? Conform to the planned arrangements, to the requirements of the standard (ISO 9001:2008) and to the quality management system requirements established by your organization, and???? Is effectively implemented and maintained.Even after the system stabilizes and starts functioning, internal audits should be planned and performed as part of an ongoing strategy.A few staff members should be trained to carry out internal auditing. Use ISO 19011 for guidance in auditing, auditor qualification and programmes.Step 11. Management ReviewWhen the installed quality management system has been operating for three to six months, an internal audit and management review should be conducted and corrective actions implemented. The management reviews are conducted to ensure the continuing suitability, adequacy and effectiveness of the quality management system.????The review should include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.The input to management review should include information on:???? Results of audits,???? Customer feed back,???? Process performance and product conformity,???? Status of preventive and corrective actions,???? Follow-up actions from previous management reviews,???? Changes that could affect the quality management system, and???? Recommendations for improvements.Management reviews should also address the pitfalls to effective implementation, including lack of CEO commitment, failure to involve everyone in the process, and failure to monitor progress and enforce deadlines.Step 12. Pre-assessment AuditWhen system deficiencies are no longer visible, it is normally time to apply for certification. However, before doing so, a pre-assessment audit should be arranged with an independent and qualified auditor. Sometimes certification bodies provide this service for a nominal charge. The pre-assessment audit would provide a degree of confidence for formally going ahead with an application for certification.Step 13. Certification and RegistrationOnce the quality management system has been in operation for a few months and has stabilized, a formal application for certification could be made to a selected certification agency. The certification agency first carries out an audit of the documents (referred to as an “adequacy audit”). If the documents conform to the requirements of the quality standard, then on-site audit is carried out. If the certification body finds the system to be working satisfactorily, it awards the organization a certificate, generallyfor a period of three years. During this three-year period, it will carry out periodic surveillance audits to ensure that the system is continuing to operate satisfactorily.Step 14: Continual ImprovementCertification to ISO 9000 should not be an end. You should continually seek to improve the effectiveness and suitability of the quality management system through the use of:???? Quality policy???? Quality objectives???? Audit results???? Analysis of data???? Corrective and preventive actions???? Management reviewISO 9004:2008 provides a methodology for continual improvement.

ISO 14001 Auditing and Registration

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ISO 14001 Registration
A registration system has grown up around the implementation of the ISO 9000 quality management documents and has formed the basis for a similar system of registration to ISO 14001. At this writing, ISO 14001 is the only specification_ document of the ISO 14000 series and the only standard that is intended to be auditable; all of the other standards are, or will be, guidance documents.
Registrars – Globally, there are 40 – 50 or more organizations established to register organizations to ISO 14001. These registration organizations are accredited by the standards bodies in, for the most part, major industrial nations that have adopted ISO 14001 as their country’s EMS standard. In the U.S., for example, the body that accredits registrars is the ANSI-ASQ National Accreditation Board (ANAB). ANAB passes on the credentials of registrars to register organizations to ISO 14001.
ISO 14001 Audits
First-, second-, or third-party auditors can assess an organization’s conformity to the requirements of the standard. First-party Audits – In the first-party circumstance, the internal auditors of the implementing organization conduct an audit to determine that the EMS has been properly implemented and is being maintained. If the organization passes the internal audit, it may self declare_ its conformity to ISO 14001.
Second-party Audits – In the second-party circumstance, the audit is conducted by a representative of a party interested in the environmental performance of the implementing organization. The interested party_ may be a customer, an environmental regulator, an insurance company, or any other organization affected by the environmental performance of the implementing organization. The second-party audit can be a condition of doing business with the auditor’s organization.
Third-party Audits – In the third-party circumstance, an external EMS auditor conducts an audit, usually at the request of the implementing organization, to determine if the organization conforms to the requirements of ISO 14001. The third-party audit is most often for the purpose of certifying_ that the organization is in conformity with the requirements of ISO 14001.
Typically, when a registration is awarded, it is for a period of three years with a provision for the periodic conduct of surveillance_ audits to ensure continuing conformity.
A principal benefit of the third-party audit is that it compels organizations to continually maintain the EMS in order to pass the follow-up surveillance audits; without this, there might be slippage in the maintenance of ISO 14001.
It is not a requirement of implementing ISO 14001 that organizations have a registration audit conducted; this is a decision made by each organization based upon its determination of the commercial value or necessity of certifying. When an ISO 14001 EMS is intended to be audited,
the requirements must be implemented and documented sufficiently for an auditor/registrar to be
able to conduct the audit based on the finding of objective evidence that the organization has implemented an EMS conforming to ISO 14001.
Establishing objective evidence requires a higher level of documentation and record keeping than is required for mere implementation of ISO 14001. The implementation of ISO 14001 is a simpler task for the organization when it is only seeking to implement the policy and sixteen procedures than when it is implementing with the intention or expectation of being audited.

The Future of ISO 14001

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ISO 14001 has the potential to reframe the conduct of environmental management. It has proven to be an elegant document that anticipates the needs of organizations of all sizes and purposes for direction on environmental management.
As ISO 14001 gains credibility as an effective system for managing and improving environmental performance, environmental regulators will be encouraged to accept registration to ISO 14001 in satisfaction of some regulatory administrative requirements and, thus, reduce the burden of compliance for those organizations that are managing their environmental exposures.
Ultimately, the greatest strides in environmental performance improvement and sustainability will come as a consequence of millions of organizations – municipalities, colleges and universities, governmental departments, and property owners and operators as well as industrial corporations – identifying and managing the environmental impacts of their activities, services, and products.

Concept of quality – historical background

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Concept Of Quality – Historical Background
The concept of quality as we think of it now first emerged out of the Industrial Revolution. Previously goods had been made from start to finish by the same person or team of people, with handcrafting and tweaking the product to meet ‘quality criteria’. Mass production brought huge teams of people together to work on specific stages of production where one person would not necessarily complete a product from start to finish. In the late 1800s pioneers such as Frederick Winslow Taylor and Henry Ford recognized the limitations of the methods being used in mass production at the time and the subsequent varying quality of output. Taylor established Quality Departments to oversee the quality of production and rectifying of errors, and Ford emphasized standardization of design and component standards to ensure a standard product was produced. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to ‘catch’ defects. Application of statistical control came later as a result of World War production methods. Quality management systems are the outgrowth of work done by W. Edwards Deming, a statistician, after whom the Deming Prize for quality is named.
Quality, as a profession and the managerial process associated with the quality function, was introduced during the second-half of the 20th century, and has evolved since then. Over this period, few other disciplines have seen as many changes as the quality profession.
The quality profession grew from simple control, to engineering, to systems engineering. Quality control activities were predominant in the 1940s, 950s, and 1960s. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Like medicine, accounting, and engineering, quality has achieved status as a recognized profession.

Five Steps to Implementing ISO 14001:2004

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ISO 14001 provides a logical, common-sense approach for
businesses to adopt. To start it is recommended to carry out an
environmental review of the business and the Annex to the Standard
provides guidance on the approach required. The Standard then
requires a management system to be developed that addresses the
key environmental issues that were identified by the review as being
relevant to the business, through a rational programme of control and
continual improvement.
There are five key steps to ISO 14001 EMS implementation, and
subsequent operation which are clearly laid out in just three pages of
text.
The five key steps are:
1. Environmental Policy
2. Planning
3. Implementation and Operation
4. Checking and Corrective Action
5. Management Review
Step 1. Environmental Policy
The company or organisation must write an environmental policy
statement which is relevant to the business activities and approved by
top management. Their full commitment is essential if environmental
management is to work. The ISO 14001 Standard clearly sets out
what to cover in the policy. Often a one page document is sufficient.
Produce a first issue and expect to amend it several times before
assessment and registration as knowledge grows in the company.
Step 2. Planning
Plan what the EMS is to address.
Environmental aspects
First make lists of the environmental aspects (issues) that are relevant
to the business. The environmental review mentioned earlier should
provide most of this information and the Annex to ISO 14001 provides
guidance on the format for doing this.
Consider the inputs, outputs and processes/activities of the business in
relation to;
a) emissions to air
b) releases to water
c) waste management
d) contamination of land
e) use of raw materials and natural resources
f) other local environmental and community issues
Consider both site (direct) and offsite (ie. indirect) aspects that you
control or have influence over (such as suppliers) and in relation to
normal operations, shut-down and start-up conditions and reasonably
foreseeable and emergencies situations.
A simple written procedure is then required to determine which of the
aspects identified are really or probably significant (important) and
training needs, outline the key stages of the project and dates that will
lead to the target achievement).
Gradually apply environmental management programme thinking to
such things as the introduction of new products, new or improved
processes and other key activities of the business. In particular,
ensure existing projects become environmental management projects
where there is a significant environmental impact involved, so that the
EMS becomes company wide. This is a frequent oversight found
during ISO 14001 assessments. The EMS must cover the whole
business – like a net thrown over the whole business and for example
including such things as engineering and maintenance
Step 3. Implementation and Operation
Structure and responsibility
Appoint one or more people, depending on the size of the business, to
have authority and responsibility for implementing and maintaining the
EMS and provide sufficient resources. (It’s worth monitoring costs
carefully and benchmarking these against key consumption figures so
that improvements delivered by the EMS become apparent).
Training, awareness and competence
Implement a procedure to provide environmental training appropriate
to identified needs for management, the general workforce, project
teams and key plant operators. This can have far reaching benefits
on employee motivation. The workforce is usually very supportive of
moves to achieve genuine environmental improvement. Every
company has its share of cynics but even some of these can be won
over with time. Training will vary from a general briefing for the
workforce to detailed environmental auditor training.
Communication
Implement procedures to establish a system of internal and external
communication to receive environmental information and respond to it
and to circulate new information to people that need to know. This will
include: new legislation, information from suppliers, customers and
neighbours and communications both with employees and for
employees about progress with the EMS. This process can often
generate worthwhile ideas from employees themselves for future
environmental improvements.
Environmental management system documentation
The EMS itself needs to be documented with a manual, procedures
and work instructions but keep it brief and simple. The Standard
clearly states where procedures are required. Eleven system
procedures are required to maintain the EMS, plus operating work
instructions but if you already have ISO 9000, this will cover most of six
of the procedures required and a quality system can certainly be
expanded to cover ISO 14001 as well. Cross reference the EMS
manual to other environmental and quality documents to link the EMS
and to integrate it with existing business practices.
Operational control
Implement additional operating procedures (work instructions) to
control the identified significant (important) aspects of production
processes and other activities. Some of these will already exist but
may need a ‘bit of polish’. Don’t forget significant aspects that relate to
goods and services from suppliers and contractors.
Emergency preparedness and response
Implement procedures to address reasonably foreseeable
emergencies and to minimise their impact should they occur. (eg. Fire,
major spillages of hazardous materials, explosion risks etc.)
Step 4. Checking and Corrective Action
Monitoring and measurement
Implement procedures to monitor and measure the progress of
projects against the targets which have been set, the performance of
processes against the written criteria using calibrated equipment (verify
monitoring records) and regularly check (audit) the company’s
compliance with legislation that has been identified as relevant to your
business. The most effective way of doing this is through regular
progress meetings.
Nonconformance and corrective and preventive action
Implement procedures to enable appropriate corrective and
subsequent preventive action to be taken where breaches of the EMS
occur (eg. process control problems, delays in project process, noncompliance
with legislation, incidents etc.).
Records
Implement procedures to keep records generated by the
environmental management system. The Annex to the Standard
suggests those that are likely to be required.
Environmental management system audit
Implement a procedure to carry out audits of each part of the EMS and
company activities and operations to verify both compliance with the
EMS and with ISO 14001. Audit results must be reported to top
management . A typical audit cycle is one year but more critical
activities will require auditing more frequently.
Step 5. Management Review
At regular intervals (typically annual), top management must conduct
through meetings and record minutes of a review of the EMS, to
determine that it is still appropriate and effective or to make changes
where necessary. Top management will need to consider audit
results, project progress, changing circumstances and the requirement
of ISO 14001 for continual improvement, through setting and achieving
further environmental targets.

Five Steps to Implementing ISO 14001:2004

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ISO 9001:2008 Requirements – QMS

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ISO 9001:2008 Requirements – Quality Management System
Establish, document, implement, and maintain a quality management system. Continually improve its effectiveness in accordance with ISO 9001 requirements. Implement the system to:? Determine processes needed for the quality management system (and their application throughout the organization)? Determine process sequence and interaction? Determine criteria and methods for process operation and control? Ensure resources and supporting information are available? Monitor, measure where applicable, and analyze these processes? Implement actions to achieve planned results and continual process improvementManage these processes in accordance with ISO 9001 requirements. Define the type and extent of control applied to any outsourced processes that affect product conformity to requirements.NOTE 1: Processes needed for the quality management system include the processes for management activities (see 5), provision of resources (see 6), product realization (see 7), and measurement, analysis, and improvement (see 8).NOTE 2: An outsourced process is a process the organization needs for its quality management system, and which the organization chooses to have performed by an external party.NOTE 3: Ensuring control over outsourced processes does not absolve your organization of the responsibility to conform to all customer, statutory, and regulatory requirements. The type and extent of control applied to an outsourced process can be influenced by factors such as:? Potential impact of the outsourced process on your organization’s capability to provide product that conforms to requirements? Degree to which the control for the process is shared? Capability of achieving the necessary control through the application of 7.4

ISO 9001:2008 Requirements – Documentation Requirements

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ISO 9001:2008 Requirements – Documentation Requirements
Include in the quality management system documentation:? Documented statements of a quality policy and quality objectives? A quality manual? Documented procedures and records required by ISO 9001? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processesNOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:? Size of the organization and type of activities? Complexity of processes and their interactions? Competence of personnelNOTE 3: The documentation can be in any form or type of medium.4.2.2 Quality ManualEstablish and maintain a quality manual with:? Scope of the quality management system? Details and justification for any exclusions? Procedures or references to the procedures? Description of interaction between processes4.2.3 Control of DocumentsControl the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.
Establish a documented procedure to:? Approve documents for adequacy prior to issue? Review, update as necessary, and re-approve documents? Identify the changes and current document revision status? Make relevant documents available at points of use? Ensure the documents remain legible and readily identifiable? Identify external documents and control their distribution? Prevent obsolete documents from unintended use? Apply suitable identification if obsolete documents are retained4.2.4 Control of RecordsEstablish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.Establish a documented procedure to define the controls needed for record:? Identification? Storage? Protection? Retrieval? Retention? DispositionKeep records legible, readily identifiable, and retrievable.

ISO 9001:2008 Requirements – Management Responsibility

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ISO 9001:2008 Requirements - Management Responsibility
All requirements in clause 5 are the responsibility of top management.5.1 Management CommitmentProvide evidence of management commitment to develop and implement the quality management system, as well as, continually improve its effectiveness by:? Expressing the importance of meeting requirements? Establishing the quality policy and quality objectives? Conducting management reviews? Ensuring the availability of necessary resources
5.2 Customer FocusEnsure customer requirements are determined and met in order to improve customer satisfaction.5.3 Quality PolicyEnsure the quality policy is:? Appropriate to the purpose of the organization? Focused on meeting requirements and continual improvement? Used as a framework for quality objectives? Communicated and understood at appropriate levels? Reviewed for continuing suitability5.4 Planning5.4.1 Quality ObjectivesEnsure quality objectives, including those needed to meet product requirements, are established at the relevant functions and levels within the organization. Ensure quality objectives are measurable and consistent with the quality policy.5.4.2 Quality Management System PlanningEnsure that planning for the quality management system:? Meets the general requirements (4.1), as well as, quality objectives (5.4.1)? Maintains the system integrity when changes are planned and implemented5.5 Responsibility, Authority, and Communication5.5.1 Responsibility and AuthorityEnsure responsibilities and authorities are defined and communicated within the organization.
5.5.2 Management RepresentativeAppoint a member of your management who, irrespective of other duties, has the responsibility and authority to:? Ensure the needed processes are established, implemented, and maintained? Report to top management on quality management system performance? Report to top management on any need for improvement? Ensuring the promotion of awareness of customer requirementsNOTE: The responsibility of a management representative can include being the liaison with external parties on matters relating to the quality management system.5.5.3 Internal CommunicationEnsure the appropriate communication processes are established and carried out within the organization regarding the effectiveness of the system.5.6 Management Review5.6.1 GeneralReview the quality management system at planned intervals to:? Ensure a suitable, adequate, and effective system? Assess possible opportunities for improvement? Evaluate the need for any changes to the system? Consider the need for changes to the quality policy and objectivesMaintain records of the management reviews.5.6.2 Review InputInputs for management review must include information on:? Results of audits? Customer feedback? Process performance and product conformity? Status of preventive and corrective actions? Follow-up actions from earlier reviews? Changes that could affect the quality system? Recommendations for improvement
5.6.3 Review OutputOutputs from the management review must include any decisions and actions related to:? Improvement of the effectiveness of the quality management system and its processes? Improvement of product related to customer requirements? Resource needs

ISO 9001:2008 Requirements – Resource Management

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ISO 9001:2008 Requirements – Resource Management
6.1 Provision of ResourcesDetermine and provide the resources necessary to:? Implement and maintain the quality management system? Continually improve the effectiveness of the system? Enhance customer satisfaction by meeting customer requirements6.2 Human Resources6.2.1 GeneralEnsure people performing work affecting conformity to product requirements are competent based on the appropriate education, training, skills, and experience.NOTE: Conformity to product requirements can be affected directly, or indirectly, by personnel performing any task within the quality management system.6.2.2 Competence, Training, and AwarenessThe organization must:? Determine the competency needs for personnel? Provide training (or take other actions) to achieve the necessary competence? Evaluate the effectiveness of the actions taken? Inform employees of the relevance and importance of their activities? Ensure they know their contribution to achieving quality objectives? Maintain education, training, skill, and experience records
6.3 InfrastructureDetermine, provide, and maintain the necessary infrastructure to achieve product conformity. Infrastructure includes, as applicable:? Buildings, workspace, and associated utilities? Process equipment (both hardware and software)? Supporting services (such as transport, communication, or information systems)6.4 Work EnvironmentDetermine and manage the work environment needed to achieve product conformity.NOTE: The term “work environment” relates to those conditions under which work is performed, including physical, environmental, and other factors such as noise, temperature, humidity, lighting, or weather.

ISO 9001:2008 FAQ

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ISO 9001:2008 FAQ
What Is The ISO 9001: 2008 Standard?
The latest edition of the ISO 9001 standard ISO 9001: 2008, Quality Management Systems – Requirements, was officially published by (ISO) the International Organization for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 standard since it was first published in 1987.
Who Is Responsible For Revising The standards?
The ISO Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) is responsible for the revision process in collaboration with consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties.
Does ISO 9001:2008 Have Additional Requirements Beyond ISO 9001:2000 ?
This latest (4th) edition of ISO 9001 contains no new requirements compared to the (3rd) year 2000 edition, which it replaces. What it does is provide clarification to the existing requirements of ISO 9001:2000 based on eight years’ experience of worldwide implementing of the standard and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.
The clarifications and changes in ISO 9001:2008 represents fine-tuning, rather than a thorough overhaul. It focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. The changes are minor in nature and address such issues as the need to clarify, provide greater consistency, resolve perceived ambiguities, and improve compatibility with ISO 14001. The numbering system and the structure of the standard remain unchanged. As a result, the new standard looks much like the old standard.
ISO has grouped the changes incorporated in this ISO 9001:2008 edition into the following categories:- No changes or minimum changes on user documents, including records- No changes or minimum changes to existing QMS processes- No additional training required or minimal training required- No effects on current certifications
In contrast, the 3rd edition, ISO 9001:2000 published in 2000, represented a major overhaul of the standard, including new requirements and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.
Then Why Was It Necessary To Introduce This Revision?All ISO standards – currently more than 17 400 – are periodically reviewed. To ensure that ISO standards are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a decision taken to confirm, withdraw or revise the documents. The review process must be initiated within 3 years of publication of a standard. The review considers several factors such as technological evolution, new methods and materials, new quality and safety requirements, or questions of interpretation and application.
The review of ISO 9001 resulting in the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176. This subcommittee, which is responsible for the ISO 9000 family, unites expertise from 80 participating countries and 19 international or regional organizations, plus other technical committees.
This review has a number of inputs that help it:
A global user questionnaire/survey
A market Justification Study
Suggestions arising from the ISO/TC 176 interpretation process
Opportunities for increased compatibility with ISO 14001
The need for greater clarity, ease of use, and improved translation
Current trends – keeping up with recent developments in management system practices.
How Does The New ISO 9001 Edition Affect Existing ISO 9001 QMS’s?
As organizations start looking at ISO 9001:2008, they will wonder to what extent the changes might affect them. To a large extent, the new standard will not result in significant change to existing quality management systems (QMS).
ISO/TC 176 was careful in not making change for change sake. In the case of editorial changes, this was especially true. This could have lead to a false impression that there was a change in requirements, carrying greater significance than was intended. In those instances, when the committee members couldn’t come to a consensus in determining if a change added or deleted a requirement, they opted to retain the existing text. They decided it was better to err on the side of caution rather than to contribute to any misunderstanding in the marketplace.
The changes that have been incorporated into this edition of the ISO 9001 standard include changes that should lead to a better understanding across a broader range of product types, including service organizations; use of deliberate wording to minimize the potential for incorrect user interpretation; and reflect nuances of similar concepts. Lastly, some of the changes to specific clauses were made based on the 2004 International User Feedback Survey. This survey was conducted after the publication of ISO 9001:2000 and had invited respondents to identify areas they most wanted to see improved.

Update on ISO 9001:2008

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Update on ISO 9001:2008
Following a recent meeting of ISO’s Technical Committee TC176 in Helsinki, Finland, from June
11 – 15t, 2007, publication of the new version of ISO 9001 has been brought forward from 2009
and is now scheduled to be published in October 2008. Experts representing over 70 ISO member
bodies, met to discuss the comments received during circulation of the Committee Draft (”CD”) of
the new standard, and concluded that in view of the very limited changes being proposed, the draft
is now sufficiently mature to progress directly to the DIS (Draft International Standard).
The main changes being introduced into the new standard are as follows:
Clause 0.2 (Process approach)
Text added to emphasize the importance of processes being capable of achieving desired outputs
Clause 1.1 (Scope)
Clarification that “product” also includes intermediate product
Explanation regarding statutory, regulatory and legal requirements
Clause 4.1 (General requirements)
Notes added to explain more about outsourcing
Types of control that may be applied to outsourced processes
Relationship to clause 7.4 (Purchasing)
Clarification that outsourced processes are still responsibility of the organization and must be
included in the quality management system
Clause 4.2.1 (Documentation)
Clarification that QMS documentation also includes records
Documents required by the standard may be combined
ISO 9001 requirements may be covered by more than one documented procedure
Clause 4.2.3 (Document control)
Clarification that only external documents relevant to the QMS need to be controlled
Clause 4.2.4 (Records control)
Editorial changes only (better alignment with ISO 14001)
Clause 5.5.2 (Management rep)
Clarifies that this must be a member of the organization’s own management
Clause 6.2.1 (Human resources)
Clarification that competence requirements are relevant for any personnel who are involved in the
operation of the quality management system
Clause 6.3 (Infrastructure)
Includes information systems as example
Clause 6.4 (Work environment)
Clarifies that this includes conditions under which work is performed and includes, for example
physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather
Clause 7.2.1 (Customer related processes)
Clarifies that post-delivery activities may include:
- Actions under warranty provisions
- Contractual obligations such as maintenance services
- Supplementary services such as recycling or final disposal
Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification and validation have distinct purposes
These may be conducted and recorded separately or in any combination as suitable for the product
and the organization
Clause 7.3.3(Design & development outputs)
Clarifies that information needed for production and service provision includes preservation of the product
Clause 7.5.4 (Customer property)
Explains that both intellectual property and personal data should be considered as customer property
Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)
Explanatory notes added regarding the use of computer software: “Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.”
Clause 8.2.1 (Customer satisfaction)
Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports
Clause 8.2.3 (Monitoring / Measurement of process)
Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.

Validity of certifications to ISO 9001:2000

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One year after the publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008.Twenty four months after publication by ISO of ISO 9001:2008, any existingcertification issued to ISO 9001:2000 shall not be valid.
Organisations that are already certified to ISO 9001:2000 should contacttheir certification/registration bodies (CB/RB) to agree a programme for analysing the clarifications in ISO 9001:2008 in relation to their individual quality management systems and for upgrading their certificates.Certified organizations should bear in mind that ISO 9001:2000 certificateshave the same status as new ISO 9001:2008 certificates during the co-existence period. (i.e. Your current ISO 9001:2000 certificate will be valid up to 13th November 2010).Organizations in the process of certification to ISO 9001:2000 should change to using ISO 9001:2008 and apply for certification to it.New users should start by using ISO 9001:2008.

ISO 9001 Standards – Document Repository

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ISO 9001 Standards - Document Repository
All QMS and product realization documents can be stored electronically within the computerize Document Management System like ISO 9001 Document Control Sytem. This provides a set of category and sub-category headings that enable users to drill down intothe different levels of the documentation category tree.QMS documents are created and maintained within a top level category entitled “ISO 9001 Quality Management System (QMS)“. Documents in this category follow a 4-tier approach:• Quality Manual – company scope and process interactions within the QMS• Quality Procedures – responsibilities, controls and activities within the QMS that effect customer service• Records – objective evidence to demonstrate our goal in achieving customer satisfaction• Forms & Reports to support the QMS processesProduct realization documents are stored in categories corresponding to Products, Projects and Departments. Each document is unique, but can be accessed from multiple categories.Documents created within the FablessSemi Inc CogniDox system are assigned a unique identifier using the format “PO-NNNNNN-XX”; where the “PO” prefix identifies them as FablessSemi Inc documents, the “NNNNNN” is an automatically generated and uniquely assigned numerical ID, and the “XX” suffix indicates the document type.All Fabless Semi Inc personnel are responsible for creating document part numbers and uploading documents to an appropriate category. Selected users with additional system privileges are responsible for creating and maintaining document categories.

Costs and resources Of ISO 9001 Standards

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Costs and resources Of ISO 9001 Standards
The largest cost of ISO 9001 is the involvement of company

employees. The ‘ownership’ created by involving employees in designing the quality system maximises the chances of them accepting it. Reducing this cost by minimising employee involvement is a false economy. The next largest cost will be for designing and developing the system. This needs to be led by someone with experience in this particular field. You may have someone within your own organisation who has carried out this role, perhaps with a former employer. Your Business Link may offer free or subsidised advice and training, and will be able to provide names of approved consultants. Grants for work in this area tend to be directed through Business Links. Different areas have different grants, which depend on local conditions. A typical grant may cover up to 50 per cent of the cost of an approved consultant. Certification fees are around £800 for the smallest companies. Overall costs depend upon company size and the number of locations involved. Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years. Typically, special rates will depend on how long the assessment is likely to take and what the company’s turnover is. Ask your certification body if it offers special rates for small companies. The standard requires that companies have trained internal auditors to conduct audits on the system. An internal audit can provide an effective means of monitoring the system and identifying areas for improvement. For further details, contact the International Register of Certificated Auditors.

ISO 9000 family of standards and SMEs

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The ISO 9000 quality management system is generic in nature and applicable to all companies, regardless of the type and size of the business, including small and medium enterprises (SMEs), and they are applicable to all categories of products, whether hardware, software, processed materials or services. ISO 9001:2008 specifies what is required to be done by an organization but does not indicate how it should be done, thus giving the enterprise a lot of flexibility to run its business.
It is simple to use, clear in language and easily understandable. The new standard is also appropriate for small companies, as it does not demand the type of paper bureaucracy needed for the implementation of the 1994 version. Only six documented procedures are now required and need for other procedures/documents can be decided by the company. Companies will, however, be required to provide objective evidence that the QMS has been effectively implemented. A small company may find it appropriate to include the description of its entire QMS within a single Quality Manual, including all the documented procedures required by the standard.
The process-based approach given in the new standard will tend to ensure that systems are documented and implemented in a manner that suits a SME’s own way of doing business. This approach makes it easier for SMEs to implement, instead of just taking over an artificial structure of QMS imposed from outside. It will also be easier for SMEs managed by their owners to demonstrate “top management commitment” towards QMS. Furthermore, in a SME, it is easier to ensure effective internal communication, better utilization of resources, people clearly understanding their roles and responsibilities, etc.
The new standard has included a provision for deciding on the applicability of
certain product realization processes included in section 7 of the standard. For example, if the SME has no responsibility for the design and development of the product it provides, the SME may say so, giving the reasoning behind it, in the Quality Manual; the certification body, being satisfied that this corresponds, would then award it certification to ISO 9001:2008. Similarly, other product realization processes such as purchasing, product identification and traceability, control of measuring devices may also be excluded if these are not applicable for the type of products or services being provided by the company.
It is also possible that SMEs may not have adequate in-house expertise or there may be other constraints to perform all processes on their own. In such cases, the new standard also permits the outsourcing of any of the QMS processes, providing the company has control over such processes. The nature of this control will depend on the nature of the outsourced or subcontracted processes and the risk involved. For example, the design and development process may be subcontracted to an expert or a specialized agency, inspection/verification of goods purchased may be subcontracted to an inspection agency, internal audit of QMS can be outsourced, etc. However, overall responsibility for ensuring control on all outsourced processes as per requirements of the standard would remain with the company’s management.

Management Principles Of ISO 9001 Standards

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Management Principles Of ISO 9001 Standards
ISO 9000 is based on eight management principles:
• Customer focus, resulting in meeting customer requirements and striving to exceed them;
• Leadership, aiming to create an internal environment in which people are fully involved;
• Involvement of people who are the essence of an organization;
• Process approach, resulting in improved efficiency to obtain desired results;
• System approach to management, leading to improved effectiveness and efficiency through identification, understanding and management of interrelated processes;
• Continual improvement, which becomes a permanent objective of the organization;
• Factual approach to decision-making, based on the analysis of data and information; and
• Mutually beneficial supplier relationships, based on an understanding of their interdependence.
ISO 9000 encourages the adoption of the process approach to manage an organization. There are five main areas considered for the revised process model in ISO 9000:
• Quality management system
• Management responsibility
• Resource management
• Product realization
• Measurement, analysis and improvement.

Costs Of Setting Up A Quality Management System

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Costs Of Setting Up A Quality Management System
Common implementation costs that companies incur can be broken down into direct and indirect costs.
The direct costs include, inter alia, the following:
• hiring consultants or external trainers, if required;
• sending personnel for external training;
• acquiring relevant national and international standards of the ISO 9000 family and other related books and publications; and
• acquiring additional equipment, instruments and other resources as identified by the company.
The indirect costs include, inter alia, the following:
• time spent by the management and other staff in developing the system;
• reorganization of the processes, including improvements in the house-keeping, if required;
• external calibration charges for equipment to ensure national and/or international measurement traceability;
• organizing in-house training;
• time spent by internal auditors for periodic internal audits;
• corrective actions, including revision of manuals and procedures, if required; and
• expenditure on word-processing, stationery and other consumables required for the preparation of manuals and documenting procedures, etc.
Some factors can help to lower the above costs. They include:
• having people in the company already conversant with QMS requirements;
• having documented system-related activities such as work instructions, quality plans, procedures, etc. already in place;
• using consultants only for specific activities like gap analysis, training of
auditors, pre-assessment audits, etc., and having in-house staff oversee the remaining activities.
On the other hand, there are factors that can mean higher implementation costs for the company. For example, if your company carries out activities at different locations, or if your company is involved in product design and development, this may increase costs.

Benefits Of Obtaining ISO 9000 Certification

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Benefits Of Obtaining ISO 9000 Certification
Implementing a quality management system brings internal benefits to most organizations, as well as opening up opportunities vis-à-vis the outside world.
Internal benefits to the company include:
• improved customer focus and process orientation within the company;
• improved management commitment and decision-making;
• better working conditions for employees;
• increased motivation of employees;
• reduced cost of internal failures (lower rates of rework, rejection, etc.) and external failures (fewer customer returns, replacements, etc.); and last but not least,
• continual improvement of the quality management system.
The following external benefits are generated:
• customers are more confident that they will receive products conforming to their requirements, which in turn results in higher customer satisfaction;
• an improved image of the company;
• more aggressive publicity, as customers can be informed of the benefits of their doing business with a company that manages the quality of its outputs;
• more confidence that the company’s products meet relevant regulatory
requirements;
• better objective evidence to defend product liability charges if such are brought by customers.
Refer http://www.iso9001-standard.us for more information.

Implementing A Quality Management System

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Implementing A Quality Management System
An ISO 9000:2008 quality management system can be implemented by following the steps detailed as follows:
1. Evaluate the organization’s need/goals for implementing a QMS Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries; high inventories; frequent production hold-ups; and high level of rework or rejection of products or services.
At this stage, identify the goals which you would like to achieve through a QMS, such as customer satisfaction, increased market share, improved communications and morale in the organization, greater efficiency and profitability, etc. Another objective in implementing a QMS may be a demonstration of compliance through third party certification, which may be requested by an important client or required for enlisting as a supplier to large companies, e.g., original equipment manufacturers (OEMs).
2. Obtain information about the ISO 9000 family
The persons identified for initiating the development of an ISO 9000 QMS need tounderstand the requirements of ISO 9001:2008 as read with ISO 9000:2000 and ISO 9001:2008.
Supporting information such as quality management principles, frequently asked questions (FAQs), guidance on clause 1.2 (application) of ISO 9001:2008, guidance on documentation requirements of ISO 9001:2008 and other brochures are available free of charge on the ISO web site;
3. Appoint a consultant, if necessary
If, within the organization, you do not have adequate competence to develop a QMS, you may appoint a consultant. Before doing so, it is good to check his/her background; knowledge about the product realization processes of your organization; and experience in helping other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing. It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out further training and development of the system.
4. Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on QMS planning; on how to identify and implement improvement processes; and on how to audit compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ)and the International Auditor and Training Certification Association (IATCA) can provide lists of training organizations.
5. Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO 9001. Prepare how to bridge these gaps, including by planning for any additional resources required. Gap analysis may be carried out through selfassessment or by the external consultant.
6. Product realization processes
Review clause 7 of ISO 9001:2008 relating to “Product realization” to determine how the requirements apply or do not apply to your company’s QMS.
The processes covered by this clause include:
• Customer-related processes
• Design and development
• Purchasing
• Production and service provision
• Control of measuring and monitoring devices
Note that if your company is not responsible for preparing the design of your product, you can exclude the requirement for “design and development” from your QMS and explain the reasons for doing so in your Quality Manual.
7. Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the QMS, including the appointment of a management representative who will oversee the implementation of the QMS. Establishing a project Steering Committee may also prove useful to oversee progress and provide resources wherever required.
8. Planning a time frame
Prepare a complete plan to close the gaps identified in Step 5 to develop the QMS processes. In the plan, include activities to be performed, resources required, responsibilities and an estimated completion time for each activity. Clauses 4.1 and
7.1 of ISO 9001:2008 provide information that should be used when developing the plan. The total time required for each phase (planning, documentation, implementation and evaluation) depends on the extent of the gaps in your existing QMS.
9. Draft a Quality Manual
In your Quality Manual;
• Include how the QMS applies to the products, processes, locations and departments of the organization;
• Exclude any requirement with justification for doing so as decided in step 6
above;
• Refer to or include documented procedures for QMS;
• Describe the interaction between the processes of the QMS, e.g., the interaction between product realization processes and other management, measurement and improvement processes; and
• Draft the quality policy and quality objectives for the organization.
The staff concerned in the organization should review the Quality Manual and the documented procedures so that their comments and suggestions can be taken into account before the Quality Manual and procedures are approved for issue and use.
The effective date of implementation should also be decided.
10. Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been written, the trained auditors should carry out one or two internal audits covering all activities for the QMS, and concerned management should take corrective action on the audit findings without delay. Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top management should review the effectiveness of the system and provide necessary resources for corrective actions and improvements.
11. Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification, you can make an application for certification to an accredited certification body. The certification audit process is explained section VII.
12. Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the effectiveness of the QMS and see how it can be “continually improved”. The organization should evaluate periodically if the purpose and goals (see Step 1) for which the QMS was developed are being achieved, including its continual improvement.

ISO 9001 Standards – Management Review

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ISO 9001 Standards – Management Review
Review the quality management system at planned intervals to:- Assess possible opportunities for improvementEnsure a suitable, adequate, and effective system

- Evaluate the need for any changes to the system
- Consider the need for changes to the quality policy and objectives
Maintain records of the management reviews.
Inputs for management review must include information on:
- Results of audits
- Customer feedback
- Process performance and product conformity
- Status of preventive and corrective actions
- Follow-up actions from earlier reviews
- Changes that could affect the quality system
- Recommendations for improvement
Outputs from the management review must include any decisions and actions related to:
- Improvement of the effectiveness of the quality management system and its processes
- Improvement of product related to customer requirements
- Resource needs

ISO 9001 Standards – Design and Development

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ISO 9001 Standards - Design and Development
Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions
- Stages of design and development
- Appropriate review, verification, and validation activities for each stage
- Responsibility and authority for design and development
The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.
NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.
Determine product requirement inputs and maintain records. The inputs must include:
- Functional and performance requirements
- Applicable statutory and regulatory requirements
- Applicable information derived from similar designs
- Requirements essential for design and development
Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.
Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:
- Meet design and development input requirements
- Provide information for purchasing, production, and service
- Contain or reference product acceptance criteria
- Define essential characteristics for safe and proper use
- Be approved before their release
Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:
- Evaluate the ability of the results to meet requirements
- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

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ISO 9001 Standards - Control of Measuring and Monitoring Equipment
Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.
Where necessary to ensure valid results:
- Calibrate and/or verify the measuring equipment at specified intervals or prior to use
- Calibrate the equipment to national or international standards (or record other basis)
- Adjust or re-adjust as necessary
- Identify the measuring equipment in order to determine its calibration status
- Safeguard them from improper adjustments
- Protect them from damage and deterioration
Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.
Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).
NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
For More Information Please Visit http://www.iso9001-standard.us

ISO 14001:2004 Standards Contents

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ISO 14001:2004 Standards
ISO 14000 is a series of international standards on environmental management. It provides a framework for the development of an environmental management system and the supporting audit programme.
The main thrust for its development came as a result of the Rio Summit on the Environment held in 1992.
ISO 14000 is an Environmental Management System (EMS), which requires that an organization consider the environmental aspects of its products and services.
Iso14000 approach forces you to take a hard look at all areas of your business that has an environmental impact.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
Iso14000 is the world’s first series of Internationally accepted Standards for Environmental Management Systems (EMS).
Iso14000 elevates Environmental Management to a Strategic Level that can be applied to any organization, from any industry, anywhere in the world.
ISO 14000 is a series of voluntary standards and guideline reference documents.
The part of the overall management system that includes organizational structure, planning activities, responsibilities, practices, procedures, processes and resources for developing, implementing, achieving, reviewing and maintaining the environmental policy.
ISO 14000 is an Environmental Management System (EMS) who’s purpose is:
· A management commitment to pollution prevention.
· An understanding of the environmental impacts (reducing) of an organization’s activities.
A commitment (pollution prevention) to employees, neighbors and customers
ISO 14001 is the corner stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System against which an organization can be certified by a third party.
The environment cannot be protected by our convictions or goodwill alone. Efforts to protect the environment must be planned, coordinated and organized into a system, such as ISO 14001.
ISO14001 requires an Environmental Policy to be in existence within the organisation, fully supported by senior management, and outlining the policies of the company, not only to the staff but to the public. The policy needs to clarify compliance with Environmental Legislation that may effect the organization and stress a commitment to continuous improvement. Emphasis has been placed on policy as this provides the direction for the remainder of the Management System.
Those companies who have witnessed ISO9000 Assessments will know that the policy is frequently discussed during the assessment, many staff are asked if they understand or are aware of the policy, and any problems associated with the policy are seldom serious. The Environmental Policy is different, this provides the initial foundation and direction for the Management System and will be more stringently reviewed than a similar ISO9000 policy. The statement must be publicised in non-technical language so that it can be understood by the majority of readers. It should relate to the sites within the organisation encompassed by the Management System, it should provide an overview of the company’s activities on the site and a description of those activities. A clear picture of the company’s operations.
The preparatory review and definition of the organization’s environmental effects is not part of a ISO14001 Assessment, however examination of this data will provide an external audit with a wealth of information on the methods adopted by the company. The preparatory review itself should be comprehensive in consideration of input processes and output at the site. This review should be designed to identify all relevant environmental aspects that may arise from existence on the site. These may relate to current operations, they may relate to future, perhaps even unplanned future activities, and they will certainly relate to the activities performed on site in the past (i.e. contamination of land).
The initial or preparatory review will also include a wide-ranging consideration of the legislation which may effect the site, whether it is currently being complied with, and perhaps even whether copies of the legislation are available. Many of the environmental assessments undertaken already have highlighted that companies are often unaware of ALL of the legislation that affects them, and being unaware, are often not meeting the requirements of that legislation.
The company will declare its primary environmental objectives, those that can have most environmental impact. In order to gain most benefit these will become the primary areas of consideration within the improvement process, and the company’s environmental program. The program will be the plan to achieve specific goals or targets along the route to a specific goal and describe the means to reach those objectives such that they are real and achievable. The Environmental Management System provides further detail on the environmental program. The EMS establishes procedures, work instructions and controls to ensure that implementation of the policy and achievement of the targets can become a reality. Communication is a vital factor, enabling people in the organisation to be aware of their responsibilities, aware of the objectives of the scheme, and able to contribute to its success.
As with ISO9000 the Environmental Management System requires a planned comprehensive periodic audit of the Environmental Management System to ensure that it is effective in operation, is meeting specified goals, and the system continues to perform in accordance with relevant regulations and standards. The audits are designed to provide additional information in order to exercise effective management of the system, providing information on practices which differ to the current procedures or offer an opportunity for improvement.
In addition to audit, there is a requirement for Management Review of the system to ensure that it is suitable (for the organization and the objectives) and effective in operation. The management review is the ideal forum to make decisions on howe to improve for the future.
The newly revised ISO 14001:2004 specifies the requirements for an environmental management system (EMS), which provides a framework for an organization to control the environmental impacts of its activities, products and services, and to continually improve its environmental performance. It applies to those environmental aspects which the organization can control and over which it can be expected to have an influence. It does not itself state specific environmental performance criteria. ISO 14001:2004 is applicable to any organization that wishes to:
· implement, maintain and improve an environmental management system
· assure itself of its conformance with its stated environmental policy
· demonstrate such conformance to others
· seek certification/registration of its environmental management system by an external organization
· make a self-determination and self-declaration of conformance with this international standard.
All the requirements in this standard can be incorporated into any environmental management system. Having been revised, the improved ISO 14001 is now expected to bring the benefits of implementing an EMS to more businesses than ever. The standard is now easier to understand and use and has more detailed checklists for inputs and outputs from the management review and has increased compatibility to ISO 9001. Organizations who are currently registered to ISO 14001:1996 will have an 18-month transition period to register to ISO 14001:2004.

ISO 9001 Standards New Blogs

2009-10-05T07:17:00.001-07:00

Some of the new blogs on ISO 9001 Standards & ISO 14001 standards was found as below:
http://iso14000standards.blogspot.com/
http://iso-9001-standards.blogspot.com/
http://iso14001environmentmanagementsystem.blogspot.com/
http://iso9001qualitymanagementsystem.blogspot.com/
http://iso9001qualitymanual.blogspot.com/
http://iso9000standards.blogspot.com/
http://iso9001-standards.blogspot.com/
http://iso14001standards.blogspot.com/

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System

2009-10-05T07:16:00.000-07:00

ADVANTAGES ACHIEVED BY THE IMPLEMENTATION OF Quality Management System (QMS)
- An Romania Perspective
The assurance of quality of the delivered products and services has always represented the main goal of any organisation which wants to be on the market. The concept of „quality” is larger than in the past, referring also to management aspects. Thus, the quality of products and services does not represent only a goal, but a consequence of the quality of the whole managerial activities, workers, and even a quality of partnerships. Modern industrial reorganisations are usually realised through the strategies of quality management, due to the fact that these are able to release the continuous and substantial improvements of the economical agents’ performances.
Within such a frame, one possibility for an organisation to maintain and to gain new positions on a market is to design, to implement and to certificate a Quality Management System (QMS), system through which all processes are controlled.
The Romanian pharmaceutical market is currently restricted as volume and value compared to other countries in the region. Joining the European Union and future improvement of living conditions will mean increase of pharmaceutical expenses per person, considering the fact that the demand for pharmaceutical products (medication) is not influenced by the evolution of prices. After 1990, foreign manufacturers have become interested in the increasing potential of Romania, a country of 22 million inhabitants with a very low intake of drugs per person, due to the low living standard. They have penetrated the market through direct import companies, through license agreements, acquisitions and privatizations.
Romanian manufacturers have tried to shift their direction towards export, but the barrier represented by the Good Manufacturing Practice (GMP – for production) and ISO 9001:2000 standards (for distribution) has stopped their penetration of new markets. Their exports mainly targeted Russia, Moldova and former socialist countries. Without norms of this kind, also known as standards, today’s international trade would be inconceivable because every product would have to be checked in keeping with individual criteria. Norms, therefore, create comparability.
Nowadays, the external market has, for several companies, the same importance as the domestic one. The conquest of external market is essential because it brings currency, improves commercial balance, creates new working places and promotes the managerial or technological know-how transfer.
ISO 9000 is a generic name given to a family of standards developed to provide a framework around which a quality management system can be effectively implemented. These standards were developed mainly to facilitate commercial relationships and to increase the confidence of consumers in the capability of a supplier to constantly satisfy the requirements of products and services quality.
The paper presents some advantages achieved by implementation of Quality Management System in pharmaceutical industry, namely S.C. X Company S.A from Tirgu-Mures, one of the most important producer and distributor of pharmaceutical products in Romania.
Using a proven management system combined with ongoing external validation, enables the X Company to continually renew its strategies, domestic and external operations and service level. To this respect, the paper presents the main steps in implementing the Quality Management System within this organisation and some benefits of the registration such as increasing domestic sales, but most off all, the penetration and increasing sales on external markets.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines related to quality management systems and related supporting standards.
ISO 9001:2000 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects. Implementing a Quality Management System within an organisation needs to be a decision of top management. The objective of the quality system needs to be clearly defined so that the system can be effective. The design and implementation of quality management system will vary depending on the type, size and products of the organisation and should be used in conjunction with the ISO 9000:2000 standards. Implementing a Quality Management System is not that difficult as it seems, the key is planning and commitment. How complex or simple the QMS is depends entirely on the organisation and what the objectives are. It can be a simple guide to the organisation policy and procedures, or it can document every task and procedure. It really depends on how much risk is involved and how much control is required.
The documentation of QMS involves:
1. The policy to refer to quality, the objectives of quality and the book of quality (Quality Management System)
2. Management Responsibility
3. Resource Management
4. Product Realisation
5. Measurements, Analysis and Improvement
A well managed quality system will have impact on:
1. customer loyalty and repeat business
2. market share
3. operational efficiencies
4. flexibility and ability to respond to market opportunities
5. effective and efficient use of resources
6. cost reductions
7. competitive advantages

ISO 9001 Standards – Documented Procedures

2009-10-05T07:15:00.002-07:00

ISO 9001 Standards – Documented Procedures

The standard requires the management system documentation to include documented procedures required by ISO 9001 Standards.
ISO 9000 defines a procedure as a specified way to carry out an activity or a process. This definition is ambiguous because an activity is on a different scale than a process. Process outputs are dependent upon many factors of which activities are but one. An activity is the smallest unit of work. Several activities accomplish a task and several tasks reflect the stages in a process but there is more to a process than a series of tasks. This definition also esults in a belief that procedures are documented processes but this too is inaccurate. Procedures tell us how to proceed don‘t need to produce any others. The specific procedures required are:

(a) A documented procedure for document control
(b) A documented procedure for the control of records
(c) A documented procedure for conducting audits
(d) A documented procedure for nonconformity control
(e) A documented procedure for corrective action
(f) A documented procedure for preventive action
These areas all have something in common. They are what the authors of the early drafts of ISO 9000 :2008 referred to as system procedures ? they apply to the whole system and are not product, process or customer specific although it is not uncommon for customers to specify requirements that would impact these areas. Why procedures for these aspects are required and not for other aspects of the management system is unclear but it seems that the authors of ISO 9000 felt these were not processes ? a conclusion I find difficult to justify.
They are certainly not business processes but could be work processes. However, there is another message that this requirement conveys. It is that procedures are not required for each clause of the standard. Previously, countless organizations produced a manual of 20 procedures to match the 20 elements of ISO 9001. Some limited their procedures to the 26 procedures cited by the standard and others produced as many as were necessary to respond to the requirements.
Document control is a work process or a number of work processes because the inputs pass through a number of stages each adding value to result in the achievement of defined objectives. These are the acquisition, approval, publication, distribution, storage, maintenance, improvement, and disposal stages. These are not tasks but processes that achieve defined objectives and involve both physical, financial and human resources. Within these processes are tasks, each of which may require documented procedures as they are initiated.
Control of records is also a work process similar to document control. There are the preparation, storage, access, maintenance and disposal stages. This is not one uninterrupted flow but a life cycle. There is not one task but several performed at different times for different reasons.
Auditing is certainly a process with a defined objective. Without the provision of competent personnel and a suitable environment, audits will not achieve their objectives no matter how many times the procedure is implemented.
Nonconformity control like records control is a work process for the same reasons. The sequence of tasks is not in the form of an uninterrupted sequence. The sequence of stages may be identification, documentation, segregation, review, remedial action and disposal but this is not a continuous sequence. There are breaks and different procedures may apply at each stage depending on what it is that is nonconforming.
There is little merit in having one corrective action procedure when the source of problems that require corrective action is so varied. One Corrective Action Form might be appropriate but its application will be so varied that it is questionable whether one size fits all. Presenting top management with a nonconformity report because it has been detected that the organization charts are not promptly updated following a change, will not motivate them into action. Corrective action forms part of every process rather than being a separate process. It is unreasonable to force all actions aimed at preventing the recurrence of problems through one process. Many problems are prevented from recurring not by following a procedure, but by the designer, the producer, supplier, manager remembering they had a problem last time and doing it differently the next ? i.e. they learn from their mistakes. No forms filled in, no procedures followed ? just people using their initiative ? this is why corrective action is part of every process operation.
Preventive action remains one of the most misunderstood requirements of ISO 9001 because it is mistaken for corrective action but more on this. There is even less justification for one preventive action procedure because the source of potential problems is so varied. Preventive actions are taken in design, in planning, in training and in maintenance under the name of FMEA, Reliability Prediction, Quality Planning, Production Planning, Logistic Planning, Staff Development, Equipment Maintenance ? preventive actions are built into these processes and similar to corrective action are part of every process design.

Continual improvement in the quality management system

2009-10-05T07:15:00.001-07:00

Continual Improvement In The Quality Management System
The ISO 9001 standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results and continual improvement of the identified processes.
ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the quality management system means continually increasing the ability of the organization to fulfil its objectives.
If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:
Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higher
Increase efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources
Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate
You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.
Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning.
There are several steps to undertaking continual improvement:
1. Determine current performance
2 Establish the need for change
3 Obtain commitment and define the improvement objectives
4 Organize diagnostic resources
5 Carry out research and analysis to discover the cause of current performance
6 Define and test solutions that will accomplish the improvement objectives
7 Product improvement plans which specify how and by whom the changes will be implemented
8 Identify and overcome any resistance to change
9 Implement the change
10 Put in place controls to hold new levels of performance and repeat step one
For more information, please visit http://www.iso9001-standard.us

Preparing ISO 9001 Quality Manual

2009-10-05T07:14:00.000-07:00

Preparing ISO 9001 Quality Manual
The standard requires a quality manual to be established and maintained that includes the scope of the quality management system, the documented procedures or reference to them and a description of the sequence and interaction of processes included in the quality management system.
ISO 9001 defines a quality manual as a document specifying the quality management system of an organization. It is therefore not intended that the quality manual be a response to the requirements of ISO 9001. As the top-level document describing the management system it is a system description describing how the organization is managed.
Countless quality manuals produced to satisfy ISO 9001:2008, were no more than 20 sections that paraphrased the requirements of the standard. Such documentation adds no value. They are of no use to managers, staff or auditors. Often thought to be useful to customers, organizations would gain no more confidence from customers than would be obtained from their registration certificate.
A description of the management system is necessary as a means of showing how all the processes are interconnected and how they collectively deliver the business outputs. It has several uses as :
1. a means to communicate the vision, values, mission, policies and objectives of the organization
2. a means of showing how the system has been designed
3. a means of showing linkages between processes
4. a means of showing who does what an aid to training new people
5. a tool in the analysis of potential improvements
6. a means of demonstrating compliance with external standards and regulations
When formulating the policies, objectives and identifying the processes to achieve them, the manual provides a convenient vehicle for containing such information. If left as separate pieces of information, it may be more difficult to see the linkages.
The requirement provides the framework for the quality manual. Its content may therefore include the following:
1 Introduction
(a) Purpose (of the manual)
(b) Scope (of the manual)
(c) Applicability (of the manual)
(d) Definitions (of terms used in the manual)
2 Business overview
(a) Nature of the business/organization – its scope of activity, its products and services
(b) The organization’s interested parties (customers, employees, regulators, shareholders, suppliers, owners etc.)
(c) The context diagram showing the organization relative to its external environment
(d) Vision, values
(e) Mission
3 Organization
(a) Function descriptions
(b) Organization chart
(c) Locations with scope of activity
4 Business processes
(a) The system model showing the key business processes and how they are interconnected
(b) System performance indicators and method of measurement
(c) Business planning process description
(d) Resource management process description
(e) Marketing process description
(f) Product/service generation processes description
(g) Sales process description
(h) Order fulfilment process description
5 Function matrix (Relationship of functions to processes)
6 Location matrix (Relationship of locations to processes)
7 Requirement deployment matrices
(a) ISO 9001 compliance matrix
(b) ISO 14001 compliance matrix
(c) Regulation compliance matrices (FDA, Environment, Health, Safety, CAA etc.)
8 Approvals (List of current product, process and system approvals)
The process descriptions can be contained in separate documents and should cover the topics identified previously (see Documents that ensure effective planning, operation and control of processes ).
As the quality manual contains a description of the management system a more apt title would be a Management System Manual (MSM) or maybe a title reflecting its purpose might be Management System Description (MSD).
In addition a much smaller document could be produced that does respond to the requirements of ISO 9001, ISO 14001, and the regulations of regulatory authorities. Each document would be an exposition produced purely to map your management system onto these external requirements to demonstrate how your system meets these requirements. When a new requirement comes along, you can produce a new exposition rather than attempt to change your system to suit all parties. A model of such relationships is illustrated in Figure 4.10. The process descriptions that emerge from the Management System Manual describe the core business processes and are addressed in Chapter 4 under the heading of Documents that ensure effective operation and control of processes.

Scope Of The Quality Management System

2009-10-05T07:13:00.002-07:00

Scope Of The Quality Management System
The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.
Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.
It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.
The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.
It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.
It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.
For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.

ISO 9001 Quality Policy

2009-10-05T07:13:00.001-07:00

ISO 9001 Quality Policy
The standard requires the quality policy to be appropriate to the purpose of the organization.
The purpose of an organization is quite simply the reason for its existence and as Peter Drucker so eloquently put it there is only one valid definition of business purpose: to create a customer”(Drucker, Peter F., 1977)2 . In ensuring that the quality policy is appropriate to the purpose of the organization, it must be appropriate to the customers the organization desires to create. It is therefore necessary to establish who the customers are, where the customers are, what they buy or wish to receive and what these customers regard as value. As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9001 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.
Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to quality policy.
Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’
– thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.
In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the quality policy.
One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision. Omitting the strategy may not ensure uniformity of approach and direction.
The standard requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system.
A commitment to comply with requirements means that the organization should undertake to meet the requirements of all interested parties. This means meeting the requirements of customer, suppliers, employees, investors, owners and society. Customer requirements are those either specified or implied by customers or determined by the organization and these are dealt with in more detail under clauses 5.2 and 7.2.1. The requirements of employees are those covered by legislation such as access, space, environmental conditions, equal opportunities and maternity leave but also the legislation appropriate to minority groups such as the disabled and any agreements made with unions or other representative bodies. Investors have rights also and these will be addressed in the investment agreements. The requirements of society are those obligations resulting from laws, statutes, regulations etc.
An organization accepts such obligations when it is incorporated as a legal entity, when it accepts orders from customers, when it recruits employees, when it chooses to trade in regulated markets and when it chooses to use or process materials that impact the environment.
The effectiveness of the management system is judged by the extent to which it fulfils its purpose. Therefore improving effectiveness means improving the capability of the management system. Changes to the management system that improve its capability i.e its ability to deliver outputs that satisfy all the interested parties, are a certain types of change and not all management system changes will accomplish this. This requirement therefore requires top management to pursue changes that bring about an improvement in performance.

ISO 14001 ENVIRONMENTAL POLICY

2009-10-05T07:12:00.000-07:00

ISO 14001 ENVIRONMENTAL POLICY
The intent of an environmental policy is to state the organization’s commitment to continuous improvement in environmental performance. A strong, clear environmental policy can serve as both a starting point for developing the EMS and a reference point for maintaining continuous improvement.The policy should be evaluated regularly and modified, as necessary, to reflect changing environmental priorities.The policy should function in two ways: (1) within the company, the policy should focus attention on environmental issues associated with company activities, products, and services; and (2) outside the company, the policy is a public commitment to addressing environmental issues and continuously improving environmental performance.The environmental policy must address:• Commitment to compliance with relevant environmental legislation andregulations• Pollution prevention• Continuous improvement
Tips for Developing an Environmental Policy:1. Develop a policy that reflects perspectives of various employees within the company (for example, line worker, owner, wastewater treatment operator, quality inspector, compliance/legal manager, production manager).2. Display the policy statement in view of all employees; the policy should be available to the public and customers if requested and be printed in languages other than English, as appropriate.3. Include top management signatures on the policy to demonstrate understanding and commitment.Purpose This procedure is used to develop and write the company’s environmental policy.
Step 1 The environmental manager will form a policy development team responsible for developing and writing the environmental policy. The policy will address, at a minimum, compliance, pollution prevention, and continuous improvement.
Step 2 The policy development team will review other relevant documents to ensure consistency with other company policies and guide the content and phrasing of the policy. Example documents include the company mission statement and the example environmental policies included in this EMS element.
Step 3 The policy will be displayed in view of all employees and introduced to new employees; the policy will be available in languages other than English, as appropriate, and to the public (on request) and customers (as appropriate).Step 4 The environmental manager will review the environmental policy at least annually, and update it if needed.
Responsible Person: _____________________________________Signature and Date: ______________________________________
Environmental Policy Example 1
It is the policy of COMPANY NAME to conduct its operations in a manner that is environmentally responsible and befitting a good corporate neighbor and citizen.In accordance with this policy, COMPANY NAME complies with all environmental laws and manages all phases of its business in a manner that minimizes the impact of its operations on the environment.To further this policy, COMPANY NAME shall:1. Include environmental requirements in planning and design activities2. Comply with applicable environmental laws and regulations3. Eliminate, or reduce to the maximum practical extent, the release of contaminants into the environment, first through pollution prevention (material substitution and source reduction), then recycling, and finally through treatment and control technologies4. Effectively communicate with company employees, suppliers, regulators, and customers, as well as the surrounding community, regarding the environmental impact of company operations5. Periodically review and demonstrate continuous improvement in the company’s environmental management system
SIGNATURE___________________
Responsible Person______________________
Environmental Policy Sample 2
Effective Date
ENVIRONMENTAL POLICY
_________________________ IS COMMITTED TO IMPROVE THE HEALTH, SAFETY AND ENVIRONMENT FOR OUR EMPLOYEES, NEIGHBORS, AND FAMILIES.
WE WILL MEET AND OR EXCEED LAWFUL COMPLIANCE THROUGH POLLUTION PREVENTION PRACTICES AND CONTINUOUS IMPROVEMENT.
TO IMPLEMENT THIS POLICY WE WILL CREATE AN ENVIRONMENTAL MANAGEMENT SYSTEM TO IDENTIFY GOALS, SYSTEMS, MEASUREMENTS AND SAMPLING METHODS.TO SUPPLEMENT THIS POLICY WE WILL INCORPORATE SOURCE REDUCTION THROUGH REUSE, RECYCLING, MATERIAL SUBSTITUTION, NEW AND IMPROVED TECHNOLOGIES, CREATIVE MANAGEMENT AND OPERATIONAL PRACTICES.
TO MAINTAIN THIS POLICY WE WILL PERFORM MANAGEMENT REVIEW, REVENTATIVE MAINTENANCE, EMPLOYEE TRAINING, AND A COMMITMENT AND INVOLVEMENT FROM OUR EMPLOYEES AND MANAGEMENT TO SUPPORT THIS POLICY.

ISO 14001 ENVIRONMENTAL ASPECTS AND IMPACTS

2009-10-05T07:11:00.002-07:00

ISO 14001 Environmental Aspects And Impacts
The fundamental purpose of the EMS is to control and reduce the environmental impacts of your facility’s processes and products. For this reason, a critical element of the EMS involves identifying and prioritizing the environmental aspects and impacts associated with your facility. An environmental aspect is an element of an organizations activities, products, or services that can interact with the environment. For example, chrome plating is a metal finishing activity and an associated aspect is chrome air emissions.This aspect may have an impact on the environment in several ways, for example, ambient air quality degradation.The environmental aspects and impacts of your metal finishing operations can be identified, prioritized, and documented in several ways. This Template includes two approaches, either of which can be used during EMS implementation. Use the approach that works best for your circumstances. This process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established.
Aspects and Impacts Form A — The first approach uses the experience and judgment ofemployees familiar with facility processes to identify the top five environmental issuescurrently facing the facility. These issues and their specific aspects and impacts shouldbe summarized using Aspects and Impacts Form A.
Aspects and Impacts Form B — The second approach uses detailed, structured matricesto list and prioritize environmental aspects and impacts according to the followingcategories:• Environmental Aspects and Impacts: Wastewater• Environmental Aspects and Impacts: Air Emissions• Environmental Aspects and Impacts: Hazardous and Solid Waste• Environmental Aspects and Impacts: Raw Materials• Environmental Aspects and Impacts: Water and Energy
The matrices that comprise Form B will help facility staff identify and document environmental aspects and impacts. The matrices also provide criteria for prioritizing environmental aspects and impacts; this process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established. One possible way to prioritize environmental aspects and impacts using Form B is described as follows:Step 1:For each aspect and impact, score each prioritization criterion on a scale from 1 to 5, where 1 indicates the criterion is very important or relevant to that aspect (for example, the aspect is strictly regulated, is the subject of compliance violations, or is a waste generated in large uantities), and 5 indicates the criterion is relatively unimportant or irrelevant to that aspect (for example, the aspect is an unregulated waste, is generated infrequently, and is inexpensive to manage).Step 2:Add the scores of all criteria for each aspect and write the total in the right-most column of the form.This number indicates the relative priority of the aspect compared to other aspects and impacts in the same category. The lower the total score, the higher the priority.Purpose Of This procedure is used to identify, document, and update the environmental aspects and impacts of facility processes and operations.
Step 1 The environmental manager and other facility personnel selected by the environmental manager are responsible for identifying and prioritizing the environmental aspects and impacts of facility operations during EMS planning and development.Environmental aspects are characteristics of facility processes and products that interact with the environment. Only environmental aspects the company can control or influence will be considered. Environmental impacts are the effects of an organization’s activitie , products or services on the environment.
Step 2 Environmental aspects and impacts will be documented and prioritized.Environmental aspects and impacts will be associated with the following categories:• Wastewater• Air emissions• Hazardous and solid waste• Raw materials• Water and energyHigh-priority environmental aspects and impacts will be considered when environmentalobjectives and targets are set.
Step 3 The environmental manager and other facility personnel will review and updatethe environmental aspects and impacts documentation annually.
Step 4 Environmental aspects and impacts documentation will be retained at the facilityfor at least 2 years.
Responsible Person: _____________________________________Signature and Date: ______________________________________

Elements of the Six Sigma Framework

2009-10-05T07:11:00.001-07:00

Elements Of The Six Sigma Framework
Management strategies, such as TQC, TQM, and Six Sigma, are distinguished from each other by their underlying rationale and framework. As far as the corporate framework of Six Sigma is concerned, it embodies the five elements of top-level management commitment, training schemes, project team activities, measurement system and stakeholder involvement.
Stakeholders include employees, owners, suppliers and customers. At the core of the framework is a formalized improvement strategy with the following five steps: define, measure, analyse, improve and control (DMAIC) which will be explained in detail in Section 2.3. The improvement strategy is based on training schemes, project team activities and measurement system. Top-level management commitment and stakeholder involvement are all inclusive in the framework.
Without these two, the improvement strategy functions poorly. All five elements support the improvement strategy and improvement project teams. Most big companies operate in three parts: R&D, manufacturing, and non-manufacturing service. Six Sigma can be introduced into each of these three parts separately. In fact, the color of Six Sigma could be different for each part. Six Sigma in the R&D part is often called “Design for Six Sigma (DFSS),” “Manufacturing Six Sigma” in manufacturing, and “Transactional Six Sigma (TSS)” in the non-manufacturing service sector. All five elements are necessary for each of the three different Six Sigma functions. However, the improvement methodology, DMAIC, could be modified in DFSS and TSS. These points will be explained in detail in Sections 2.6 and 2.7.2.2 Top-level Management Commitment and Stakeholder Involvement
(1) Top-level management commitment
Launching Six Sigma in a company is a strategic management decision that needs to be initiated by top-level management. All the elements of the framework, as well as the formalized improvement strategy, need top-level management commitment for successful execution. Especially, without a strong commitment on the part of top-level management, the training program and project team activities are seldom successful. Although not directly active in the day-to-day improvement projects, the role of top-level management as leaders, project sponsors and advocates is crucial. Pragmatic management is required, not just lip service, as the top-level management commits itself and the company to drive the initiative for several years and into every corner of the company.
There are numerous pragmatic ways for the CEO (chief executive officer) to manifest his commitment. First, in setting the vision and long-term or short-term goal for Six Sigma, the CEO should play a direct role. Second, the CEO should allocate appropriate resources in order to implement such Six Sigma programs as training schemes, project team activities and measurement system. Third, the CEO should regularly check the progress of the Six Sigma program to determine whether there are any problems which might hinder its success. He should listen to Six Sigma reports and make comments on the progress of Six Sigma. Fourth, he should hold a Six Sigma presentation seminar regularly, say twice a year, in which the results of the project team are presented and good results rewarded financially. Finally, he should hold a Champion Day regularly, say once in every other month, in which Champions (upper managers) are educated by specially invited speakers and he should discuss the progress of Six Sigma with the Champions.
It is also the responsibility of top-level management to set “stretch goals” for the Six Sigma initiative. Stretch goals are tough and demanding, but are usually achievable. Some companies set the stretch goal for process performance at 6 sigma or 3.4 DPMO for all critical-to-customer characteristics.
However, the goals can also be set incrementally, by stating instead the annual improvement rate in process performance.
The industry standard is to reduce DPMO by 50% annually.
(2) Stakeholder involvement
Stakeholder involvement means that the hearts and minds of employees, suppliers, customers, owners and even society should be involved in the improvement methodology of Six Sigma for a company. In order to meet the goal set for improvements in process performance and to complete the improvement projects of a Six Sigma initiative, top-level management commitment is simply not enough. The company needs active support and direct involvement from stakeholders.
Employees in a company constitute the most important group of stakeholders. They carry out the majority of improvement projects and must be actively involved. The Six Sigma management is built to ensure this involvement through various practices, such as training courses, project team activities and evaluation of process performance. Suppliers also need to be involved in a Six Sigma initiative.
A Six Sigma company usually encourages its key suppliers to have their own Six Sigma programs. To support suppliers, it is common for Six Sigma companies to have suppliers sharing their performance data for the products purchased and to offer them participation at in-house training courses in Six Sigma. It is also common for Six Sigma companies to help small suppliers financially in pursuing Six Sigma programs by inviting them to share their experiences together in report sessions of project team activities. The reason for this type of involvement is to have the variation in the suppliers’ products transferred to the company’s processes so that most of the process improvement projects carried out on suppliers’ processes would result in improvement of the performance.
Customers play key roles in a Six Sigma initiative. Customer satisfaction is one of the major objectives for a Six Sigma company. Customers should be involved in specific activities such as identifying the critical-to-customer (CTC) characteristics of the products and processes. CTC is a subset of CTQ from the viewpoint of the customers. Having identified the CTC requirements, the customers are also asked to specify the desired value of the characteristic, i.e., the target value and the definition of a defect for the characteristic, or the specification limits. This vital information is utilized in Six Sigma as a basis for measuring the performance of processes. In particular, the R&D part of a company should know the CTC requirements and should listen to the voice of customers (VOC) in order to reflect the VOC in developing new products.

Environment Policy In ISO 14001:2004

2009-10-05T07:10:00.000-07:00

Environment Policy In ISO 14001:2004
To develop a successful and effective EMS, five key tasks that must be undertaken by management:a. Select an EMS CoordinatorThe selection of an EMS Coordinator is crucial to the success of your EMS. This person will be responsible for developing and implementing the environmental policy and the EMS. Great care must be taken to ensure that the person chosen is well qualified to handle the responsibilities associated with the EMS.b. Perform a gap analysisA gap analysis determines the differences, or gaps, between one system and another. Not only will this analysis identify the gaps, but it also should etermine the size of the gaps. These findings will lead to recommendations, project plans, and the identification of necessary resources for filling the gaps.
c. Prepare a budget, and obtain the appropriate resourcesAfter conducting a gap analysis, the EMS Coordinator will develop a budget that covers the necessary resources to complete an EMS that conforms with ISO 14001. For some organizations, this may mean establishing a budget for the entire process; other organizations may only need to update certain portions of their existing management system.
ISO 14001 Section 4.4.1 requires top management to provide the essential resources to implement, control, and manage the EMS.
d. Select an EMS TeamTop management and the EMS Coordinator may consider creating an EMS Team to assist in developing and implementing the system. This decision should be based on the size of the organization or facility that will be implementing the EMS.
This team should consist of key individuals from various divisions, departments, and operating work areas within the organization who are familiar with the facility, the various processes, and its environmental requirements. Diversity among team members will bring together a pool of expertise and ideas from which to develop and implement the EMS.
e. Develop an environmental policyThe environmental policy is an essential part of an organization’s EMS. The environmental policy must establish the overall direction of the organization in terms of its commitment to environmental responsibility. A policy should also set the foundation and framework for meeting the environmental objectives and targets for the organization.
The ISO 14001 standard establishes certain requirements that an organization’s environmental policy must meet. If your organization already has an environmental policy, review this section to ensure it meets the ISO 14001 requirements.
The first requirement is that top management must establish and define the environmental policy. Note that ISO 14001 does not specifically state that top management must write the policy, only that it be committed to the policy and ensure its implementation.
These actions are essential in constructing a firm foundation for an effective EMS.

ENVIRONMENTAL and HEALTH & SAFETY COMPLIANCE CHECKLIST

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Self-Audit Procedures
The following checklist should be used as an aid in reviewing your facility’s compliance with industry environmental and health & safety regulations and requirements.
Additional Information: This checklist is based on the current laws and regulations as of the date of publication. Regulations frequently change.
Therefore, you should review current laws and regulations for any recent changes in the requirements. Some of the items you should check include:
Additional Requirements: In addition to recent changes in the requirements, you should also consider additional Cal/OSHA standards that might apply to your facility.
These might include any of the following:
Employer postings; ergonomics; process safety management; use of asbestos, formaldehyde, or lead containing substances; blood borne
pathogens; welding operations; use of compressed air and gases; boiler operations; use of power tools, hoists and grinding equipment; spray coating; elevated platforms; aisle way, ramp, door and exit requirements; fire sprinkler requirements; and seismic requirements.
Legal Authority : The compliance requirements provided on the following pages are taken from the respective laws and regulations, as indicated in the references column. In addition to the statutory and regulatory requirements, some compliance items that reflect improved and accepted management practices have been included. These management practices have been included because of their overall industry acceptance and their potential to reduce environmental risk and improve compliance.

Implementing A Quality Management System

2009-09-18T15:58:00.000-07:00