Does ISO/IEC 17021 Accreditation work for 13485

M

MattyvSweden

#1
Hello,

We are finally ready to go for our ISO 13485 audit. We found a company in Sweden that is certified by Swedac, but only for ISO/IEC 17021, NOT 13485.

The company claims that ISO/IEC 17021 is an umbrella certification and they are qualified to issue a 13485 certificate.

Is this common place? Will regulatory agencies accept this certification (17021) as being sufficient for a 13485 certificate?

Is this confusing? :bonk:
 
Elsmar Forum Sponsor
#2
Not too confusing - 17021 is the right standard for Notified Bodies.

From the introduction to ISO 17021:-
ISO/IEC 17021:2011 contains principles and requirements for the competence, consistency and impartiality of the audit and certification of management systems of all types (e.g. quality management systems or environmental management systems) and for bodies providing these activities. Certification bodies operating to ISO/IEC 17021:2011 need not offer all types of management system certification.

Certification of management systems is a third-party conformity assessment activity. Bodies performing this activity are therefore third-party conformity assessment bodies.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#3
Hello,

We are finally ready to go for our ISO 13485 audit. We found a company in Sweden that is certified by Swedac, but only for ISO/IEC 17021, NOT 13485.

The company claims that ISO/IEC 17021 is an umbrella certification and they are qualified to issue a 13485 certificate.

Is this common place? Will regulatory agencies accept this certification (17021) as being sufficient for a 13485 certificate?

Is this confusing? :bonk:
You should ask for proof/evidence by the CB that they have been specifically accredited to issue certificates against ISO 13485. The CB has to have a certificate of accreditation from their respective accreditation body that lists the CB as approved for ISO 13485 QMS certification.

There are two IAF Mandatory Documents that are specific to the application of ISO 13485:

IAF MD 8:2011 Application of ISO/IEC 17011 in Medical Device Quality Management Systems (ISO 13485)
(Issue 1, issued on 15 July 2011; Application from 15 July 2012)
The objective of this Mandatory Document is to enable accreditation bodies to harmonize their application of ISO/IEC 17011 for the accreditation of bodies providing audit and certification to ISO 13485.

IAF MD 9:2011 Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485)
(Issue 1 Version 2, issued on 15 July 2011; Application from 15 July 2012)
Sets out the general requirements for bodies operating audit and certification of organizations' Quality Management Systems in accordance with ISO 13485.

IAF MD8 applies to Swedac (in your case) and the other AB's offering accreditation to ISO 13485 and IAF MD9 applies to the CB.
 
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