ISO13485 Clause 8.3 and Sub-Clause 8.3.2 and 8.3.3

I do internal auditing at a major medical device company and there has been some debate regarding the above mentioned clauses. It's the wording.

8.3.2 Actions in response to nonconforming product detected before delivery-

The organization shall deal with nonconforming product by one or more of the following ways:
a) taking action to eliminate the detected nonconformity
b) taking action to preclude its original intended use or application
c) authorizing its use, release or acceptance under concession.

The organization shall ensure that nonconforming product is accepted by concession only if the
justification is provided, approval is obtained and applicable regulatory requirements are met.

Records of the acceptance by concession and the identity of the person authorizing the concession shall be maintained (see 4.2.5).


8.3.3 Actions in response to nonconforming product detected after delivery-

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. Records of actions taken shall be maintained (see 4.2.5).

The organization shall document procedures for issuing advisory notices in accordance with applicable regulatory requirements. These procedures shall be capable of being put into effect at any time. Records of actions relating to the issuance of advisory notices shall be maintained (see 4.2.5).

____________________________________________________________________________________

No matter how many times I read and re-read these, to me, they are referring to raw material before "delivery" to the company and after "delivery" to the company and it does not at all refer to finished goods that have been "delivered" to the customer nor finished goods that have gone through a routine failure in the field.

For instance 8.3.2 would refer to source inspection and 8.3.3 would refer to after the raw material after the company has received it and it is in use as in, in inventory and being distributed to the lines.

 

Regarding the poll, I don't think you can rely on the customer having any "responsibility" here. Hopefully they do report NC product but if they don't, they don't. Nobody's going after them.

I think the standard is a little confusing. I have always taken that before delivery / after delivery line to be once the finished goods are released for distribution (pass final acceptance testing). Everything before, including raw materials, would be "before delivery."

Probably trying to put too fine a point on it will just bog things down. Control NCs (wherever) and take appropriate actions. If you're doing that, you should be ok in audits.

 

It depends on the scope/context of the organization you are auditing. Ultimately, raw material/finished product differs for each organization. E.g. if the organization is manufacturing hospital beds, then the "nonconforming product" refers to "hospital bed".