Laboratory analytical instruments
Analytical instruments in a quality control or test laboratory, where 21 CFR 211, 21 CFR 58 or ISO/IEC 17025 usually applies alongside the certification standard.
Instrument classes
8- pH meterbench pH meter with electrode
- Conductivity meterconductivity meter for purified water
- SpectrophotometerUV Vis spectrophotometer
- Chromatography systemHPLC with UV detector
- Moisture analyserhalogen moisture analyser
- Viscometerrotational viscometer
- Hardness testerRockwell hardness tester
- Refractometerdigital refractometer for coolant
Clauses, by standard
9 cited| Standard | Clause | Applies to |
|---|---|---|
| ISO 9001 | ISO 9001 7.1.5 Monitoring and measuring resources | a manufacturer holding ISO 9001 certification |
| AS9100D | AS9100D 7.1.5 Monitoring and measuring resources | an aerospace supplier holding AS9100 certification |
| ISO 13485 | ISO 13485 7.6 Control of monitoring and measuring equipment | a medical device maker holding ISO 13485 certification |
| ISO/IEC 17025 | ISO/IEC 17025 6.4 Equipment | a testing or calibration laboratory accredited to ISO/IEC 17025 |
| ISO/IEC 17025 | ISO/IEC 17025 6.5 Metrological traceability | a testing or calibration laboratory accredited to ISO/IEC 17025 |
| IATF 16949 | IATF 16949 7.1.5.2.1 Calibration and verification records | an automotive supplier holding IATF 16949 certification |
| 21 CFR 211 | 21 CFR 211.68 Automatic, Mechanical, and Electronic Equipment | a drug maker under 21 CFR 211 |
| 21 CFR 58 | 21 CFR 58.63 Maintenance and Calibration of Equipment | a laboratory running nonclinical studies under 21 CFR 58 |
| 21 CFR 211 | 21 CFR 211.160 Laboratory controls: general requirements | a drug maker under 21 CFR 211 |