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Does ISO 13485 cover incoming sampling inspection?

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Guest user Created:   Jul 13, 2022 Last commented:   Oct 28, 2024

Does ISO 13485 cover incoming sampling inspection?

my question is about if iso 13485 considers the sampling plan from receiving inspection and the criticality of the components? I want to check if ISO covers the incoming sampling inspection?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 15, 2022

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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Anlahak Oct 24, 2024

I agreed what you said. My question is related to ISO 13485 8.2.6 Monitoring and measurement of product. 

In that clause, it is mentioned that "The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met."

Is that same as incoming goods? If yes then, we do not need to write process description if i already wrote it for incoming goods inspection?

Thanks!!!

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Kristina Zvonar Brkić Oct 24, 2024

No this is not referring for the incoming goods, rather for final product. The only way how this can be the same if you are purchasing the final product that you than put on the market and not doing anything with it. 

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Anlahak Oct 28, 2024

Thanks for the reply. Exactly, we are doing the same thing as what you mentioned. We buy final product and release on the market.

Thank you again for your time and effort kristina.

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Jul 13, 2022

Oct 28, 2024