1. What is ISO ?
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.
2. What are the ISO 9000 standards ?
The ISO 9000 family of standards is related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to the product. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems,including the eight management principles on which the family of standards is based.
3.WHO IS RESPONSIBLE FOR DEVELOPING THE ISO 9000 STANDARDS ?
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.
4.WHERE CAN COPIES OF THE STANDARDS BE OBTAINED ?
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.
5.WHERE CAN COPIES OF THE SUPPORTING ISO 9000 GUIDANCE NOTES OR OTHER DOCUMENTS BE FOUND ?
Copies of the ISO 9000 Introduction and Support Package modules:
Guidance on ISO 9001:2008 Sub-clause 1.2 ‘Application’.
Guidance on the Documentation Requirements of ISO 9001:2008.
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/.
6.WHERE CAN INFORMATION BE OBTAINED ON THE ISO 9000 STANDARDS ?
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 registars bodies will be able to provide guidance on registration arrangements.
7. Why are the standards being revised ?
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.
8. Who is responsible for revising the standards ?
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.
9.When will the revised standards be available ?
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 2008.
More significant changes are planned for ISO 9004 (a “revision”) to be published in mid 2009.
10. How much is the implementation of the new standard going to cost?
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 9001:2008 was to limit the impact of changes on users.
11. Where can I obtain information on the revised standards ?
See the ISO Catalogue 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 bodies will be able to provide guidance on transitional arrangements in due course.
12. Where can my organization go if it needs additional clarification or interpretation of the ISO 9001:2008 standard ?
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. The agreed interpretations can be found at http://www.tc176.org/.
13. Will my organization need a full reassessment once the revised standards are available ?
This is primarily an issue between your organization and yourregistration/certification bodyISO/TC 176 is working with the IAF(International Accreditation Forum) andISO/CASCO(the ISO Policy Committee for ConformityAssessm ent)in order to provide relevant information in a timely manner.It is expected that conformity to the new ISO 9001:2008 standard will be evaluated by certification bodies during regular surveillance visits and that full reass essment 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 9001:2008 within 2 years of publication of the amended standard. By Now you should have upgraded.
14. Will the revised standards be available in my national language immediately after they are published by ISO?
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 For further details contact your National Standards Body.
15.Will my organization have to re-write all its documentation ?
No. ISO 9001:2008 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.
16. Will the revised standards address financial issues ?
Financial issues are not addressed in ISO 9001:2008, 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.