ISO 9001 requirements for new equipment
I was trying to find information about what the ISO 9001:2015 requirement is for new equipment. Our company purchased welding equipment which is certified by the company we purchased it from. I was just wondering what has to be done before using it to produce parts! Is there a specific section in the Standard pertaining to Human Resources?
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ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 9001 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
First, considering the topic generally, I think about clauses 5.5.1 b) and f).
Welding equipment is a typical case of what can be included in entry f).
If the welding equipment operates automatically it must be previously validated.
If the welding equipment operates under human supervision, the human competence must be validated. The point is, whenever a critical operation is performed and cannot be tested with quality control, the process must be validated.
The following material will provide you more information:
- How to establish process validation in the QMS https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/
- Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
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Aug 10, 2020