![]() These include:Ībility to meet requirements – How well does the supplier meet your requirements? Can they meet the tolerances you need? Are they compliant with any legal requirements that are necessary to provide their products? For example, if there is a certificate of quality or certificate of analysis for purchased material, are the tolerances listed on the certificate in accordance with your requirements? So, how do you make sure that suppliers will meet your needs? ISO 13485 contains a list of things to consider when approving a supplier. This list, which includes the dates for re-evaluations, ensures that you always use a supplier who is in good standing with your company.Ĭriteria for evaluation and selection of suppliers While not strictly a requirement of the standard, many companies maintain a list of the suppliers who are currently approved for use by the purchasing department. This approval, monitoring, and any necessary correction of suppliers needs to be demonstrated by records that are maintained to demonstrate that the suppliers are capable of meeting requirements. Failure to meet requirements needs to be addressed and corrected as soon as it is noticed. ![]() Supplier evaluation is not intended to be a one-time thing: once a supplier is approved for use, monitoring of performance is crucial to ensure that they continue to meet your requirements. Your supplier evaluation, and subsequent supplier monitoring, are intended to be based on the risks that each supplier poses to your ability to provide medical devices that meet customer and regulatory requirements. ![]() ![]() One of the purchasing controls to ensure that you get the right products for your medical device manufacturing is supplier evaluation. ISO 13485:2016 supplier management requirements
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