Lab equipment and instruments
- I was wondering if you know if the ISO 13485 also covers lab equipment and instrumentation?
- Should we have to have the lab equipment at the same QMS standard do you know? under the 13485
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
I was wondering if you know if the ISO 13485 also covers lab equipment and instrumentation?
If I understand you correctly, you are asking if the requirements of ISO 13485: 2016 cover the maintenance of laboratory equipment and validation of the methodology in which that equipment is used. Yes, there are requirements in ISO 13485: 2016 for maintenance of the equipment (6.3 Infrastructure), how to define the work environment (6.4 Work environment and contamination control), and how to validate certain processes (7.5.6 Validation of processes for production and service provision).
If you need more information how requirements from ISO 13485:2016 are applicable, please read following free download Clause-by-clause explanation of ISO 13485:2016
https://info.advisera.com/13485academy/free-download/clause-by-clause-explanation-of-iso-13485
Should we have to have the lab equipment at the same QMS standard do you know? under the 13485
I am apologizing, but I do not understand your question. Can you please clarify it?
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Feb 01, 2020