ISO/IEC 17025: what it asks of a calibration register

The laboratory shall be able to use the equipment needed to perform its activities correctly and that can affect results (for example software, measuring instruments, measurement standards, reference data and materials, reagents, consumables and auxiliary apparatus), and where it uses equipment it does not permanently control, it shall make sure that equipment meets these requirements. It shall: have a procedure for how equipment is handled, transported, stored, used and maintained according to plan; verify that equipment meets the specified requirements before it enters or re-enters service; make sure measuring equipment can reach the accuracy or uncertainty needed; calibrate measuring equipment where its accuracy or uncertainty affects whether results are valid or where metrological traceability depends on calibration; set up and review a calibration programme; label, code or otherwise mark equipment to show its calibration status or how long it remains valid; remove from service equipment that has been overloaded or mishandled, gives doubtful results, is defective or is outside specified requirements, isolate or label it, look into how the fault affected earlier work, and start the procedure for nonconforming work; carry out intermediate checks according to a procedure where needed; keep reference values and correction factors up to date and apply them; stop equipment from being adjusted by accident; and keep records for each item covering its identity with software and firmware version, its type, serial number and who made it, evidence that it was verified as conforming, where it is, calibration dates and results, adjustments, acceptance criteria and next due date, documentation for reference materials, the maintenance plan and maintenance done, and any damage, malfunction, modification or repair.

The laboratory shall set up and keep the metrological traceability of its results through a series of calibrations that is documented and has no gaps that ties them to a suitable reference, every calibration in the series adding to the measurement uncertainty. It shall make sure results trace to the SI through calibration by a competent laboratory, through the certified values of reference materials from a competent producer whose traceability to the SI is stated, or through realizing SI units directly, confirmed by comparing with national or international standards, directly or indirectly. Where tracing to the SI is not technically possible, it shall show traceability to another suitable reference, such as certified reference materials supplied by a competent producer, or the results of reference measurement procedures, of specified methods, or of consensus standards, all clearly described, accepted as fit for their purpose and backed by suitable comparison.

For each laboratory activity the technical records shall hold the results and the report, together with enough information to identify what influences the measurement result and its uncertainty and to let the work be repeated in conditions that come as close as they can to the first time, including the date and who was responsible for each activity and who checked the results and data. Original data, observations and calculations are to be written down at the moment they arise and shall be traceable to the specific task. Any change to technical records shall be traceable to the earlier version or the original observation, keeping both the original and the changed data, with the date of the change, what was changed and who changed it.

Have a procedure that is put into effect whenever any part of the laboratory's activities or results fails to conform to its own procedures or to the requirements agreed with the customer (for instance, equipment or environmental conditions outside set limits, or monitoring results that miss the criteria). The procedure shall make sure that: responsibility and authority for managing nonconforming work are set; actions, such as stopping or repeating work and holding back reports, follow the risk levels the laboratory has set; the significance of the nonconforming work is judged, including analysing its impact on earlier results; a decision is reached on whether it is acceptable; where needed, the customer is told and work is recalled; and it is defined who may authorize work to restart. Keep records of nonconforming work and of what was done. Where the evaluation shows the nonconformity could happen again, or raises doubt about whether operations conform to the management system, take corrective action.

The laboratory shall create and keep legible records showing that it meets this document's requirements, and shall apply controls to how records are identified, stored, protected, backed up, archived, retrieved, kept and disposed of. Records shall be kept for as long as contractual obligations require, access to them shall match the laboratory's confidentiality commitments, and they shall be easy to retrieve.