ISO 15189 · Medical laboratories
ISO 15189 accreditation consulting for results clinicians can act on and patients can trust.
Get your medical laboratory accredited to ISO 15189:2022 by the accreditation body, for the disciplines, examinations and point-of-care sites your clinicians and regulators rely on, on a timeline you can plan around. Sterling's expert and experienced consultants build the management system and the technical evidence with your scientists, and stay with you through the on-site assessment and beyond, in 60+ countries. We ensure successful accreditation for our clients.
- One all-inclusive proposal for a defined scope: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced medical laboratory accreditation consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not accredit; the accreditation body assesses and decides
8,100+ client engagements in 60+ countries.
ISO 15189 client experience
What it is
What is ISO 15189 and what is it used for?
ISO 15189 is the international standard for quality and competence in medical laboratories. It sets out what a laboratory that examines 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: an accreditation body, itself working to ISO/IEC 17011, sends a lead assessor and technical assessors into the laboratory, watches examinations being performed and, if satisfied, grants accreditation for a defined scope: the disciplines, examinations and sites, including point-of-care testing, listed on a public schedule. An examination outside that scope is not accredited.
Current edition. ISO 15189:2022, the fourth edition, was published in December 2022 and replaced both ISO 15189:2012 and ISO 22870:2016, whose point-of-care testing requirements now sit in Annex A. Its structure was aligned with ISO/IEC 17025:2017, so the management system requirements come last, in clause 8, and the emphasis on risk management and on the patient increased. The three-year transition ended on 6 December 2025: accreditation to the 2012 edition is no longer recognised, and accreditations that had not transitioned were suspended or withdrawn. ISO's routine systematic review of the 2022 edition is under way; until ISO publishes a decision, ISO 15189:2022 is the edition you are assessed against. Since 1 January 2026 the recognition behind an accredited result comes from Global ACI (Global Accreditation Cooperation Incorporated), which replaced the IAF MLA and ILAC MRA; medical testing to ISO 15189 is one of its MRA scopes. ISO 15189 requirements explained, clause by clause
Who it is for
Who needs ISO 15189 accreditation?
The standard applies to medical laboratories of every size and discipline, from clinical chemistry and haematology to microbiology, histopathology and molecular diagnostics, in hospitals, diagnostic chains, reference laboratories and public health institutes, and to the point-of-care testing a laboratory is responsible for. Licensing by the health authority is separate; accreditation is the evidence of competence on top of it. Laboratories come to Sterling from four starting points:
- A regulator, payer or hospital programme expects accredited results. Health authorities in a growing number of countries require or recognise ISO 15189, insurers and hospital accreditation programmes increasingly ask for it, and trial sponsors will not accept data from an unaccredited laboratory.
- You are licensed, or ISO 9001 certified, and want to prove competence. A licence says you may operate and an ISO 9001 certificate says your management system works; neither says your reference intervals are right or your external quality assessment performance is acceptable.
- You are adding examinations, sites or point-of-care testing. A new analyser, a molecular panel, a satellite laboratory or glucose meters on twenty wards each need verification, authorised operators and quality assessment evidence before the body adds them to your schedule.
- You serve referring laboratories, hospital groups or markets abroad. Under the Global ACI MRA, accreditation by a signatory body is recognised as equivalent by the other signatories, except where regulation or law provides otherwise, so your results can be accepted without repeats.
Business benefits
How ISO 15189 accreditation supports your laboratory, your clinicians and your patients
Accreditation should make results safer to act on and the laboratory easier to run. We start where a haemolysed sample is examined anyway or a critical result waits in the information system overnight, and build the system around those points.
- Results that are safe to act onVerified methods, known measurement uncertainty, appropriate reference intervals and quality control that stops a wrong result reaching the clinician.
- Recognition that travelsA published scope of accreditation, recognised through the Global ACI MRA, so referring laboratories, sponsors and regulators accept your reports instead of asking for repeats.
- Fewer pre-examination errorsClear collection instructions for the wards, acceptance and rejection criteria at receipt, and controlled transport and storage, where most laboratory errors begin.
- Competence you can showDefined competence for each examination, authorisation before independent work, and reassessment on a schedule, for scientists and for the nurses running point-of-care devices.
- Performance you can measureQuality indicators for turnaround, sample rejection, critical result communication and external quality assessment performance, reviewed by management and acted on.
- A service that keeps runningContinuity and emergency preparedness planning, validated information systems and managed reagents and suppliers, so an outage or a recall does not stop reporting.
Measure what these priorities change: rejected samples, turnaround, critical results communicated in time, external quality assessment scores, corrected reports. A longer quality manual is not an outcome.
Requirements
What are the main ISO 15189 requirements?
ISO 15189:2022 is organised in five requirement clauses, 4 to 8, in the same pattern as ISO/IEC 17025:2017 rather than the harmonised structure of the management system standards: clauses 4 to 7 cover the laboratory, its resources and the path of a sample from request to report, and clause 8 the management system that supports them. Annex A adds the requirements for point-of-care testing; Annexes B and C compare the standard with ISO 9001:2015 and with the 2012 edition. The table is a plain-language map.
| Clause | What it requires of you | What it looks like in practice |
|---|---|---|
| 4 General requirements | Impartiality, confidentiality, and requirements regarding patients: their information, consent, safety, welfare and access to the service | An impartiality assessment covering ownership, commercial pressure and referral arrangements; confidentiality undertakings for staff, students and contractors; arrangements for patient information, consent and complaints |
| 5 Structural and governance requirements | A legal entity, a laboratory director with defined competence and responsibilities, defined laboratory activities including POCT, a structure with clear authority, objectives and policies, and risk management | A documented scope of laboratory activities, an organisation chart with technical and quality responsibilities, measurable objectives, and a risk process that reaches from patient harm to the daily rota |
| 6 Resource requirements | Competent personnel, suitable facilities and environmental conditions, equipment with calibration and metrological traceability, controlled reagents and consumables, service agreements, and externally provided products and services | Competence criteria and authorisations per examination, monitored environmental conditions, an equipment register with calibration history, reagent lot acceptance records, agreements with users and referral laboratories, and evaluated suppliers |
| 7 Process requirements | Pre-examination processes from information for users and requests to sample collection, transport, receipt and storage; examination processes covering verification and validation of methods, measurement uncertainty, reference intervals and clinical decision limits, examination procedures and ensuring the validity of results; post-examination reporting and sample handling; nonconforming work; control of data and information management; complaints; and continuity and emergency preparedness planning | A collection manual the wards use, rejection criteria, verification files and uncertainty estimates per method, documented reference intervals, quality control and external quality assessment with reviewed results, reports with every required element and a route for critical results, a nonconforming work process that decides on affected results, a validated information system and a tested continuity plan |
| 8 Management system requirements | A management system that supports clauses 4 to 7: documentation, control of documents and records, actions to address risks and opportunities, improvement, nonconformities and corrective actions, evaluations through quality indicators and internal audits, and management reviews | A concise management system in Effivity: controlled procedures and records, a risk register, quality indicators with targets, an internal audit programme that covers the technical clauses, corrective actions closed with evidence and management reviews that decide |
What does useful ISO 15189 evidence look like?
A risk assessment that names the ways a patient could be harmed and what was done about each, competence records by examination, an equipment register with a traceability chain you can draw, verification files with uncertainty and reference interval decisions, quality control and external quality assessment results with a documented review, a collection manual the wards actually use, and the nonconforming work, internal audit and management review records that show the system reacting. We identify the records each examination genuinely needs; the management system records live in Effivity from the first workshop.
ISO 15189 requirements explained, clause by clauseAccreditation process
How do you get ISO 15189 accredited?
First build a laboratory that meets the standard and can prove it, examination by examination. Then apply to an accreditation body, which assesses the laboratory on site and decides; Sterling supports you through consulting and preparation, and the independence of that decision is what gives your schedule its value. Each body publishes its own procedure; this sequence is common to them.
- 01Settle the scope and select the body.Agree which disciplines, examinations, sites and point-of-care services go on the application, confirm who will rely on the results, and select the body, normally the national one, checking that it is a Global ACI MRA signatory.
- 02Gap analysis: review the laboratory against clauses 4 to 8 and Annex A, examination by examination.The gap analysis covers governance, personnel, equipment, reagents, the pre-examination path from the wards, method verification, quality control and assessment, reporting and the management system, keeps what works and agrees actions, owners and dates.
- 03Build the evidence, examination by examination.Verify each method, estimate uncertainty, confirm reference intervals, set up quality control, enrol in external quality assessment, close calibration gaps, authorise staff and POCT operators and put the procedures into daily use.
- 04Internal audit, management review, findings closed.An internal audit that covers the technical clauses and the point-of-care sites as well as the management system, then a management review; findings are raised by us first and closed with evidence before the application.
- 05Go through the accreditation body's assessment.Application and document review, a pre-assessment where offered, then the on-site assessment by a lead assessor and technical assessors for each discipline, who witness examinations; nonconformities are closed by the body's deadline and its committee decides.
- 06Maintain the accreditation.Quality control, external quality assessment, competence reassessment, internal audits and management reviews continue, alongside the body's surveillance, normally each year, and a full reassessment on the cycle it sets.
Verify the route before you compare prices. Only accreditation bodies operating to ISO/IEC 17011 accredit medical laboratories; an "ISO 15189 certificate" from a certification body or a consultant is not accreditation and appears on no register. Confirm the body on the Global ACI list before you sign anything. How to choose a credible ISO 15189 provider · The accreditation buyer's checklist
Cost
How much does ISO 15189 accreditation cost?
No single figure describes ISO 15189 accreditation. A single-discipline laboratory needs a different programme from a hospital laboratory applying for six disciplines and point-of-care testing on every ward, and the body charges by the assessor days each discipline needs. What we can promise is a proposal that shows every component, with Sterling's fee fixed.
| Cost component | What affects it |
|---|---|
| Consulting and implementation | Current maturity, the number of disciplines and examinations in scope, sites and POCT locations, and how much of the work your laboratory takes on (Design™ or Drive™) |
| Accreditation body fees | Application, document review, assessment days for the lead assessor and a technical assessor per discipline, witnessing, travel, and the body's annual and surveillance charges |
| Technical investment | External quality assessment subscriptions per discipline, calibration of equipment and reference materials, verification studies, information system validation and any environmental control the examinations need |
| Internal resources | Scientist time for verification and records, the laboratory director's and quality manager's involvement, ward and POCT training and operational change |
| Software and learning | Included in a Sterling engagement: Effivity for the management system and Sterling Academy access for your people, with users and courses confirmed in the proposal |
| Continued support | Internal audits, surveillance readiness, scope extensions, refresher learning and future changes under Sustain™ |
What moves the price
- The number of disciplines and examinations on the scope: each needs verification, quality assessment and assessor time
- Sites, satellite laboratories and point-of-care locations, and whether one schedule or several
- The state of equipment calibration, reagent control and the information system
- Whether external quality assessment schemes exist for your examinations, and their distribution dates
- Whether an ISO 9001 system exists today, and the deadline a regulator has set
What a Sterling proposal always shows
- Deliverables, responsibilities, assumptions and exclusions, in writing
- Accreditation body fees identified separately, so the full programme cost is comparable
- Effivity, training and Academy access itemised at no additional cost
- Payment milestones tied to deliverables, not to the calendar
- One all-inclusive proposal. No surprises, ever
Timeline
How long does ISO 15189 accreditation take?
Plan on eight to fourteen months for a first accreditation, with a single-discipline laboratory at the lower end and a multi-discipline hospital service with point-of-care testing at the upper end. Three things cannot be compressed: every examination has to be verified and its quality control established before the records mean anything; external quality assessment distributions run on the scheme's calendar, not yours; and the body needs time for document review, a technical assessor per discipline, the on-site assessment and the closure of findings. We build the plan around those dependencies.
| Phase | What determines the pace |
|---|---|
| Scope and gap analysis | Access to the laboratory director, section heads, method files and equipment records, and how quickly the scope is settled |
| Build and implementation | The number of examinations to verify, instruments to bring under calibration control, staff and POCT operators to authorise, and the laboratory's daily workload |
| Evidence and review | External quality assessment distribution dates, quality control data accumulating over normal operation, then internal audit and management review |
| Accreditation assessment | The body's application queue, technical assessor availability per discipline, witnessing at each site, the deadline for closing findings and its decision date |
If a regulator, a hospital board or a sponsor has set a date, share it at the start. We will tell you what is achievable and which external quality assessment schemes to enrol in now. A date promised before anyone has looked at your examinations is not a plan.
Challenges
Common ISO 15189 implementation challenges
Most medical laboratory programmes stall on the same five points, most of them at the bench or on the wards rather than in the quality manual. Each has a practical answer.
Methods were installed by the supplier and never verified by the laboratory.
An analyser's claims are the manufacturer's, not yours. We plan the verification each examination needs, run the studies with your staff, estimate uncertainty from the quality control data you already generate, and record the reference interval decision for your population.
The pre-examination phase belongs to everyone and no one.
Samples are collected by nurses, transported by porters and requested by clinicians the laboratory does not manage. We write the collection manual with the wards, set rejection criteria the receipt bench applies without argument, and put transport and storage under monitoring.
External quality assessment is patchy, or the results were never acted on.
A plan that covers every examination on the scope, enrolment in the schemes that exist, and a documented review of every return, with root cause and corrective action for the unacceptable ones. Where no scheme covers an examination, an alternative comparison is agreed and documented.
Competence was assessed at induction and never again, and POCT devices are run by staff the laboratory does not see.
We define competence per examination, capture the training and observation that already happened, authorise each person for specific work, set the reassessment cycle, and extend the same arrangement to ward and clinic operators under Annex A.
The information system was never validated and records live in three places.
We define which records matter, who owns them and where they live, configure Effivity for the management system records, and bring the laboratory information system under the control the standard expects: validated calculations and transfers, access control, backup and tested continuity arrangements.
Your engagement
What your ISO 15189 engagement includes
Your agreed scope brings together everything an accreditation-ready medical laboratory needs: the management system, the technical evidence and a team that can explain both to an assessor, under one all-inclusive proposal.
Scope, gap analysis and implementation plan
Examination by examination, with responsibilities, dates and decision owners agreed before work starts.
Management system and technical documentation
Procedures, the collection manual, examination procedure and verification templates and forms, built on Sterling's template sets with your section heads.
Effivity ISO & GRC software
Your management system is configured in Effivity from the first workshop, included with the engagement at no additional cost.
Training for everyone
Internal auditor training for your audit team, as applicable to your standard, and preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.
Internal audit and management review
Conducted or facilitated as agreed, covering the technical clauses, the point-of-care sites and the management system, with findings closed before the assessors arrive.
Assessment readiness and support
Preparation for the document review, the pre-assessment where offered and the on-site assessment, and support until the decision.
Accreditation decisions remain with the independent accreditation body.
How we deliver
How Sterling supports your ISO 15189 implementation
Every ISO 15189 engagement runs on Sterling OS™, our delivery operating system: five phases with named deliverables, decision owners and evidence at each stage. Choose the level of support that matches your capacity; the method and the accountability stay the same.
- 01Design™Guided implementation: your section heads and quality manager verify, document and implement with Sterling's structure, templates, workshops and coaching.
- 02Drive™Fully managed consulting: Sterling consultants take on the agreed documentation, verification planning and evidence work with your process owners.
- 03Sustain™Post-accreditation operation: surveillance readiness, internal audits, external quality assessment follow-up, refreshers and new-starter training, year after year.
- 04Automate™The management system running in Effivity: documents, records, competence, equipment, suppliers, risks, quality indicators, audits, actions and management review in one workspace.
- 05Revise™Scope extensions, new sites and POCT services, changes in regulation or in the body's requirements, and any future edition of the standard.
The engagement team, the weekly working session, the deliverables and the decision owners are named before work starts.
How Sterling OS™ worksOften combined with
Standards organisations pair with ISO 15189
- CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
- ISO 10012ISO 10012 Measurement Management certification consulting: measurement processes and equipment controlled for valid results, ready for a certification audit.
- ISO 14065ISO 14065 accreditation and requirements for bodies verifying environmental information: GHG statements, footprints, the route, cost and timing factors.
- ISO 15190ISO 15190 laboratory safety for medical labs: gap and risk assessment, procedures, training and internal audit alongside ISO 15189.
- ISO 17034ISO 17034 accreditation consulting for reference material producers: competence and consistent operation evidenced and prepared for accreditation assessment.
- ISO 20387ISO 20387 accreditation and requirements for biobanks: competence, impartiality and sample quality, with expert consultants, Effivity and an all-inclusive proposal.
Effivity · ISO 15189 management system software, included in every engagement
How Effivity helps you fulfil, automate and simplify the requirements of ISO 15189:2022.
Every Sterling ISO 15189 engagement includes Effivity, the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Effivity's modules are management system modules, the layer of ISO 15189 that laboratories find hardest to keep alive between assessments: documents, records, competence, equipment, suppliers, risks, quality indicators, complaints, nonconforming work, audits and management review. Your laboratory information system and quality control data stay in your own systems and are linked as evidence. Sterling consulting clients get their Effivity subscription included with the engagement, at no additional cost.
Impartiality risks and confidentiality commitments
Risks to impartiality in a register with owners, actions and review dates, and confidentiality undertakings recorded against each person, so clause 4 is reviewed on a schedule.
Risks to patients, to results and to the service
The risk process of clause 5 and the actions to address risks and opportunities of clause 8 in one register: the harm, the cause, the control, the owner and the review.
Competence, authorisation and training records
Competence criteria per examination, the training, observation and authorisation of each person, the reassessment cycle and the records for ward operators of POCT devices, so the authorisation matrix is a report, not a reconstruction.
Equipment register and calibration records
Every analyser, pipette, refrigerator and POCT device with its calibration and maintenance programme, due dates, certificates and status, so an overdue calibration is flagged before an assessor finds it.
Suppliers, referral laboratories and service agreements
Evaluation criteria, approval and re-evaluation records for reagent suppliers, calibration and external quality assessment providers and referral laboratories, with their accreditation evidence attached.
Nonconforming work, complaints and corrective action
Raised, evaluated for the effect on reported results, with the decision to withhold, recall or amend a report recorded, and closed with root cause and evidence that the correction held.
Documents, records and improvement
Documentation with versions, approvals and distribution, controlled records with retention periods, and the improvement actions from user feedback and reviews: the clause 8 elements in one place.
Quality indicators, audit programme and management review
Quality indicators with targets and trends, an internal audit programme covering the technical clauses and every site, findings tracked to closure, and a management review that records its inputs and decisions.
What this means at the assessment
The technical assessor asks for the authorisation record of the scientist being witnessed, the calibration status of the analyser on the bench and the last external quality assessment return for the examination. In Effivity each answer is a screen with dates, owners and evidence attached, not a binder assembled the week before the visit. After accreditation, Sustain™ runs in the same workspace.
In your engagement
- Subscription included with the engagement, at no additional cost
- Configured by your Sterling consultant within the agreed scope
- Your procedures, records and registers migrated, not retyped
- Admin and user training for your laboratory team
- Modules for QMS, EMS, OHSMS and ISMS when the hospital or group integrates other standards
ISO 15189 client experience
Client letters on file, available on request.
Signed client letters for ISO 15189 are available on request. The client feedback wall lists every letter by standard.
How an integrated programme with ISO 15189 runs
One laboratory, one system, several standards.
- 01Read the case study
Hospital: consistent patient care and reliable laboratory results
A hospital needed consistent, safe care across its units and laboratory results that doctors and patients could rely on. ISO 9001 made practice consistent between hospital units, putting patient safety first, reducing errors and lifting patient satisfaction scores. ISO 15189 gave the laboratory robust processes and rigorous quality control, increasing confidence in its diagnostic results; its chief medical officer said care had improved at its core, from emergency treatment through to the laboratory.
Sterling Academy · ISO 15189 e-learning
Train the whole laboratory on ISO 15189, not just the quality manager.
An assessor witnesses scientists, phlebotomists and the nurse running a point-of-care device, not the quality manual. Sterling Academy delivers e-learning for everyone who touches a sample or a result and for the people who run the system: video lessons with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online, which serves as training evidence in competence records. Sterling consulting clients benefit from preferential course access and special pricing through their Sterling consultant, including complimentary awareness training for their people as part of the engagement.
- ISO 15189 awareness for every member of the laboratory and its collection points, with the training record competence needs
- Practitioner courses for the quality manager, section heads and method owners
- Internal auditor training for the people who will audit the laboratory, as applicable to your standard, as part of the engagement
- Learner progress by section and a training status report for the assessor
- New scientists and ward operators trained as they arrive, so records are current at every surveillance
- A Sterling consultant reachable when a learner needs one
Sterling Academy courses for an ISO 15189 programme
The courses your people take, and who takes them.
ISO 15189 Awareness
What accreditation is and how it differs from licensing and certification, what the standard requires of each person in the laboratory, and why the pre-examination phase, quality control, external quality assessment and reporting matter to the patient.
View the courseDocumented Information Management
Management system documentation, control of documents and records under clause 8, and the examination procedures, verification files and technical records that let a result be traced back to the request.
View the courseNonconformity Management
Identifying and evaluating nonconforming work, deciding on affected results and withholding, recalling or amending reports, handling complaints, and corrective action with evidence that the cause was removed.
View the courseRisk Management
Risk management under clause 5, risks to impartiality under clause 4 and actions to address risks and opportunities under clause 8, with the register, ownership and review that make patient harm visible in daily decisions.
View the courseInternal auditor training
Delivered by your Sterling consultant for the people who will audit the laboratory's management system, technical operations and point-of-care sites, with exercises on your own examinations.
Integrating other standards?
Awareness courses for ISO 9001, ISO/IEC 27001, ISO 45001, ISO 14001, ISO 13485 and more, so a hospital or diagnostic group trains one workforce on one platform.
See all coursesSterling consulting clients arrange access through their consultant. Sterling Academy certificates are training certificates; accreditation remains with the accreditation body.
Keep exploring
Explore more about ISO 15189
Watch a video on how to implement ISO 15189 here.
Watch a video on ISO 15189 requirements here.
Why Sterling
Want successful ISO 15189 accreditation? Come to Sterling.
Whether you are accrediting one clinical chemistry laboratory or bringing the laboratories of a hospital group in several countries onto one system, Sterling helps you build competence you can demonstrate and a management system your staff will keep running.
Management systems in 60+ countries since 2003
Healthcare and laboratory clients prepared across regions and national bodies, with one engagement team accountable wherever you operate.
All-inclusive proposal
Consulting, Effivity, training and Academy access in one all-inclusive proposal; the accreditation body's fees are shown separately. No surprises, ever.
A system your laboratory can use
Less documentation and maximum effectiveness: procedures, records, training and software connected to the bench and the ward, so staff adopt the system rather than tolerate it.
Expert and experienced consultants
Consultants who understand how a medical laboratory works between the request and the report, building the technical evidence properly the first time.
The Sterling Promise
What our ISO 15189 accreditation success guarantee means
We stay with you until your agreed ISO 15189 accreditation outcome is achieved, supporting implementation, assessment preparation and the resolution of the assessors' findings. Clear explanations, practical delivery, included software and staff learning turn the investment into lasting capability rather than a schedule on the wall.
The engagement letter names the standard, the scope applied for, the outcome and who is responsible for what. Your laboratory supplies accurate information, performs the agreed verification and quality assessment work and puts the controls into use. The accreditation body assesses competence, and the decision is its alone. Our commitment concerns the agreed accreditation support.
After accreditation
What happens after ISO 15189 accreditation?
Accreditation is a cycle, not an event. The body comes back for surveillance, normally every year, and for a full reassessment on its own cycle: UKAS confirms accreditation annually and reassesses every fourth year; other bodies work to two- or three-year cycles. Between visits the laboratory keeps running quality control and external quality assessment, reassessing competence, auditing and reviewing the system, and reports significant changes as the body's rules require.
Many laboratories that transitioned from ISO 15189:2012 still carry documentation that mirrors the old structure, so that risk management, patient requirements, quality indicators and continuity planning sit in the wrong places or nowhere. Under Sterling OS™ Sustain™ we review external quality assessment outcomes, nonconforming work and quality indicators with you alongside internal audits, management reviews and surveillance preparation.
FAQs
Frequently asked questions about ISO 15189
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.
The wards collect the samples. Are they our problem at the assessment?
Yes. The pre-examination requirements cover information for patients and users, requests, sample collection, transport, receipt and storage, and the laboratory is responsible for the arrangements even when other departments perform the steps. Assessors follow a sample from the ward to the report, so the collection manual and the training of collectors are your evidence.
Does Sterling accredit medical laboratories or issue certificates?
No. Sterling provides consulting and readiness for the assessment. The accreditation body assesses on site and makes the decision; anyone offering both is offering paper.
Can a small single-discipline laboratory, or a clinic's point-of-care service, be accredited?
Yes. The standard applies regardless of size, and the scope can be as narrow as the examinations you actually report. A two-scientist laboratory needs the same verification, quality control and competence evidence as a hospital service, with far fewer procedures, and a point-of-care service is assessed under Annex A.
What do you need to prepare an ISO 15189 proposal?
The disciplines and examinations you want on the scope, the sites and point-of-care locations, the number of staff, the main analysers, whether a licence, an ISO 9001 system or an earlier accreditation exists, the intended body and any deadline. That is enough for a scoped, all-inclusive proposal.
Before the first call
Prepare a useful ISO 15189 readiness brief
You do not need a quality manual or verification data before the first discussion. Seven questions suffice:
- Which disciplines and examinations do you want on the scope, at which sites and point-of-care locations, and who has asked for accredited results: a regulator, a hospital, a sponsor or your own management?
- Who is the laboratory director, and how are technical and quality responsibilities assigned today?
- Which examinations were verified by the laboratory after installation, and is uncertainty or a reference interval documented for any of them?
- Which external quality assessment schemes does the laboratory take part in, with what results, and how is quality control reviewed?
- How are samples requested, collected, transported and accepted, and what is rejected today?
- Does a licence, an ISO 9001 system or an earlier accreditation exist, and who can make decisions and contribute time to implementation?
- Which body do you intend to apply to, and by when?
With these answers we can scope the work and prepare a realistic proposal. They open a discussion; they are neither a scored assessment nor an accreditation decision.
Don’t be fooled by certification scams
If it takes ten days, it is not ISO 15189 accreditation.
Medical laboratory accreditation is valuable because someone competent in your discipline watched your people examine a sample and checked the quality control behind the result. The market sells shortcuts around that: "ISO 15189 certificates" from certification bodies, document sets sold as accreditation, and "assessments" without a witnessed examination. They cost less, until a regulator looks for your scope on a register and finds nothing.
How to choose a credible ISO 15189 provider
- Ask which accreditation body will assess you, then find it on the Global ACI list of recognised bodies, check that medical testing is in its scope and read one of its published schedules.
- Refuse any "ISO 15189 certificate" from a certification body. Certification bodies work to ISO/IEC 17021-1 and certify management systems; only an accreditation body working to ISO/IEC 17011 accredits medical laboratories.
- Ask how examinations will be verified and quality assessment arranged. A provider who talks only about documents has never sat across from a technical assessor in a laboratory.
- Identify who carries each task, which body, quality assessment and calibration fees are separate, and what support exists when findings need closing.
- Ask what your scientists and ward operators will learn and where the records will live. Without training and a system, the competence evidence ends when the consultant's contract does.
- Walk away from "accredited in ten days", "no site visit" and a single invoice covering consulting and accreditation. A laboratory has to operate, take part in external quality assessment and be witnessed first.
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