ISO/ IEC 17021 Accreditation replacing Guide 62 & Guide 66

[Sidney Vianna]

Talk about waiting till the last minute!

ANAB has established a dedicated page in their website, listing the CB's that have achieved to transition their accreditation: (broken link removed)

Deadline for transition is less than a week away.

 

[GStough]

ANAB has established a dedicated page in their website, listing the CB's that have achieved to transition their accreditation: (broken link removed)

Deadline for transition is less than a week away.

Thanks for the update, Sidney!

 

[howste]

It is 10 PM. Do you know the status of your registrar accreditation?

Now it's 3:00 AM...

 

[howste]

Time's up. Were there any registrars that didn't make it?

 

[Sidney Vianna]

Time's up. Were there any registrars that didn't make it?

Yes, if you search ANAB's directory, you will find a number of CB's who have lost their accreditation.

 

[howste]

ANAB must have updated this morning. Yesterday I looked and they weren't listed yet...

 

[Sidney Vianna]

I just checked the UKAS website. They too had to suspend a few CB's. Probably did not make the transition in time.

 

[Sidney Vianna]

In a recent press release by a prestigious CB with worldwide representation, it is stated:

There are two major changes that will impact organizations with certified quality and environmental management systems:
SNIP

-- ISO/IEC 17021 also introduces a new requirement with regards to the way in which "Minor Nonconformities" (minor deficiencies present in a management system that is being audited) are addressed during the certification process. Under the new requirement, certification bodies are not allowed to issue a certificate to an organization where Minor Nonconformities have been raised until it has reviewed and accepted the organization's plan to correct the issue in question.

Well, the IAF GD 2:2005 Guidance on the Application of Guide 62:1996 document states in paragraph G.3.5.3

Certification/registration shall not be granted until all nonconformities as defined in guidance G.1.3.1. have been corrected and the corrective action verified by the certification/registration body (by site visit or other appropriate forms of verification).

So, is the requirement really a change? I am confused. ​

 

[howste]

I suppose it all depends on where you look for the definition of nonconformity or "major" and "minor" nonconformity. Look at the definition in the Guidance to Guide 62 you linked to under G.1.3.1:

Nonconformity: The absence of, or the failure to implement and maintain, one or more quality management system requirements, or a situation which would, on the basis of available objective evidence, raise significant doubt as to the quality of what the organization is supplying.

Some would read that as a major nonconformity, especially the last part. ISO 19011 refers to ISO 9000 (and ISO 14050) for definitions. The ISO 9000 definition is only this:

nonconformity
non-fulfilment of a requirement

In the past certificates have been issued with open (minor) nonconformities. ISO 17021 now states:

9.1.15 The certification body shall confirm, prior to making a decision, that
a) the information provided by the audit team is sufficient with respect to the certification requirements and the scope for certification;
b) it has reviewed, accepted and verified the effectiveness of correction and corrective actions, for all nonconformities that represent
1) failure to fulfil one or more requirements of the management system standard, or
2) a situation that raises significant doubt about the ability of the client's management system to achieve its intended outputs;
c) it has reviewed and accepted the client's planned correction and corrective action for any other nonconformities.

The blue text I highlighted shows that ISO 17021 still does not require all nonconformities to closed, but the plan must be reviewed for them. This item c) is additional to what GD 2 included. I don't think that's a very significant change...

Just for fun, here's one more "nonconformity" reference to muddy up the waters. AS9104's definition sounds pretty familiar:

Nonconformity:
The absence of, or the failure to implement and maintain, one or more quality management system requirements, or a situation that would, on the basis of available objective evidence, raise significant doubt as to the quality of what the organization is supplying.
Major: The absence of, or total breakdown of a quality management system element specified in the AQMS standard or any non-conformities where the effect is judged to be detrimental to the integrity of the product, processes or service.
Minor: A single system failure or lapse in conformance with a procedure relating to the AQMS standard.
NOTE: A number of minor non-conformities against one requirement can represent a total breakdown of the system and this can be considered as a major nonconformity.

 

[Sidney Vianna]

Thanks a lot, Howste, for the detailed response. So, based on what you explained, the CB, subject of the press release, will uphold certification of a registrant until all minor NC's are resolved and closed, even though it is not a requirement of ISO 17021.