ISO 9001: what it asks of a calibration register

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.

Documented information that the QMS and the standard call for is controlled so that it is on hand and fit for use wherever and whenever it is needed, and is adequately protected against loss of integrity, loss of confidentiality or misuse. The organization deals with: distribution, access, retrieval and use; storage and preservation, including keeping it legible; control of changes, including versions; and retention and disposition. Documented information from outside sources that the organization has judged necessary is identified and controlled, and documented information kept to evidence conformity is protected against unintended alteration.

The organization makes sure that any output failing to meet its requirements is identified and controlled so that it is not used or delivered by mistake. It acts on the nonconformity in proportion to what the nonconformity is and how it affects whether products and services conform, and this applies also to outputs found to be nonconforming after delivery. Possible actions include: correcting the output; segregating or containing it; returning it or suspending supply; informing the customer; and getting authorization to accept it under concession. When a nonconforming output is corrected, its conformity is verified again. Documented information is retained that describes the nonconformity, what was done about it, any concession obtained, and who decided the action.

Whenever a nonconformity arises, complaints included, the organization responds to it: as applicable it acts to control and correct it and deals with what follows from it. It then judges whether action is needed to remove the causes, so the nonconformity does not happen again or somewhere else, by reviewing and analysing it, finding its causes, and finding out whether similar nonconformities exist or could arise. It carries out any action needed, reviews whether corrective action worked, updates the risks and opportunities identified during planning where necessary, and changes the QMS where necessary. Corrective action must suit the effects of the nonconformity in question. Documented information is retained on what the nonconformities were, what was done, and what corrective action achieved.