Critical supplier - Obligated to have an ISO-certified QMS?

S

snoopy2017

#1
Hi everyone,

As a critical supplier (contract manufacturer), are they obligated to have an ISO-certified QMS? Or any kind of QMS?

Thanks!
 
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Sidney Vianna

Post Responsibly
Staff member
Admin
#2
You didn't provide much context of the situation, but if you are a medical device manufacturer and have a Notified Body working with you for the CE-marking of your products, some NB's may require (their) auditing and/or certification of critical suppliers.

As for having a critical supplier without a quality system, that would violate any basic risk management concept; so don't confuse a quality system with a quality system STANDARD.
 

John Broomfield

Staff member
Super Moderator
#5
This depends of your supplier selection criteria.

The reports you require from your supplier depend on your contract as agreed with each supplier.

Do not depend on the standard or your customer for your supplier to have an effective QMS.
 

JoshuaFroud

Involved In Discussions
#6
I think this really comes down to risk. We have a supplier we class as our "high-risk component" supplier, they do not have an accredited quality system, but do have a quality system in place. It was put in place under ISO 9001:2000 and they have not kept up with the new versions.

Our supplier selection procedure states that all high-risk component suppliers should have an accredited quality system and so there is a risk assessment in our supplier file to cover this. This specific supplier also receives audits more frequently from us than suppliers with an accredited QMS.

I would not say that (unless your NB says otherwise) a critical supplier must have a QMS but there should be some assessment of the risk involved in them not having something in place. Are the processes and procedures they do have in place sufficient to meet the requirements of you as a medical device manufacturer especially with regards to traceability.
 

htcoztrk

Starting to get Involved
#7
I agreed with the JoshuaFroud. Considering ISO 13485:2016 is risk based standard, it is a high risk having a critical supplier without a ISO-certified QMS. But that does not mean you cannot have one as soon as you control the risks properly.

As John Broomfield mentioned this depends of your supplier selection criteria. What's the criteria for your critical supplier in regard to QMS?

If your NB does not have any problem with the situation, I would personally re-define my supplier selection criterias so that criterias would cover also the critical supplier without a ISO-certified. Then I would set stricter controls for this supplier than other suppliers with ISO certified QMS such as more frequent evaluation at least 1 audit per year, supplier survey etc. And perform a detailed risk assessment proving that your controls over supplier reduced the foreseeable risks.

Also the other important point is if your critical supplier have a QMS nut not certified or does not have QMS at all. Because this two situation have different risk outputs. However in both case you should be able to show your NB or any third party that your supplier keep all the records that is required by ISO 13485:2016 for whole product realization process.

-Hatice
 

John Broomfield

Staff member
Super Moderator
#8
Hatice,

Here is our discussion on supplier selection criteria:

ISO 13485:2016 - Supplier Selection Criteria

Usually, those criteria are set by the organization or, occasionally, by their customer but not by the standard.

How those criteria are changed as a result of risk assessment or in response to a new design would of course be monitored for effectiveness and eventually sampled by internal auditors.

Best wishes,

John
 

htcoztrk

Starting to get Involved
#9
Usually, those criteria are set by the organization or, occasionally, by their customer but not by the standard.
John,

I think there is a misunderstanding becasue I never said that the standard set the criteria for supplier selection. I said if the bookish set any requirement for QMS for his suppliers/critical suppliers in his supplier selection criteria.

Regards,
Hatice
 
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