Overdue Calibration Finder
Findings · finding 7 of 12

Traceability not recorded in this register

A screening question, never a statement that the chain is broken: the register's traceability column is blank or reads "no", and the certificate is where the chain is shown. Where traceability of measurement is required, the standards ask for calibration against standards traceable to international or national standards, with the basis recorded where none exist; ISO/IEC 17025 6.5 asks for an unbroken, documented chain to the SI. The provider, accreditation body, scope reference, reference standard and uncertainty columns are read and shown when the register carries them, not evaluated.

When the finder raises it

Raised as a screening question when the traceability column is blank or "no" for an instrument in service with a recorded calibration source. It never says the chain is broken: the certificate shows it. Read only when the register has a traceability column. The calibration provider, accreditation body, scope reference, reference standard and uncertainty columns are read and shown when present, not evaluated.

A question for the calibration lead

What does the certificate trace to, or what basis was recorded, and should the register say so?

Clauses behind it

4 across the standards
StandardClauseApplies to
ISO 9001ISO 9001 7.1.5 Monitoring and measuring resourcesa manufacturer holding ISO 9001 certification
ISO/IEC 17025ISO/IEC 17025 6.5 Metrological traceabilitya testing or calibration laboratory accredited to ISO/IEC 17025
ISO 13485ISO 13485 7.6 Control of monitoring and measuring equipmenta medical device maker holding ISO 13485 certification
AS9100DAS9100D 7.1.5 Monitoring and measuring resourcesan aerospace supplier holding AS9100 certification
ISO 9001 7.1.5Monitoring and measuring resources

Where monitoring or measurement is used to check that products and services conform, the organization identifies and provides the resources needed for results to be valid and reliable. It makes sure those resources suit the kind of monitoring and measurement done and are maintained so they stay fit for purpose, and it retains documented information as evidence that they are. Where traceability of measurement is required, or the organization judges it essential to confidence in the results, measuring equipment is: calibrated or verified, or both, at set intervals or before use, against standards traceable to international or national ones (and where none exist, the basis used is recorded); identified so its status is known; and protected from adjustment, damage or deterioration that would make its calibration status or later results invalid. If equipment proves unfit for its purpose, the organization judges whether earlier results remain valid and acts as needed.

What a certification body auditor asks to see: Register of monitoring and measuring equipment with calibration status; Calibration certificates traceable to national standards; Procedure for handling out-of-tolerance equipment and assessing previous results; Identification and safeguarding of equipment
Where registers usually fall short: Equipment used for acceptance not in the calibration register; Out-of-tolerance findings not followed by an assessment of prior results; Software used for measurement not validated
Source: ISO 9001:2015, quality management systems

See it on the specimenAll twelve findings