Control of nonconforming product of ISO 13485
Control of nonconforming product of ISO 13485
Clause 8.3
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
The organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession;
c) by taking action to preclude its original intended use or application.
The organization shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met. Records of the identity of the person(s) authorizing the concession shall be maintained (see 4.2.4).
Records of the nature of non-conformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.
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.
If product needs to be reworked (one or more times), the organization shall document the rework process in a work instruction that has undergone the same authorization and approval procedure as the original work instruction. Prior to authorization and approval of the work instruction, a determination of any adverse effect of the rework upon product shall be made and documented (see 4.2.3 and 7.5.1).
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