IATF 16949: what it asks of a calibration register

Statistical studies examine the variation in the results from each type of measurement, test and inspection equipment system named in the control plan. The methods of analysis and the acceptance criteria follow the reference manuals for measurement systems analysis unless the customer approves other methods, and where it does, records of that acceptance are kept together with the results. When deciding which MSA studies come first, the focus should be on critical or special characteristics.

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.

An 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.

External laboratories used for inspection, calibration or test work have a defined scope that includes the service needed. Each one either holds ISO/IEC 17025 accreditation (or the national equivalent), with the service inside the accreditation scope and the accreditation body's mark on the certificate or report, or else it is shown to be acceptable to the customer, for example by a customer assessment or by a second-party assessment the customer has approved. Where no qualified laboratory exists for a piece of equipment, the equipment's manufacturer may calibrate it, as long as the organization makes sure the internal laboratory requirements of 7.1.5.3.1 are satisfied; using other calibration services may require confirmation by a regulator. As revised: SI 10 (April 2018, revised June 2018, April 2021, July 2021): accreditation is by a body that signs the ILAC MRA, against ISO/IEC 17025 or the national equivalent, with the accreditation mark on the certificate or report; the SI also lists when a laboratory without accreditation may be used (specialist or integrated equipment, parameters for which no traceable standard exists, the equipment's manufacturer) and what the organization then has to ensure.

Any product whose status is unknown or doubtful is treated and controlled as nonconforming, and all relevant manufacturing staff receive training in containing product that is suspect or nonconforming.