One, if the spare parts also belongs to the medical device, this case can be purchased;
Two, if the spare parts belong to the raw material category should refer to the "Medical Device Manufacturing Enterprises Supplier Audit Guidelines"
Audit Principles
(a) Classification management: the production enterprise should be centered on the quality of the product and according to the degree of impact of purchases on the product
Classification management should take into account the following factors:
1. Purchased items are standard or customized parts;
2. Purchased items of the complexity of the production process;
3. Purchased items of the product quality and safety of the extent of the impact of the product;
4. Purchased items are the first time the supplier or continue to be produced for the production of medical equipment enterprises.
Third, you can refer to:/p/4396825437