TL;DR
- ISO 15189 requirements define quality and competence for medical laboratories, and the 2022 edition also covers point-of-care testing (POCT).
- The requirements sit in clauses 4 to 8 (general, structural and governance, resource, process and management system), with Annex A for POCT.
- ISO 15189:2022 adds weight on patient risk and information management, and drops the quality manual and quality manager requirements.
- In the US, ISO 15189 is voluntary and sits alongside required CLIA certification. CAP 15189, A2LA and ANAB all accredit to it.
ISO 15189 requirements are the conditions a medical laboratory must meet to demonstrate quality and competence under ISO 15189:2022. They cover impartiality and confidentiality, governance, personnel, equipment, the pre-examination, examination and post-examination process, information management and the management system. The standard also applies to POCT.
Knowing the clauses is only half the job. Assessors want evidence that each requirement works in practice, so this guide pairs every clause with the records to have ready.
What Are the ISO 15189 Requirements?
The fourth edition, from ISO/TC 212, was published in December 2022. ISO lists ISO 15189:2012 and ISO 22870:2016 as withdrawn. This page paraphrases the paid standard and quotes clause titles only.
How ISO 15189:2022 is structured
Clauses 1 to 3 cover scope, references and terms. The auditable ISO 15189 standards sit in clauses 4 to 8, Annex A (normative) adds POCT, and Annex B (informative) compares the standard with ISO 9001:2015.
What changed from ISO 15189:2012
According to CAP's summary of the 2022 changes, the clauses now follow the general structure of ISO/IEC 17025, and the old split between management requirements (clause 4) and technical requirements (clause 5) is gone. It is less prescriptive, with fewer documented procedures. A quality manual and a "quality manager" are no longer required, and requests can be in any format the lab and its users agree. CAP also notes more emphasis on risk and on information systems, impartiality, confidentiality, data protection and contingency planning. POCT requirements from ISO 22870 are now inside ISO 15189.
The transition to ISO 15189:2022
ILAC Resolution GA 26.08 set a three-year transition from publication, ending in December 2025. After that date, accreditation to ISO 15189:2012 is no longer recognized under the ILAC arrangement.
ISO 15189 Requirements by Clause
For background on what ISO 15189:2022 is and who it applies to, start there. The summaries below follow the 2022 clause titles and serve as practical ISO 15189 guidelines, not the standard's text.
Clause 4: General requirements
The lab must act impartially, protect confidential information and meet its obligations to patients:
- Impartiality (4.1), including identifying and managing risks to it
- Confidentiality (4.2), including release of information and personnel responsibility
- Requirements regarding patients (4.3)
Evidence to prepare: impartiality risk review, signed confidentiality agreements and a patient-information policy.
Clause 5: Structural and governance requirements
Clause 5 defines accountability and organization:
- Legal entity (5.1) and laboratory director (5.2), including competence, responsibilities and delegation
- Laboratory activities, including advisory activities (5.3)
- Structure and authority, including quality management roles (5.4)
- Objectives and policies (5.5) and risk management (5.6)
Evidence to prepare: org chart, director job description and written delegations, defined scope of activities, quality objectives and a risk register.
Clause 6: Resource requirements
Clause 6 covers the people, places and materials behind results. Key areas include personnel qualification, training, authorization and competence; facilities and environmental conditions; equipment, calibration and metrological traceability; reagents and consumables; service agreements; and externally provided products and services.
Evidence to prepare: training and competence records, environmental monitoring, equipment and calibration logs, reagent lot acceptance, supplier evaluations and service agreements.
Clause 7: Process requirements
Clause 7 follows the sample through the lab. Key areas include:
- Pre-examination processes (7.2): user information, requests, collection, transport, receipt and storage
- Examination processes (7.3): method verification and validation, measurement uncertainty (MU), reference intervals and clinical decision limits, and valid results through internal quality control (IQC) and external quality assessment (EQA)
- Post-examination processes (7.4): reporting results and handling samples after examination
- Nonconforming work (7.5)
- Control of data and information management (7.6), including information systems and downtime plans
- Complaints (7.7) and continuity and emergency preparedness planning (7.8)
Evidence to prepare: rejection criteria, verification and validation reports, uncertainty estimates, IQC and EQA records, approved report templates, a nonconforming work log, downtime procedures, a complaint log and a continuity plan.
Clause 8: Management system requirements
Clause 8 keeps the quality system running and improving. Key areas include general management system requirements (8.1), documentation (8.2), control of documents (8.3), control of records (8.4), actions to address risks and opportunities (8.5), improvement (8.6), nonconformities and corrective actions (8.7), evaluations including internal audits (8.8) and management reviews (8.9).
Evidence to prepare: a controlled document register, record retention rules, internal audit reports, corrective action records and management review minutes.
Annex A: Point-of-care testing (POCT)
Annex A applies when the lab's scope includes POCT. Key areas include governance of the POCT service, agreements with the clinical areas that use it, a quality assurance program, and operator training and competence.
Evidence to prepare: a named POCT owner or committee, service agreements, QC and EQA records for POCT devices and operator competence records.
ISO 15189 Requirements in the US: CLIA, CAP 15189, A2LA and ANAB
Is ISO 15189 mandatory in the US?
No. CAP describes ISO 15189 as voluntary in the US, while CLIA is required. CAP also states that ISO 15189 accreditation is in addition to CLIA and does not replace it. Under CLIA (42 CFR 493), CMS issues certificates and conducts inspections, FDA categorizes tests by complexity, and CDC develops technical standards. See our guide to CLIA requirements for the federal side.
US bodies that accredit to ISO 15189
- CAP 15189:accredits to ISO 15189:2022 and requires the CAP Laboratory Accreditation Program as a prerequisite. Its three-year cycle has an initial assessment, then management and technical surveillance. Point-of-care is outside CAP 15189's scope.
- A2LA:runs an ISO 15189 accreditation program and a Platinum Choice program that assesses ISO 15189:2022 and CLIA requirements together.
- ANAB: runs a medical testing accreditation program for ISO 15189 that it states is recognized by ILAC.
ISO 15189 vs ISO/IEC 17025 vs ISO 9001
See our ISO/IEC 17025 requirements guide.
How to Show Evidence for Each ISO 15189 Requirement
Requirement-to-evidence checklist
Use this table as an ISO 15189 checklist for readiness reviews. It is indicative, not exhaustive.
Common evidence gaps under ISO 15189:2022
Labs often have the procedure but not the proof: records that don't show who did what and when, document control and training records that drift apart, and risk and downtime plans that live in a binder. For the step-by-step accreditation path, see the ISO 15189 certification process.
How Scispot Supports ISO 15189 Requirements
Software does not make a lab ISO 15189 compliant or accredited. The lab remains responsible for its quality system, validation and competence. Software can keep the evidence connected to the work.
Scispot can link sample, method, instrument run, result, review, approval and report in one record, with audit trails, e-signatures and role-based access. Its QMS adds versioned document control, approval workflows and training linked to SOPs. Scispot can also help you map requirements to controls and evidence, and it can work alongside an existing QMS or laboratory information management system. See audit-ready lab operations or how Scispot supports ISO 15189 accreditation.
Preparing evidence for ISO 15189? Connect samples, methods, instruments, results and approvals in one record with Scispot. Book a Demo →