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Exclusion of clauses for ISO 13485 for small business

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Guest user Created:   Apr 24, 2019 Last commented:   Jul 30, 2021

Exclusion of clauses for ISO 13485 for small business

1. I have been told that small businesses of less than 5 employees can be excluded from some areas of IsO 13485. Can you let me know what these are please?
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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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Verlene Law Apr 24, 2019

Answer:

Regardless of the size of the business, the exclusion is always applicable for companies who can justify the non-applicability of the clauses for ISO 13485. We are not able to advise what are the exclusion areas. Some examples of common exclusion would be 4.1.5 outsourcing activities, 7.3 Design and development, 7.5.3 Installation activities and 7.5.4 Servicing activities.

2. What is the typical qualification that someone who implements ISO 13485 must have? I know that if you do a clinical evaluation you need 5 years experience and at least masters?

Answer:

There is not a typical qualification tied to the implementation of ISO 13485. The most basic would be the person involved in the implementation of ISO 13485 who should have the ability to understand the clauses of ISO 13485 and what is required to comply with ISO 13485.

For more information, please read the follo wing articles:

What is ISO 13485?
https://advisera.com/13485academy/what-is-iso-13485/

ISO 13485: How to write a short quality manual
https://advisera.com/13485academy/knowledgebase/iso-13485-how-to-write-a-short-quality-manual/

How to manage the Quality Manual according to ISO 13485:2016 requirements
https://advisera.com/13485academy/knowledgebase/how-to-manage-the-quality-manual-according-to-iso-13485-requirements/
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ineborupupte Jul 30, 2021
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