Monday, August 31, 2009

ISO 9001 Quality Policy

On customers
We will listen to our customers, understand and balance their needs andexpectations with those of our suppliers, employees, investors and society andendeavour to give full satisfaction to all parties.

On leadership
We will establish and communicate our vision for the organization and throughour leadership exemplify core values to guide the behaviour of all to achieve ourvision.

On people
We will involve our people in the organization’s development, utilize theirknowledge and experience, recognize their contribution and provide an environ-ment in which they are motivated to realize their full potential.

On processes and systems
We will take a process approach towards the management of work and manage ourprocesses as a single system of interconnected processes that delivers all theorganization’s objectives.

On continual improvement
We will provide an environment in which every person is motivated tocontinually improve the efficiency and effectiveness of our products, processes andour management system.

On decisions
We will base our decisions on the logical and intuitive analysis of data collectedwhere possible from accurate measurements of product, process and systemcharacteristics.

On supplier relationships
We will develop alliances with our suppliers and work with them to jointlyimprove performance.
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ISO 9001:2008 Quality Management System Standard

ISO 9001:2008 is the world most successful standard addressing best practice in the application of quality management systems.
The standard is based around the principles of customer satisfaction, continual improvement and the development of a process based quality management system. Although not referenced in the standard itself the ISO 9001:2008 document is underpinned by eight key quality management principles;
a customer focused organisation
leadership
the involvement of people
ensuring a process approach
a systematic approach to management
a factual approach to decision making
mutually beneficial supplier relations
continuous improvement
ISO 9001:2008 has been written to ensure that its guiding principles are equally relevant to all sectors of industry and to all types of organisation. Although containing requirements to control the key processes within an organisation, it only requires six documented procedures. The standard emphasises the need for an organisation to continually monitor their own processes and systems, with many clauses making reference to self monitoring or measurement or both. This emphasis aims for an integrated approach to business processes. Instead of operating to a business plan on one hand and a quality management system on the other, the standard aims to integrate both of these functions into one system.
What is a quality management system?ISO 9001:2008 is a standard that specifies criteria for a quality management system (QMS). A QMS incorporates those elements of an organisations management system that direct and control it with regard to quality. Such a system will need to be supported by top management who will need to be able to demonstrate management commitment.
How do you demonstrate management commitment?Management commitment is one of the cornerstones of ISO 9001:2008, requiring top management to develop and improve the QMS throughout the organisation. This commitment can be demonstrated by a number of methods including creating a quality policy, conducting management reviews and establishing quality objectives.
What is a quality policy?ISO 9001:2008 specifies that an organisation must have a quality policy that documents the organisations overall intentions and direction related to quality as formally expressed by top management. Such a policy will include a commitment to comply with ISO 9001:2008, to continuously improve the QMS and to set and monitor measurable quality objectives.
What are quality objectives?The quality objectives are those targets sought or aimed for by the organisation that are related to quality. These quality objectives must be SMART (suitable, measurable, achievable, reviewed and timely). Examples of quality objectives might be; to reduce machine down time by 20% or to reduce rework costs by ?00 p/m. Whatever quality objectives are chosen they must be meaningful and adequately resourced by the organisation.
What is a management review?A management review is a key element of how the top management of an organisation can assess its performance in terms of the objectives it sets itself, the requirements set by the standard and how its systems are operating. Normally, a management review is a regular meeting of the top management team and uses the information that the organisation? systems have derived. It is a useful forum to review and revise quality objectives.
What are internal audits and why do I need to carry them out?Internal audit is one of the key monitoring processes required by the standard and functions as a check on the organisation? systems. It is the opportunity for an organisation to determine compliance to the systems it has established and maintained to meet the needs of its customers and identify opportunities for improvement. Internal audit can be seen as a ealth check?for an organisation.
The ore?of ISO 9001:2008, Product realisationClause 7 of ISO 9001:2008 contains the core processes that most organisations carry out. Any clause or sub-clause in section 7 can be excluded from an organisations quality management system if it can be justifiably excluded. Examples of common exclusions are clause 7.3 design and development, clause 7.5.3 traceability and clause 7.6 the control of monitoring and measuring devices. Clauses can only be excluded if their exclusion does not affect the company? ability to provide a product or service that meets customer requirements.
These core processes should be managed and controlled via the quality management system, and are evaluated for effectiveness and suitability by the internal audits with feed back into the management review.
This is a clear demonstration of one of the key principles of ISO 9001:2008, continuous improvement by critical self-evaluation. The output from the self-evaluation is fed into a planning stage to determine actions needed to improve the system. Following the planning and consultation comes the action phase where the proposed changes are implemented. Then the cycle starts again by checking that the changes are effective and meaningful by self-evaluation.
Other requirements of section 7 are;Product planning to ascertain and then implement the necessary controls and resources to ensure product realisation.
Purchasing control to verify purchased product against comprehensive purchasing information and the selection and evaluation of suppliers.
Production and service provision to ensure that this activity is carried out in controlled conditions and that any processes that cannot be verified during production are validated to ensure capability. Where appropriate the product must be identified, and if required, traceable at all stages of production. Any customer property must be identified and protected from harm and all products must be stored and handled in such a way to preserve product conformity.
Any monitoring and measuring devices needed to provide evidence of product conformity must be identified and if necessary calibrated.
But what about the customer? All of the clauses in ISO 9001:2008 are in some way focused towards meeting and exceeding the customer? expectations. For example the requirement of management to determine and communicate the importance of customer requirements throughout the organisation, and the review of customer orders to ensure that they can be met. Companies are required to implement methods for effective communication with the client at all stages of the business including ascertaining customer satisfaction after the product or service has been delivered as well as resolving customer complaints.
Finally?ISO 9001:2008 is widely acclaimed as being the pre-eminent specification for quality management systems, it requires a company to look at itself and ask the question, ‘how can we improve?’ An ISO 9001:2008 management system should be an essential part of any business process, requiring continual improvement by self-evaluation with a goal of ensuring that current and future customer expectation can be met and exceeded.
If you have any queries concerning ISO 9001:2008 please visit http://www.iso-consults.com/

Sunday, August 30, 2009

Thursday, August 27, 2009

TQM and Six Sigma

While Six Sigma is definitely succeeding in creating some impressive results and culture changes in some influential organizations, it is certainly not yet a widespread success. Total Quality Management (TQM) seems less visible in many businesses than it was in the early 1990s. However, many companies are still engaged in improvement efforts based on the principles and tools of TQM. It appears at least in Korea that Six Sigma is succeeding while TQM is losing its momentum.
One of the problems that plagued many of the early TQM initiatives was the preeminence placed on quality at the expense of all other aspects of the business. Some organizations experienced severe financial consequences in the rush to make quality “first among equals.” The disconnection between management systems designed to measure customer satisfaction and those designed to measure provider profitability often led to unwise investments in quality, which has been often practiced in TQM. Ronald Snee (1999) points out that although some people believe it is nothing new, Six Sigma is unique in its approach and deployment. He defines Six Sigma as a strategic business improvement approach that seeks to increase both customer satisfaction and an organization’s financial health. Snee goes on to claim that the following eight characteristics account for Six Sigma’s increasing bottom-line (net income or profit) success and popularity with executives.
• Bottom-line results expected and delivered
• Senior management leadership
• A disciplined approach (DMAIC)
• Rapid (3–6 months) project completion
• Clearly defined measures of success
• Infrastructure roles for Six Sigma practitioners and leadership
• Focus on customers and processes
• A sound statistical approach to improvement
Other quality initiatives including TQM have laid claim to a subset of these characteristics, but only Six Sigma attributes its success to the simultaneous application of all eight. Six Sigma is regarded as a vigorous rebirth of quality ideals and methods, as these are applied with even greater passion and commitment than often was the case in the past. Six Sigma is revealing a potential for success that goes beyond the levels of improvement achieved through the many TQM efforts. Some of the mistakes of yesterday’s TQM efforts certainly might be repeated in a Six Sigma initiative if we are not careful.
A review of some of the major TQM pitfalls, as well as hints on how the Six Sigma system can keep them from derailing our efforts is listed below.
1. Links to the business and bottom-line success:
In TQM, quality often was a “sidebar” activity, separated from the key issues of business strategy and performance. The link to the business and bottom-line success was undermined, despite the term “total” quality, since the effort actually was limited to product and manufacturing functions. Six Sigma emphasizes reduction of costs, thereby contributing to the bottom-line, and participation of three major areas: manufacturing, R&D and service parts.
2. Top-level management leadership:
In many TQM efforts, top-level management’s skepticism has been apparent, or their willingness to drive quality ideas has been weak. Passion for and belief in Six Sigma at the very summit of the business is unquestioned in companies like
Motorola, GE, Allied Signal (now Honeywell), LG and Samsung. In fact, top-level management involvement is the beginning of Six Sigma.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.
4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money to help people meet those standards.
5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.
6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.
3. Clear and simple message:
The fuzziness of TQM started with the word “quality” itself. It is a familiar term with many shades of meaning. In many companies, Quality was an existing department with specific responsibilities for “quality control” or “quality assurance,” where the discipline tended to focus more on stabilizing rather than improving processes. Also TQM does not provide a clear goal at which to aim. The concept of Six Sigma is clear and simple. It is a business system for achieving and sustaining success through customer focus, process management and improvement, and the wise use of facts and data. A clear goal (3. 4 DPMO or 6s quality level) is the centerpiece of Six Sigma.

4. Effective training:
TQM training was ineffective in the sense that the training program was not so systematic. Six Sigma divides all the employees into five groups (WB, GB, BB, MBB and Champion), and it sets very demanding standards for learning, backing them up with the necessary investment in time and money
to help people meet those standards.

5. Internal barriers:
TQM was a mostly “departmentalized” activity in many companies, and it seemed that TQM failed to break down internal barriers among departments. Six Sigma places priority on cross-functional process management, and cross-functional project teams are created, which eventually breaks down internal barriers.

6. Project team activities:
TQM utilized many “quality circles” of blue-collar operators and workers, and not many “task force teams” of white-collar engineers even if they are needed. Six Sigma demands a lot of project teams of BBs and GBs, and the project team activities are one of the major sources of bottom-line and top-line success.

Tuesday, August 25, 2009

The Advent of Superior Quality Standard

ISO 9001 2008 was created with a view to specifying the requirements for a quality management system especially where an organization or firm needs to demonstrate its capacity to provide customers with durable products and appropriate regulatory and statutory requirements. ISO 9001 2008 and ISO 9001 2008 draft also helps enhance customer satisfaction by ensuring effective application of a system including various processes that promote continual development and assurance of product conformity for the customer. All requirements of ISO 9001 2008 are usually generic in nature and are intended to be applied in various organizations regardless of the type of product that they produce. The formal international standards and technical reports that govern ISO 9001 2008 are contained in ISO 9000 standards. The same applies to various web based documents and technical specifications that regulate ISO 9001 2008 (FAQ).
Information on quality assurance of ISO 9001 2008 can be found at the Quality Information Center. In order to improve the quality of a business process output through identifying and removing defects and to enhance ISO 9001 2008 , the six sigma was created for organizations and businesses. The business management strategy that seeks to promote ISO 9001 2008 uses various sets of quality management methods that are all aimed at creating unique infrastructure within organizations known as black belts. This in turn helps enhance quality control and quality management especially for ISO 9001 and ISO 9001 2008 . One way through which an organization can enhance ISO 9001 2008 is by adopting methods such as process control. A process control is a discipline that deals with mechanisms, architectures and algorithms for regulating the output of a particular process. It helps the ISO standard to be upheld.
ISO 9000 helps ensure quality improvement. Organizations that have ISO certification, which meet ISO standards such as ISO 9001, ISO 9001 2008 and ISO 14000 have the ability of ensuring that services and products that they produce achieve standards of quality that are widely recognized in all parts of the world. Other regulations and requirements that govern ISO 9001 2008 are set out in 14001 ISO. ISO 14001 is basically an internationally recognized standards especially for environmental management systems that are to be implemented in an organization or business. The International Standards Organization released the standards in order to cater for ISO 9001 2008 . It also helps organizations to promote ISO 9001 2008 requirements and to minimize the negative effects of their ISO 9001… operations.
Various training institutes offer ISO training particularly for ISO 9001 2008 standards. This also helps promote ISO quality and ISO audit systems. ISO 17799 and ISO 17025 are intended to be the launch pad for individuals and organizations that are seeking help with international standards including ISO 9001 2008 . ISO 9001 is particularly helpful for promoting 9001 quality that meets ISO 9000 standards. One program that helps in the successful carrying out of an audit 9001 ISO system can be found in an ISO manual. Most organizations are now carrying out a transition to standard 9001 management standards. ISO 9002 is a Quality Managed Standard that is published by the International Organization for Standardization to uphold ISO 9001 2008 standards. In order to uphold ISO control especially for ISO 9001 2008 , various organizations undergo certification 9001 and ISO 9001 training.

Origins of the ISO 9001’s Work

The ISO is a federation of non-governmental organizations established in 1947 to develop international standards, improve international communication and collaboration, and facilitate the exchange of goods and services. The federation is currently comprised of close to 100 national standards bodies (member bodies) from countries representing approximately 95 percent of the world’s industrial production.
The headquarters of the ISO secretariat is in Geneva, Switzerland.2 The ISO’s involvement in establishing environmental standardsbegan in 1991 after organizers for the UN Conference on Environment and Development (held in Rio de Janeiro in 1992) asked whether or not ISO would be attending the conference and whether it was involved in any environmental activities. As a result, the ISO established a Strategic Advisory Group on the Environment (SAGE) in 1991 to assess the need for international environmental management standards.3 SAGE recommended that ISO proceed with an environmental standard by 1992 and that a technical committee be established to carry it through. On June 1, 1993, ISO’s Technical Committee 207 (TC 207) held its first plenary meeting.
TC 207 was directed to establish environmental standards in five areas of environmental management:- environmental management systems; environmental auditing and related- environmental investigation; environmental labeling; environmental performance evaluation; and life-cycle assessment.
Consequently, TC 207 was divided into five subcommittees (SCs) for each category of standard and one SC to cover the terms and definitions of the standards. In addition, a working group, which reports directly to TC 207, was formed to deal with the environmental aspects in product standards. The five SCs have two or more working groups (WGs) that report to them (unlike the WG on product standards previously mentioned which reports directly to TC 207).
The key factor that has propelled the ISO 14000 series of standards forward throughout the early 1990s is the increase in national environmental standards. Examples of these standards include some two dozen eco-labeling schemes worldwide (see Annex 1), the British Standards Institute’s BS 7750 (Specification for Environmental Management Systems), the Canadian Standards Association’s Z750 (A Guide for a Voluntary Environmental Management System), and the EU EMAS (Eco-Management and Audit Scheme). Other similar environmental management standards have been developed by the French Standards Association, the South African Bureau of Standards and the Spanish Standards Association.
With the proliferation of environmental standards, concerns have been expressed that these standards would fragment international markets and unduly favor the companies of the countries or of the regions where these standards were developed, unless they were developed by authoritative and broadly based international bodies. The ISO was to serve this role.

Tuesday, August 18, 2009

ISO 14001:2004 Audit Checklist

ISO 14001:2004 Audit Checklist

Environmental aspects in ISO 14001:2004 – What evidence exists that the organization has established, implemented and maintains (a) procedure(s) to identify the environmental aspects of its activities, products or services within the defined scope of the
Who was involved in determining aspects?
Were air emissions, posshible ground and surface water contamintation, landfill issues, use of natural resources, raw materials and energy considered as well as community issues such as noise, traffic and odor?
Are current, planned and modified activities considered? Look for potential aspects that have not been taken into consideration and ask why they were not considered. How are significant environmental aspects determined?

Does the decision making process take into consideration inputs and outputs, normal and abnormal operating conditions, start ups and shut downs, actual influences, potential influences and potential emergency situations, as well as those that are beneficial to the environment?
Does the decision making process take into consideration the amount of control and influence the organization has over its aspects? Look for procedures.
How/when are aspects reviewed and maintained; changes to processes, changes to regulations, introduction of new raw materials?
Does the documentation reflect this change?
Legal and other requirements – Has the organization established, implemented and do they maintain a procedure(s) to identify and have access to the applicable legal requirements and other requirements to which the organization subscribes, related to its environmental aspects and determined how these requirements apply to its environmental aspects?
What is the procedure regarding this requirement? How does the organization know what regulations and requirements they may be subject to? Do they subscribe to industry newsletters or websites? Do they have a third party environmental service monitor regulations for them and alert them as to any changes?
Is there a list of applicable rules and regulations?
Who is responsible for keeping this information updated and current?
Does the list include any voluntary standards?
How does the organization ensure it is complying with these regulations?
Speak with people in the organization to determine if they are aware of any regulations.
Did the organization consider national, international, state and local rules and regulations?
Does the organization have any agreements with public authorities, or with customers?
Do they subscribe to any voluntary guidelines or industry practices such as Responsible Care?
What process does the organization have for reviewing requirements to make sure they are current in the face of changing processes and business requirements?
Do regulations include such things as Federal Title V or Synthetic Minor, State Emissions Inventory and Permit Fee Program, Regulated Toxic Air Pollutants ENV-A 1400, SARA Title III Toxic chemical releases, SARA Title II Tier II report, Federal EPA clean water act, National Pollution Discharge Elimination systems (NPDES) and Storm water program permit?.
Check the organization’s objective and targets to determine if requirements are included. Was the selection of significant aspects based partially on applicable legal requirements and other requirements?
Objectives, targets and programs – Are the objectives and targets measurable, where practical, and consistent with the environmental policy, including the co mmitments to prevention of pollution, to compliance with applicable legal requirements and with other requirements to which the organization subscribes, and to continual improvement?
How does the organization develop objectives and targets? Who is responsible for developing them? What types of things were taken into consideration during development? Were reducing the creation of waste, reducing the release of specific elements to the air, reducing ground water contamination, reducing use of raw materials by reducing rework and scrap, taken into consideration? Was promoting awareness within
the organization and the surrounding community considered?
Do the objectives and targets reflect the vision of the EMS policy? Are they consistent with the policy?
Do they include commitments to the prevention of pollution and compliance with applicable rules, requirements and
regulations?
Have measurable targets been defined? If not, why not?
Are targets both short and long term?
What factors does the organization consider in setting objectives and targets? How are significant impacts considered? Are legal and other requirements, available technology, financial, operational and business requirements considered? Were interested parties involved in the development of objectives? If so, how?
How were objectives developed? Who participated in their development?
Has the organization established, implemented and does it maintain a program(s) for achieving its objectives and targets, including designation of responsibility for achieving objectives and targets at each relevant function and level of the organization and the means and time-frame by which they are to be achieved?
What plans have been developed to achieve objectives and targets? Do plans include responsibility for achieving the objectives and targets? Do plans reflect objectives and targets at lower levels of the organization? Does the plan include its own targets and timelines for reaching them?
Look at plans. Is there one for every objective and target? What happens when something doesn’t go
according to plan? Is corrective action taken?
How is management kept informed of the progress towards the targets?
How are employees informed of the progress towards the targets?
Look for graphs, information in newsletters, meeting minutes, and posters.
How does the organization plan to achieve objectives and targets?
Have responsibilities been defined?
Have time lines been defined?
How is progress monitored? Is it measurable?

Implementing ISO 9000 Quality Management System

Implementing 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.

Friday, August 14, 2009

ISO 9001-2008 Vs. ISO 9001-2000 - the New Requirements and a Comparison Between Them

Congratulations to all of us quality managers. We have a new standard. ISO 9001: 2008. This is really an exciting moment for quality managers. In order to celebrate this event in a way that only quality managers know how, I prepared here a comparison article between the ISO 9001:2000 and the new born ISO 9001:2008. I also included my comments regarding my experience and my perspective of things.
At the end of it I will summon the new requirements from the new ISO 9001:2008 standard. Paragraph number 0.1 - Changes here are a statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It's also clarified that these requirements are restricted to those applicable to the product.
Paragraph number 0.4 - There is a comment that state that the new standard is made due consideration to ISO 14001:2004.
My comment - Of course. The world is getting greener every day so they must remind you of the ISO 14001 standard. I believe and recommend to any organization that is needed of the ISO 14001 standard to implement also the 9001. There is a big correlation between these two. They actually help one another.
Paragraph number 1 - Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.
My comment - After so many years of auditions the long last debate had been settled. Statutory legal requirements and statutory requirements are obliged to the purchasing processes. It was always an open area that no one had the correct answer: is your supplier must follow the law or not? Apparently yes.
Paragraph number 2 - Normative reference - the ISO 9000 is now referred to ISO 9000:2005
Paragraph number 3 - Explanation about what is a customer and what is an organization and what is a supplier had been removed.
Paragraph number 4.1 - Clause a - The word "determine" is replacing the "identify". A note had been added stating that a purchased processes are regarded as purchasing products and another note that demand that these processes would be controlled as far as products. My comment - Come on, like it wasn't obvious before....
Paragraph number 4.2.1 - Slight change of words but when you examine the change you realize the meaning is the same. Note2 was changed - a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document. My comment - It's about time. A lot of headaches are vowed to be save. If your audit was one of the old school and demanded everything by the book - now you may combine two quality procedures to one document: Job description and training for example or you can split one document into two. How ever it is suitable for you as long as you provide the demands.
Paragraph number 4.2.3 - A clarification that external documentation are the ones needed for the quality management system.
Paragraph number 5.1 - Clause a - the word "statutory" had been added.
Paragraph number 5.5.2 - An addition for a demand that the management representative would be a member of the organization's management.
My comment - That addition puts all external consultants at risk - you can no longer be the management representative. That sets a whole new line of forms and documentations for you to develop in order that the external consultants would be considered as a management representative.
Paragraph number 6.2 - Change of words from "affecting product quality" to "affecting conformity to product requirements"
Paragraph number 6.2.2 - Clause b -"provide training or take other actions to satisfy these needs" changed to "where applicable training needs to be provided to achieve the necessary competence". My comment - It all goes back to defining .You defined what is necessary now you must provide it - nothing is new.
Clause c - you must ensure that the training is with competence rather than if it was an effective training.
My comment - On one hand it is an improvement. The training must be reviewed before. But I think it's not such an improvement. Instead of testing your employees if they got anything of the training you must now check the training itself before. Only time will tell...
Paragraph number 6.3 - Clause c - information systems are included. My comment - They are totally right!
Paragraph number 6.4 - A new note: noise, humidity, temperatures are part of a working environment.
My comment - That also puts an old debate aside. No longer can cruel owners of factories ignore these factors. Wait until they will combine OHSAS 18001...
Paragraph number 7.1 - Clause c - measurement had been added to the activities.
Paragraph number 7.2.1 - Clause a - change of words - not of the meaning. Clause c- the word 'applicable' replaces 'related'. Clause d - change of words - not of meaning. A note has been added to explain what is the meaning of "post delivery activities".
My comment - I agree with the "post delivery activities" - it wasn't clear enough for my opinion. Paragraph number 7.3.1 - A note had been added clarifying that design review, verification and validation are separated processes but they might be conducted together.
Paragraph number 7.3.3- A change of wording. A note had been added clarifying what is included in "preservation of product".
Paragraph number 7.5.3 - A requirement added specifying that product traceability must be included throughout the product realization.
My comment - That actually means that the product must be identifying not only on the shelves but also throughout the realization process.
Paragraph number 7.5.4 - A change of words to in the requirement to inform the customer of any problem regarding his property. The note had been amended that also personal data is included as customer's property.
Paragraph number 7.5.5 - A change of words: from "conformity of" to "in order to maintain conformity to requirements"
Paragraph number 7.6 - A change of words: from "devices" to "equipment" The reference to paragraph 7.2.1 had been removed. Clause c - from "be identified to enable the"to " identification to enable their"
Changes in the notes: Note 1 - the reference to ISO 100012-2 had been removed. Note 3 - explanation about when configuration of computer must be applied when the computer is used for monitor and measurements processes.
My comment - That means that from now on a computer that provides any kind of measurements services is considered a monitoring and measuring device. How can one calibrate a computer? Ask the supplier or your system administrator. They will know better than anyone.
Paragraph number 8.2.1 - A note had been added to suggest some means of conducting customer satisfaction evaluation.
Paragraph number 8.2.2- Requirements for the audit evidence and results had been added and also that the management is responsible for ensuring preventive and corrective action to be taken. The reference to the ISO 10011 is changed to ISO 19011.
Paragraph number 8.2.3 - A change of words: "to ensure conformity of the product" had been removed. A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.
Paragraph number 8.2.4 - A change of word: "maintain evidence of conformity with acceptance criteria" had been removed but it is still a requirement.
Paragraph number 8.3 - An addition - Clause d - specify how to deal with a nonconforming product that was discovered after delivery - but actually there nothing new only that they moved it to a new clause.
So, what are the new requirements of the new standard?
· Statutory requirements are given scale as any other legal or customer's requirements.
· The statutory requirements are including the suppliers as well.
· A purchased process is just like any other product that the organization purchased. If it's affecting the product it must be under the quality system.
· You may include two quality processes in one document and split one process to two documents.
· The management representative must be a member of the management.
· A requirement to ensure that trainings are suitable for the product in advance and not to check if the training was effective after it was taken.
· Information system in now officially considered as a substructure.
· Parameters such as humidity, noise and temperatures, concerning the employees' health are considered as working environment.
· Measuring is considered as one of the activities of product realization.
· The product must be identifying not only on the shelves but also throughout the realization process.
· The management is now responsible for preventive and corrective actions regarding nonconformities that were discovered during audit.
· The organization should determine the type of the monitoring and measuring according to the processes and how will this affect the quality management system.

Tuesday, August 11, 2009

Documenting a quality management system

The standard requires the organization to document a
quality management system in accordance with the
requirements of ISO 9001.

A document (according to ISO 9000 clause 2.7.1) is
information and its supporting medium. A page of
printed information, a CD ROM or a computer file is
a document, implying that recorded information is a
document and verbal information is not a document.
Clause 4.2 requires the management system doc-
umentation to include certain types of documents
and therefore does not limit the management system
documentation to the types of documents listed.

As a management system is the means to achieve
the organization’s objectives, and a system is a set of interrelated processes, it
follows that what has to be documented are all the processes that constitute the
system.

While there is a reduction in emphasis on documentation in ISO 9001:2008
compared with the 1994 version, it does not imply that organizations will need
less documentation to define their management system. What it does mean is
that the organization is left to decide the documentation necessary for effective
operation and control of its processes. If the absence of specific documentation
does not adversely affect operation and control of processes, such documenta-
tion is unnecessary.


Before ISO 9000 came along, organizations prospered without masses of
documentation and many still do. Those that have chosen not to pursue the
ISO 9000 path often only generate and maintain documents that have a useful

purpose and will not produce documents just for auditors unless there is a
legal requirement. Most of the documentation that is required in ISO 9000 came
about from hindsight – the traditional unscientific way organizations learn and
how management systems evolve.
ISO 9000 contains a list of valid reasons for why documents are necessary
and here is a list used in previous editions of this handbook.
To communicate requirements, intentions, instructions, methods and results
effectively
To convert solved problems into recorded knowledge so as to avoid having
to solve them repeatedly
To provide freedom for management and staff to maximize their contribu-
tion to the business
To free the business from reliance on particular individuals for its
effectiveness
To provide legitimacy and authority for the actions and decisions needed
To make responsibility clear and to create the conditions for self-control
To provide co-ordination for inter-departmental action
To provide consistency and predictability in carrying out repetitive tasks
To provide training and reference material for new and existing staff
To provide evidence to those concerned of your intentions and your
actions
To provide a basis for studying existing work practices and identifying
opportunities for improvement
To demonstrate after an incident the precautions which were taken or which
should have been taken to prevent it or minimize its occurrence
If only one of these reasons make sense in a particular situation, the
information should be documented. In some organizations, they take the
view that it is important to nurture freedom, creativity and initiative and
therefore feel that documenting procedures is counterproductive. Their view
is that documented procedures hold back improvement, forcing staff to
follow routines without thinking and prevent innovation. While it is true that
blindly enforcing procedures that reflect out-of-date practices coupled with
bureaucratic change mechanisms is counter productive, it is equally short-
sighted to ignore past experience, ignore decisions based on valid evidence
and encourage staff to reinvent what were perfectly acceptable methods.
Question by all means, encourage staff to challenge decisions of the past, but
encourage them to put forward a case for change. That way it will cause
them to study the old methods, select the good bits and modify the parts that
are no longer appropriate. It is often said that there is nothing new under thesun – just new ways of packaging the same message.

Criteria and methods for effective operation and control

The criteria that ensure effective operation are the standard operating
conditions, the requirements or success criteria that need to be met for the
process to fulfil its objectives.
The methods that ensure effective operation are those regular and systematic
actions that deliver the required results. In some cases the results are depend-
ent upon the method used and in other cases, any method might achieve the
desired results. Use of the word ‘method’ in this context is interesting. It
implies something different than had the standard simply used the word
‘procedure’. Procedures may cover both criteria and methods but have often
been limited to a description of methods. Methods are also ways of
accomplishing a task that are not procedural. For example, information may be
conveyed to staff in many ways – one such method might be an electronic
display that indicates information on calls waiting, calls completed and call
response time. The method of display is not a procedure although there may be
an automated procedure for collecting and processing the data.


A process that is operating effectively delivers the required outputs of the
required quality, on time and economically, while meeting the policies and
regulations that apply to the process. A process that delivers the required
quantity of outputs that do not possess the required characteristics, are
delivered late, waste resources and breach policy and safety, environmental or
other regulations is not effective. It is therefore necessary to determine the
criteria for the acceptability of the process inputs and process outputs and the
criteria for acceptable operating conditions. Thus it is necessary to ascertain the
characteristics and conditions that have to exist for the inputs, operations andoutputs to be acceptable.


In order to determining the criteria for effective operation and control you need
to identify the factors that affect success. Just ask yourself the question: What
are the factors that affect our ability to achieve the required objectives? In a
metal machining process, material type and condition, skill, depth of cut, feed
and speed affect success. In a design process input requirement adequacy,
designer competency, resource availability and data access affect success. In an
auditing process, objectives, method, timing, auditor competency, site access,
data access and staff availability affect success. In a computer activated
printing process, the critical factor may be the compatibility of the input data
with the printer software, the format of the floppy disk and the resolution of
the image. There are starting conditions, running conditions and shutdown
conditions for each process that need to be specified. Get any one of these
wrong, and whatever the sequence of activities, the desired result will not be
achieved.
Determining the methods can mean determining the series of actions to
deliver the results or simply identifying a means to do something. For example
there are various methods of control:
Supervisors control the performance of their work groups by being on the
firing line to correct errors.
Automatic machines control their output by in-built regulation.
Manual machines control their output by people sensing performance and
taking action on the spot to regulate performance.
Managers control their performance by using information.
The method is described by the words following the word ‘by’ as in the above
list. A method of preventing failure is by performing a Failure Mode and

Effects Analysis (FMEA). You don’t have to detail how such an analysis is
performed to have determined a method. However, in order to apply the
method effectively, a procedure may well be needed. The method is therefore
the way the process is carried out which together with the criteria contributes
to the description of the process.

Quality in ISO 9001

We all have needs, wants, requirements and expectations. Needs are essential
for life, to maintain certain standards, or essential for products and services, to
fulfil the purpose for which they have been acquired. According to Maslow
(Maslow, Abraham H., 1954)1 , man is a wanting being; there is always some
need he wants to satisfy. Once this is accomplished, that particular need no
longer motivates him and he turns to another, again seeking satisfaction.
Everyone has basic physiological needs that are necessary to sustain life. (Food,
water, clothing, shelter). Maslow’s research showed that once the physiological
needs are fulfilled, the need for safety emerges. After safety come social needs
followed by the need for esteem and finally the need for self-actualization or
the need to realize ones full potential. Satisfaction of physiological needs isusually associated with money – not money itself but what it can buy.

These needs are fulfilled by the individual purchasing, renting or leasing
products or services. Corporate needs are not too dissimilar. The physiological
needs of organizations are those necessary to sustain survival. Often profit

comes first because no organization can sustain a loss for too long but
functionality is paramount – the product or service must do the job for which
it is intended regardless of it being obtained cheaply. Corporate safety comes
next in terms of the safety of employees and the safety and security of assets
followed by social needs in the form of a concern for the environment and the
community as well as forming links with other organizations and developing
contacts. Esteem is represented in the corporate context by organizations
purchasing luxury cars, winning awards, badges such as ISO 9000, superior
offices and infrastructures and possessing those things that give it power in
the market place and government. Self-actualization is represented by an
organization’s preoccupation with growth, becoming bigger rather than better,
seeking challenges and taking risks. However, it is not the specific product or
service that is needed but the benefits that possession brings that is important.
This concept of benefits is most important and key to the achievement of
quality.
Requirements are what we request of others and may encompass our needs
but often we don’t fully realize what we need until after we have made our
request. For example, now that we own a mobile phone we discover we really
need hands-free operation when using the phone while driving a vehicle. Our
requirements at the moment of sale may or may not therefore express all our
needs. By focusing on benefits resulting from products and services, needs can
be converted into wants such that a need for food may be converted into a
want for a particular brand of chocolate. Sometimes the want is not essential
but the higher up the hierarchy of needs we go, the more a want becomes
essential to maintain our social standing, esteem or to realize our personal
goals. Our requirements may therefore include such wants – what we would
like to have but are not essential for survival.
Expectations are implied needs or requirements. They have not been requested
because we take them for granted – we regard them to be understood within
our particular society as the accepted norm. They may be things to which we
are accustomed, based on fashion, style, trends or previous experience. One

therefore expects sales staff to be polite and courteous, electronic products to be
safe and reliable, policemen to be honest, coffee to be hot etc. One would like
politicians to be honest but in some countries we have come to expect them to
be corrupt, dishonest or at least, economical with the truth!
In supplying products or services there are three fundamental parameters
that determine their saleability. They are price, quality and delivery. Customers
require products and services of a given quality to be delivered by or be
available by a given time and to be of a price that reflects value for money.
These are the requirements of customers. An organization will survive only if
it creates and retains satisfied customers and this will
only be achieved if it offers for sale products or
services that respond to customer needs and expecta-
tions as well as requirements. While price is a
function of cost, profit margin and market forces, and
delivery is a function of the organization’s efficiency
and effectiveness, quality is determined by the extent
to which a product or service successfully serves the
purposes of the user during usage (not just at the
point of sale). Price and delivery are both transient features, whereas the
impact of quality is sustained long after the attraction or the pain of price and
delivery has subsided.

The word quality has many meanings:
A degree of excellence
Conformance with requirements
The totality of characteristics of an entity that bear on its ability to satisfy
stated or implied needs
Fitness for use
Fitness for purpose
Freedom from defects imperfections or contamination
Delighting customers
These are just a few meanings; however, the meaning used in the context of ISO
9000 was concerned with the totality of characteristics that satisfy needs but in
the 2000 version this has changed. Quality in ISO 9000 :2000 is defined as the
degree to which a set of inherent characteristics fulfils requirements. The
former definition focused on an entity that was described as a product or
service but with this new definition, the implication is that quality is relative to
what something should be and what it is. The something maybe a product,
service, decision, document, piece of information or any output from a process.
In describing an output, we express it in terms of its characteristics. To
comment on the quality of anything we need a measure of its characteristics
and a basis for comparison. By combining the definition of the terms quality

and requirement in ISO 9000 :2000, quality can be expressed as the degree to which
a set of inherent characteristics fulfils a need or expectation that is stated, generally
implied or obligatory.
Having made the comparison we can still assess whether the output is
‘fitness for use’. In this sense the output may be of poor quality but remain fit
for use. The specification is often an imperfect definition of what a customer
needs; because some needs can be difficult to express clearly and it doesn’t
mean that by not conforming, the product or service is unfit for use. It is also
possible that a product that conforms to requirements may be totally useless.
It all depends on whose requirements are being met. For example, if a company
sets its own standards and these do not meet customer needs, its claim to
producing quality products is bogus. On the other hand, if the standards are
well in excess of what the customer requires, the price tag may well be too high
for what customers are prepared to pay – there probably isn’t a market for a
gold-plated mousetrap, for instance, except as an ornament perhaps!

Monday, August 10, 2009

ISO 14001 STANDARD

ISO 14001 is in fact a series of international standards on environmental management. It provides a framework for the development of an [url=htttp://www.iso9001store.com/]environmental management system[/url] and the supporting audit programme.
The ISO 14001 series emerged primarily as a result of the Uruguay round of the GATT negotiations and the Rio Summit on the Environment held in 1992. While GATT concentrates on the need to reduce non-tariff barriers to trade, the Rio Summit generated a commitment to protection of the environment across the world.
After the rapid acceptance of ISO 9000, and the increase of environmental standards around the world, the International Standards Organisation (ISO) assessed the need for international environmental management standards. They formed the Strategic Advisory Group on the Environment (SAGE) in 1991, to consider whether such standards could serve to:
Promote a common approach to environmental management similar to quality management;Enhance organizations’ ability to attain and measure improvements in environmental performance; andFacilitate trade and remove trade barriers.In 1992, SAGE’s recommendations created a new committee, TC 207, for international environmental management standards. This committee and its sub-committees included representatives from industry, standards organizations, government and environmental organizations from many countries. What developed was a series of ISO14000 standards designed to cover:
-environmental management systems-environmental auditing-environmental performance evaluation-environmental labelling-life-cycle assessment-environmental aspects in product standards
ISO 14001 was first published as a standard in 1996 and it specifies the actual requirements for an environmental management system. It applies to those environmental aspects over which an organization has control and where it can be expected to have an influence.
ISO 14001 is often seen as the corner-stone standard of the ISO 14000 series. It specifies a framework of control for an Environmental Management System and is the only ISO 14000 standard against which it is currently possible to be certified by an external certification body. However, it does not in itself state specific environmental performance criteria.

IS0 14001 HISTORICAL DEVELOPMENT

Firstly ISO 14000 environment system standards was prepared in June of 1992 year in Rio at world apex and this standard brooks decisions of this world apex and Rio contract principles. After 1 year, ISO established one technique committee which is yielded by 50 different country representatives to prepare international environment management system in 1993 year. ISO 14001 environment management system standard was issued in September of 1996 year with works of this committee. ISO 14001 standard is used as voluntary now but ISO 14001 will be burden by coercions of societies, international organizations, states in the future. Levels which environment management system passed are the following briefly:
= Europe community countries issued I action plan in 1973 year (to practice protecting preventions of environment )= BS 7750 Standard in 1992= Rio Declaration in 1992 year= ISO/TC 207. Environmental management technique committee was established in 1993 year to develop ISO 14000 family standards= TS 9719 standard (environment management system – General features) in 1994 year= ISO 14001 standard in 1996 year= ISO 14001 current version in April of 2005 Nisan 2005
The www.iso9001store.com website provided the software very helpful to my company.

Identification of environmental aspects and impacts

An organization’s policy, objectives and targets should be based on knowledge about the environmental aspectsand significant environmental impacts associated with its activities, products or services. This can ensure that thesignificant environmental impacts associated with these aspects are taken into account in setting the environmentalobjectives. The relation between environmental aspects and impacts is one of cause and effect. An environmentalaspect refers to an element of an organization’s activity, which can have a beneficial or adverse effect on theenvironment. For example, it could involve a discharge, an emission, consumption or reuse of a material, ornoise. An impact refers to the change which takes place in the environment as a result of the aspect. Examples ofimpacts might include contamination of water or depletion of a natural resource.
The identification of environmental aspects and the evaluation of environmental impacts is a process that can bedealt with in four steps:
Step 1: Select an activity or process. (The selected activity or process should be large enough for meaningfulexamination and small enough to be sufficiently understood.)
Step 2: Identify environmental aspects of the activity product or service. (Identify as many environmental aspectsas possible associated with the selected activity or process.)
Step 3: Identify environmental impacts. (Identify as many actual and potential, positive and negative,environmental impacts as possible associated with each identified aspect.)

Templates for Quality Manuals and Forms

Using templates for ISO 9001 quality manuals, procedures and forms can have huge benefits for an organization. Templates are usually in the form of existing and proven manuals, procedures and forms. Follow the link for more information on the use of Templates.
The ISO 9000 quality manual and the ISO 9000 quality procedures are a vital part of any ISO 9001 quality system.
You can get a huge head start by purchasing a good template quality manual (a sample quality manual that you can
use as a good example and that you can modify to make it your own quality manual). There are numerous
companies that sell ISO 9000 quality manuals that you can use as templates to create your own quality manual.
We urge you to carefully evaluate them before making a purchase decision as we found the majority to be
convoluted, bureaucratic and cumbersome.

ISO 14001:2004 Audit Checklist

Environmental aspects – What evidence exists that the organization has established, implemented and maintains (a) procedure(s) to identify the environmental aspects of its activities, products or services within the defined scope of the
Who was involved in determining aspects?
Were air emissions, posshible ground and surface water contamintation, landfill issues, use of natural resources, raw materials and energy considered as well as community issues such as noise, traffic and odor?
Are current, planned and modified activities considered? Look for potential aspects that have not been taken into consideration and ask why they were not considered. How are significant environmental aspects determined?

Does the decision making process take into consideration inputs and outputs, normal and abnormal operating conditions, start ups and shut downs, actual influences, potential influences and potential emergency situations, as well as those that are beneficial to the environment?
Does the decision making process take into consideration the amount of control and influence the organization has over its aspects? Look for procedures.
How/when are aspects reviewed and maintained; changes to processes, changes to regulations, introduction of new raw materials?
Does the documentation reflect this change?
Legal and other requirements – Has the organization established, implemented and do they maintain a procedure(s) to identify and have access to the applicable legal requirements and other requirements to which the organization subscribes, related to its environmental aspects and determined how these requirements apply to its environmental aspects?
What is the procedure regarding this requirement? How does the organization know what regulations and requirements they may be subject to? Do they subscribe to industry newsletters or websites? Do they have a third party environmental service monitor regulations for them and alert them as to any changes?
Is there a list of applicable rules and regulations?
Who is responsible for keeping this information updated and current?
Does the list include any voluntary standards?
How does the organization ensure it is complying with these regulations?
Speak with people in the organization to determine if they are aware of any regulations.
Did the organization consider national, international, state and local rules and regulations?
Does the organization have any agreements with public authorities, or with customers?
Do they subscribe to any voluntary guidelines or industry practices such as Responsible Care?
What process does the organization have for reviewing requirements to make sure they are current in the face of changing processes and business requirements?
Do regulations include such things as Federal Title V or Synthetic Minor, State Emissions Inventory and Permit Fee Program, Regulated Toxic Air Pollutants ENV-A 1400, SARA Title III Toxic chemical releases, SARA Title II Tier II report, Federal EPA clean water act, National Pollution Discharge Elimination systems (NPDES) and Storm water program permit?.
Check the organization’s objective and targets to determine if requirements are included. Was the selection of significant aspects based partially on applicable legal requirements and other requirements?
Objectives, targets and programs – Are the objectives and targets measurable, where practical, and consistent with the environmental policy, including the co mmitments to prevention of pollution, to compliance with applicable legal requirements and with other requirements to which the organization subscribes, and to continual improvement?
How does the organization develop objectives and targets? Who is responsible for developing them? What types of things were taken into consideration during development? Were reducing the creation of waste, reducing the release of specific elements to the air, reducing ground water contamination, reducing use of raw materials by reducing rework and scrap, taken into consideration? Was promoting awareness within
the organization and the surrounding community considered?
Do the objectives and targets reflect the vision of the EMS policy? Are they consistent with the policy?
Do they include commitments to the prevention of pollution and compliance with applicable rules, requirements and
regulations?
Have measurable targets been defined? If not, why not?
Are targets both short and long term?
What factors does the organization consider in setting objectives and targets? How are significant impacts considered? Are legal and other requirements, available technology, financial, operational and business requirements considered? Were interested parties involved in the development of objectives? If so, how?
How were objectives developed? Who participated in their development?
Has the organization established, implemented and does it maintain a program(s) for achieving its objectives and targets, including designation of responsibility for achieving objectives and targets at each relevant function and level of the organization and the means and time-frame by which they are to be achieved?
What plans have been developed to achieve objectives and targets? Do plans include responsibility for achieving the objectives and targets? Do plans reflect objectives and targets at lower levels of the organization? Does the plan include its own targets and timelines for reaching them?
Look at plans. Is there one for every objective and target? What happens when something doesn’t go
according to plan? Is corrective action taken?
How is management kept informed of the progress towards the targets?
How are employees informed of the progress towards the targets?
Look for graphs, information in newsletters, meeting minutes, and posters.
How does the organization plan to achieve objectives and targets?
Have responsibilities been defined?
Have time lines been defined?
How is progress monitored? Is it measurable?

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ISO 9001:2008 Documentation Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
ISO 9001:2008 Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual
documented procedures required by this International Standard
documents needed by the organization to ensure the effective planning, operation and control of its processes, and
records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:- Quality policy (clause 4.2.1.a)- Quality objectives (clause 4.2.1.a)- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:- Process maps, process flow charts and/or process descriptions- Organization charts- Specifications- Work and/or test instructions- Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.