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.
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 9001:2008 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 9001:2008 within 2 years of publication of the amended standard.
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.
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.
The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually, by focusing on their major processes. The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties.
The management of an organization should be able to view the adoption of the quality management system standards as a profitable business investment, not just as a required certification issue.
Among the perceived benefits of using the standards are:
The connection of quality management systems to organizational processes.
The encouragement of a natural progression towards improved organizational performance, via:
People in the organization will get benefit by:
Owners and investors will get benefit by :
Suppliers and partners will get benefit by :
Partnership and mutual understanding Society will benefit get by :
ISO 9001:2008 refers specifically to only 6 documented procedures; however, other documentation (including more documented procedures not specifically mentioned in ISO 9001:2008) may be required by an organization, in order to manage the processes that are necessary for the effective operation of the quality management system. This will vary depending on the size of the organization, the kind of activities in which it is involved and their complexity. For further guidance, please also refer to the ISO 9000 Introduction and Support Package module "Guidance on the Documentation Requirements of ISO 9001:2008"
Organizations have their quality management system registered/certified to ISO 9001:2008. The scope of registration/ certification will need to reflect precisely and clearly the activities covered by the organization's quality management system; any exclusion to non-applicable requirements of the standard (permitted through ISO 9001 clause 1.2 "Application") will need to be documented and justified in the quality manual (see also the ISO/TC 176/SC2 ISO 9000 Introduction and Support Package module Guidance on ISO 9001:2008 clause 1.2 'Application').
When initially starting to use ISO 9001, an organization should familiarize its personnel with the Quality Management Principles, analyze the standards (especially ISO 9000 and ISO 9004), and consider how their guidance and requirements may affect your activities and related processes. If it then wishes to proceed to registration/certification, it should perform a gap analysis against the requirements of ISO 9001 to determine where its current quality management system does not address the applicable ISO 9001:2008 requirements, before developing and implementing additional processes to ensure that compliance will be achieved.
Certification to ISO 9001:2008 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 9001:2008.
ISO and the International Accreditation Forum (IAF) have agreed the following "Implementation Plan" with respect to accredited certification to ISO 9001:2008:. "Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard.
Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of ISO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or re-certification audit against ISO 9001:2008. Validity of certifications to ISO 9001:2000
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 by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.
The standards are applicable to all types of organizations, operating in all types of sectors, including service providers.
(Note: the definition of the term 'product' in ISO 9000:2005 also includes 'services'. ISO 9001:2008 and ISO 9004:2000 have been written to reflect this definition.)
