Changes Made in the 2000 Version of ISO 9001

The ISO 9001:2000 standard represents a major revision from the 1994 standards. The new version of the Standard emphasizes the following concepts:

A Process Management Model

All work gets done as part of a process. An interconnected system of processes represents all of the work of the organization. If these processes are designed to be capable of providing satisfactory outputs, and if they are supplied with adequate resources and run by competent personnel, then quality products and services will be provided and customers will be satisfied. If the results are not as planned, then the process structure, resources or competency of the people has to be examined and improved. Process management concepts are discussed in more detail in the appendix, “Process Management”, beginning on page .

Management Responsibility for Continual Improvement

The operation of the quality management system is continuously monitored, measured and improved. The quality policy establishes an commitment to continual improvement. Quality objectives establish measurable quality goals. Audits assess the effectiveness of the quality management system. Information regarding customer satisfaction, product conformity, product characteristics and trends, process characteristics and trends, supplier performance is collected and understood. Customer feedback is gathered and customer complaints are reviewed. Nonconforming product is controlled and records are kept. This information is analyzed to identify actions to be taken to improve the quality management system. Management has explicit responsibility to review this information and take action to improve the quality management system. See section 8.5.1 of this book for more detailed information.

Increased Customer Involvement

Customer requirements for products and services are identified and reviewed with the customer. Effective communications are established with the customer to discuss and resolve issues regarding product information , inquires, contracts, order handling, changes to orders, customer feedback and complaints. Customer satisfaction information, including their opinion of your products and services, is gathered, analyzed and acted upon to improve the quality management system. See sections 5.2, 7.2 and 8.2.1 of this book for more detailed information.

Increased Emphasis on Results

The ISO 9001:2000 Standard relies heavily on measurement analysis and improvement to evolve the quality management system into an effective system. Documentation requirements are less specific, currently only six written procedure documents are explicitly required by the Standard (see the list in section 4.2.3 of this book.). Other documentation is provided by the organization as needed to create an effective quality management system.

Other Changes

Other changes include consideration of statutory and regulatory requirements, increased attention to resource availability and the determination of training effectiveness.

Major Benefits of the Changes

Major benefits of the revised quality management systems standards include the following:

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
Support for 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.

Changes in the Structure of the Standards

The structure of the Standards has changed as follows:

The merging of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 into a single ISO 9001:2000 standard
The merging of ISO 8402 and part of the content of ISO 9000-1 into a new ISO 9000:2000 standard
The revision of ISO 9004-1 into a new ISO 9004:2000 standard
The merger of ISO 10011 (Parts 1, 2 and 3) with ISO 14010, ISO 14011 and ISO 14012 into a new guidelines standard for quality and environmental management system auditing (to be numbered ISO 19011).

The elimination of ISO 9002 and 9003 will require organizations to take particular care in defining their scope statements and in including or excluding sections of the Standard relevant to their organization. Section 1.2 of this book provides more detail on this topic. Additional guidance is also available from:

ISO 9000 Introduction and Support Package: Guidance on the ISO 9001:2000 clause 1.2 ‘Application’, Charles Corrie for BSI Secretariat, ISO/TC 176/SC 2, Document ISO/TC 176/SC2/N544R, Available from http://isotc176sc2.elysium-ltd.net/

Transition Planning

Organizations currently accredited to the ISO 9001:1994 Standard have until December 15, 2003 to complete the transition to the ISO 9001:2000 standard.

Detailed Changes

The detailed changes to the Standard are described in the “2000” section following each paragraph of the Standard in the book ISO 9001, The Standard Interpretation. (third edition) A cross-reference between the ISO 9001:1994 and the ISO 9001:2000 clauses of the standard is included in Annex B of the Standard (and included in the book). Detailed information regarding transition planning is provided in:

Transition Planning Guidance for ISO 9001:2000, Charles Corrie for BSI Secretariat, ISO/TC 176/SC 2, Document ISO/TC 176/SC 2/N 474R2, Available from http://isotc176sc2.elysium-ltd.net/

Important web sites providing authoritative information on the ISO 9000 family of Standards are:

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