Trusting ISO 13485 Certification of a Supplier... A Sad Story

MIREGMGR · Sep 12, 2011

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.

Ronen E · Sep 12, 2011

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.

Sidney Vianna · Oct 25, 2011

Re: Trust of ISO13485 Certification... A Sad Story

MIREGMGR said:
I've emailed Orion. After their response or a suitable time, I'll inquire similarly of the AB if necessary.

Responses will be shared here.

Any update?

MIREGMGR · Oct 25, 2011

Orion promptly responded to my original inquiry, saying that they had not been aware of the issue and would look into it. I've had no further contact from them.

The supplier's website continues to display the now-expired ISO 13485 certificate.

My assumption is that for one reason or another, the certificate already was not in the process of being renewed at the time of my inquiry, and Orion regards the matter as no longer their problem since the certicate now is expired.

We had some lab testing done on the most recent five batches of product provided to us. Such testing of course didn't prove sterility, but it did give us some indication that at least those product batches weren't wholly nonsterile.

We've had no downstream contact from either the supplier or FDA regarding a product recall or other field action.

We've made several revisions to our supplier control procedures, and we're working on further changes to improve control.

MIREGMGR · Nov 6, 2013

As a follow-up, I just checked the ex-supplier's website to see if they had eventually renewed their ISO 13485 certificate, or obtained a new certificate from another certifier. If either had happened, I could follow up with the certifier.

Apparently neither has happened--the ex-supplier's website continues to display the 2011-expired certificate.

tampk · Mar 20, 2014

We are amongst ones who have been engaged in quality awareness at the national level and who have undertaken numerous trainings (LAC etc) and also conducted 3rd party audits on behalf of branded CBs. However since past 8 years we have only been accepting requests for 2nd party supplier audits on behalf of our clients - a process which provides more confidence to our clients as well as their suppliers. The only difference being that we are required to take care of many standard requirements at the same time that can be assured only through employment of very knowledgeable and experienced auditors. These audits are not expensive, and have proven to be more fruitful, fulfilling and professional than 3rd party audits conducted by CBs. More and more organizations, manufacturers, and companies are resorting to consulting-cum-audit companies like us who have experienced auditors on panel in each country as such bring in better dividends than CBs.

Wilderness Woody · Mar 20, 2014

But their website is "Certified by GoDaddy.com" so they must have something working right... :frust:

The "letter of regret" link on the site: https://www.pharminnovations.com/FDA.pdf

MIREGMGR · Mar 21, 2014

The company in question filed suit against the FDA recently for refusing to provide them a Certificate to Foreign Government.

Wes Bucey · Mar 21, 2014

As much as we want to trust our government agencies, sometimes they mess up. I seem to recall a case (very fuzzy details) about a company in the southwest USA which fought FDA over some issue and won. Is this the one I'm thinking of? Scott Catron followed it pretty closely.

AndyN · Mar 21, 2014

tampk said:
We are amongst ones who have been engaged in quality awareness at the national level and who have undertaken numerous trainings (LAC etc) and also conducted 3rd party audits on behalf of branded CBs. However since past 8 years we have only been accepting requests for 2nd party supplier audits on behalf of our clients - a process which provides more confidence to our clients as well as their suppliers. The only difference being that we are required to take care of many standard requirements at the same time that can be assured only through employment of very knowledgeable and experienced auditors. These audits are not expensive, and have proven to be more fruitful, fulfilling and professional than 3rd party audits conducted by CBs. More and more organizations, manufacturers, and companies are resorting to consulting-cum-audit companies like us who have experienced auditors on panel in each country as such bring in better dividends than CBs.

And who oversees that these audits are doing what you say? Returning to second party audits isn't (generally speaking) any better. There's no assurance of any auditor being even remotely competent and certainly no oversight or adherence to standards, such as ISO/IEC 17021 etc.

Trusting ISO 13485 Certification of a Supplier... A Sad Story

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