The ISO 9000 standards are a set of international quality management standards and guidelines. Since their initial publication in 1987, they have earned a global reputation as the basis for establishing Quality Management Systems (QMS).Three of the current standards, ISO 9001, 9002 and 9003, have been used extensively as the basis for independent (third party) quality system certification. Current estimates cite 200,000 companies registered worldwide to an ISO 9000 Quality assurance standard. Experts predict that additional 350,000 organizations will be registered by the year 2000. The actual and forecasted figures both suggest that ISO 9000 has become the de facto world standard for quality management.
Since ISO protocols require that all standards be reviewed at least every five years to determine whether they should be confirmed, revised or withdrawn, the 1994 versions of the ISO 9000 family are currently being revised by ISO’s Technical Committee TC 176, for publication in the year 2000.
The current ISO 9000 family, which comprises over 20 standards, will be reduced to 3 quality management systems standards only:
ISO 9000:2000 (QMS – Fundamentals and vocabulary)
ISO 9001:2000(QMS – Requirements)
ISO 9004:2000(QMS – Guidance for performance improvement)
These will be complemented by a small number of additional standards, technical reports and/or brochures to address specific issues.
There will only be one QMS requirement standard – ISO 9001, which will replace the current ISO 9001, ISO 9002 and ISO 9003. ISO 9004 will be the QMS standard which will drive organizations towards business performance improvement and will form a consistent pair with ISO 9001 with the same sequence and numbering. The standards will be compatible with the environmental management standards, will be readily applied to small, medium and large organisations in the public and private sectors, and equally applicable to users in manufacturing, service and software fields.
The new standard will provide familiar core attributes of TQM, Baldridge, QS-9000 and an overall business orientation that will bring the Quality System clauses into a new process structure. The new ISO 9001 is being developed based on a process model using eight quality management principles facilitating an evolution towards business excellence and with an emphasis on customer satisfaction. ISO 9004 uses the same process model and quality management principles, but has an emphasis on satisfying the needs of other interested parties through sustained customer satisfaction.
The revision reflects the evolving quality management practice but retains the essential elements of the current (1994) edition. It will have improved compatibility with the ISO 14000 Environmental Management System series of standards and will also reduce its manufacturing sector orientation. The proposed ISO 9000:2000 standard is, therefore, a very significant revision to the ISO 9000 family of standards.
2. The reason and the process of the revision
3.1 The reason of the revision
The main reason for the year 2000 revision to the ISO 9000 standards is to give users the opportunity to add value to their activities and to improve their performance continually by focussing on the major processes within the organization.
Extensive surveys have been performed on a worldwide basis to understand the needs of all users of the quality management system standards. The new revisions will take into account previous experience with quality management system standards (1987 and 1994 revisions) and emerging insights into generic management systems. They will result in a closer alignment of the quality management system with the needs of the organization and reflect the way those organizations run their business activities.
ISO directives also specify that standards be periodically revised to ensure that those standards are current and satisfy the needs of the global community.
The major reasons for the year 2000 revisions of the standards include emphasizing the need to measure customer satisfaction, meeting the need for more user-friendly documents, assuring consistency between quality management system requirements and guidelines, and incorporating generic quality management principles into organizations.
2.2 The process of the revision
The revision process is the responsibility of ISO’s Technical Committee TC-176, and is conducted on the basis of consensus among quality experts from member countries around the world. For the “Year 2000” revision, TC-176 has adopted a project management approach in order to cope with the complexity of the task. Initial project specifications and goals were established after extensive user surveys had been carried out, to determine needs and expectations for the new revisions. Furthermore an essential part of the revision will be the user verification and validation process, which should ensure that the standards produced, will actually respond to user needs.
The work of the committee has resulted in drafts which are in the process of being commented on by the TC 176 member countries.
The project schedule is currently as follows, enabling further comments to be made:
4th quarter 1997 – 1st Working Draft (WD1) for use by TC-176 WG18 (complete)
1st quarter 1998 – 2nd Working Draft (WD2) for use by TC-176 WG18 (complete)
2nd quarter 1998 – 3rd Working Draft (WD3) for use by TC-176 WG18 (complete)
3rd quarter 1998 – Committee Draft (CD1) issued for comment by Member Countries (complete)
1st quarter 1999 – Committee Draft (CD2) issued for vote by TC-176 Member Countries (complete)
4th quarter 1999 – Draft International Standard (DIS) for vote by Member Countries (complete)
3rd quarter 2000 – Publication of Final Draft International Standard (FDIS)
4th quarter 2000 – Publication of International Standard (ISO)
Changes to the detailed content of the standards are possible during the revision process (prior to the “DIS” phase), and it is for this reason that organisations are recommended not to act prematurely based on speculation as to what the new standards may or may not require.
3. The changes of the ISO 9000:2000 version
3.1 The system process model
The revision of the ISO quality management standards includes a significant change to the structure of ISO 9001 and ISO 9004, which, while retaining the essence of the original requirements, will reposition the 20 elements of the current ISO 9001:1994 and the guidelines of ISO 9004-1:1994 into four main sections: (Refer to Appendix I Correspondence list of ISO 9000:1994 and ISO9000:2000.)
* Management responsibility
(Policy, objectives, planning, system, review)
* Resource management
(Human resources, information, facilities)
* Product realization
(Customer, design, purchasing, production, calibration)
* Measurement, analysis and improvement
(Audit, process/product control, improvement)
The standard is being rewritten around the business process model that looks more like how businesses actually operate. And there is a more logical sequence of requirements and guidelines due to the process orientation of the new standards. The new system process model can be shown as below:
Figure 1, System process model
3.2 The change to the ISO family
Another significant modification to ISO 9000:2000 will be its consolidated quality management systems requirements. The three former “registration” standards – ISO 9001, ISO 9002, and ISO 9003 – will be brought together in the single revised ISO 9001 Standard, known as ISO 9001:2000 Quality Management Systems – Requirements. Its title will no longer refer to quality assurance. The purpose of this revised standard will be to provide confidence, as a result of demonstration, in product conformance to established requirements. ISO 9001 will continue to provide the basis for the certification of organizations but because of its more generic language should be more readily applicable to such diverse sectors as hardware, software, processed materials and services.
The revision will also significantly enhance the scope of the new ISO 9004 (Quality Management Systems- Guidance for Performance Improvement) standard which again will be the focus for consolidation of a number of current individual standards. An analysis of user needs for this standard indicates that it should provide guidelines that go beyond ISO 9001 requirements and should provide a foundation for the establishment of a complete Quality Management System. The latest draft of ISO 9004 includes informative guidelines to self-assessment. Nevertheless, the revised ISO 9001 and 9004 will be presented and used as a consistent and coordinated pair of documents. The most apparent change will be a common structure for the two standards based on a Process Model and the use of the four main clause headings discussed above.
Current ISO 9000 family of quality standards contains over twenty other standards and documents. This proliferation of standards has been a particular concern of ISO 9000 users and customers. ISO/TC 176 had decided that the other standards and documents in the ISO 9000 family will either be withdrawn or replaced by technical reports (with the exception of ISO 10011 and ISO 10012). To the maximum extent possible, the key points in the other standards and documents (and sector-specific needs) will be integrated into the three primary standards.
3.3 The principles and new requirements
The scope of the ISO 9001:2000 standard can be stated as: “To provide demonstration of the capability to provide conforming product and/or service ” as well as “…achieving customer satisfaction by meeting or exceeding customer requirements…”. Although the 1994 ISO 9000 standard was aimed at preventing nonconformities at all stages, it did not explicitly state requirements for achieving continuous improvement and customer confidence and satisfaction. The revised standard will, however, respond to the need for explicit requirements and guidance on achieving customer satisfaction and continuous improvement. .
The revisions of ISO 9001 and 9004 are based on eight quality management principles that reflect best management practices.
The eight quality management principles are:
* Customer – focused organisation
* Involvement of people
* Process approach
* System approach to management
* Continual improvement
* Factual approach to decision making
* Mutually beneficial supplier relationships
3.3.1 Top management
More emphasis has been placed on the role of top management, which includes its commitment to the development and improvement of the quality management system, with a customer focus, consideration of legal and regulatory requirements, and establishment of measurable objectives at relevant functions and levels.
3.3.2 Continual Improvement
This concept of Continual Improvement is one of the new additions to the old standard’s requirements. The 1994 standards’ Customer Complaint, Self-Audit, and Corrective and Preventive Action components are pointed in the direction of continual improvement, but now it will be a fundamental theme. This enhancement, as anticipated, into ISO 9001, defining a complete cycle, is intended to help an organization respond to the changing needs of its customers, while stimulating the efficiency of the organization and improving its competitive position.
3.3.3 Customer Satisfaction
Another new item that has been introduced into ISO 9001:2000 is the requirement for the organization to monitor information on customer satisfaction and/or dissatisfaction as a measure of system performance. “Customer satisfaction” is recognized as one of the driving criteria for any organisation. Improvements can be made by taking action to address any identified issues and concerns.
The concept of customer satisfaction as a metric for quality system performance is a scoring criterion for the U.S. Government’s coveted Malcolm Baldrige Award for excellence in quality management, and a fundamental feature of most modern quality management system models. The intent being that organizations will have meaningful dialog with their customers and monitor processes so that both continual improvement and customer satisfaction are achieved.
3.4 other changes
3.4.1 Permissible Exclusions
ISO/DIS 9001:2000 now includes a clause entitled “Permissible exclusions”. This clause will allow organizations to formally ‘exclude’ certain non-applicable requirements of the future ISO 9001 standard, yet still claim conformance to it. Only those organizations that can demonstrate that the nature of their products, or customer and applicable regulatory requirements, mean that they do not need to meet the full requirements of the future ISO 9001, will be permitted to invoke these exclusions. For example, organizations whose products require no design activities (and who might currently seek certification to ISO 9002:1994) may be able to claim compliance to ISO 9001:2000 by excluding the requirements for design and/or development.
The 1994 standard contains a single paragraph (220.127.116.11) that refers to the requirement for management to provide necessary resources to support the Quality System. The new standard will place more emphasis on the need to provide and make available specific types of resources. Requirements now include evaluation of the effectiveness of training, provision of relevant information, internal and external communication, facility needs, and human and physical factors of the work environment.
ISO/DIS 9000:2000 now includes a description of the basic approach to quality management adopted by the drafts (the ‘fundamentals’) as well as including a revised vocabulary to reflect the usage of new and revised terms and associated definitions in ISO/DIS 9001 and ISO/DIS 9004. For example, the definition of “quality” has been revised. In developing the terms and definitions, the concept diagram approach (as defined in International Standards produced by ISO/TC 37) has been more rigorously applied.
The most important changes concern the use of the term “organization” instead of “supplier”, still used in the current standards, and the use of the term “supplier” instead of “subcontractor”. These changes respond to the need of being more consistent and friendly with the normal use and meaning of the words.
The number of requirements for documented procedures has been reduced in ISO 9001:2000, and the emphasis placed on the organization demonstrating effective operation.
3.4.5 Compatibility with ISO14000
The revised ISO 9001 is being developed to have enhanced compatibility with ISO 14001- the environmental management system standard, particularly with regard to terminology and content. There is close collaboration between the technical experts of ISO/TC176 and TC207.
A recent review of ISO 14001 and ISO 14004 by ISO/TC 207/SC1 has led to the initiation of a revision of those standards. This will provide the opportunity for further enhancement of the compatibility between the ISO 9000 and ISO 14000 standards.
3.4.6 Other changes
Other detailed changes of a less strategic nature are also being studied, wherever possible with the intention to simplify or clarify requirements of the existing standards, and to make them more “user-friendly”.
The considerations of the benefits and needs of all interested parties and the legal and regulatory requirements are also the new features of the ISO9000:2000 version.
4. The effectiveness and efficiency of the ISO 9000:2000 version
4.1 Effectiveness of the ISO 9000:2000
ISO/DIS 9001:2000 is focused towards “providing confidence, as a result of demonstration, in product conformance to established requirements”.
ISO/DIS 9004:2000 is focused towards providing “benefits for all interested parties through sustained customer satisfaction”.
By demonstrating to organizations that the process of certification based on the new ISO 9000 standards adds value to their own business goals, a market wide improvement in the perception of ISO 9001 certification should be developed.
The rationale behind the revision process places great emphasis on making quality management systems closer to the processes of the organization, and on continual improvement. As a result, the revised standards (ISO 9001:2000 and ISO 9004:2000) are directed to the achievement of business results, including satisfaction of customers and others.
There is confidence that management of the organization will be able to adopt the quality management system standards not only for certification purposes, but also as a profitable investment.
4.2 The fitness for specific business sectors
The text of ISO 9001:2000 will be more generic than the 1994 version to be applicable to different types of product (including services) and to organizations of different sizes. Due to this generic nature it may be that some industrial or commercial sectors will identify additional requirements to attend to their specific needs.
To assure consistency between the ISO 9000 requirements and sector requirements, a pilot study is being conducted using the development of an automotive industry document as the test vehicle. The pilot project has successfully achieved the publication of an ISO technical specification. The full results of the pilot scheme, and the working methods employed, will be reviewed in due course. Other industry sectors (e.g. aerospace, telecommunications) have already indicated their wish to develop similar documents.
4.3 The efficiency of the ISO 9000:2000
ISO 9001:2000 aims at guaranteeing the effectiveness (and not the efficiency) of the organization. For improved organizational efficiency, however, the best results can be obtained by using the new ISO 9004:2000 in addition to ISO 9001:2000. The guiding quality management principles are intended to assist an organization in continual improvement, which should lead to efficiencies throughout the organization.
Continual improvement is the process focussed on continually increasing the effectiveness and/or efficiency of the organization to fulfill its policies and objectives. Continual improvement (where “continual” highlights that an improvement process requires progressive consolidation steps) responds to the growing needs and expectations of the customers and ensures a dynamic evolution of the quality management system.
“Customer satisfaction” is recognized as one of the driving criteria for any organization. In order to evaluate if the product and/or service meet customer needs and expectations, it is necessary to measure the extent of customer satisfaction and/or dissatisfaction. The quality management system described in the revised standard is based on quality management principles that include the process approach and customer focus. The adoption of these principles should provide customers with a higher level of confidence that the product (including service) meets their needs and increases their satisfaction.
4.4 The benefits of the revised version
There are a number of major benefits with the revised quality management systems standards. The benefits are:
* Applicability to all product categories, in all sectors and to all sizes of organizations
* Simple to use, clear in language, readily translatable, and easily understandable
* Significant reduction in the amount of required documentation.
* Connection of quality management systems to organizational processes
* Provision of a natural move towards improved organizational performance
* Greater orientation toward continual improvement and customer satisfaction
* Compatibility with other management systems such as ISO 14000
* Provision of a consistent basis to address the needs and interests of organizations in specific sectors (e.g. medical devices, telecommunications, automotive, etc)
* The concept of the consistent pair – ISO 9001 covering the requirements and ISO 9004 for going beyond the requirements in order to further improve the performance of the organization.
* Consideration of the needs of and benefits to all interested parties.
If the system is appropriately implemented, utilising the eight Quality Management Principles, all the interested parties will benefit from ISO 9004.
* Customers and users will benefit by receiving the products that are: conforming to the requirements; dependable and reliable; available when needed; and maintainable.
* People in the organization will benefit by: better working conditions; increased job satisfaction; improved health and safety; improved morale; and improved stability of employment.
* Owners and investors will benefit by: increased return on investment; improved operational results; increased market share; and increased profits.
* Suppliers and partners will benefit by: stability, growth; partnership and mutual understanding.
* Society will benefit by: fulfillment of legal and regulatory requirements; improved health and safety; reduced environmental impact; increased security.
The upcoming revisions will caution organizations against implementing change in the absence of a structured process for managing information/useful data. Organizations will need to redefine their concept of information and reevaluate what, where, when, why, how and by whom information is captured, organized/integrated, analyzed, validated and disseminated within their organization, according to the ISO 9000:2000 requirements and/or guidelines. Thus, the new vision for the next revision will not only encompass issues relating to continuous improvement and customer confidence and satisfaction, but it will also embed these issues into its own purpose, presentation and structure.
With the addition of clause 6.3.1, ISO 9001:2000 evolves beyond 4.5-document and data control, extending the previous framework, and effectively establishing basic requirements for much needed information and knowledge management standards. Managing information/useful data may function effectively, in some simple cases, using a paper-based application. However, in more complex situations paper based systems lack the efficiency of an electronic quality management system. An electronic system will, not only capture, organize, integrate, analyze, validate and disseminate useful data effectively and efficiently, but is also capable of producing a multi-dimensional global view of the organization’ s information. Thus, properly implemented, the new standard will provide organizations worldwide with requirements and guidelines for strategic, effective, and efficient quality management system in the new millennium.
References and bibliographies
1) http://www.tc176.org ISO/TC176
2) http://www.bsi.org.uk/iso-tc176-sc2 ISO/TC176/SC 2
3) http://www.bywater.co.uk/iso9000.2000.htm Bywater ISO 9000:2000 page
4) http://www.bsi.org.uk/iso-tc176-sc2/ ISO 9000:2000 Work Group Home Page
Standards Australia ISO 9000:2000 page
System Corp / Harrington Article
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8) http://www.amsup.com/PUB/content.html ASI Press – SPC, QFD, Deming,
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14) http://www.access.gpo.gov/nara/index.html Federal Register (US)
15) http://www.connect.ab.ca/~praxiom/ ISO 9000 in plain English