nonconformity

A nonconformity is a failure to meet a requirement that applies to the laboratory. The requirement may come from legislation, an accreditation standard, a contract, or the laboratory's own approved arrangements. A useful description identifies the requirement, the observed evidence, and the specific gap between them. An opinion that something could be improved is not automatically a nonconformity.

Examples include an overdue required equipment check, unauthorized release of results, or failure to follow an established specimen-identification process. The immediate response depends on the risk and scope of the issue. Correction addresses what went wrong now; corrective action addresses the cause to prevent recurrence. Not every isolated issue needs the same depth of investigation, but decisions should be proportionate, justified, and traceable.

For accreditation, clear nonconformity records make follow-up objective and support effective learning. Avoid descriptions that blame individuals without examining the work system. Track containment, causes, actions, and effectiveness as appropriate, and examine patterns across departments. Repeated minor gaps can reveal a wider process weakness that deserves more attention than isolated closure dates suggest.