Accreditation is the confirmation of a laboratory's competence by an independent organization. For testing and calibration laboratories, the primary reference standard is ISO/IEC 17025; for pharmaceuticals, GMP is applicable, while for safety studies, the GLP framework is used.
The system's contribution to oversight.
The auditor asked
The system provides
Who produced this result, and were they competent?
User registration and method-based competency matrix
Was the device calibrated at that time?
Calibration validity record and result-device correlation.
Which standard lot was used?
Result-based reagent and standard lot record
Did this result change later?
Audit report along with the reason for the change.
Has the method been validated?
Method-related validation and verification files
What did you do about the out-of-specification result?
Research record, root cause and CAPA chain.
What is your measurement uncertainty?
Method-based uncertainty budgeting and reporting record.
Did you participate in proficiency tests?
Participation records, z-scores, and actions open to adverse outcomes.
What has changed
In a well-structured laboratory, preparing for an audit is not a project. The records requested by the auditor have already been produced; preparation consists of reporting those records. In a paper-based lab, however, the weeks leading up to the audit are spent completing retrospective records—which in itself is a cause for findings during audits.