ISO 13485 audit checklist about control of monitoring and measuring devices
ISO 13485 audit checklist about control of monitoring and measuring devices
Clause 7.6
1. How do you determine the measurements to be taken and the measuring equipment needed to demonstrate conformity with requirements?
2. What process is in place to ensure that measurements are taken per the requirements?
3. Can you show me documented procedures for this?
a) How do you ensure that measuring and test equipment is calibrated or verified proper frequencies with NIST traceable standards? If no such standards exist, where do you record the basis used for calibration or verification?
b) What process is used to adjust or re-adjust measuring and test equipment when needed?
c) How are measuring tools identified to enable the calibration status to be determined?
d) How do you safeguard measuring equipment from adjustments that would invalidate the measurement results?
e) How do you ensure that measuring its test equipment is protected from damage and deterioration during handling, maintenance and storage?
4. When equipment is found to be out of calibration, how do you assess and record the validity of the previous measuring results?
5. What actions do you take on the equipment and any product affected?
6. Can I see your records of the results of calibration and verification?
7. Do you use computer software for monitoring and measurement? If so, is its ability to perform that function confirmed prior to initial use and reconfirmed as necessary?
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