Answered; Registrar Dropped ISO 14971 Certification Program; What Now?

[MDDRegAffairs]

Dear all,

I was recently informed by our ISO 13485, and ISO 14971 auditor, Intertek, that they no longer certify ISO 14971. Their justification is that 14971 certification is not required for MDD, FDA, or Health Canada, only compliance is required.

We are a U.S. based company. Our 3 year audit is scheduled for May 2015.

Can anyone comment on this? Should we find another auditor? What concerns are there for being compliant and not certified (other than all the paper work where 14971 certification is claimed)?

Any thoughts, comments, or suggestions would be greatly appreciated.

Kind Regards,

MDDRegAffairs

 

[ScottK]

Re: Auditor Dropped ISO 14971 Certification Program; What Now?

If you feel it's necessary there are other organization that offer that.
Certification is not required although compliance is expected as part of ISO 13485 registration.
I think a management decision needs to be made as to whether you find another registrar or just let it go.
No device company I've been with has gotten certified in 14971.

 

[MIREGMGR]

Re: Auditor Dropped ISO 14971 Certification Program; What Now?

US FDA doesn't expect such a certificate. The major EU NB that certifies my employer's CE Mark and ISO 13485 compliance doesn't expect such a certificate. No national regulatory body with whom I've interacted, in my fairly active global marketing experience, has asked for such a certificate.

 

[AndyN]

Re: Auditor Dropped ISO 14971 Certification Program; What Now?

I'd rather doubt it was an accredited certification to ISO 14971, since it isn't a standard for that purpose. So dropping it isn't really a bad thing - for those who understand it isn't certification in the same way as ISO 9001/13485 etc.

 

[Ronen E]

Re: Auditor Dropped ISO 14971 Certification Program; What Now?

No big deal. IMO ISO 14971 "certification" was just another commercial feature. It's only added value would have been in an additional knowledgeable and experienced individual checking the risk management files.

BTW, even ISO 13485 doesn't require ISO 14971 compliance. It is just a recommended way of compliance with the risk management clause.