The purpose of this procedure is to define the requirements for conducting receiving inspection of finished devices, sub-assemblies and components.
This four-page procedure is the primary document meeting the applicable regulatory requirements for conducting receiving inspection as defined in the Quality System Manual (POL-001). The procedure is updated for compliance with ISO 13485:2016 (Clause 7.4.3), 21 CFR 820.80, and Regulation (EU) 2017/745 for CE Marking.
The procedure includes details for inspections performed by your company, as well as inspections performed by your suppliers. The procedure also includes suggestions for a statistical sampling plan. Along with the procedure, you will also receive a template for receiving inspection log. You will need to create an inspection plan or work instructions for specific products if your component drawings and specifications do not include inspection requirements already.
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