Internal Audit-Clause 7.4

Hello everyone,

In our small R&D company with ISO 13485 certification, the roles and responsibilities of our small QC team (manager and operator only) include purchasing and inventory management. However, there is no official documentation or evidence explicitly permitting them to perform tasks related to the purchasing process. This authorization is not outlined in their designated roles and responsibilities or within the company's organizational chart. The team is fully trained on all procedures required for this process.

I have recently conducted an internal audit of the purchasing process as per clause 7.4 of ISO 13485. In light of the aforementioned situation, should I consider this as major NC (against clause 5.5 of ISO)?

Thank you.

5.5.1. Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks.
How does your organization (and "all procedures required for this process") ensure the independence of purchaser and QC inspector for the same items? Can you buy 1 item and QC it yourself?

SeanN said:

5.5.1. Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks.
How does your organization (and "all procedures required for this process") ensure the independence of purchaser and QC inspector for the same items? Can you buy 1 item and QC it yourself?

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Good question. QC doesn’t decide what required for manufacturing or testing. Technical team or whoever requires material creat purchase order then QC receives, inspects, creates GRN form, assigns PN, for new material, and does testing, if required then approves material for use.
To be honest i am not sure whether this is acceptable or not!

AQARA said:

whoever requires material creat purchase order then QC receives, inspects, creates GRN form, assigns PN, for new material, and does testing, if required then approves material for use.

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As you said, "The team is fully trained on all procedures required for this process." If this training is documented and you can't find any independence issues, it's not a NC.