ISO 13485: what it asks of a calibration register

Records are kept to show that requirements have been met and that the quality management system is operating effectively. A documented procedure sets the controls needed for identifying, storing, securing and keeping the integrity of records, for retrieving them, for how long they are retained and for their disposition. The organization defines and applies ways of protecting confidential health information held in records, in line with the regulatory requirements that apply. Records must stay legible, easy to identify and retrievable, and any change to a record must remain identifiable. The organization keeps records for no less than the device lifetime the organization has defined, or longer where regulatory requirements say so, and in any case for no less than two years after the organization released the device.

The organization decides what monitoring and measuring must be done, and what equipment is needed, to give evidence that product conforms, and documents procedures so that monitoring and measuring can be, and actually are, done in a way consistent with the requirements. Where valid results depend on it, measuring equipment is: calibrated or verified, or both, at set intervals or before use, against measurement standards that trace back to national or international standards (if none exist, whatever basis is used for calibration or verification is recorded); adjusted or re-adjusted as needed, with each adjustment recorded; identified so its calibration status can be seen; protected from adjustments that would invalidate the results; and protected from damage and deterioration. Calibration and verification are done according to documented procedures. If equipment turns out not to conform, the organization assesses and records whether earlier measurement results are still valid, and acts on the equipment and on any product affected. Records of calibration and verification are kept. The organization also documents procedures for validating software used in monitoring and measuring, applied before first use and after any change, in proportion to the risk, including the effect on product conformity, and keeps records of the validation results, conclusions and actions.

The organization makes sure product that fails to meet requirements is identified and controlled so it is not used or delivered by mistake. A documented procedure sets the controls, and the responsibilities and authorities, for identifying, documenting, segregating, evaluating and disposing of nonconforming product. Evaluating a nonconformity includes deciding whether an investigation is needed and whether any outside party responsible for the nonconformity must be told. Records are kept of what each nonconformity was and of the action taken afterwards, covering the evaluation, any investigation and the reasons behind the decisions made.

The organization acts to remove the causes of nonconformities so they do not happen again. It does this promptly and in proportion to the effects of the nonconformities found. A documented procedure sets the requirements for: reviewing nonconformities, complaints included; finding what caused them; deciding whether action is needed so they do not recur; planning, documenting and carrying out the action required, updating documentation where appropriate; checking that the action does not harm regulatory compliance or the device's safety and performance; and reviewing whether the corrective action worked. Records are kept of investigation results and of the action taken.