8.2.6   Monitoring and measurement of product

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at applicable stages of the product realization process in accordance with the planned and documented arrangements and documented procedures.

Evidence of conformity to the acceptance criteria shall be maintained. The identity of the person authorizing release of product shall be recorded (see 4.2.5). As appropriate, records shall identify the test equipment used to perform measurement activities.

Product release and service delivery shall not proceed until the planned and documented arrangements have been satisfactorily completed.

For implantable medical devices, the organization shall record the identity of personnel performing any inspection or testing.

8.3   Control of nonconforming product

8.3.1 General

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 organization shall document a procedure to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation and disposition of nonconforming  product.

The evaluation of nonconformity shall include a determination of the need for an investigation and notification of any external party responsible for the nonconformity.

Records of the nature of the nonconformities and any subsequent action taken, including the evaluation, any investigation and the rationale for decisions shall be maintained (see 4.2.5)

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).

8.3.4 Rework

The organization shall perform rework in accordance with documented procedures that takes into account the potential adverse effect of the rework on the product. These procedures shall undergo the same review and approval as the original procedure.

After the completion of rework, product shall be verified to ensure that it meets applicable acceptance criteria and regulatory requirements.

Records of rework shall be maintained (see 4.2.5).