ISO 9001 Certification of the QMS of a Certification Body

M

MIREGMGR

As an ISO 13485 certified medical device maker that makes devices subject to EC Medical Device Directive and Personal Protective Equipment Directive, my employer utilizes the services of two different major western European based Certification Bodies.

Our QMS generally requires that critical suppliers must provide valid evidence of certification of their QMS.

Recently, we decided to consider the above mentioned C.B.s as critical suppliers. Lo and behold, the only certificates they have to provide to us are in regard to ISO 17021, similar accreditation standards, and various national conformances thereto.

One of the C.B.s had this to say today:

Because (XXXXXX) is a registrar and we issue ISO 9001 and ISO 13485 certificates to our customers, we are not allowed to be certified to ISO 9001. We have implemented an Integrated Management System that is based on ISO 9001, and is compliant with standards ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021 and ISO/IEC 17065. All of these ISO/IEC standards require that the company must implement and maintain a Quality Management System that is very similar to, and in many cases more stringent than, the one described by 9001. Our ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021 and ISO/IEC 17065 certificates of accreditation serve as evidence that we in fact have implemented and maintained a QMS that conforms to appropriate requirements of accreditation bodies including A2LA, ANAB, ANSI, SCC, DAkkS, UKAS and others.

I have no expertise in accreditation. Is the above a satisfactory statement of how this works?
 

AndyN

Moved On
As an ISO 13485 certified medical device maker that makes devices subject to EC Medical Device Directive and Personal Protective Equipment Directive, my employer utilizes the services of two different major western European based Certification Bodies.

Our QMS generally requires that critical suppliers must provide valid evidence of certification of their QMS.

Recently, we decided to consider the above mentioned C.B.s as critical suppliers. Lo and behold, the only certificates they have to provide to us are in regard to ISO 17021, similar accreditation standards, and various national conformances thereto.

One of the C.B.s had this to say today:



I have no expertise in accreditation. Is the above a satisfactory statement of how this works?

Yes, this is correct. A CB, according to the requirements of ISO/IC 17021, may NOT certify another CB to ISO 9001 - even though, a CB may use a QMS based on the requirements of ISO 9001. (not because they "issue certificates" - they aren't allowed to do it, period)
 

Big Jim

Admin
Think about it for a moment. If the CB is compelled to live up to 17021, do they really need to be 9001 as well? Think of 17021 as the standard for certification bodies, and they are audited to it by accreditation bodies just as you are audited to 9001 by certification bodies.
 

John Broomfield

Leader
Super Moderator
MIREGMGR,

A management system that delivers competence to ISO 17021 likely also conforms to ISO 9001.

So, your supplier selection criterion could say "certified to ISO 9001 or equivalent".

John
 
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