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