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ISO 13485:2016 clause 4.1.1 - documenting roles

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Guest user Created:   Aug 07, 2020 Last commented:   Aug 20, 2020

ISO 13485:2016 clause 4.1.1 - documenting roles

So far the templates have been helpful but have a question about ISO 13485:2016 clause 4.1.1 "The organization shall document the role(s) undertaken by the organization under the applicable regulatory requirement: My company manufactures and distributes...so exactly what am I documenting and how do I present it in good form?
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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 Aug 19, 2020

You need to document here an organizational chart. In our Quality manual, you have an example which you can adapt to your business situation. 

For more information about defining roles and responsibilities within an ISO 13485-based QMS please see following article:

The following article can also be helpful:

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Guest user Aug 19, 2020

I understand your answer in relation to the company's employees and their roles, but the clause is asking in regard to the company's role/s in the realization and supply of the medical device, such as a manufacturer, distributor, authorized representative, importer.
How do present this?

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Expert
Kristina Zvonar Brkić Aug 20, 2020

You can also present it in some chart, in the table or just in the text where you will describe the roles of a particular entity.

For more details on responsibilities among this entities, please see following articles in MDR 2017/745

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