Does ISO 13485 cover incoming sampling inspection?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
No, ISO 13485 does not cover directly the incoming sampling inspection. Requirement 7.4.3 is stated that the manufacturer must implement inspection activities based on the supplier evaluation results and proportional to the risk associated with the purchased product.
However, most manufacturers who have medical devices organized in lots use ISO 2859-1:2012 Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection.
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Jul 15, 2022