At long last, the first ISO 9000 revisions are now available. What standards have been revised? How do the final standards differ from the final drafts? What are the overall changes? Read below for the answers to these questions, and many others...

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-- ISO 9000 Revisions --

1. ISO 9000 Dec-2000 Replaced by   ISO 9000:2005 This Product Has Been Amended Quality management systems - Fundamentals and vocabulary Buy H Language: [English] $106.00 Ships In 24-48 hrs Buy H Language: [Spanish] $98.00 Ships In 24-48 hrs Buy PDF Language: [English] $92.00 Immediate Download 2. ISO 9001:2000 Dec-2000 Quality management systems -- Requirements Buy H Language: [English] $100.00 Ships In 24-48 hrs Buy H Language: [Spanish] $100.00 Ships In 24-48 hrs Buy PDF Language: [English] $87.00 Immediate Download Buy PDF Language: [Spanish] $87.00 Immediate Download Track It What's This? 3. ISO 9004:2000 Dec-2000 Quality management systems -- Guidelines for performance improvements Buy H Language: [English] $151.00 Ships In 24-48 hrs Buy H Language: [Spanish] $163.00 Ships In 24-48 hrs Buy PDF Language: [English] $131.00 Immediate Download Track It What's This?

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-- Questions about the Revisions --

What are the main changes?

• A new process-oriented structure and a more logical sequence of the contents.
• A continual improvement process as an important step to enhance the quality management system.
• The measurement of customer satisfaction to provide key information for improvement.
• Increased attention to resources such as communication and work environment.
• Terminology changes/improvements, for easier interpretation.
• Increased compatibility with the environmental management system standard.

What are the Benefits of the Revisions?

• Standards that are applicable to all product and/or service sectors and to all sizes of organizations
• Easier to use, clear in language, readily translatable, and easily understandable
• Connection of quality management systems to organizational processes
• Provision of a natural stepping stone towards improved organizational performance
• An increased emphasis 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
• 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.

What are the differences between the final published standards and the previously circulated final drafts?
The differences between the final published versions and the final drafts of ISO 9001 and ISO 9004 are only slight -- the changes are editorial in nature, to improve the clarity of the documents. ISO 9000 has been substantially modified in the area of defining auditing. These changes have been made in light of the current work being done to update ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing.

Will the 1994 versions of ISO 9001, 9002 and 9003 standards be usable?
The new ISO 9001 standard is a combination of these three standards. The 1994 versions are therefore designated as withdrawn and superceded documents.

Will other current standards in the ISO 9000 series remain?
The current ISO 9000 family of quality standards contains over twenty seven standards and documents. This proliferation of standards has been a particular concern of ISO 9000 users and customers. This is one reason why many of the key points of part of this series have been amalgamated into the four core documents - ISO 9000, ISO 9001, ISO 9004, and ISO 19011 (ISO 19011 will be published sometime later in 2001).

At present, it is intended that the other standards and documents in the ISO 9000 family will either be withdrawn, transferred to other Technical Committees, or replaced by technical reports, technical specifications or brochures (with the exception of ISO 10012, "Quality Assurance for Measuring Equipment", which will remain as an international standard). The migration of the other ISO 9000 family standards and documents to the year 2000 ISO 9000 family is being reviewed by ISO/TC176.
ISO 9001 and ISO 9004 take into consideration the points of guideline documents in the family and therefore these documents, (such as ISO 9004-2, 9004-3, ISO 9004-2, ISO 10005), may be earmarked for withdrawal. Other documents (ISO 10006, 10007, 10013, 10014, 10015 and 10017) may become technical reports at their next revisions. ISO 10012 will remain as an international standard.

ISO 10012-1 and ISO 10012-2 will remain current this year; there are plans to merge them into one document.

ISO-published items such as the 8th edition of the ISO 9000 Compendium will be replaced during the first half of 2001 with a new edition. In the meantime, individuals may wish to purchase either the ISO 9000 Revisions individually, as a set of three, or along with the other ISO 9000 family of standards as a complete set.

To which standard is my organization to be registered/certified?
As the currently existing ISO 9001,ISO 9002, and ISO 9003 standards have been replaced by the revised ISO 9001 standard, the choice is clear and simple: all organizations will be registered/certified to ISO 9001-2000. The scope of registration/certification will need to reflect clearly the activities covered by the organization's Quality Management System, and any exclusions to non-applicable requirements of the standard (through clause 1.2 "Application") documented and justified in the quality manual

What if I am currently registered to ISO 9002?
There are significant differences between the current ISO 9003 standard and the revised ISO 9001-2000 standard, notably in the product realization activities. You should perform a gap analysis based on the draft standards to determine what areas in your organization's quality management system already comply with the revised requirements. Where your current system does not address the applicable ISO 9001-2000 requirements, development and implementation of processes to ensure compliance will need to be made.

What if I am currently registered to ISO 9003?
The organization is not obliged to include within the scope of its certification all the products that it provides. (Note that the ISO 9000:2000 definition of "Product" includes services!). HOWEVER, for those products that ARE included in the certification scope, all applicable requirements of ISO 9001:2000 will need to be addressed. The standard allows for the exclusion of some requirements (via clause 1.2 "Application"), but only if it can be shown that these requirements are not applicable to the organization.

Exclusions are limited to Section 7 ("Product Realization"), and requirements may only be excluded if it can be shown that they do not affect the organization's ability to provide product which meets customer and applicable statutory/regulatory requirements. If design activities are required to demonstrate your organization's capability to meet customer or statutory/regulatory requirements for products covered by the quality management system certification, then these design activities must be included in the scope of your registration/certification to the ISO 9001:2000 standard.

If design activities are not required to demonstrate your organization's capability to meet customer and applicable statutory/regulatory requirements, or if your product is provided on the basis of established design, you will still be registered to ISO 9001:2000. In this case, you will need to justify the exclusion of the design and development requirements in your quality manual

Can organizations remain registered to the 1994 version of ISO 9001, 9002 and 9003?
Although organizations are encouraged to make the transition to ISO 9001-2000 certification as soon as possible, according to the IAF/ISO-CASCO/ISO-TC176 Communique on transition policy, organizations may choose to continue or even seek new certification/registration to the 1994 versions of ISO 9001, ISO 9002, and ISO 9003. Any certificates issued or renewed will, however, only remain valid for a maximum of three years after the publication of ISO 9001-2000.

What does my organization need to do if it is currently registered/certified to ISO 9002-1994 or ISO 9003-1994?
ISO 9002 and ISO 9003 are obsolete. You will need to evaluate which specific requirements of ISO 9001-2000 are applicable to the nature of your business and the extent to which your present QMS meets those requirements. Provisions have been made to exclude non-applicable requirements within Section 7 of the standard through clause 1.2 "Application". If, for example, the nature of your products does not require you to perform design activities or if your product is provided on the basis of established design, you will need to discuss and justify the exclusion of these requirements with your certification/registration body.

Will there be a common auditing standard for ISO 9001 and ISO 14001?
Yes. A specific agreement between the two ISO Technical Committees (TC 176 and TC 207) has set up a joint working group to prepare a single standard on auditing activities, both for quality management and environmental management systems. This new standard will replace the existing ISO 10011 and ISO 14010, ISO 14011, and ISO 14012 documents. The planned publication date for this new standard is in the second quarter of 2001.

What will happen to the ISO guide for small business?
The "Guide for Small Businesses" was published by ISO in 1996 and was intended to provide guidance from ISO/TC176 for the 1994 versions of ISO 9001, ISO 9002, and ISO 9003. ISO 9001-2000 applies a more generic approach, devoid of the hardware and manufacturing bias of the current standard, and is designed to be much more user-friendly for smaller organizations. It has recently been decided to withdraw the 1996 edition in favor of developing a new guide, which is intended to be released sometime during the first half of 2001.

Will small organizations be able to adopt the standards? How will a small organization be able to adapt the requirements of the standard? What flexibility will be allowed?
The requirements of the revised ISO 9001 is applicable to small, medium, and large organizations alike. There is guidance on excluding certain requirements for specific processes (such as design activities) that are not performed by the organization (see ). Provisions have been made to exclude non-applicable requirements through clause 1.2 "Application". It will, however, be up to the individual organization to determine the complexity of the system needed to demonstrate its capability to meet customer and applicable statutory/regulatory requirements for its products.
Source: ISO. "ISO 9000 revisions for publication on 15 December 2000," Press release dated 24 November 2000. Retrieved 12/08/00 from http://www.iso.ch/presse/9000published.htm; and, ISO TC 176/SC2. "Frequently Asked Questions (FAQs)." Retrieved 12/08/00 from http://www.bsi.org.uk/iso-tc176-sc2/FAQs.html For further details on the ISO revisions, individuals may wish to consult these particular pages.