Manufacturers shall establish in writing and maintain procedures for inspection and testing activities in order to verify that products meet specified requirements.
The inspection and testing referred to in the preceding Paragraph, as well as the records to be established of said activities, shall be detailed in the quality plan or in documented procedures.
Article 134. Manufacturers shall apply the following control measures to incoming products:
(1) Manufacturers shall ensure that incoming products are not used or processed until said products have been inspected or otherwise verified as complying with specified requirements. Verification of compliance with specified requirements shall be carried out in accordance with the quality plan or documented procedures.
(2) In determining the nature and amount of receiving inspection, consideration shall be given to the amount of control implemented at the subcontractor’s premises and the records of conformance provided.
(3) Where incoming products are released for urgent production purposes prior to verification, said products shall be clearly identified and a record kept in order to facilitate immediate recall and replacement in the event of noncompliance with specified requirements.
Article 135. Manufacturers shall implement the following in-process inspection and testing measures:
(1) Inspect and test products in accordance with quality plan or documented procedural requirements.
(2) Hold products until required inspection and tests have been completed or necessary reports have been received and verified; however, this requirement does not apply to products that are released under positive-recall procedures.
Products released under positive-recall procedures must still be inspected and tested in accordance with Subparagraph 1 of the preceding Paragraph.
Article 136. Manufacturers shall carry out final inspection and testing, and create a record of said activities, in accordance with the quality plan or documented procedures, to ensure that end products are in compliance with specified requirements.
The quality plan or documented procedures for final inspection and testing shall require that all specified inspection and tests (including those specified either on receipt of product or in-process) have been carried out and that results meet specified requirements.
No product shall be dispatched until all the activities specified in the quality plan or documented procedures have been satisfactorily completed and the associated data and documentation is available and authorized.
Article 137. Manufacturers shall establish and maintain records that give evidence that products have been inspected and/or tested.
The records described in the preceding Paragraph shall meet the following conditions:
(1) Said records shall show clearly whether products have passed or failed the inspection or tests performed according to acceptance criteria; where products fail to pass any inspection or test, the procedures for control of nonconforming products shall apply.
(2) Records shall identify the inspection authority responsible for the release of products.
(3) Manufacturers shall record the identity of personnel performing any inspection or testing of active implantable medical devices or implantable medical devices.
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