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What should be question for getting feedback from production of product?

ISO 13485 & EU MDR
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Guest user Created:   May 22, 2019 Last commented:   May 22, 2019

What should be question for getting feedback from production of product?

ISO 13485 & EU MDR
8.2 Monitoring and measurement 8.2.1 Feedback As one of the measurements of the effectiveness of the quality management system, the organization shall gather and monitor information relating to whether the organization has met customer requirements. The methods for obtaining and using this information shall be documented. The organization shall document procedures for the feedback process. This feedback process shall include provisions to gather data from production as well as post-production activities.
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Step-by-step implementation for smaller companies.
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Verlene Law May 22, 2019

What should be question for getting feedback from production of product?

Answer:

Feedback from production would be questions pertaining to the safety and performance of the product, e.g:
-Is there any OOS (out of specification) detected during QC of the product?
-Is the process in place efficient to ensure that the product meets the final specifications?
-Are there any recurring issues in the production of devices?

For mor e information, read this article :

Production and service provision process in ISO 13485
https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

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May 22, 2019

May 22, 2019

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