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)
(Human resources, information, facilities)
(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
- Leadership
- 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.
3.4.2 Resources
The 1994 standard contains a single paragraph (4.1.2.2) 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.
3.4.3 Terminology
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.
3.4.4 Documentation
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.
5. Conclusion
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
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http:// ISO/TC176
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http:// ISO/TC176/SC 2
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Bywater ISO 9000:2000 page
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http://www.bsi.org.uk/iso-tc176-sc2/ ISO 9000:2000 Work Group Home Page
-
http://www.standards.com.au/standardization/quality/default.htm
Standards Australia ISO 9000:2000 page
-
http://www.systemcorp.com/iso2000/executive_brief.html
System Corp / Harrington Article
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AQA - ISO 9000, ISO 14000, QS-9000
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http://www.amsup.com/PUB/content.html ASI Press - SPC, QFD, Deming,
Taguchi
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http://www.cancom.com/ Canon Communications - quality
publications, trade shows
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http://global.ihs.com/ Global Engineering Documents
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http://www.iso.ch/infoe/catinfo.html ISO Catalog
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http://www.qualitycoach.net/ QualityCoach.net
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http://www.asq.org/ ASQ - American Society for Quality
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http://www.access.gpo.gov/nara/index.html Federal Register (US)
-
http://www.connect.ab.ca/~praxiom/ ISO 9000 in plain English
-
http://www.tqnet.com/ Total Quality Net
Appendix I
Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994
Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994 –continued
Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994 - continued
Appendix II Contents of ISO 9000:2000
0. INTRODUCTION
0.1 General
0.2 Process Model
0.3 Compatibility With Other Management System Disciplines
1. SCOPE
1.1 General
1.2 Reduced Scope and Tailoring
1.2.1 General
1.2.2 Reduced Scope - Design and Development excluded
1.2.3 Tailoring
2. NORMATIVE REFERENCE
3. TERMS AND DEFINITIONS
4. QUALITY MANAGEMENT SYSTEM REQUIREMENTS
5. MANAGEMENT RESPONSIBILITY
5.1 General
5.2 Customer Needs And Requirements
5.3 Quality Policy
5.4 Quality Objectives And Planning
5.4.1 Quality Objectives
5.4.2 Quality Planning
5.5 Quality Management System
5.5.1 General
5.5.2 Responsibility and Authority
5.5.3 Quality Manual
5.5.4 system Procedures
5.5.5 Management Representative
5.5.6 Control of Documents
5.5.7 Control of Quality Records
5.6 Management Review
6. RESOURCE MANAGEMENT
6.1 General
6.2 Human Resources
6.2.1 Assignment Of Personal
6.2.2 Training, Qualification and Competence
6.3 Other Resources
6.3.1 Information
6.3.2 Infrastructure
6.3.3 Work Environment
7. PROCESS MANAGEMENT
7.1 General
7.2 Customer-Related Processes
7.2.1 Identification of Customer Requirements
7.2.2 Review of Customer Requirements
7.2.3 Review of Ability to Meet Defined Requirements
7.2.4 Customer Communication
7.2.5 Customer Property
7.3 Design and Development
7.3.1 General
7.3.2 Design And Development Inputs
7.3.3 Design And Development Outputs
7.3.4 Design And Development Review
7.3.5 Design And Development Verification
7.3.6 Design And Development Validation
7.3.7 Design And Development Changes
7.4 Purchasing
7.4.1 General
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Product and/or Service
7.5 Production and Service Operations
7.5.1 General
7.5.2 Identification and Traceability
7.5.3 Handling, Packaging, Storage , Preservation and Delivery
7.5.4 Validation of Processes
7.6 Control of Nonconformity
7.6.1 General
7.6.2 Nonconformity Review and Disposition
7.7 Post Delivery Services
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
8.1 General
8.2 Measurement And Analysis
8.2.1 Measurement of System Performance
8.2.1.1 Measurement of Customer Satisfaction
8.2.1.2 Internal Audit
8.2.2 Measurement of Processes
8.2.3 Measurement of Product and/or Service
8.2.4 Control of Measuring, Inspection and Test Equipment
8.3 Analysis Of Data
8.4 Improvement
8.4.1 Corrective Action
8.4.2 Preventive Action
8.4.3 Improvement Processes
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