Guest user Created: Jan 28, 2019 Last commented: Jan 28, 2019

ISO 9001 and ISO 13485 internal auditor requirements

"Company has both certificates 9001 and 13485. There was only one internal audit, not divided depend of ISO number. The question is either internal auditor needs to have certificates for both ISO or only one, because both ISO is for Quality Management."

0 0

Assign topic to the user

Select user

Expert

Carlos Pereira da Cruz Jan 28, 2019

Answer:
Auditors should dominate the audit criteria used.
ISO 13485 includes the entire ISO 9001 standard with additional requirements.
So, your organization’s internal auditors can have ISO 13485 awareness training or can have ISO 9001 awareness training with an additional module about what is specific of ISO 13485.
Remember, organizations have the authority to define internal auditor competence requirements.

The following material will provide you information about integrating ISO 9001 and ISO 13485:
- ISO 9001 vs. ISO 13485 - https://advisera.com/9001academy/blog/2015/01/21/iso-9001-vs-iso-13485/
- What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
- free online training ISO 9001:2015 Internal Auditor Course - https://community.advisera.com/topic/iso-9001-and-iso-13485-internal-auditor-requirements/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Quote

0 0

Comment as guest or Sign in

HTML tags are not allowed

Name *

Email *

I accept the Privacy and Terms

Notify me when someone replies

Jan 28, 2019

Expert Advice Community