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Correspondence Between Iso 13485 2016

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INTERNATIONAL ISO STANDARD 13485

INTERNATIONAL ISO STANDARD 13485

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Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015 ... ISO 13485:2016(E) 0.2 Clarification of concepts In this International Standard, the following terms or phrases are used in the context described below.

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Correspondence between ISO13485:2016 and MHLW MO …

Correspondence between ISO13485:2016 and MHLW MO …

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Correspondence between ISO13485:2016 and MHLW MO 169 Chapter 2, as revised in 2021 15 5.5.1 16 5.5.2 17 5.5.3 18 5.6.1 19 5.6.2 The organization is not required to input “reporting to regulatory authorities”, the item specified in ISO13485:2016 5.6.2 c), to management review, when the organization is the person operating

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