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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?
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.