ISO 9001 2008 Often Asked Questions FAQ
What Is The ISO 9001: 2008 Common?
The most current edition of the ISO 9001 normal ISO 9001: 2008, Good quality Management Techniques Requirements, was officially published by (ISO) the Global Business for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 common because it was very first printed in 1987.
ISO 9001:2008 is a common that provides a generic set of needs for organizations wishing to create a good quality management program (QMS). The ISO 9001:2008 common focuses on strengthening an organizations company processes. It does not specify any requirements for item or services high quality.  Customers normally set product and service high quality demands. Nonetheless, the expectation is that an organization with an efficient ISO 9001 based QMS will without a doubt enhance its potential to meet customer, statutory and regulatory requirements.
This is the only QMS common to which an business may receive formal3rd get together certification. Because demands are generic and not certain, organizations have overall flexibility in tailoring their QMS to match their organization, tradition and hazards.
ISO 9001 requirements complement contractual and relevant statutory and regulatory specifications. Those employing a QMS conforming to ISO 9001 need to make sure that the specific demands of their buyers and related statutory and regulatory agencies are met.
Who Is Responsible For Revising QMS Standards?
The ISO Technical Committee no.176, Sub-committee no.two (ISO/TC 176/SC two) is accountable for the revision approach in collaboration with consensus among good quality and sector professionals nominated by ISO Member bodies, and representing all fascinated events.
Does ISO 9001:2008 Have Further Specifications Beyond ISO 9001:2000?
This most recent (4th) edition of ISO 9001 contains no new needs in contrast to the (3rd) yr 2000 edition, which it replaces. What it does is offer clarification to the active requirements of ISO 9001:2000 based mostly on 8 many years encounter of throughout the world implementing of the standard and introduces changes intended to increase consistency with the environmental management technique standard, ISO 14001:2004.
The clarifications and alterations in ISO 9001:2008 symbolize great-tuning, fairly than a thorough overhaul. It focuses on alterations that organizations may make to much better comply with the spirit of the regular with out adding, deleting, or altering its specifications. The changes are slight in nature and tackle this sort of problems as the need to have to clarify, offer better consistency, resolve perceived ambiguities, and improve compatibility with ISO 14001. The numbering technique and the framework of the common remain unchanged. As a result, the new common seems much like the previous standard.
ISO has organized the modifications included in this ISO 9001:2008 edition into the adhering to groups:
– No changes or minimal adjustments on user paperwork, like documents
– No alterations or minimal changes to active QMS processes
– No added training needed or minimal coaching required
– No effects on latest certifications
In contrast, the 3rd edition, ISO 9001:2000 published in 2000, represented a significant overhaul of the common, like new specifications and a sharpened consumer concentrate, reflecting developments in quality management and expertise obtained given that the publication of the initial version.
Then Why Was It Necessary To Introduce This Revision?
All ISO specifications, presently more than 17 400, are periodically reviewed. To guarantee that ISO standards are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a determination used to verify, withdraw or revise the documents. The assessment approach should be initiated in 3 decades of publication of a standard. The review considers a number of factors this sort of as technological evolution, new strategies and components, new top quality and safety specifications, or queries of interpretation and software.
The review of ISO 9001 resulting in the 2008 edition was carried out by subcommittee SC 2 of ISO/TC 176. This subcommittee, which is accountable for the ISO 9000 family, unites knowledge from 80 participating nations and 19 international or regional organizations, in addition other technical committees.
This overview has a amount of inputs that assist it:
o A global user questionnaire/survey 
o A industry Justification Examine 
o Suggestions arising from the ISO/TC 176 interpretation procedure 
o Opportunities for increased compatibility with ISO 14001 
o The need to have for larger clarity, ease of use, and improved translation
o Current developments – retaining up with modern developments in management program practices.
How Does The New ISO 9001 Normal Influence Existing ISO 9001 Good quality Management Programs?
As at the moment licensed organizations commence looking at ISO 9001:2008, they will wonder to what extent the changes will influence them. To a huge extent, the new regular will not consequence in significant modify to active quality management techniques (QMS).
ISO/TC 176 was careful in not producing alter for modify sake. The changes that have been incorporated into this edition of the ISO 9001 regular incorporate alterations that really should lead to a greater understanding across a broader assortment of products sorts, including service organizations use of deliberate wording to minimize the prospective for incorrect person interpretation and reflect nuances of equivalent word concepts. Lastly, some of the adjustments to specific clauses were created based on the 2004 Worldwide User Feedback Survey. This survey was performed after the publication of ISO 9001:2000 and had invited respondents to determine areas they most wanted to see improved.
What Is The Transition Time Frame To Comply With This Revision And Does My Business Require Total Re-Evaluation For Certification?
Certification to ISO 9001:2008 is not considered an upgrade.  The policies for transition are as follows:
one. The new edition will not require any distinct reassessment for certification. Certification Bodies will evaluate conformity to the new ISO 9001:2008 common throughout normal surveillance visits and complete reassessment will only take place the moment your current certificate expires.
2. ISO and the IAF have agreed that all certificates to ISO 9001 need to be transitioned to ISO 9001:2008 within two decades of publication date, (i.e., by November 14, 2010). Your organization can request your Certification Physique (Registrar) to asses your QMS toISO 9001:2008 at your following Surveillance audit.
3. One yr soon after publication of ISO 9001:2008 (i.e., by November 14, 2009), all certifications issued (new certifications and re-certifications) should be to ISO 9001:2008.
four. Two decades after publication of ISO 9001:2008 (i.e., by November 14, 2010), active ISO 9001:2000 certifications will not be valid.
5. Organizations in the approach of certification to ISO 9001:2000 are encouraged to apply for certification to ISO 9001:2008.
This transition approach is deemed practical, since ISO 9001:2008 introduces no new demands. So fundamentally, you have a two year transition window starting up from November 14, 2008, so don’t depart it to the last moment to make the transition.
What Will Transpire To The Other Requirements And Documents In The Existing (2000) ISO 9000 Family?
The 4 principal specifications of the latest ISO 9000 family members are the following:
o ISO 9000:2005 currently published  - no major changes expected for 2009 
o ISO 9001:2000 to be superseded by ISO 9001:2008 
o Significant changes are planned for ISO 9004 with a planned publication date of late 2009. 
o ISO 19011:2002 is at the moment in the preliminary stages of the revision procedure, with a new version anticipated in 2011.
The other standards and documents will be reviewed and up-to-date as needed.
How Significantly Is The Implementation Of The New Standard Likely To Value?
One of the goals of ISO/TC 176/SC 2 is to generate requirements that will decrease any prospective charges in implementation or transition.  Any extra charges may be considered as a value-incorporating investment. A crucial element in the improvement of ISO 9001:2008 was to restrict the effect of adjustments and expenses on end users. So do not flinch at negotiating with your certification / registration body, if they try to boost charges of certification.
What Do Auditors Need To Know About ISO 9001:2008 Regular? 
Auditors, whether or not external or inner, really should be able to show their competence on the framework, material and terminology of the specifications detailed under, and also on the underlying Good quality Management Concepts.
The expectations require that auditors are ready to realize the organization’s routines and processes and appropriately audit versus the demands of the ISO 9001 in relation to the organization’s targets. Auditors should be capable to show competency in:
o The needs of the ISO 9001:2008. 
o The concepts and terminology of the ISO 9000:2005. 
o The 8 Quality Management Rules 
o A standard knowing of  ISO 9004 
o Familiarity with the auditing assistance standard ISO 19011. 
How Will ISO 9001:2008 Relate To The Requirements Of DistinctOrganization Sectors? 
ISO 9001:2008 remains suitable with present management methods expectations for particular enterprise sectors like ISO/TS 16949, AS 9000/EN 9100 and TL 9000. 
Consumers of a distinct sector scheme really should refer to the business that is responsible for that sector scheme, e.g. for:
o           ISO/TS 16 949 refer to the IATF, 
o           TL 9000 refer to the QuEST Forum 
o           For AS 9000/EN 9100 refer to the IAQG
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