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QMS

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Guest user Created:   Feb 10, 2021 Last commented:   Feb 11, 2021

QMS

I have a question regarding QMS and I am just wondering if you could help me with advice.
I am working for a software company which develops stand-alone SaMD and trying to establish a QMS (ISO 13485) but the clause 7.6 makes me confused. We are only using software tools (automated software development tools, source code management tools etc.) without any measuring and monitoring functions, no calibration needed, therefore, those "equipment" according to my interpretation does fall under 6.3 infrastructure (b) process equipment software. I would control (maintain) them as part of 7.5.6 Validation and documentation of computer software SOP and the records of these activities would be maintained accordingly. 
Is it possible to exclude 7.6 if I can ensure the validation of software under the umbrella of 4.1.6, and 7.5.6?

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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 Feb 11, 2021

Yes, it is possible to exclude requirement 7.6 if you do not use any measuring equipment. You must state that in your Quality manual and put a justification why it is not applicable. 

However, consider the following. If you have a server in your company and that server is located in a separate room, is it defined what the temperature must be in that room. If you have a defined temperature range and if you monitor the temperature in that room, then it is necessary that the thermometer be calibrated, and thus covered by this requirement 7.6. 

For more information regarding the calibration, please see the following link:

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Feb 10, 2021

Feb 11, 2021