Overdue Calibration Finder
Findings · finding 9 of 12

Certificate reference not recorded in this register

An evidence question, not a gap: a blank certificate column does not show that no calibration record exists, only that this register does not point to it. IATF 16949 7.1.5.2.1 asks for records of every calibration, ISO/IEC 17025 6.4 for calibration dates and results in the equipment record, and the records clauses for records that can be retrieved. Read only when the register has a certificate column.

When the finder raises it

Raised as an evidence question when the certificate column is blank for an instrument with a last calibration date: the reference is not recorded in this register, which does not show that no calibration record exists. Read only when the register has a certificate column, so a register without one is never flagged line by line.

A question for the calibration lead

Where is the certificate for the last calibration, and can it be retrieved in the audit?

Clauses behind it

6 across the standards
StandardClauseApplies to
IATF 16949IATF 16949 7.1.5.2.1 Calibration and verification recordsan automotive supplier holding IATF 16949 certification
ISO/IEC 17025ISO/IEC 17025 7.5 Technical recordsa testing or calibration laboratory accredited to ISO/IEC 17025
ISO/IEC 17025ISO/IEC 17025 8.4 Control of recordsa testing or calibration laboratory accredited to ISO/IEC 17025
ISO 9001ISO 9001 7.5.3 Control of documented informationa manufacturer holding ISO 9001 certification
AS9100DAS9100D 7.5.3 Control of documented informationan aerospace supplier holding AS9100 certification
ISO 13485ISO 13485 4.2.5 Control of recordsa medical device maker holding ISO 13485 certification
IATF 16949 7.1.5.2.1Calibration and verification records

A documented process manages records of calibration and verification. Such records are kept for every gauge and every piece of measuring and test equipment needed to show conformity to internal, legal, regulatory and customer requirements, including equipment owned by employees, by the customer or by suppliers working on site. The activities and records cover: revisions made after engineering changes that affect measurement systems; readings found outside specification when equipment is received for calibration or verification; an assessment of what risk that condition poses to the intended use of the product; when equipment turns out to be faulty or no longer in calibration, a judgement on whether earlier measurements remain valid, with the standard's most recent calibration date and when it is next due; telling the customer if suspect product has been shipped; statements of conformity once calibration or verification is done; confirmation of the software version used for controlling product and process; and records of calibration and maintenance, and of verification of production-related software, for all gauging.

What a certification body auditor asks to see: Calibration records for all gauges including employee-, customer- and supplier-owned; As-received out-of-specification readings with the risk assessment and customer notification; Software version verification records
Where registers usually fall short: Employee-owned gauges outside the calibration system; Out-of-calibration findings with no assessment of previously measured product; Software versions on control equipment never verified
Source: IATF 16949:2016, automotive production quality management

See it on the specimenAll twelve findings