Supplier Survey vs. On-site Audit - 13485 Calibration



Supplier Survey vs. on-site audit

I am fairly new to the FDA regulated medical device industry – 3 months. I come from an ISO/QS industry where my primary responsibilities were document control and calibration. We recently had an internal audit – not for registration. We have an auditor come in to do internal audits to make sure we are meeting the QSR 21 CFR part 820 and ISO 13485 intent. I’m struggling with a particular finding. We have a form named the “Supplier/Subcontractor Approval Check Sheet”. A section of the form is titled ”Survey / Audit Selection”. In this section we chose whether to send a survey or do an on-site audit. Typically we send the survey. The form also has a space that requires a rationale for why we chose the survey over an on-site audit – it was put there at the insistence from a previous audit finding. I don’t remember this being a requirement at my ISO/QS establishment. I really don’t see where in the QSR or ISO 13485 it is required – ISO 13485 section 7.4 Purchasing. There is paragraph that mentions “Criteria for selection, evaluation and re-evaluation shall be established”, but I take that to mean the supplier selection not the method of evaluation. Is this a normal request for this type of industry? HELP??

Deb Mitchell

Aaron Lupo


You are correct doing audits of your suppliers is not a requirement of either ISO 13485:2003 or the QSR. What you need to do is evaluate your suppliers and that is up to your orginization on how that is done. ISO 13485 7.4.1 states: "The organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluationshall be maintained (see 4.2.4)."

21CFR820.50 a States: " Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirments, that must be meet by suppliers, contractors, and consultants....." "Establish and maintain records of acceptable suppliers, contractors, and consultants."

You may want to look at your internal procedure and see if you require that supplier audits be done, or call your auditor and ask for clarification, as suppliers audits are not a requirement of either.


ISO Guy:

Our internal Purchasing Control procedure leaves the method of supplier evaluation to us. The auditor is asking us to document the rationale as to why we have chosen one over the other - supplier survey or on-site audit. I don't understand why?

Also on another finding we were asked to distinguish between active and inactive suppliers. Some suppliers that are still on our Approved Vendor List are not presently being used and their surveys and other quality documents were not up to date. We do not want to remove them from the AVL because we might utilize them again in the future. I've suggested an inactive memo to file. What do you think?
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