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Do people working in departments excluded from scope have to be trained for QMS?

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Guest user Created:   Sep 10, 2019 Last commented:   Sep 10, 2019

Do people working in departments excluded from scope have to be trained for QMS?

I have a question regarding how to decide if a person needs to be trained in various parts of a QMS set up for 13485:2016 compliance. People processing medical device have to be trained. But what about a person for example in marketing, who has nothing to do with any part of the work affecting product quality. Do people working in departments excluded from the scope of the QMS (for example finance, legal, marketing) have to be trained in various procedures contained in the quality manual?

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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 Sep 10, 2019

Answer:

People from marketing (included in the scope) need to be trained for the certain procedure related to QMS, that you as a management find it necessary. People working in departments excluded from the scope of the QMS does not need do be trained in various procedures from QMS.

According to point 6.2, it is the responsibility of the organization to determine what competencies and training are required for a particular job.
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Sep 10, 2019

Sep 10, 2019