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ISO 9001 2008 new standard

ISO 9001 2008 new standard

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Published by Vijayasekar
ISO 9001 has released new version in Nov 2008.
ISO 9001 has released new version in Nov 2008.

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Published by: Vijayasekar on Oct 20, 2008
Copyright:Attribution Non-commercial

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05/09/2014

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ENERGIZE
 Your 
QMS
QMS
 
In 50 WordsOr Less
Changes to the ISO9001:2008 amendmentare high benefit and lowimpact.Even though changesare minor, they offer or-ganizations the oppor-tunity to improve theirquality managementsystems and overallperformance.A two or three-yeartransition period is ex-pected to be approved.
by Lorri Hunt
 
by Lorri Hunt
Though minor, the changesto ISO 9001:2000
shouldnot be taken lightly
 
ANTICIPATION SURROUNDING 
the ISO 9001:2008 amendment
the ISO 9001:2008 amendment
is growing as the standard nears
is growing as the standard nears
publication. But, if you are in a
 publication. But, if you are in a
panic because of this, take a deep
 panic because of this, take a deep
breath and relax.
breath and relax.
Members of ISO technical
Members of ISO technical
committee 176 (TC 176) realize it
committee 176 (TC 176) realize it
is difficult not to flash back and
is difficult not to flash back and
remember the transition to ISO
remember the transition to ISO
9001:2000. It was a tedious pro-
9001:2000. It was a tedious pro-
cess for many organizations and
cess for many organizations and
required that significant resources
required that significant resources
be applied to the effort. Require-
be applied to the effort. Require-
ments included providing training
ments included providing training
to employees, updating docu-
to employees, updating docu-
ments and, in some cases, making
ments and, in some cases, making
significant changes to the overall
significant changes to the overall
structure of quality management
structure of quality management
systems (QMS).
systems (QMS).
 
October 2008 • QP21
STANDARDS
 
QP • www.qualityprogress.com22
Fast forward to 2008. The ISO 9001:2008 amend-ment process has been 180 degrees different from its2000 predecessor. First and foremost, it is an amend-ment and not a revision. That does not mean it shouldbe taken lightly. Instead, it should be welcomed as anopportunity to improve your QMS through a betterunderstanding of requirements. It can also be used towork with your registrar to review any inconsistenciesin interpretations of requirements.
The process
Because the International Organization for Standard-ization (ISO) directives do not differentiate betweenan amendment and a revision, it was important for thetechnical experts on TC 176 to clarify what an amend-ment was.These technical experts determined an amendmentwould be something used to address known issues,but not to create new or delete existing requirements.When drafting started, however, that determination be-came a difficult task.For that reason, the technical experts developed adesign specification for the amendment to ensure theyexercised care and stayed on track for what the usercommunity was demanding: no significant change. Thedesign specification that was developed clearly identi-fied the parameters of what could be considered partof the amendment.The technical experts also developed a risk matrix.Each change was reviewed against this matrix to en-sure the modification was of high benefit and low im- pact.High-benefit changes included those things identi-fied in the design specification as goals of the amend-ment. Low-impact ones included types that wouldrequire minimal change to an organization’s existingQMS. Table 1 shows characteristics that are high ben-efit and low impact. As you can see by the list of the characteristics of ahigh-benefit/low-impact change, the technical expertshad a sharp focus on the types of changes that wouldbe made for this amendment. Additionally, not onlycould a specific change not modify requirements, butit also could not give the perception a requirement hadbeen changed.For that reason, the technical experts decided theywould lean toward no change if consensus could notbe reached on whether a change added or deleted arequirement.
What to expect
With these controls in place, what types of enhance-ments can users expect to see? First, changes will notbe wholesale text ones, as with previous revisions. Infact, some of the changes are so subtle that they willnot be noticeable when users review the document.Because it is important for users to be able toidentify changes quickly, and because even the mostsubtle change offers improvement to the standard, ISO9001:2008 includes Annex B, which outlines the textchanges that have been made to specific clauses.This annex will include the clause number and textfrom ISO 9001:2000, with strike-throughs and addedtext. But, having the annex at hand will not eliminatethe need for organizations to consider each change andits potential impact. The annex also does not eliminatethe need to review the change in context with the otherrequirements in a specific clause.Keeping to the spirit of the amendment, which wasto make modifications without changing requirements,the technical experts had to be creative in how theyincorporated the improvements.One way clarifications were made was to restruc-ture a clause, as was done with clause 8.3, control of nonconforming product. The clause was restructuredto improve its ability to apply to all types of organiza-tions, specifically service ones. Additionally, clause 4.2.4, control of records, was
High-benefit and low-impactchanges
/ TABLE 1
High benetLow impact
Addresses a widely expressed specificuser need by improving clarity andeliminating confusion (for example,improve compatibility with ISO14001, reduce the need for officialinterpretations)No increased or reduced requirementCorrects an error in the existingstandardNo change in intent of requirementIs consistent within the ISO 9000family of standards, including ISO 9001No impact on most usersImproves translation into otherlanguagesNo need for additional education ortraining for usersOnly minimal or marginal changesof an organization’s documentationneeded

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