ISO 13485:2016 clause 4.1.1 - documenting roles
Assign topic to the user
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:
- 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/
The following article can also be helpful:
- Can determining the context of the organization be beneficial for ISO 13485 implementation? https://advisera.com/13485academy/knowledgebase/can-determining-the-context-of-the-organization-be-beneficial-for-iso-13485-implementation/
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?
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
- EU MDR Article 11 Authorised representative https://advisera.com/13485academy/mdr/authorised-representative/
- EU MDR Article 13 General obligations of importers https://advisera.com/13485academy/mdr/general-obligations-of-importers/
- EU MDR Article 14 General obligations of distributors https://advisera.com/13485academy/mdr/general-obligations-of-distributors/
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Aug 20, 2020