accreditation

Accreditation is formal recognition by an accreditation body that a laboratory is competent to carry out specified activities against stated requirements. For medical laboratories, ISO 15189 is a commonly used basis. The recognition applies to a defined scope and is maintained through the accreditation body's assessment and oversight arrangements. It should not be confused with certification of a management system or participation in a training programme.

Assessment normally examines both management arrangements and technical competence through records, interviews, observation, and other evidence. The exact process depends on the accreditation body. Accreditation does not mean every possible examination, location, or service of an organization is covered, nor does it guarantee that mistakes cannot occur. Users should consult the current scope and status when relying on an accreditation claim.

For laboratory staff, accreditation provides an external framework for demonstrating dependable service and competence. Preparation should strengthen routine practice rather than create evidence solely for a visit. Maintain accurate public claims, address findings effectively, and notify the accreditation body of relevant changes according to its rules. The objective is sustained conformity within the recognized scope, not just obtaining a certificate.