![]() ![]() Contrary to ISO 13485, it explicitly mentions a quality assurance agreement: The FDA mentions practically identical requirements in 21 CFR part 820.50 “Purchasing Controls”. You can find further requirements on supplier assessment in the ZLG documents, e.g. risks, which are generally assumed for the medical device (regardless of the product purchased). ![]() ![]() analysis of the effects of the product/service purchased on the safety and performance of the medical device.ISO 13485 adds aspects that are specific to medical devices such as: Test the products according to these specifications.Establish what procedures*, processes and tools are to be used to test the delivered products.Provide the providers/suppliers with the necessary information in writing.Establish specifications for the products to be purchased.Monitor providers according to these criteriaĪlongside suppliers, the regulatory requirements also concern products and services respectively.Select providers/suppliers according to these criteria.Evaluate providers/suppliers according to these criteria.Establish criteria for the providers/suppliers (examples of criteria are mentioned below).ISO 9001:2015 and ISO 13485:2016 place concrete requirements on the selection and evaluation of external suppliers of products and services – supplier selection, supplier evaluation and supplier assessment. The manufacturers must specify which suppliers and sub-contractors are involved in development and production (see Annex II, 3.c.). The notified body is obliged to take samples of the documentation from the supplier (“sub-contractor”), particularly if the delivered parts have an influence on the conformity of the products and the manufacturer is unable to demonstrate sufficient control over its suppliers (Annex VII 4.5.2). If this applies, even the suppliers (“sub-contractors”) are subject to unannounced audits – “at least once every five years” (Annex IX 3.4). The notified body must decide whether a specific supplier or sub-contractor audit is necessary (Annex VII 4.5.2.a, Annex IX 2.3 and 3.3). The notified bodies must check that this actually happens. The MDR makes it unequivocally clear that quality management must regulate “selection and control of suppliers and sub-contractors” (Article 10 (9)d.). Regulatory requirements for supplier management a) MDR QM system requirements within the scope of the supplier audit and evaluate the suppliers regularly, for example, based on audit results and the quality of the products and services delivered. Manufacturers monitor suppliers continually, e.g. Based on this supplier evaluation they select the most suitable supplier/s ( supplier selection). Then they carry out the supplier evaluation. Here, it would be necessary to determine whether this service is a part of your products or services.ī) Supplier selection, supplier evaluation, supplier monitoringįirst of all, manufacturers should establish criteria by which they assess the suppliers. You use an IT service like server hosting and a cloud service. This includes external software as a service, e.g. You use a “ready”, that is, an already existing product within your product or medical device as the case may be. Component purchasing (“catalogue goods”).Here too, if this part or component is part of a medical device, it is to be considered a special case. You order the development of part of a product. A special case would be if this product is a medical device. You order the development of an entire product. Examples of products and services supplied externally are: Basic principles of supplier management a) Examples of suppliers and delivered products and servicesĪs soon as manufacturers stop developing something themselves and start buying it in, they require a supplier evaluation. It also gives you tips on how to implement them and tells you when a supplier audit is necessary. This article not only gives you an overview of the regulatory requirements. The MDR and ISO 13485:2016, just like the FDA, set out clear requirements regarding supplier evaluation, supplier selection and supplier monitoring. Supplier evaluation – supplier selection – supplier audits ![]()
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