Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form?

[SANE]

Dear all,

May I ask you for your input related to supplier re-evaluation. I feel unsure.
Our company has a supplier evaluation form used internally filled in by our company's employees annually.
For our critical suppliers a QSA exists keeping the possibility of a supplier audit as option.
Then we have a form for supplier self assesment.
I wonder to which class of suppliers this self- assessment form has to be sent on the defined regular basis (usually once per year) ?

• all suppliers (with or without certifcate like ISO 13485, 21 CFR 820)
• all critical suppliers (with or without certifcate like ISO 13485, 21 CFR 820)
• critical suppliers only if no supplier audit is performed (with or without certifcate like ISO 13485, 21 CFR 820)
• critical suppliers without certifcate like ISO 13485, 21 CFR 820
• all non critial suppliers (with or without certifcate like ISO 13485, 21 CFR 820)
• all non critical suupliers without any certificate as ISO 13485, 21 CFR 820

Can you tell me the reference in the ISO 13485 which gives me the hint which category of suppliers I have to send the self assessment.

Thinking about a risk based approach, I would only send this form to critical suppliers without certficate, but possibly this is a misinterpretation by myself.

Thanks for your support

 

[Tagin]

13485:2016 7.4.1 says:
"The organization shall establish criteria for the evaluation and selection of suppliers...."
"The organization shall plan the monitoring and re-evaluation of suppliers..."

So, its really up to how your company wants to define these requirements. The criteria would have to be justifiable to an auditor.
(Note: I don't know if there are separate regulatory requirements for supplier monitoring that apply to your company.)

 

[SANE]

Dear Tagin,

thanks for this fast and helpful reply. I can work with this and understand that I have a certain flexibility as long as it is logic for the external auditor.
I took up the monitoring as short chapter in the SOP supplier management since it is performed but I did not list it as a separte step.

 

[Ninja]

I wonder to which class of suppliers this self- assessment form has to be sent on the defined regular basis (usually once per year) ?

None. Kill the supplier self assessment (and definitely kill the form to send out).
Your company should assess the supplier, not the supplier assessing themselves.
{written as a supplier that gets those forms ... many ... all year long ... }

 

[yodon]

@Tagin is spot on saying it's up to you. I'd just add that I've yet to see much benefit in using supplier self-assessment forms. For one, you don't know if their answers are truthful. For another, a standard form likely does not give you the information you need to make a good decision.

 

[Ninja]

Many threads here on the forum regarding how to get suppliers to send the forms back... end result of most discussions is "you can't".

 

[SANE]

Dear all,
I inherited this kind of documentation and I am happy if I can skip the self assessment forms if it is just an unneeded compulsary exercise. We have the monitoring, evalution of the monitored performance by us using internal evaluation forms and for the critical ones Quality agreements combined with special income controls. The self assessment forms seemed so common but I did not find them requested by the ISO itself.
Based on your feedback, I dared to take them out from the QM system of a small company yesterday working with all the above listed controls.
Thanks a lot to all of you