Implementation walkthrough
How to implement ISO 15189: video walkthrough
A walkthrough of preparing a medical laboratory for ISO 15189 accreditation, from settling the scope of examinations to the accreditation body's on-site assessment.
Key takeaways
- Medical laboratories are accredited to ISO 15189, not certified.
- Accreditation covers a defined scope of examinations, sites and point-of-care services.
- Preparation runs examination by examination, from request to report.
- Quality control and external quality assessment show results stay reliable.
- ISO 15189:2022 now includes the requirements for point-of-care testing.
Results that are safe to use in patient care
ISO 15189 is the international standard for quality and competence in medical laboratories. It sets out what a laboratory examining samples from patients must have in place for its results to be trusted in clinical decisions: a laboratory director accountable for the service, competent staff, calibrated equipment, verified methods with known measurement uncertainty and reference intervals, quality control and external quality assessment, reports that reach the right clinician in time, and a management system that holds it together. Its stated objective is the welfare of patients and the satisfaction of laboratory users.
It is not a certification standard. A medical laboratory is accredited by an accreditation body, which sends assessors into the laboratory, watches examinations being performed and grants accreditation for a defined scope of examinations. This short film walks through how a laboratory prepares for that.
Preparing examination by examination
First settle the scope and select the body: which disciplines, examinations, sites and point-of-care services go on the application, who will rely on the results, and which accreditation body, normally the national one. Each body publishes its own procedure, but the sequence is common to them.
A gap analysis then reviews the laboratory against the standard examination by examination, covering impartiality, confidentiality and patient-related requirements, governance and the laboratory director's role, resources, the path of a sample from request to report, and the management system. Implementation closes the gaps: methods verified, uncertainty and reference intervals established, quality control and external quality assessment in place, reporting arrangements tested and records kept. Internal audit and management review follow before the application and the on-site assessment, after which the accreditation body decides.
Sterling's expert and experienced consultants support the laboratory team through preparation and implementation under Sterling OS™, with the records held in Effivity. The current edition is ISO 15189:2022, which replaced the 2012 edition and ISO 22870 for point-of-care testing; the transition from the 2012 edition ended in December 2025.
ISO 15189 at a glance
- Purpose
- Quality and competence in medical laboratories, so that examination results are reliable, timely and safe to use in the care of patients
- Relevant to
- Hospital, independent, reference and public health laboratories in every discipline, and the point-of-care testing they are responsible for
- Edition
- ISO 15189:2022, the fourth edition, which replaced ISO 15189:2012 and ISO 22870:2016; the transition from the 2012 edition ended in December 2025
- Accreditation
- Assessed and granted by an accreditation body for a defined scope of examinations, then maintained through surveillance and reassessment
- Sterling's role
- Consulting with your team, Effivity, training, internal audit and assessment readiness, then Sustain™
- Cost and timing
- Total investment for an ISO 15189 medical laboratory management system depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 8 to 14 months
ISO 15189: questions people ask
Is ISO 15189 a certification or an accreditation?
An accreditation. An accreditation body assesses the laboratory's competence for a defined scope of examinations and publishes the scope on its register. Certification bodies certify management systems; they do not accredit medical laboratories, and an "ISO 15189 certificate" from one of them is not accreditation.
What changed in ISO 15189:2022, what happened to ISO 22870, and is the transition over?
The 2022 edition follows the structure of ISO/IEC 17025:2017, with the management system last, and puts more weight on risk management and on the patient. ISO 22870:2016 was withdrawn in December 2022 and its point-of-care testing requirements became Annex A. The three-year transition ended in December 2025: accreditation to the 2012 edition is no longer recognised, and a laboratory still holding 2012-era documentation applies against the 2022 edition.
Which accreditation body should we choose, and will our results be recognised abroad?
Normally the national body, for example PAB (Philippines), NABL (India), UKAS (United Kingdom), EIAC (Dubai), GAC (Gulf states), ANAB or A2LA (United States) or NATA (Australia), provided it is a Global ACI MRA signatory for medical testing. Signatory bodies recognise one another's accreditations as equivalent, except where regulation or law provides otherwise, so check the register and the rules of the regulator or sponsor that will rely on your results. In the United States, A2LA also holds deemed status for CLIA.
We are licensed by the health authority and ISO 9001 certified. Does that satisfy ISO 15189?
No. The licence permits you to operate and the ISO 9001 certificate covers the management system; ISO 15189 adds the technical requirements: the laboratory director, competence per examination, equipment and traceability, method verification, uncertainty, reference intervals, quality control and external quality assessment, reporting and the pre-examination phase. Annex B shows where the two overlap, so an existing system is reused, but clauses 4 to 7 still have to be assessed.
Do we have to take part in external quality assessment?
The standard requires the laboratory to ensure the validity of its examination results through internal quality control and external quality assessment, and accreditation bodies expect a plan covering the scope, with evidence that every return was reviewed and acted on. Where no scheme exists, an alternative interlaboratory comparison is agreed and documented.
Keep exploring
Related to this video
The complete guide
Everything on ISO 15189
Start with the ISO 15189 page, or go straight to the guide you need.
On the ISO 15189 page
- What are the main ISO 15189 requirements?
- How do you get ISO 15189 accredited?
- How much does ISO 15189 accreditation cost?
- How long does ISO 15189 accreditation take?
- Who needs ISO 15189 accreditation?
- How ISO 15189 accreditation supports your laboratory, your clinicians and your patients
- Frequently asked questions about ISO 15189
Often combined with ISO 15189
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