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Trusting ISO 13485 Certification of a Supplier... A Sad Story - Page 4


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  Post Number #25  
Old 12th September 2011, 09:58 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

What is the significance in AB terms of the subject company's CAB issuing an ISO 13485 certificate, but not having ISO 13485 listed within the scope of the ANAB certificate issued to that CAB?

Is ISO 13485 formally defined at the AB level as a variant of ISO 9001, and therefore any CAB certified for ISO 9001 also may certify to ISO 13485?

This link is dead as of 30 June 1014 --> anab.remoteauditor.com/EQM/CustomData/Controls/Certificates/IssuedCertificates.bb9ec374-83be-420c-83dd-78fc46d45c14.pdf

Last edited by Marc; 30th June 2014 at 02:16 PM. Reason: Live link removed because it is now a dead link.

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  Post Number #26  
Old 12th September 2011, 10:11 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,508
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

Quote:
In Reply to Parent Post by MIREGMGR View Post

What is the significance in AB terms of the subject company's CAB issuing an ISO 13485 certificate, but not having ISO 13485 listed within the scope of the ANAB certificate issued to that CAB?

Is ISO 13485 formally defined at the AB level as a variant of ISO 9001, and therefore any CAB certified for ISO 9001 also may certify to ISO 13485
ISO 13485 certification requires it's own accreditation. In this case, as I mentioned before, the ISO 13485 certificate was issued under the RvA Accreditation and the CB is accredited with RvA for 13485.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
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  Post Number #27  
Old 12th September 2011, 11:52 AM
MIREGMGR

 
 
Total Posts: 3,685
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

Given accreditation of the CAB for ISO 13485 only by RvA, what is the chain of control under ISO 17021, both at present and in regard to the eventual implementation of the IAF guidance discussed above?

The guidance will require the certified organization to comply with "the statutory and regulatory requirements applicable to the safety and performance of the medical devices", and to "show that appropriate action has been taken in cases of non-compliance with relevant legislation and regulations, including the notification to the Regulatory Authority of any incidences that require reporting."

This I think begs the question: what expectations or obligations currently exist for RvA's supervision of the CAB, so that RvA can identify if the CAB has correctly verified the certified organization's performance?

Is there a current requirement that RvA be aware of matters indicating potential non-compliance with legislation and regulations, such as FDA issuance of a 483 or Warning Letter?
  Post Number #28  
Old 12th September 2011, 12:37 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,508
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

Quote:
In Reply to Parent Post by MIREGMGR View Post

Given accreditation of the CAB for ISO 13485 only by RvA, what is the chain of control under ISO 17021, both at present and in regard to the eventual implementation of the IAF guidance discussed above?

The guidance will require the certified organization to comply with "the statutory and regulatory requirements applicable to the safety and performance of the medical devices", and to "show that appropriate action has been taken in cases of non-compliance with relevant legislation and regulations, including the notification to the Regulatory Authority of any incidences that require reporting."

This I think begs the question: what expectations or obligations currently exist for RvA's supervision of the CAB, so that RvA can identify if the CAB has correctly verified the certified organization's performance?

Is there a current requirement that RvA be aware of matters indicating potential non-compliance with legislation and regulations, such as FDA issuance of a 483 or Warning Letter?
ISO 17011 (which applies to the AB's) state
Quote:
7.11.7 The accreditation body may conduct extraordinary assessments as a result of complaints or changes (see 8.1.2), etc. The accreditation body shall advise CABs of this possibility.
So, if an interested party were to complain to the RvA, they MIGHT trigger a special audit IF they think it is justified. And, in case the AB does not take appropriate action, ISO offers to get involved: ISO accepting complaints about Management System Certificates to ISO Standards

Last edited by Sidney Vianna; 12th September 2011 at 12:53 PM.
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #29  
Old 12th September 2011, 01:30 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

Wes expressed the opinion:
Quote:
It is absolutely unacceptable for any CB to be unaware of an adverse report from FDA or any regulatory body.
I'm trying to sort out how our QMS should be corrected to reflect how this currently works as a matter of rule. In particular, I'm trying to sort out whether the upstream aspects of ISO 13485 amount to a viable Corrective and Preventative Action mechanism under FDA rules.

Under the current standards and guidances:

Is a CB mandated to be aware (as soon as reasonably possible) of a regulatory action by a third party, such as an inspection-finding 483 or a Warning Letter issued by US FDA?

Is a CB, having learned of US FDA findings in a Warning Letter, mandated (after verifying the substance of the findings) to take action in regard to any corresponding non-conformances to ISO 13485?

Do I correctly understand per the above explanation of ISO 17011 that an AB is not mandated to take substantial action in the event that a CB does not take substantial action regarding an FDA Warning Letter, etc.?

If all of this is non-mandatory, I don't think it's acceptable under 21CFR 820.100.

If it's not acceptable under 21CFR 820.100, then my company's practice of relying partially or completely (depending on material/service criticality) on third party audits (i.e. ISO 13485 certificates) to implement supplier and material/service qualification under 21CFR 820 is out the window.

I wish I'd pursued this line of thinking two years ago.
  Post Number #30  
Old 12th September 2011, 01:50 PM
Wes Bucey's Avatar
Wes Bucey

 
 
Total Posts: 11,043
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

For my part, I think the contract between registrar and registrant should include a clause requiring registrant to notify registrar instantly of such "pending action" from a regulatory agency. The penalty should be that certification is immediately withdrawn if registrar learns independently of the regulatory action more than a week after registrant. Note, regulatory notice or action alone is not sufficient to invalidate a certificate (especially when it is not final), but it should put the registrar on alert and maybe trigger its own review of its registrant.

The relationship between a CB and an AB often seems like a shell game to outsiders. I've never been personally involved in the complaint process, but it seems from "anecdotal evidence" that the primary reason ABs penalize CBs and CBs penalize registrants is only when the requisite fees for registration have not been paid. Any real "nonconformance" on the part of a registrant or CB never seems to come to public light.

In the past we had threads which pointed out CBs were not required (except as a "courtesy") to advise their registrants if the CB had its approval/registration withdrawn by the AB. I don't recall seeing anything saying that state of affairs had changed.

Given that neither CBs nor ABs seem eager to "rat out" their registrants, organizations which rely on a supplier's registration as a primary factor in approval as a supplier seem to be shooting craps with loaded dice with the current system. How is the average organization to know if registration has any value if there is no public notice when a link from registrant to CB to AB is broken because of REAL nonconformance, not just a matter (especially in today's economic climate) of whether the renewal fees were paid on time?

Sidney has indeed put his finger on the point - TRANSPARENCY!
Thank You to Wes Bucey for your informative Post and/or Attachment!
  Post Number #31  
Old 12th September 2011, 01:59 PM
MIREGMGR

 
 
Total Posts: 3,685
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

At present, I care less about our supplier's CB's authorization to issue certificates than I do about my company having a legally acceptable supplier qualification and CAPA process.

The specific meaning of "lack of transparency" to me right now is unacceptable CAPA.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #32  
Old 12th September 2011, 06:22 PM
Ronen E

 
 
Total Posts: 3,020
Re: Trusting ISO 13485 Certification of a supplier... A Sad Story

In a nutshell: Who will guard the guards?...

In my opinion ISO 13485 certification is very desirable for supplier qualification (not a must!), but it is very far from sufficient. Supplier quality score must be rightfully earned, first-hand, over time. Until then, respect and suspect.
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