Medical Laboratories
ISO 15189
Medical laboratories support patient care by producing reliable examination results. GTAF accreditation focuses on competence across the laboratory examination process, from pre-examination arrangements through examination and post-examination activities, with emphasis on quality, patient safety and result reliability.
Competence, impartiality and confidence
GTAF’s accreditation approach is designed to provide a structured, evidence-based evaluation of organizations performing conformity assessment activities. The emphasis is on technical competence, impartiality, consistent processes and confidence in results or certification decisions.
Patient-focused quality
Processes designed to support reliable examination results and appropriate communication of critical information.
Competent personnel
Defined competence requirements, authorization and ongoing competence monitoring.
Controlled examination processes
Suitable methods, equipment, quality controls and management of examination activities.
Result and information integrity
Controlled reporting, records, confidentiality and continual improvement arrangements.
Define the scope with precision
The accreditation scope should clearly describe the activities, sectors, methods, schemes or technical fields for which competence is demonstrated.
- Clinical biochemistry
- Haematology and coagulation
- Microbiology
- Immunology and serology
- Molecular and other specialized examinations
Evidence that supports reliable outcomes
Assessment considers the organization’s documented arrangements and their effective implementation. Depending on the programme and scope, evidence may include:
- Competent personnel and defined responsibilities
- Controlled procedures, records and technical methods
- Suitable facilities, equipment and resources
- Impartiality and confidentiality controls
- Quality assurance, monitoring and continual improvement
- Effective handling of complaints, appeals or feedback where applicable
A clear path from application to surveillance
The detailed sequence is tailored to the programme and requested scope, while maintaining a consistent accreditation decision framework.
Application
Application and scope review
Technical
Technical and quality system assessment
Witnessing
Witnessing and examination process evaluation
Corrective action review
Corrective action review
Accreditation decision
Accreditation decision and surveillance
Frequently asked questions
Explore accreditation for your organization.
Review the applicable requirements and submit your accreditation enquiry or application to begin the process.