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Would becoming ISO 13485 compliant benefit customers more than ISO 9001?

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

Would becoming ISO 13485 compliant benefit customers more than ISO 9001?

We manufacture machines that are not subject to FDA oversight. However, our customers use them in an FDA regulated environment. Would our becoming ISO 13485 compliant benefit our customers more than an ISO 9001 certification?

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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:

Yes, because ISO 13485 is made strictly for the manufacturer of medical devices. ISO 13485 allows a company to demonstrate that it consistently meets customer's needs, medical device regulatory requirements and complies with local legislation. It is, in certain points, related to ISO 9001, but ISO 13485 emphasizes areas such as risk management, the work environment, and medical device documentation and reporting.

For more information about ISO 13485 structure and requirements, please read the following article:
ISO 13485 structure and requirements https://advisera.com/13485academy/blog/2019/03/18/iso-13485-structure-and-requirements/

For more information about similarities beteweed FDA nad ISO 13 485, please read the following link:
https://advisera.com/13485academy/blog/2017/10/05/differences-and-similarities-between-fda-21-cfr-part-820-and-iso-13485/
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Sep 10, 2019

Sep 10, 2019