A newbie here.
I would like to ask your opinions on how to address this ISO 13485:2016 7.6 requirement : "the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action in regard to the equipment and any product affected"
- does this mean when the equipment is found to be non conforming to the specs or out calibration, we need to gather the previous measurement results for which this equipment was used for, and analyze the acceptability of the previous measurements and its effect to the product?
- the scope of previous results to gather- is it 1 whole year result or 2 years or just a few testing/usage results?
- will the "Investigation Report" sufficient as evidence of the assessment of the validity?
Hoping for your kind assistance - thank you.
I would like to ask your opinions on how to address this ISO 13485:2016 7.6 requirement : "the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action in regard to the equipment and any product affected"
- does this mean when the equipment is found to be non conforming to the specs or out calibration, we need to gather the previous measurement results for which this equipment was used for, and analyze the acceptability of the previous measurements and its effect to the product?
- the scope of previous results to gather- is it 1 whole year result or 2 years or just a few testing/usage results?
- will the "Investigation Report" sufficient as evidence of the assessment of the validity?
Hoping for your kind assistance - thank you.