Calibrated in house with no procedure named
An in-house calibration is done to a documented procedure: IATF 16949 7.1.5.3.1 asks the internal laboratory for technical procedures inside a defined scope, ISO 13485 7.6 for documented procedures, 21 CFR 211.68 for a written program and 21 CFR 58.63 for written standard operating procedures.
When the finder raises it
Fires for an instrument calibrated in house with no procedure named. Raised only under a ticked standard that asks for one: IATF 16949, ISO 13485, ISO/IEC 17025, 21 CFR 211 or 21 CFR 58.
A question for the calibration lead
Which procedure is it done to, and is that procedure inside the internal lab's scope?
Clauses behind it
5 across the standards| Standard | Clause | Applies to |
|---|---|---|
| IATF 16949 | IATF 16949 7.1.5.3.1 Internal laboratory | an automotive supplier holding IATF 16949 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 |
| 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 |
IATF 16949 7.1.5.3.1Internal laboratoryAn internal laboratory has a defined scope, forming part of the QMS documentation, that covers its ability to deliver the inspection, test or calibration services needed. As a minimum it specifies and applies requirements for: whether its technical procedures are adequate; how competent its staff are; testing of the product; its ability to perform the services correctly and with traceability to the relevant process standard (and, where no such standard exists, a defined method for confirming measurement capability); customer requirements; and review of the associated records. Accreditation to ISO/IEC 17025 or an equivalent may serve to show that it conforms.