Medical laboratory accreditation supports confidence in patient testing by confirming that laboratory examinations are technically valid and supported by an effective quality system.
Purpose
This program is for medical laboratories performing examinations that support diagnosis, treatment, monitoring, and health decisions.
- Confirms competence in pre-examination, examination, and post-examination processes.
- Supports reliable patient results and laboratory quality improvement.
- Promotes control of equipment, reagents, personnel competence, and records.
Typical requirements
Medical laboratories should maintain documented quality and technical processes covering sample handling, method verification, internal quality control, external quality assessment, result review, and reporting.
- Quality manual or equivalent documented system.
- Method validation or verification records.
- Internal quality control and external quality assessment records.
- Personnel qualification, training, and authorization records.
Assessment focus
Assessment may include review of patient sample flow, technical records, equipment maintenance, result reporting, confidentiality, and corrective action records.
- Pre-examination sample acceptance and rejection criteria.
- Examination performance and quality control evidence.
- Post-examination review and report release controls.
Applications and contact
Organizations seeking accreditation should review the current documents in the Center of Documents and contact IACA before submitting an application, so the correct scope, standard, and supporting records can be confirmed.
Email: accreditation@iacaab.org / info@iacaab.org