ANSI - American National Standards Institute
 Print this article  Previous Next 

ISO Releases New Edition of Quality Management System Standard

New York, Nov 14, 2008

The International Organization for Standardization (ISO) published today a new edition of one of the world’s most widely implemented standards: ISO 9001:2008, Quality management system – Requirements.

ISO 9001 details requirements for a Quality Management System (QMS), which is a framework for an organization to control its processes in order to achieve objectives including customer satisfaction, regulatory compliance, and continual improvement. The International Standard is used by organizations in 175 countries.

ISO 9001 was developed by ISO Technical Committee (TC) 176, Quality management and quality assurance. TC 176 is the developer of 17 standards on quality management supporting tools. The U.S. Technical Advisory Group (TAG) Administrator to TC 176 is the American Society for Quality (ASQ), an accredited standards developer and member of the American National Standards Institute (ANSI).

Revising International Standards

According to ISO's rules for the development of International Standards, published documents are required to undergo periodic review to determine if any revisions or maintenance are needed, or if a given standard should be withdrawn.

Standards can be considered in need of revision for a number of reasons, including:

  • technological evolution, new methods and materials
  • new quality and safety requirements
  • questions of interpretation and application
No additional requirements have been added to the standard; instead, revisions are focused on providing clarification to existing requirements. The changes also lead to improved consistency with ISO 14001:2004, Environmental management systems.

Revisions to the standard were developed based on input from a number of sources, including the criteria outlined in ISO Guide 72:2001, Guidelines for the justification and development of management system standards; feedback from the ISO/TC 176 interpretations process; a two-year systematic review of ISO 9001:2000 within ISO/TC 176/SC2, Quality systems; a worldwide user survey carried out by ISO/TC 176/SC 2; and further data from surveys conducted by ISO national member bodies.

“The revised ISO 9001 results from a structured process giving weight to the needs of users and to the likely impacts and benefits of the revisions,” said ISO Secretary-General Alan Bryden. “ISO 9001:2008 is therefore the outcome of a rigorous examination confirming its fitness for use as the international benchmark for quality management.”

For organizations that currently use an earlier edition of ISO 9001, ISO and the International Accreditation Forum (IAF) have developed an implementation plan that will facilitate the transition to ISO 9001:2008.

Although certification is not a requirement of the standard, the QMS of about one million organizations have been audited and certified by independent certification bodies (CBs) to ISO 9001:2000.

CBs that wish to provide further confidence in their services may apply to be accredited as competent by an IAF-recognized national accreditation body. The ANSI-ASQ National Accreditation Board (ANAB) is the U.S. accreditation body for management systems, accrediting CBs to ISO 9001, ISO 14001, and numerous other management systems and industry-specific requirements.

According to the ISO/IAF implementation plan, one year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008. Twenty-four months after publication of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall no longer be valid.

For more information, see the ISO press release.

ISO TC 229 Nano technology Wiki