ISO 9001 2008 Often Asked Inquiries FAQ
What Is The ISO 9001: 2008 Common?
The most current edition of the ISO 9001 normal ISO 9001: 2008, Good quality Management Methods Requirements, was officially revealed by (ISO) the Worldwide Business for Standardization on November 14, 2008. It is the fourth edition of the ISO 9001 normal given that it was first revealed in 1987.
ISO 9001:2008 is a normal that offers a generic set of requirements for organizations wishing to build a good quality management program (QMS). The ISO 9001:2008 normal focuses on enhancing an organizations business processes. It does not specify any specifications for item or services good quality.  Buyers generally set product and services quality demands. Nonetheless, the expectation is that an organization with an effective ISO 9001 primarily based QMS will in fact increase its capability to meet client, statutory and regulatory needs.
This is the only QMS regular to which an business may possibly obtain formal 3rd social gathering certification. Simply because requirements are generic and not particular, organizations have versatility in tailoring their QMS to match their company, culture and pitfalls.
ISO 9001 specifications complement contractual and relevant statutory and regulatory demands. These employing a QMS conforming to ISO 9001 need to make certain that the specific specifications of their clients and related statutory and regulatory companies are satisfied.
Who Is Accountable For Revising QMS Standards?
The ISO Technical Committee no.176, Sub-committee no.two (ISO/TC 176/SC two) is responsible for the revision procedure in collaboration with consensus between high quality and sector professionals nominated by ISO Member bodies, and representing all fascinated events.
Does ISO 9001:2008 Have Further Needs Past ISO 9001:2000?
This latest (4th) edition of ISO 9001 consists of no new demands compared to the (3rd) year 2000 edition, which it replaces. What it does is supply clarification to the active demands of ISO 9001:2000 primarily based on 8 years encounter of globally implementing of the standard and introduces changes meant to improve consistency with the environmental management technique common, ISO 14001:2004.
The clarifications and adjustments in ISO 9001:2008 represent fine-tuning, fairly than a thorough overhaul. It focuses on changes that organizations may possibly make to greater comply with the spirit of the standard without incorporating, deleting, or altering its demands. The modifications are small in nature and handle such issues as the need to make clear, provide larger consistency, resolve perceived ambiguities, and enhance compatibility with ISO 14001. The numbering technique and the structure of the common stay unchanged. As a result, the new regular looks much like the old normal.
ISO has organized the modifications included in this ISO 9001:2008 edition into the subsequent groups:
– No modifications or minimal alterations on user paperwork, like information
– No alterations or minimal alterations to active QMS processes
– No added training essential or minimum training needed
– No results on existing certifications
In contrast, the third edition, ISO 9001:2000 published in 2000, represented a key overhaul of the standard, including new requirements and a sharpened client target, reflecting developments in high quality management and knowledge acquired considering that the publication of the preliminary edition.
Then Why Was It Required To Introduce This Revision?
All ISO requirements, presently more than 17 400, are periodically reviewed. To make certain that ISO requirements are maintained at the state of the art, ISO has a rule requiring them to be periodically reviewed and a decision taken to affirm, withdraw or revise the paperwork. The review process should be initiated within 3 manyyears of publication of a normal. The evaluation considers several components this sort of as technological evolution, new approaches and components, new high quality and security needs, or questions of interpretation and application.
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 responsible for the ISO 9000 loved ones, unites experience from eighty participating nations and 19 international or regional organizations, in addition other technical committees.
This review has a range of inputs that assist it:
o A world-wide user questionnaire/survey 
o A market Justification Study 
o Suggestions arising from the ISO/TC 176 interpretation procedure 
o Opportunities for elevated compatibility with ISO 14001 
o The need for higher clarity, ease of use, and improved translation
o Current developments – retaining up withrecent developments in management system practices.
How Does The New ISO 9001 Regular Impact Current ISO 9001 Quality Management Programs?
As at present licensed organizations start off seeking at ISO 9001:2008, they will wonder to what extent the changes will influence them. To a significant extent, the new regular will not outcome in substantial modify to active quality management programs (QMS).
ISO/TC 176 was cautious in not making alter for adjust sake. The modifications that have been incorporated into this edition of the ISO 9001 regular include changes that really should lead to a far better comprehending across a broader assortment of products types, like support organizations use of deliberate wording to minimize the possible for incorrect user interpretation and reflect nuances of similar word ideas. Lastly, some of the changes to specific clauses were created primarily based on the 2004 Worldwide User Feedback Survey. This survey was performed after the publication of ISO 9001:2000 and had invited respondents to establish regions they most wished to see improved.
What Is The Transition Time Body To Comply With This Revision And Does My Organization Demand Full Re-Evaluation For Certification?
Certification to ISO 9001:2008 is not thought to be an upgrade.  The policies for transition are as follows:
1. The new edition will not require any specific reassessment for certification. Certification Bodies will examine conformity to the new ISO 9001:2008 normal in the course of standard surveillance visits and complete reassessment will only consider location once your current certificate expires.
two. ISO and the IAF have agreed that all certificates to ISO 9001 should be transitioned to ISO 9001:2008 in 2 decades of publication date, (i.e., by November 14, 2010). Your organization can request your Certification Entire body (Registrar) to asses your QMS to ISO 9001:2008 at your subsequent Surveillance audit.
three. One particular yr right after publication of ISO 9001:2008 (i.e., by November 14, 2009), all certifications issued (new certifications and re-certifications) ought to be to ISO 9001:2008.
4. Two many years soon after publication of ISO 9001:2008 (i.e., by November 14, 2010), active ISO 9001:2000 certifications will not be legitimate.
five. Organizations in the method of certification to ISO 9001:2000 are advised to utilize for certification to ISO 9001:2008.
This transition strategy is deemed reasonable, simply because ISO 9001:2008 introduces no new specifications. So essentially, you have a two yr transition window starting up from November 14, 2008, so never depart it to the very last instant to make the transition.
What Will Transpire To The Other Requirements And Paperwork In The Present (2000) ISO 9000 Household?
The 4 primary requirements of the latest ISO 9000 family members are the adhering to:
o ISO 9000:2005 currently printed  - no major alterations predicted 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 currently in the original stages of the revision process, with a new version expected in 2011.
The other specifications and paperwork will be reviewed and updated as necessary.
How Significantly Is The Implementation Of The New Common Going To Price?
A single of the objectives of ISO/TC 176/SC two is to generate specifications that will reduce any likely charges in implementation or transition.  Any added fees may be deemed as a worth-incorporating expense. A key element in the improvement of ISO 9001:2008 was to restrict the influence of alterations and charges on consumers. So do not flinch at negotiating with your certification / registration entire body, if they try to boost costs of certification.
What Do Auditors Need to have To Know About ISO 9001:2008 Regular? 
Auditors, no matter whether exterior or internal, should be able to demonstrate their competence on the structure, content material and terminology of the expectations outlined below, and also on the underlying High quality Management Rules.
The specifications demand that auditors are in a position to understand the organization’s routines and processes and appropriately audit towards the requirements of the ISO 9001 in relation to the organization’s aims. Auditors ought to be able to show competency in:
o The demands of the ISO 9001:2008. 
o The ideas and terminology of the ISO 9000:2005. 
o The 8 Top quality Management Ideas 
o A standard comprehending of  ISO 9004 
o Familiarity with the auditing assistance normal ISO 19011. 
How Will ISO 9001:2008 Relate To The Desires Of Distinct Enterprise Sectors? 
ISO 9001:2008 continues to be compatible with current management methods requirements for distinct enterprise sectors like ISO/TS 16949, AS 9000/EN 9100 and TL 9000. 
End users of a specific sector scheme should refer to the business that is responsible for that sector scheme, e.g. for:
o           ISO/TS sixteen 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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