![]() In fact, in the section in the section 21 CFR 820.250(b), it is reported: Very similar requirements are mentioned in the US 21 CFR 820 Code of Federal regulation, thus the FDA regulation for Quality Management System. The frequency of the review of the sampling plans should be based on the occurrence of nonconforming products, audit results and complaints records. The organization should also periodically review the sampling methods to ensure they are consistent and suitable for their intended use. For example, Anvisa Regulation requires evidence that sampling plans are based on valid statistical rationale. If we consider the MDSAP, specific requirements for acceptance activities should also be taken in consideration. As usual, a risk based approach shall be applied and thus the extent of the verification activities shall be based on the results of the supplier evaluation and proportionate to the risk associated with the purchased products. Basically the requirements are related to the necessity to have a system for the verification that purchased products are aligned with the specifications defined with the supplier. ![]() If we consider the ISO 13485:2016 there are specific requirements associated to the verification of purchase products, specifically in the section 7.4.3. ![]() Acceptance Activities and QMS Requirements ![]()
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