ISO 15189 medical laboratory accreditation, explained
ISO 15189 sets out requirements for quality and competence in medical laboratories, including the work before, during and after the examination itself. Laboratories are assessed and accredited by an accreditation body, not certified. It suits clinical and diagnostic laboratories, and point-of-care testing arrangements run by them. This page explains the pathway and how it differs from ISO 9001 certification.
Updated 5 November 2026
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Who it may be relevant for
- Hospital, clinic and private diagnostic laboratories
- Public health and reference laboratories
- Laboratories managing point-of-care testing programmes
- Referring clinicians, insurers and buyers who want to understand what accreditation means
What it covers
- Patient-focused requirements, impartiality, confidentiality and ethical conduct
- Competence of personnel, facilities, equipment and reagents
- Pre-examination steps such as requests, sample collection and transport
- Examination processes, method validation, quality control and result validity
- Post-examination reporting, complaints, risk management and a management system
What it can help with
- Independent assessment of the quality and technical competence of medical examinations
- More consistent handling of samples, results and reporting along the whole pathway
- A framework for managing risk to patients from laboratory processes
- Clear scope information so clinicians know which examinations are covered
What the pathway means
Medical laboratories are assessed and accredited by an accreditation body against ISO 15189. The accurate wording is laboratory accredited to ISO 15189, not certified. Assessment covers both the quality system and technical competence for the examinations in scope, and often includes on-site visits by assessors with relevant clinical laboratory expertise. Accreditation is for a defined scope. This differs from ISO 9001 certification, which is awarded by a certification body to a management system and does not show that medical examination results are technically competent. MIYAAR CONNECT does not accredit, audit or certify.
Edition. ISO 15189:2022 replaced the 2012 edition and added requirements for point-of-care testing. Accreditation bodies set their own transition arrangements for laboratories. Ask the accreditation body how it applies to a laboratory you are considering. We do not state deadlines.
The typical process
Steps and timing vary by body and scope. This is the usual shape, not a promise.
- You and us
Your inquiry
You ask about the pathway and share the basics.
- Accreditation body
Application
The laboratory applies for a defined scope of tests or calibrations.
- Accreditation body
Document review
The body reviews the management system and technical records.
- Accreditation body
On-site assessment
Assessors evaluate technical competence and how work is carried out.
- This part is theirs
Accreditation decision
Made by the accreditation body, never by MIYAAR CONNECT.
- Accreditation body
Ongoing surveillance
Periodic assessment and reassessment to keep accreditation current.
Where it is typically used
- A hospital laboratory moving to a structured, assessed quality system across disciplines
- A private diagnostic lab showing referrers the examinations covered by its accreditation
- A lab network standardising point-of-care testing governance across sites
What affects cost
- Number of employees
- Number of sites
- Complexity of what you do and its risks
- The number of disciplines and examinations requested for accreditation
- Technical complexity, instrument platforms and sites, including point-of-care testing
- Participation in external quality assessment or proficiency programmes
- Accreditation body fees and assessor requirements, which that body sets
What affects timing
- Time to validate or verify methods and build quality control and traceability records
- Evidence from internal audits, external quality assessment and management review
- Availability of assessors with the right clinical laboratory expertise
- Time to resolve findings before accreditation is granted
What to have ready
- A list of examinations and disciplines you want in scope, with the methods and platforms used
- A general description of sites, staff and sample pathways
- Whether you take part in external quality assessment
- Requirements from health authorities, insurers or referrers that mention accreditation, to confirm with them
- Which accreditation body can assess your scope and territory
Accreditation and recognition
Accreditation applies to the scope on the accreditation schedule and is checked with the accreditation body that granted it. Accreditation bodies that are signatories to the arrangement now run by Global Accreditation Cooperation Incorporated (Global ACI), which took over the work of ILAC and the IAF on 1 January 2026, recognise each other's accreditations, but you should still read the scope. Health authorities, insurers and referrers decide what they require or accept, and rules differ by country, so check with them and do not assume.
Common questions
Is a lab 'ISO 15189 certified'?
How does it differ from ISO/IEC 17025?
Is accreditation mandatory?
Does it cover point-of-care testing?
Related standards
Relevant industries
Useful reading
Sources
- ILAC: ISO 15189:2022 for medical labs published (checked 5 November 2026)
- APAC: Global Accreditation Cooperation Incorporated replaces IAF and ILAC (checked 5 November 2026)
Have a question about ISO 15189?
Laboratories are accredited by an accreditation body, not certified. Tell us what you are trying to do and we will point you in the right direction.