Supplier Certification for ISO 13485

Hello everyone,

we have a supplier of some critical part of our device (class III implant) which is not certified for ISO 13485. the component itself is pretty unique and 100% verification by us is not possible (for both budjet and professional issues). additional point is that the supplier does not agree to allow on-site audit for IP protection reasons. could certification for ISO 13485 solve this problem (than they should have all necessary processess in place to ensure conformance to our specifications and our receiving inspections could be based on CoC)?

Thanks.

danush said:

Hello everyone,

we have a supplier of some critical part of our device (class III implant) which is not certified for ISO 13485. the component itself is pretty unique and 100% verification by us is not possible (for both budjet and professional issues). additional point is that the supplier does not agree to allow on-site audit for IP protection reasons. could certification for ISO 13485 solve this problem (than they should have all necessary processess in place to ensure conformance to our specifications and our receiving inspections could be based on CoC)?

Thanks.

Click to expand...

It sounds as if you intend to rely fully on your supplier's ISO registration for conformance to your specs. While it may be of some assurance having ISO-registered suppliers, it should not take the place of monitoring your suppliers' performance. It is your company's responsibility to ensure that your product meets customer requirements and your own internal specifications. Part of this includes the supplier performance and how you monitor it.

Bottom line: Don't put all of your confidence into ISO certificates when it comes to supplier selection and performance. You must do the leg work and verify that your suppliers are providing what you're paying them to provide.

I hope this helps.

It'd be a better stance than what I gather you have at present. Whether it'd be good enough seems like a gray area.

What did your NB have to say about the situation during their pre-market review of the product design and manufacturing? What have they had to say during surveillance audits?

Have you ever had an instance of the supplied critical part not fully meeting your specifications and/or being causative, or suspected of causation, of your product being insufficiently safe or effective?

GStough,

thanks for the informative post....it seems that many rely too heavily on a supplier's ISO certification.....as you pointed out, spec compliance or a cert of compliance is/are not a bullet proof guarantee or certainty that you are receiving what you purchased...which can lead to a false sense of security.

Marty

Thank you everebody for your responses. for some resone i haven't received notofications about responses to my thread.
i am aware that ISo certificate alone is not enough to be confident in your supplier performance but as i mentioned we have several problems with this particular supplier- we have no technical ability to test the component and the supplier doesn't permit on-site audits because of manufacturing secrets issue.
our NB expressed some concerns about our control over supplier performance and product being conforming to specs. this is the reason we thought, ISO certification, which requires audit by third party may solve the problem at least partially.

thanks again.

danush said:

....................... our NB expressed some concerns about our control over supplier performance and product being conforming to specs.............................

Click to expand...

Have you exhausted all means? How about control of outsourced processes?

danush said:

our NB expressed some concerns about our control over supplier performance and product being conforming to specs. this is the reason we thought, ISO certification, which requires audit by third party may solve the problem at least partially.

Click to expand...

I'd agree with GStough that...even in theory, and certainly in current practice...supplier certification is not sufficient to assure that an individual supplied part conforms to specs. Especially in a Class-III-critical context.

My recommendation would be that either the supplier has to cooperate, or you have to establish a way to verify the parts, or you have to find a different supplier.

Let's see...

A class III device... that's risky.

A critical part... definitely important.

Supplier is not 13485 certified... gets hot... (BTW, any other QMS / other certifications available?)

Supplier is not auditable... complicated, not to say a bit fishy!...

Purchaser doesn't have technical competence to ascertain goods' acceptability... almost a show stopper.

But - no viable supply alternatives around...

I'd say - either you find a 3rd party with the required technical competence, and monitor incoming supply quality rather closely, or you're stuck!...

IMHO 13485 may (may) support better overall conduct and hence lower risk, but it definitely won't guarantee acceptability of a class III devices's critical component to a reasonable extent.

Cheers,
Ronen.