The International Organization for Standardization (ISO) was established in 1947 and is (currently) an association of approximately 157 members, which each represent their own country. ISO employs a system of Technical Committees, Sub-committees and Working Groups to develop International Standards. Besides the National Standards Bodies, ISO permits other international organizations that develop standards to participate in its work, by accepting them as Liaison members. ISO works in accordance with an agreed set of rules of procedure, the ISO/IEC Directives, which also include requirements on the presentation of standards.
The ISO 9000 standards are a collection of formal International Standards, Technical Specifications, Technical Reports, Handbooks and web based documents on Quality Management. There are approximately 25 documents in the collection altogether, with new or revised documents being developed on an ongoing basis. (It should be noted that many of the International Standards in the ISO 9000 family are numbered in the ISO 10000 range.)
ISO Technical Committee (TC) number 176 (ISO/TC 176), and its Sub-committees, are responsible for the development of the standards. The work is conducted on the basis of “consensus” among quality and industry experts nominated by the National Standards Bodies, representing a wide range of interested parties.
Copies of the standards may be purchased from your National Standards Body (see list with contact details), or from ISO Central Secretariat through the ISO Store of by contacting the Marketing and Communication department (email@example.com). Many National Standards Bodies have them available in local-language versions.
Copies of the ISO 9000 Introduction and Support Package modules:
Guidance on ISO 9001:2015 Sub-clause 1.2 ‘Application’
Guidance on the Documentation Requirements of ISO 9001:2015
Guidance on the Terminology used in ISO 9001 and ISO 9004
Guidance on the Concept and Use of the Process Approach for management systems
Guidance on ‘Outsourced Processes’ as well as details of the Quality Management Principles
can be found at: www.iso.org/tc176/sc2. Copies of the ISO 9001 Auditing Practices Group guidance notes. Copies of the sanctioned ISO/TC 176 sanctioned “Interpretations” of ISO 9001 can be found at: http://www.tc176.org/
There are a number of sources of information on the ISO 9000 quality management system standards, including ISO’s web site (www.iso.org), which carry information on the standards. Your National Standards Body should be able to provide copies of the standards, and registrars/certification bodies will be able to provide guidance on registration arrangements.
ISO’s formal review process:
Requires continual review to keep standards up to date. Must be initiated within 3 years of publication of a standard.
User inputs from:
A global user questionnaire/survey
A market Justification Study
Suggestions arising from the interpretation process
Opportunities for increased compatibility with ISO 14001
The need for greater clarity, ease of use, and improved translation
Keeping up with recent developments in management system practices.
The revision process is the responsibility of ISO Technical Committee no.176, Sub-committee no.2 (ISO/TC 176/SC 2) and is conducted on the basis of consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties.
The revised quality management system standards (ISO 9000, 9001 and 9004) are scheduled as follows:
ISO 9000:2005 already published – no major changes expected for 2009
Current plan is for small changes to ISO 9001 (an “amendment”) to be published in November 2015.
More significant changes are planned for ISO 9004 (a “revision”) to be published in mid 2009.
One of the goals of ISO/TC 176/SC 2 is to produce standards that will minimize any potential costs during a smooth implementation. Any additional costs may be considered as a value-adding investment. A key factor in the development of ISO 9001:2015 was to limit the impact of changes on users.
See the ISO Catalog on ISO Online web site that carries general information on the revision program. Your National Standards Body will give you additional information and the certification/registration bodies will be able to provide guidance on transitional arrangements in due course.
The starting point for any individual request for an interpretation should be with the enquirer’s National Standards Body. ISO Central Secretariat and ISO/TC 176/SC 2 cannot accept direct requests from individuals for interpretations of the ISO 9000 standards. ISO/TC 176 has a Working Group that only accepts formal requests for interpretations from the National Standards Bodies.
This is primarily an issue between your organization and your registration/certification body. ISO/TC 176 is working with the IAF (International Accreditation Forum) and ISO/CASCO (the ISO Policy Committee for Conformity Assessment) in order to provide relevant information in a timely manner. ISO/CASCO is responsible for the standards to which the Certification Bodies work (ISO/IEC 17021), and the Accreditation Bodies are responsible for monitoring and approving the performance of Certification Bodies within their geographical area.
It is expected that conformity to the new ISO 9001:2015 standard will be evaluated by certification bodies during regular surveillance visits and that full reassessment will only take place once current certificates expire. However, it should be noted that ISO and the IAF have agreed that all certificates to ISO 9001 should be upgraded to ISO 9001:2015 within 2 years of publication of the amended standard. By Now you should have upgraded.
The active participation of experts from around the world in the preparation of the new standards, and the broad distribution of the draft standards, will facilitate the timely translation of the International Standards.
Given the global importance of the quality management system standards, many National Standards Bodies are already working on the translation issue. ISO itself will publish the new standards in English and French, but if national language translations of the standards are currently available from your National Standards Body, we expect that they will have the translation of the revised standards ready at the time of publication by ISO or very soon thereafter.
For further details contact your National Standards Body.
No. ISO 9001:2015 doesn’t introduce major changes to the requirements, when compared to ISO 9001:2000. However, to benefit from the changes, we suggest you get acquainted with the new version of the standard and the clarifications introduced. If, during your analysis of the clarifications you find there are differences from your current interpretation of ISO 9001:2000, then you should analyse the impact on your current documentation and make the necessary arrangements to update it. It is intended that the amendment of ISO 9001 will have minimal or no impacts on documentation.
Financial issues are not addressed in ISO 9001:2015, which is a requirements standard. The ISO 10014:2006 and ISO 9004:2000, Guidelines for performance improvements standards will emphasize the financial resources needed for the implementation and improvement of a quality management system.
For ISO 9001:2015 the major benefits are:
Simple to use
Clear in language
Readily translatable and easily understandable
Compatibility with other management systems such as ISO 14001.
For ISO 9004 : Facilitates improvement in users’ quality management systems.
Provides guidance to an organization for the creation of a quality management system that:
– creates value for its customers, via the products it provides
– creates value for all other interested parties
– balances all interested-party viewpoints.
– Provides guidance for managers on leading their organization towards sustained success.
– Forward compatibility to allow organizations to build on existing quality management systems.
ISO 9001:2015 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improve compatibility with ISO 14001:2004. ISO 9001:2015 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2015 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2015 All changes between ISO 9001:2000 and ISO 9001:2015 are detailed in Annex B to ISO 9001:2015.