Hi everyone, Do you have any sugge 2

[Zinov]

Hi everyone,
Do you have any suggestions concerning the approved supplier list in an ISO13485 certified company.
What are all the good practices related to this issue, as a preparation for coming FDA audit.
Regards,
Zinov

 

[ornerynorsk]

Just make sure you have performed your supplier audits and equipment validations per your requirements and have incoming goods inspection reports, non-conforming materials reports, and corrective actions all documented. Should be no problem. If your suppliers are ISO, have copies of their certificates in your files, as well.

It is better to have enough ideas for some of them to be wrong, than to be always right by having no ideas at all.

 

[Zinov]

Thanks ornerynorsk,
I think that the supplier audit is not mandatory.
In our case we are too 'small' compared to our suppliers
We 'cannot' audit them.

Regards,
Zinov

 

[ornerynorsk]

Not so. In the true spirit of ISO 13485, you do have the obligation and the authority to set certain requirements and parameters for your vendors, even if you have to ask for their advice in certain technical aspects. The goal of the standard is to achieve measurable consistency in order to effectively detect non-conformances and deviations in components.

Even without a quality system in place, you are still the customer.

It is better to have enough ideas for some of them to be wrong, than to be always right by having no ideas at all.