The standards behind every finding
Seven standards, each finding cited to the applicable clause under the standards you tick; ISO 10012 (measurement management systems); 21 CFR 820 (the US quality system regulation for medical devices); ILAC-G24 / OIML D10 (guidance on setting and reviewing calibration intervals); 21 CFR 211.160(b)(4) (calibration of laboratory instruments) are named, not quoted.
- ISO 9001:2015, quality management systems4 clauses
- IATF 16949:2016, automotive production quality management5 clauses
- AS9100D, aerospace quality management4 clauses
- ISO 13485:2016, medical device quality management4 clauses
- ISO/IEC 17025:2017, testing and calibration laboratories5 clauses
- 21 CFR Part 211, current good manufacturing practice for finished pharmaceuticals2 clauses
- 21 CFR Part 58, good laboratory practice for nonclinical laboratory studies1 clauses