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Quality management

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Guest user Created:   Oct 31, 2019 Last commented:   Nov 04, 2019

Quality management

Does any ISO 9001, 13485, etc require a company to have a Quality manager? I know ISO 17025 and ISO 34 did.

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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 Nov 04, 2019

In ISO 9001:2015 there is no direct requirement for Quality manager, while ISO 13485:2016 have a requirement for person called Management representative (requirement 5.5.2). The management representative is usually the same person as the quality manager because he or she is responsible for implementing and maintaining quality in the organization.

For more detailes, please read following articles: 

How to define roles and responsibilities within an ISO 13485-based QMS

https://advisera.com/13485academy/blog/2017/11/16/how-to-define-roles-and-responsibilities-within-an-iso-13485-based-qms/

What is the job of the Quality Manager according to ISO 9001?

https://advisera.com/9001academy/blog/2016/08/23/what-is-the-job-of-the-quality-manager-according-to-iso9001/

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Oct 31, 2019

Nov 04, 2019