Reliable results. Satisfy NATA.Prove Competence.
Going it alone eats months of internal effort. We take the whole build off your plate — gap analysis to certification.
ISO 15189 is the international standard for quality and competence in medical and pathology laboratories, and the basis for NATA/RCPA accreditation in Australia. We build it around how your lab actually works and get you assessment-ready. Done-for-you, fixed fee, dedicated Australian consultant.
Part of the global IMSM network
1 fee
fixed and agreed upfront — no hourly billing
ISO 15189:2022
the current edition we implement to
NATA + RCPA
Australia's joint medical laboratory accreditation program
1 consultant
one dedicated Australian consultant, start to finish
Why laboratories choose IMSM for ISO 15189
Built around your laboratory
We shape the system to your disciplines, methods and workflow rather than handing you a generic template that never fits how you actually test.
One dedicated Australian consultant
You work with a single consultant who understands the Australian accreditation landscape and stays with you from gap analysis through to assessment readiness.
Assessment-ready for NATA/RCPA
We prepare your documentation, records and evidence so your laboratory can go into NATA assessment (delivered with the RCPA) with confidence.
Fixed fee, no surprises
One price, agreed before we start. No hourly billing and no scope creep — just a clear, done-for-you path to accreditation readiness.
Tell us your situation and headcount, we'll scope your fixed fee within 24 hours.
Get my fixed-fee quote →What ISO 15189 certification involves
ISO 15189 sets out the quality management and technical competence requirements a medical or pathology laboratory must meet to produce reliable, traceable results. IMSM implements it around your existing people, methods and workflow, then prepares you for assessment towards NATA accreditation (delivered jointly with the RCPA). One fixed fee, agreed upfront.
Quality management and technical competence
We put in place the management system ISO 15189 expects — policies, responsibilities and controls — sitting alongside the technical competence requirements that are specific to a medical laboratory.
Pre- and post-examination processes
We cover the whole testing journey: request handling, patient identification, sample collection, transport and storage, then result reporting, interpretation and communication to the requester.
Method validation and quality control
We document how examination methods are validated or verified and kept under control through internal quality control and external quality assurance so results stay dependable over time.
Equipment, calibration and traceability
We establish controls for analysers, reagents and consumables — calibration, maintenance and metrological traceability — so measurements are reliable and defensible.
Personnel competence
We set up training records, authorisation to perform testing, and ongoing competency assessment so it is clear every person is qualified for the work they do.
Internal audit and continual improvement
We build internal audit, management review, nonconformity handling and corrective action into a cycle that keeps the laboratory assessment-ready, not just ready once.
What ISO 15189 does for your business
Reliable patient results
Demonstrate that every result your laboratory reports is accurate, traceable and clinically dependable — the outcome patients and their treating doctors depend on.
Meets NATA, RCPA and Medicare requirements
Accreditation to ISO 15189 underpins recognition under the NATA/RCPA program and the Medicare requirements that apply to Australian pathology, keeping your laboratory eligible and compliant.
Referrer and clinician confidence
Give referring GPs, specialists and hospitals clear assurance that your quality and competence are independently verified, strengthening the referral relationships your laboratory relies on.
Fewer errors and lower risk
Structured pre-examination, examination and post-examination controls catch problems before they reach a report, reducing rework, recalls and clinical risk.
Demonstrated staff competence
Clear training, authorisation and ongoing competency assessment show that the right people are performing and interpreting each test to a defined standard.
A stronger competitive position
Accreditation is a recognised mark of quality when tendering for contracts, winning referrers and standing apart from laboratories that cannot evidence the same rigour.
Ready for your fixed-fee quote?
Tell us where to send it — your exact ISO 15189 fixed fee, back within 24 hours. No obligation.
Who ISO 15189 is for in Australia
Not sure if ISO 15189 fits your sector? Tell us what you do, we'll tell you straight, no pressure.
Get my fixed-fee quoteWhat does ISO 15189 certification cost?
Your fee depends on one thing: the size of your organisation. Tell us your headcount and we'll send a single fixed fee covering gap analysis, documentation, consultancy and your certification audit, agreed upfront, no hourly billing, no surprises.
Get your ISO 15189 fixed fee
One number, agreed upfront — gap analysis, documentation, implementation and audit. Sent within 24 hours.
Five steps to certified
One dedicated Australian consultant from quote to certificate, we do the heavy lifting.
- 01
Quick quote & scope
Tell us your standard and headcount, your quote arrives within 24 hours, agreed before we start.
- 02
Gap analysis
Your dedicated consultant maps what you already have against the standard, so you only build what's missing.
- 03
System build
We write the policies, procedures and records with you, tailored to how your business actually operates.
- 04
Implementation & internal audit
We embed the system, train your team and run the internal audit to confirm you're ready.
- 05
Certification audit
We prepare and support you through the audit, independent or JAS-ANZ accredited, your choice.
EFQM 5★ Recognised for Excellence
Fewer than 400 organisations worldwide hold it, IMSM is one of them
Think of it as ISO certification for our own business, we hold ourselves to the same standard we hold you to.
It's an independent assessment of our own quality management against the European Foundation for Quality Management framework.
ISO 15189, common questions
Is ISO 15189 certification or accreditation?＋
It is accreditation, not certification. In Australia, a medical laboratory is accredited to ISO 15189 by NATA, working jointly with the Royal College of Pathologists of Australasia (RCPA). IMSM implements the quality and competence requirements and gets you assessment-ready; NATA (with the RCPA) carries out the assessment and grants accreditation.
How long does ISO 15189 accreditation take?＋
There is no fixed answer up front — it depends on the size and scope of your laboratory, the disciplines and methods involved, and how much documentation you already have in place. We confirm a realistic timeline at the gap-analysis stage, once we have seen how your laboratory works, so the plan reflects your actual starting point rather than a generic estimate.
What is the difference between ISO 15189 and ISO 9001?＋
ISO 9001 is a general quality management standard for any organisation. ISO 15189 is specific to medical laboratories and adds detailed technical competence requirements — covering examination methods, quality control, equipment traceability and personnel competence — that ISO 9001 does not address. For pathology and medical testing, ISO 15189 is the relevant standard.
How do NATA and the RCPA fit in?＋
NATA is Australia's accreditation body and assesses medical laboratories against ISO 15189 through a long-standing joint program with the RCPA. IMSM prepares your laboratory for that assessment; we do not grant accreditation ourselves — NATA and the RCPA do. Our role is to build the system and evidence so you meet the requirements when they assess.
Does accreditation affect Medicare eligibility?＋
Recognition under the NATA/RCPA accreditation program is central to the requirements that apply to Australian pathology, including eligibility for Medicare benefits. Implementing and maintaining ISO 15189 is a key part of keeping your laboratory accredited and compliant. We build the system to support those obligations.
What does IMSM actually do for us?＋
We do the heavy lifting. Your dedicated Australian consultant runs a gap analysis, develops the quality management system and technical documentation around how your laboratory works, sets up the records and controls ISO 15189 requires, and prepares your team and evidence for NATA/RCPA assessment — all for one fixed fee agreed upfront.
Ready to get ISO 15189 certified?
Most clients have their quote within 24 hours. Let's see what certification looks like for your business.