Manufacturers shall establish in writing and maintain procedures for contract review and for the coordination of review activities.
Article 109. Before submitting a tender, or accepting a contract or order, manufacturers shall review said tender, contract or order to ensure that the following conditions are met:
(1) Requirements are adequately defined and documented; where an order is placed orally and there is no accompanying documentation, steps shall be taken to ensure that requirements have been met before said order is accepted.
(2) Any discrepancies between items in contact/order and tender have been resolved.
(3) Contract/order requirements are capable of being fulfilled.
Manufacturers shall identify contract amendments and accurately communicate said amendments to relevant departments within the organization.
Records of the review procedures described in the preceding two Paragraphs shall be kept and maintained.
Chapter 5 Design Control
Article 110. Manufacturers shall control and verify product design, and establish in writing and maintain procedures to ensure that specified requirements are met. However, products for which the central competent health authority does not mandate the implementation of design control, are not required to comply with the provisions of this Chapter.
Manufacturers shall, in the course of the design process, assess the need for risk analysis and keep and maintain records of any risk analysis performed.
Article 111. Manufacturers shall draft plans for each design and development activity; said plans shall comply with the following conditions:
(1) Each plan shall document or refer related activities.
(2) Implementation responsibility shall be defined.
(3) Design and development tasks shall be assigned to qualified personnel equipped with adequate resources.
(4) Plans shall be updated as designs evolve.
Manufacturers shall define organizational and technical interfaces between the different groups involved in the design process; necessary information shall be documented, circulated and reviewed on a regular basis.
Article 112. Manufacturers shall identify, document and adequately review product design input requirements (including applicable statutory and regulatory requirements). Where said requirements are incomplete, ambiguous or conflicting, solutions shall be reached in consultation with those responsible for imposing said requirements.
Design input shall take into consideration contract review results.
Article 113. Manufacturers shall document design output; said output shall comply with the following conditions:
(1) Design output shall comply with design input requirements, and expressed in terms that can be verified and validated against design input requirements.
(2) Design output shall contain or make reference to acceptance criteria.
(3) Design input shall identify the design characteristics that are crucial to the safe and proper functioning of the product (e.g. operation, storage, shipping, maintenance and handling requirements).
(4) Design output documentation shall be reviewed before release.
Article 114. Manufacturers shall, in the course of the design process, plan and conduct formal written reviews of design results.
Participants in said reviews shall include representatives of all departments involved in review of the design stage; where necessary, other specialist personnel shall be asked to participate.
Records of said reviews shall be kept and maintained.
Article 115. Manufacturers shall perform design verification at appropriate stages in the design process to ensure that design stage output complies with design stage input requirements.
Records of the design verification measures referred to in the preceding Paragraph shall be kept and maintained.
Article 116. Manufacturers shall perform design validation and clinical evaluations to ensure that products comply with established user needs and specified requirements; records of these activities shall be kept and maintained as part of the design validation process.
The clinical evaluations referred to in the preceding Paragraph shall include relevant scientific literature and established evidence proving that similar designs and materials are clinically safe, or use clinical studies or experiments to ensure that said equipment conforms to specified functions.
Article 117. All design alterations and modifications made by manufacturers shall be identified, documented and reviewed, as well as approved by authorized personnel, prior to implementation.
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