SPRING DISCOUNT
Get 30% off on toolkits, course exams, and books.
Limited-time offer – ends May 26, 2022
Use promo code:
SPRING30

Expert Advice Community

Guest

ISO 13485 implementation

  Quote
Guest
Guest user Created:   Dec 28, 2020 Last commented:   Dec 29, 2020

ISO 13485 implementation

When a company is going for IS 13485 certification, is it mandatory to go for ISO 9001

0 0

Assign topic to the user

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Dec 29, 2020

No, it is not mandatory for the company to go for the ISO 9001 as well. ISO 13485:2016 is a standard that is specific for Manufacturers of medical devices (Medical devices — Quality management systems — Requirements for regulatory purposes). Besides that, on the web pages of the European Commission are stated which standards are applicable for all types of medical devices:  https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices On that list, which has around 300 standards, only ISO 13485:2015 is the standard for the quality management system.

For more information, please see the following links:

Quote
0 0

Comment as guest or Sign in

HTML tags are not allowed

Dec 28, 2020

Dec 29, 2020

Suggested Topics

Guest user Created:   May 17, 2021 ISO 13485 & EU MDR
Replies: 1
0 0

ISO 13485 implementation

Guest user Created:   Oct 20, 2020 ISO 13485 & EU MDR
Replies: 0
0 0

ISO 13485 implementation