Is a First Article Inspection (FAI) Procedure required by ISO 13485?

[cabjerk]

We were talking about FAI and a person brought up we need a SOP and point me to a website.

On the site it has the following-

The ISO 13485 First Article Inspection (FAI) Procedure provides instruction on conducting first article inspections and generating a first article inspection report.

• ISO 13485:2016 Compliant
• FDA QSR Compliant

I checked ISO 13485 and no where does it call out anything for a FAI. It does call out inspections and records. Is there anything under the FDA QSR that calls out FAI? Just looking for any feedback people have on FAI and where if any place in the Reg it calls out FAI's.

Thank you

 

[chris1price]

No, there is nothing in ISO13485, FDA 21CFR820 that discusses FAI. However auditors may ask for a rationale for not performing one.

 

[Lokus200]

No, you don't need a stand-alone SOP for FAI. However, you do need to define somewhere how you perform this inspection.

 

[Gwhittaker22]

Hello Colleagues:

What are your thoughts about the the obligations and rights provided to the seller and buyer under the UCC?
Would you agree that the basic privileges provided by the UCC, i.e...the rules in Section 2-606 of the Texas Business and Commercial Code, wherein the buyer does not have to pay for goods that do not fully meet the requirements set out in the PO contract?
FAI seems to be an crucial if not mandatory action for the sale of the goods to be legal and proper.
It would seem that a policy and procedure addressing the FAI should be included in the QMS regardless of the standard applicable for the organization?

Goods are merchantable if the following is true:

1) The good(s) pass without objection in the trade under the contract description; Most PO contracts don't spell this out.
2) are fit for the ordinary purposes for which the good is used; Most PO contracts don't state how the goods are intended to be used.
3) When used, the variation in performance permitted by the agreement, of even kind, quality and quantity is consistent for all units, not to the units in the sample.
4) Conform to the promises or affirmations of fact made on the container, packaging , or in certifications delivered with the product.

The aforementioned expectations are explained in Section 2-314(b) of the Texas Business and Commercial Code

I have to deal with contracts for suppliers affecting the FAR and DOD. I would like to learn more about the experience of other like-minded professionals.

George