ISO 13485:2016 - Supplier Selection Criteria

Nancylove

Starting to get Involved
#1
Hello All,

Need some help. The 2016 version of ISO 13485 has two requirements that seem nearly the same, at least from my experience. It says Supplier Selection and Evaluation criteria shall be (skipping a and b): c) based on the effect of the of the purchased product on the quality of the medical device, d) proportionate to the risk of the medical device.

Effect on quality of the device and proportionate to the risk of the device seem joined at the hip to me. Things that affect quality also affects risk of the device. Any idea what the intent of this requirement was? Interested in your experience and opinions regarding this. Thanks!
 
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rob73

looking for answers
#2
This is how we have interpreted this clause.
The "risk" in d) is more related to the risk class of the device. For example say an electronic blood pressure cuff and a pacemaker both use the same capacitor from the same supplier, it fails, both devices will fail to work but only the patient with the pacemaker is at risk of death or serious injury.
So the supplier may be selected for the cuff but not the pacemaker when considering d), if you also consider c) if the failure rate is 1 in 10 this would affect product quality (many returns and complaints) so again the supplier would not be accepted.
 

Marcelo

Inactive Registered Visitor
#3
The requirements mentioned could have been better written (but this is a general problem in some parts of the 2016 anyway).

The requirement on "quality" is more focused on internal compliance. Thus it's not related to risk to patients, user etc.

The risk requirement is related to risk to patients, user, etc.

It's not related to risk classes. Risk classes are only used by the regulatory bodies to determine the level of regulatory scrutiny to be applied to a device.
 
Last edited:

Nancylove

Starting to get Involved
#4
Ok, I understand that there may be some quality aspects of the product that are not related to patient risk, however, back to the criteria, letter a) is: based on the supplier's ability to provide product that meets the organizations requirements.

In my experience, the quality aspects (criteria c) are part of the product requirements (criteria a) and such as covered by criteria a. So, now my question is, what Criteria C items are not part of Criteria A?
 
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