ISO 15189:2022 Laboratory Module
For any facility that operates a laboratory — or is a laboratory. 65 additional criteria covering the full ISO 15189:2022 technical requirements. ASF assesses them alongside your accreditation and issues a formal ISO 15189 Ready statement.
Who this module is for
All hospitals operate a laboratory. This module adds to your hospital accreditation. Prerequisite: active ASF hospital accreditation.
Clinics operating an in-house laboratory. Declare the lab at registration. Module assessed alongside your ambulatory accreditation.
Diagnostic centres with no clinical services. Requires the ISO 9001 Management Module as a prerequisite (ISO 15189 itself requires a QMS foundation).
What the 65 criteria cover
ISO 15189:2022 is structured in two halves: management requirements (covered by ASF accreditation + the ISO 9001 module) and technical requirements specific to laboratory operations. These 65 criteria cover the technical half in full.
Qualifications, ongoing training, competency assessment and authorisation for each examination type performed.
Temperature, humidity, lighting, contamination controls and workspace separation for each examination area.
Selection, installation, calibration, maintenance and records for all analytical instruments.
Request handling, patient preparation instructions, sample collection procedures and primary sample identification.
Validation and verification of examination methods, measurement uncertainty, biological reference intervals and quality control.
Review and authorisation of results, critical value reporting, result format and turnaround time targets.
Report content requirements, amended reports, verbal reporting protocol and result retention.
Participation in proficiency testing or interlaboratory comparison programmes for every examination performed.
How the assessment works
The laboratory module requires a dedicated assessment day in the laboratory, separate from the facility’s clinical accreditation visit. The assessor is a qualified laboratory specialist — not a general healthcare surveyor.
The assessment follows the same practice-based evidence standard: the assessor observes actual processes, reviews working documents in whatever format your laboratory uses, and interviews bench-level staff. No documentation needs to be created for the assessment.
On successful completion, ASF issues a formal ASF ISO 15189 Ready statement specifying the examination types assessed, the sections confirmed, and the date of assessment.
- Hospital / ambulatory: active ASF accreditation
- Standalone lab: ASF ISO 9001 Module (required by ISO 15189 itself)
- Laboratory declared at facility registration
- ASF ISO 15189 Ready statement (PDF, dated)
- Examination-type specific compliance record
- QR-verified certificate page on the ASF registry
- Logo badge: “ISO 15189 Ready — verified by ASF”
This statement confirms ISO 15189:2022 readiness as mapped in the ASF–ISO Crosswalk. It does not constitute accreditation under ISO 15189. Formal laboratory accreditation requires engagement with a national accreditation body.
