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?