ISO 15189 Accreditation in the Philippines

ISO 15189 accreditation, achieved — and the clinical trust that comes with it

Sterling International Consulting prepares your medical laboratory to earn ISO 15189:2022 accreditation and takes you through assessment by an accreditation body — in the Philippines, the Philippine Accreditation Bureau (PAB) under the Department of Trade and Industry. We are a consultancy: we build the technical competence and the evidence, then hand you to the assessors ready to pass. The payoff is concrete — examination results that a clinician, a referring hospital, an overseas reference laboratory or an international insurer will trust; eligibility for referral networks and tenders that specify accreditation; fewer repeat tests and analytical errors; and recognition of your results well beyond Philippine borders.

This is deliberately not an encyclopaedia entry. It is a buyer’s page for laboratory directors, quality managers, pathologists and hospital administrators who have already decided that “we know our results are good” is no longer enough to say — they need it demonstrated to a standard the world recognises. Below is what ISO 15189 actually does for a Philippine laboratory, who is driving the demand, what the 2022 edition requires, how Sterling delivers it, and the mistakes that quietly cost laboratories their first assessment.

The business case: what ISO 15189 actually does for a laboratory

Every clinical laboratory believes its results are reliable. ISO 15189 is the difference between believing it and being able to prove it — to a competent third party, on demand, for every discipline you run. That distinction is the entire commercial argument, and it converts into value in several concrete ways.

It makes your results defensible. Accreditation is a formal, witnessed judgement that your laboratory is both competent (technically able to produce correct results) and quality-managed (able to keep producing them). Assessors do not read a manual and leave; they watch your staff perform examinations, trace your calibrations back to reference materials, examine your measurement-uncertainty budgets, and check how you performed in external quality assessment. When a result is later questioned — by a clinician, a patient, a lawyer, or an insurer — an accredited laboratory has an evidentiary trail that an unaccredited one simply does not.

It reduces the cost of being wrong. Most laboratory error does not happen at the analyser. It happens before and after — wrong patient identification, poor collection, delayed transport, a haemolysed specimen accepted when it should have been rejected, a critical value that never reached the physician, a transcription error at reporting. ISO 15189 forces control across the whole path, from patient preparation through to the released report. Laboratories that implement it properly see fewer repeats, fewer recollections, fewer complaints and fewer of the near-misses that erode a clinician’s confidence in the lab.

It opens doors that are otherwise closed. Referral relationships increasingly assume accreditation. A tertiary hospital sending esoteric work to a reference laboratory, a multinational sending samples to a Philippine hub, a clinical-trial sponsor selecting a local laboratory, an international insurer or medical-tourism facilitator vetting where a patient’s bloods are run — all of these are more comfortable, and in many cases will only deal with, a laboratory whose competence has been independently assessed. Accreditation is frequently the entry ticket, not the differentiator.

It gives your results a passport. Where your accreditation is granted by a body that is a signatory to the relevant international mutual-recognition arrangement, your results carry recognition beyond the Philippines — the principle of “tested once, accepted everywhere” that underpins cross-border referral and reference testing. It is worth confirming the current scope of your chosen accreditation body’s mutual-recognition coverage for medical laboratories, but the direction is unambiguous: accreditation is the language in which laboratories talk to each other internationally.

It is a management system, not a plaque. Done well, ISO 15189 sharpens the things a laboratory director already worries about — competency of staff, uptime and calibration of equipment, turnaround time, the reliability of point-of-care devices scattered around the wards, the handling of critical results. The accreditation is the by-product. The operational grip is the point.

Who needs ISO 15189 in the Philippines — and what is driving the demand

Let us be honest about the legal position first, because the market is full of confident nonsense on this. ISO 15189 accreditation is not the legal permit that lets you operate. Clinical laboratories in the Philippines operate under a licence to operate issued by the Department of Health, and that licence — with its own inspection regime and standards — is the mandatory floor. Confirm your current licensing obligations with the DOH; they are the law. ISO 15189 sits above that floor. It is, for most laboratories, voluntary — a demonstration of quality and competence that goes beyond the minimum needed to keep the doors open. Keeping that distinction straight is a matter of professional honesty, and it is the first thing we clarify with any laboratory that calls us.

Voluntary, however, does not mean optional in practice. The demand in the Philippines is real and it is accelerating, driven by:

• Hospital laboratories seeking recognised quality and competence. Tertiary and specialty hospitals — particularly those pursuing their own institutional quality recognitions or courting international patients — increasingly want their laboratory’s competence independently proven, not asserted. For a hospital lab, accreditation is part of the institution’s overall credibility.
• Standalone diagnostic and reference laboratories. The private diagnostic sector is competitive, and accreditation is a hard-to-fake signal in a market where every laboratory claims accuracy. For a reference laboratory that receives referred work from smaller labs, accreditation is close to a commercial necessity — the referring labs are, in effect, outsourcing their reputation to you.
• Labs inside referral and network arrangements. Laboratory networks, hospital groups and consolidators standardise on accreditation to guarantee that a result produced in one node means the same thing as a result produced in another. If you want to be a node, you need the standard.
• Labs supporting clinical trials, pharma and CRO work. Sponsors and contract research organisations select laboratories on demonstrable quality systems. ISO 15189 accreditation materially strengthens a Philippine laboratory’s case to win that work.
• Alignment with DOH direction. The public-health system itself is moving in this direction — national and regional reference laboratories, and DOH clinical laboratories, have been actively engaging with ISO 15189:2022 through the DTI-PAB. A private laboratory that aligns early is moving with the current, not against it.
• Medical tourism and international patients. Where a laboratory serves international patients, or feeds hospitals that market to them, accredited results reduce friction with overseas clinicians and insurers who want assurance in a currency they understand.

The overseas head office and the overseas partner. A large share of the serious ISO 15189 demand we see in the Philippines originates outside the country. A multinational diagnostics chain mandates accreditation of its Philippine laboratory as a group standard. An overseas reference laboratory will only accept referred samples from — or send esoteric work to — a Philippine partner that is accredited. A foreign hospital group or insurer building a corridor for patients into the Philippines requires it of the local lab in the loop. These mandates arrive with their own complications: group-defined quality manuals to reconcile with local reality, reporting and documentation expected in English, remote coordination across time zones with a corporate quality function, and an expectation that the Philippine entity will pass an assessment on the first attempt because the group’s own credibility rides on it. This is exactly the kind of engagement Sterling is built for — we speak both to the laboratory on the bench in Metro Manila or Cebu and to the quality director on the other end of the video call, and we make the two versions of the truth agree.

One clarification that saves a lot of wasted effort: if your laboratory is a testing or calibration laboratory rather than a medical one — environmental, water, food, materials, calibration — the standard you want is ISO/IEC 17025 accreditation, not ISO 15189. ISO 15189 is specifically for medical laboratories examining materials derived from the human body for the purpose of diagnosis, patient management and clinical decision-making. If you are unsure which recognition your organisation actually needs, that is a conversation worth having before you spend a peso.

What ISO 15189:2022 requires — in plain language

ISO 15189:2022 is the current, fourth edition of the standard, titled Medical laboratories — Requirements for quality and competence. It was published in December 2022 and replaced the 2012 edition; the three-year transition window for laboratories moving off ISO 15189:2012 closed on 6 December 2025. New and maintained accreditations now run against the 2022 requirements, so any laboratory still thinking in 2012 terms is already behind.

The 2022 revision did two structurally important things. First, it re-organised the standard to mirror ISO/IEC 17025:2017 — technical and competence requirements come first, and the management-system requirements sit at the end. This makes the two laboratory-accreditation standards feel like members of one family, which matters if your organisation runs both a medical and a testing laboratory. Second, it absorbed point-of-care testing directly into the main standard. The requirements that previously lived in the separate ISO 22870 for POCT are now part of ISO 15189 itself, so the glucometer on the ward and the blood-gas analyser in the ICU fall under the same accredited system as the core laboratory.

Rather than quote clause numbers you can look up, here is what the standard actually asks of a laboratory, grouped as the 2022 edition groups it:

• General requirements — impartiality, confidentiality and the patient. The laboratory must act impartially, protect the confidentiality of patient information, and — distinctively for this standard — put patient welfare and safety at the centre. ISO 15189 is unusual among ISO standards in that the person your quality ultimately protects is the patient, not the customer, and the standard says so.
• Structural and governance requirements. There must be a competent laboratory director (or equivalent) with defined responsibility and authority for the laboratory, and a clear organisational structure. This role is not a nameplate; the director carries accountability for the quality and competence of everything the laboratory reports.
• Resource requirements. This is the competence backbone. It covers personnel (qualification, training, authorisation and ongoing competency assessment — not a one-time sign-off); facilities and environmental conditions; equipment, including maintenance, calibration and the metrological traceability of measurements back to recognised references; reagents and consumables; and externally provided products and services — including, now, point-of-care testing devices and the referral laboratories you send work to. If you cannot show your results are traceable and your people are demonstrably competent, no amount of documentation will carry you.
• Process requirements. The standard follows the specimen’s whole journey. Pre-examination: request handling, patient preparation, collection, identification, transport and sample acceptance or rejection. Examination: verification and, where needed, validation of methods; evaluation of measurement uncertainty; establishment of biological reference intervals and clinical decision limits; and quality control. Post-examination: review, reporting, the release of results, the handling of critical or alert values, and retention. The standard also requires you to manage nonconforming work and to control your data and information systems.
• Management-system requirements. Documented information, management of risk and opportunity, internal audit, management review, corrective action, continual improvement, and the machinery that keeps the technical competence in place year after year rather than just on assessment day.

Running underneath all of it is risk-based thinking — an explicit expectation, drawn from the wider ISO family, that the laboratory identifies where things can go wrong for the patient and for the result, and manages those risks rather than reacting after harm. Two practical technical anchors distinguish real ISO 15189 competence from a paperwork exercise: metrological traceability with measurement uncertainty, and participation in external quality assessment (EQA) / proficiency testing, where your results on blind samples are compared against other laboratories and against target values. Assessors look hard at both. A laboratory that cannot demonstrate traceability, cannot state the uncertainty of its measured quantities, or performs poorly in EQA will not pass on the strength of a tidy manual.

How Sterling delivers ISO 15189 — the Sterling OS approach

We run accreditation projects through Sterling OS, our operating system for building, running and evolving management and competence systems. It exists so that you buy an outcome and a way of working, not a box of templates. For a medical laboratory it maps cleanly onto the reality of accreditation, where the assessment is witnessed — assessors watch your staff actually perform examinations — so the preparation has to be technical and behavioural, not merely documentary.

Design — guided, your team implements. We architect the ISO 15189 system with you and coach your quality manager and technical staff to build it. You keep ownership and internal capability; we make sure what you build is competent and assessable. This suits laboratories with a capable quality function and the bandwidth to do the work under expert direction.

Drive — done for you, end to end. We develop, implement and manage the system for you — from gap assessment through document architecture, method-verification and measurement-uncertainty support, EQA and internal-QC discipline, competency frameworks, internal audit and the pre-assessment — right up to the accreditation assessment. This is the route for laboratories that need the result and cannot spare the internal hours, or where an overseas head office wants the Philippine entity brought to assessment-ready without draining local operations.

Sustain — after the assessment. Accreditation is not a one-off. It runs on a cycle of surveillance and reassessment, and it decays the moment attention drifts — competency records lapse, calibrations slip, EQA underperformance goes unaddressed, the corrective-action log stops moving. Sustain keeps the system alive between assessment visits so that the second and third assessments are as clean as the first.

Automate — the digital layer. We deploy Effivity and Vegam AI to carry the administrative weight of the system — documented information, competency and training records, equipment and calibration schedules, nonconformity and CAPA workflows, internal-audit management. The Effivity platform, a genuine value of around US$5,000 per year, is included with our consulting rather than sold as an extra. For a multi-discipline laboratory drowning in records, this is often the difference between a system that is maintained and one that is merely intended.

Revise — transitions and recovery. If your laboratory was accredited to the 2012 edition and let the transition lapse, or is carrying a system built to the old structure, Revise brings you onto ISO 15189:2022 cleanly. It is also how we fold in point-of-care testing that was previously managed — if at all — outside the accredited system.

Across all of these, the honest mechanism behind our confidence is simple and non-negotiable: we do not put your laboratory in front of the assessment team until it has passed our own internal audit and pre-assessment. That is why we can talk about success rather than hope. We are a consultancy — we prepare, implement and rehearse; the accreditation itself is granted by the accreditation body (PAB or another recognised body), never by us. Any consultant who tells you they can “give” you ISO 15189 accreditation is telling you something that is not true, and it is worth walking away from.

Timeline and cost drivers — realistic, and without a price tag

Two questions arrive first on every call: how long, and how much. Both deserve honest ranges rather than a marketing number.

Timeline. We do not quote day-counts, and you should distrust anyone who does — a witnessed accreditation assessment cannot be compressed to a slogan, and the schedule is partly the accreditation body’s, not the consultant’s. What we can say honestly is that timeline scales with scope and starting maturity. A focused, single-discipline laboratory with an existing DOH licence, decent records and staff already participating in EQA moves considerably faster than a large multi-discipline hospital laboratory building metrological traceability and measurement-uncertainty budgets across chemistry, haematology, microbiology, immunology, histopathology and molecular from a standing start. The genuine long poles are almost always the technical ones: getting method verification, measurement uncertainty, calibration traceability and a full EQA cycle in place — not writing the manual.

Cost drivers. The consulting corridor above is a planning guide, not a fixed quote for your laboratory. What determines the investment is a specific and predictable set of drivers:

• Scope and test menu — the number and complexity of disciplines and examinations you want inside the accreditation. Breadth is the single biggest driver.
• Number of sites and collection points — a single laboratory versus a network with satellite collection sites or multiple processing locations.
• Point-of-care testing in scope — how many POCT devices, in how many clinical areas, under whose control.
• Current maturity — an established laboratory with a working internal quality system starts far ahead of a greenfield or a laboratory whose “system” is a licence file and habit.
• Personnel competence and training gaps — how much competency framework and training has to be built from scratch.
• Equipment, calibration and traceability status — whether your metrological traceability and calibration regime already stands up, or needs building.
• EQA / proficiency-testing coverage — whether every accredited examination is covered by suitable external quality assessment.
• Whether software is used — a digitised system (Effivity) versus paper changes the maintenance burden materially.
• Choice of accreditation body — the accreditation body’s own assessment fees are separate from our consulting, and they are quoted by the body, not by us. We never mark them up.

The cleanest way to get a real number is to let us scope your laboratory. Sterling’s consulting charge for ISO 15189 depends on the drivers above; the accreditation body’s assessment charges are separate and quoted by the body for your scope. Contact us for an estimate against your actual disciplines, sites and maturity, and we will give you something you can plan against rather than a headline you cannot.

Common mistakes — where laboratories lose their first assessment

We are called in to rescue as many stalled accreditations as we are to start fresh ones, so the failure patterns are familiar. Nearly all of them come from treating ISO 15189 as a documentation exercise rather than a competence one.

• Buying a manual and mistaking it for accreditation. A purchased quality manual is not a quality system, and ISO 15189 assessment is witnessed. Assessors watch your people work and trace your results; a beautiful document set draped over an unchanged bench fools no one and wastes the assessment fee.
• Confusing the DOH licence with accreditation. They are different things with different owners. The licence is the legal permit to operate; ISO 15189 is a voluntary demonstration of quality and competence. One does not substitute for the other, and assuming your licence “basically covers it” guarantees a hard assessment.
• Underestimating metrological traceability and measurement uncertainty. This is the most common technical failure. Laboratories that have never formally established traceability chains or calculated measurement uncertainty for their measured quantities discover, late and painfully, that these are not optional and cannot be improvised the week before assessment.
• Skipping method verification and validation. Running a commercial assay off the box without documented verification — or deploying a laboratory-developed method without validation — is a finding waiting to happen.
• Weak or incomplete EQA participation. Every accredited examination needs suitable external quality assessment, and poor EQA performance that has not been investigated and corrected is a red flag assessors look for specifically.
• Treating the laboratory director role as ceremonial. The standard vests real accountability in the director. A director who cannot demonstrate active oversight of quality and competence is a structural weakness assessors will probe.
• Ignoring the pre- and post-examination phases. Laboratories over-invest in the analyser and under-invest in collection, identification, transport, sample acceptance, critical-value reporting and result release — which is precisely where most real-world error and most patient harm actually occur.
• Leaving point-of-care testing uncontrolled. Since POCT is now inside ISO 15189:2022, those ward and clinic devices are in scope. Laboratories that have never governed POCT — operator competency, QC, connectivity, device maintenance — often find it is their weakest area.
• Scope inflation. Trying to accredit every examination at once, including low-volume esoteric tests, balloons cost and timeline. A staged scope, expanded at surveillance, is usually the wiser commercial choice.
• Chasing a “fast” accreditation. The accreditation-mill promise — quick, cheap, guaranteed — collides with the reality of witnessed assessment and internationally governed assessment norms. A cut-price certificate that no referring laboratory or overseas partner respects is worse than none, because you have paid for a signal that does not signal.
• Stopping at assessment day. The system that passed will not maintain itself. Competency reviews, calibrations, EQA and corrective actions all have to keep moving, or the next surveillance visit becomes another emergency.

Why Sterling International Consulting

ISO 15189 is not the field for a generalist or a template vendor. It sits at the intersection of laboratory medicine, metrology and management systems, and it is assessed by people who do this for a living. Here is why laboratories choose us for it.

• Depth, not dabbling. Sterling International Consulting brings more than 20 years of practice and over 8,100 client engagements across 60-plus countries. Sterling works across the full laboratory and quality-standards family — ISO 15189, ISO/IEC 17025, and the wider management-system standards — so we understand where competence-based accreditation genuinely differs from a certification audit, and we build accordingly.
• Named local consultants and a Makati base. You work with real, named Philippine practitioners who come to your laboratory, not a call-centre and a document portal. Our Metro Manila presence means we can be on your bench in Manila, Cebu or beyond, and we understand the local operating reality — DOH licensing context, the domestic referral market, and the practicalities of Philippine laboratory staffing.
• The honest accreditation chain. We are unambiguous about who does what: Sterling prepares and implements; the accreditation body — PAB under the DTI, or another recognised body — assesses and grants. We do not pretend to hand out accreditations, and we do not mark up the assessment body’s fees. In a market with too many mills, that honesty is the point of the brand.
• A success mechanism you can inspect. Our confidence is not a slogan. We do not present your laboratory to the assessors until it has cleared our own internal audit and pre-assessment. The rehearsal is the reason the performance holds.
• The software is included. Effivity — a genuine value of around US$5,000 per year — comes with our consulting, giving your competency, calibration, document and CAPA records a home that survives staff turnover and makes the next surveillance visit routine.
• Counsel, not just compliance. Because we run the full standards estate, we will tell you honestly when ISO 15189 is the right recognition and when it is not, when a staged scope beats a big-bang one, and when your money is better spent shoring up traceability than adding examinations. That is the difference between a consultancy and a certificate shop.

If you already know ISO 15189 is the target, the next step is a scoping conversation; if you are still weighing it against other recognitions, that conversation is still the right place to start.

Frequently asked questions about ISO 15189 in the Philippines

Is ISO 15189 accreditation mandatory for medical laboratories in the Philippines?

No. The mandatory requirement to operate a clinical laboratory in the Philippines is a licence to operate from the Department of Health, and you should confirm your current licensing obligations directly with the DOH. ISO 15189 accreditation is voluntary and sits above that legal floor — it is a demonstration of quality and competence, not a permit. In practice, though, it is increasingly expected by referral networks, reference-lab partners, clinical-trial sponsors and overseas buyers, so “voluntary” rarely means “optional” for a laboratory that wants to compete.

Is ISO 15189 a “certification” or an “accreditation” — and does it matter?

It matters, and the correct word is accreditation. Medical laboratories are accredited to ISO 15189 by an accreditation body — in the Philippines, the Philippine Accreditation Bureau (PAB) under the DTI. This is different from certification, where a certification body issues a certificate against a management-system standard. Accreditation is a competence judgement: the assessors evaluate whether your laboratory is technically able to produce correct results, not only whether it has a documented system. Using “certified to ISO 15189” is a giveaway that a provider does not understand the standard.

What is the current version of ISO 15189?

ISO 15189:2022 — the fourth edition, published in December 2022, titled Medical laboratories — Requirements for quality and competence. It replaced ISO 15189:2012, and the three-year transition window for laboratories moving off the 2012 edition closed on 6 December 2025. All current accreditation activity runs against the 2022 requirements.

Who grants ISO 15189 accreditation in the Philippines, and does Sterling issue it?

Accreditation is granted by an accreditation body. In the Philippines that is the Philippine Accreditation Bureau (PAB) under the Department of Trade and Industry; some laboratories choose an international accreditation body instead, often to match a group standard. Sterling does not — and cannot — issue accreditation. We are a consultancy: we prepare your laboratory, build the competence and evidence, run the internal audit and pre-assessment, and take you to the assessment ready. The body assesses and grants. Anyone claiming to “provide” you the accreditation directly is misrepresenting how the system works.

How is ISO 15189 different from ISO/IEC 17025?

Both are laboratory-competence accreditation standards, and the 2022 editions share a structure, but their scopes differ. ISO 15189 is for medical laboratories — examining materials derived from the human body for diagnosis, patient management and clinical decisions — and it uniquely centres patient welfare. ISO/IEC 17025 is for testing and calibration laboratories generally — environmental, water, food, materials, calibration. If you examine human samples for clinical purposes, you want ISO 15189. If you are unsure which applies to a mixed-scope operation, talk to us before committing.

How long does ISO 15189 accreditation take?

We do not quote a day-count, and neither should anyone else — a witnessed accreditation assessment cannot be reduced to a slogan, and part of the schedule belongs to the accreditation body. Realistically, timeline scales with scope and starting maturity: a single-discipline laboratory with existing EQA participation and sound records moves faster than a multi-discipline hospital laboratory building traceability and measurement-uncertainty budgets from scratch. The technical work — method verification, measurement uncertainty, calibration traceability, a completed EQA cycle — is usually the pacing item, not the documentation.

How much does ISO 15189 accreditation cost?

There is no honest single figure, so we do not print one. Your investment is driven by scope and test menu, number of sites and collection points, whether point-of-care testing is in scope, your current maturity, personnel and training gaps, the state of your equipment calibration and traceability, EQA coverage, whether you use software, and your choice of accreditation body. Two things to know: the accreditation body’s assessment fees are separate from Sterling’s consulting and are quoted by the body — we never mark them up — and any client-side laboratory or instrument investment is your own. Contact us for an estimate scoped to your laboratory.

What are metrological traceability and measurement uncertainty, and why do assessors focus on them?

Metrological traceability means your measurements can be linked, through an unbroken chain of calibrations, back to recognised references — so a result means the same thing in your laboratory as anywhere else. Measurement uncertainty is the quantified doubt around a measured value. Together they are the technical heart of competence: they are what let a clinician rely on a number. Assessors focus on them because they cannot be faked with documentation — either your calibrations are traceable and your uncertainties are evaluated, or they are not. Building both properly is often the longest part of a project, which is why we start on it early.

Is point-of-care testing covered, and what does that mean for our wards and clinics?

Yes. Since ISO 15189:2022 absorbed the former ISO 22870 requirements, point-of-care testing performed near the patient — glucometers, blood-gas analysers, rapid devices in the ICU, ER or clinics — is part of the standard. If POCT is inside your accreditation scope, those devices and their operators come under the same system as the core laboratory: operator competency, quality control, maintenance, connectivity and result management all have to be governed. Laboratories that have historically left POCT to clinical staff often find it is the area needing the most work.

Our overseas head office (or reference-lab partner) requires ISO 15189 of our Philippine laboratory. How do you handle a group mandate?

This is a large part of what we do. We reconcile the group’s quality manual and expectations with the reality on your bench in Manila or Cebu, produce documentation and reporting in English to the corporate standard, and coordinate remotely with your head-office quality function across time zones. Where the group requires a specific international accreditation body rather than PAB, we prepare you to that body’s expectations. And because the parent’s credibility rides on a clean first assessment, we hold to the same rule as always — you do not go in front of the assessors until you have passed our internal audit and pre-assessment.

We are accredited to ISO 15189:2012 but lapsed during the transition. Can you recover it?

Yes — this is what our Revise service is for. We assess where your existing system stands against ISO 15189:2022, close the gaps created by the restructure and the incorporation of point-of-care testing, and bring you back to an accreditation-ready state on the current edition. Recovering a lapsed accreditation is usually faster than starting from nothing, because the competence is often still there and needs re-evidencing rather than rebuilding.

What happens after we are accredited?

Accreditation runs on a cycle of surveillance and reassessment, and it has to be maintained continuously — competency records, calibrations, EQA performance, internal audits and corrective actions all keep moving between visits. Our Sustain service, backed by the included Effivity platform, keeps the system live so that each surveillance and reassessment is routine rather than a fresh scramble. The laboratories that struggle are the ones that treated the first assessment as the finish line.

Is training included with Sterling’s ISO 15189 consulting?

Every Sterling engagement includes live internal auditor training for your audit team and preferential access to Sterling Academy, with complimentary ISO 15189 awareness training for your people as part of the engagement. Special pricing applies to the wider catalogue — Nonconformity Management, Documented Information Management and Risk Management — through your Sterling consultant. Learners who complete a course and its final exam receive a numbered Certificate of Completion, verifiable online, and the completion records serve as evidence for clause 6.2.

Last updated: July 2026 · Reviewed by Zia Bautista, Lead Auditor & Lead Implementer (Cebu), Sterling International Consulting.