Category: Practice & Regulations | Estimated reading time: 10 minutes
An Essential Reframing
Most clinical laboratories in Indonesia are already accredited. The good news: everything requested by ISO 15189 auditors is essentially a QA component that has been discussed in previous articles—living SOPs, scheduled calibrations, medical laboratory technologist (ATLM) training, reagent management, internal audits, and CAPA.
This is a meaningful reframing, especially for ATLMs who have previously felt that accreditation is a burden or a source of pressure, rather than a reflection of good practice.
The reality is often the opposite: laboratories panic before an audit, prepare documents in a rush, and train ATLMs to answer auditor questions in the "correct" way—not because the system is truly running well, but because the appearance of the system is good enough to pass.
This approach is not only ineffective in the long run—it is dangerous. A laboratory that "passes accreditation" but does not actually implement solid QA has lost the essence of what accreditation itself is supposed to guarantee.
The correct framing: if QA is already running well, an audit is a confirmation—not an exam.
Mapping ISO 15189 to QA Components
The following five clauses of ISO 15189 are directly related to the QA components already discussed—but it is important to understand why each clause exists, not just what it asks for.
Clause 5.3 — Laboratory Equipment
QA Implementation: Scheduled calibration & maintenance + equipment history
This clause exists because equipment performance is the foundation of all laboratory results. Equipment that is not calibrated correctly or maintained properly is a source of systematic error that will not be detected by QC—because the QC uses the same problematic equipment to evaluate itself.
ISO 15189:2022 requires that every piece of equipment has: a documented and adhered-to calibration schedule; written maintenance procedures with proof of execution; an equipment history record that logs all calibration, maintenance, repair, and technical issues; as well as clear procedures for situations where equipment malfunctions.
Auditors examining this clause do not just look at whether a calibration schedule exists—they check whether that schedule is actually followed, whether there are unexplained gaps, and whether there is a correlation between calibration issues and QC problems occurring in the same period.
Clause 5.5 — External Quality Assessment (EQA/PME)
QA Implementation: Routine EQA program → Youden Plot, SDI, Z-Score
This clause exists because Internal Quality Control (IQC/PMI) alone is not enough to detect all types of errors—especially systematic errors that occur evenly across all measurements and are not visible from internal data alone.
ISO 15189:2022 requires active participation in an accredited EQA program—and more importantly, evaluation and follow-up on the results. It is not just about participating, but understanding what the SDI, Youden Plot, and Z-Score show in the EQA report, and taking appropriate action when results indicate a problem. These tools are not merely academic concepts—they are explicitly linked to accreditation requirements, and understanding them is part of the competence expected of every ATLM in an accredited lab.
Clause 5.6 — Quality Assurance of Examination Results
QA Implementation: Daily QC + evaluation of TE vs TEa + Sigma Metric
This clause is the heart of the entire QC system. It requires the laboratory to have written procedures for: the selection and use of control materials; the establishment of control limits based on the laboratory's own data (not manufacturer ranges); the evaluation of QC data using valid statistical rules; actions taken when QC fails; and periodic evaluation of method performance—including TE vs TEa and ideally Sigma Metric.
What is often misunderstood: this clause does not just require that QC be performed—it requires that QC be effective. The effectiveness of QC can only be proven through data: documented preliminary test data, recorded monthly evaluations, and evidence that corrective actions were taken and effective when problems occurred.
Clause 5.1 — Personnel
QA Implementation: Training, competency testing, analyst competency records
This clause exists because humans are the greatest variable in any laboratory system—and also the most difficult to control automatically.
ISO 15189:2022 requires every person performing examinations to have verified competence for the specific tasks they perform: appropriate educational qualifications, specific training for each procedure, documented and periodically repeated competency testing, and complete records for every individual.
The most common audit findings in this area: training records exist, but competency testing is not documented; competency testing was done upon initial hiring but never repeated even after many years; or there are personnel running specific procedures without records that they were trained and declared competent for that procedure.
Clause 4.14 — Corrective & Preventive Actions
QA Implementation: CAPA for every QC problem or audit finding
This is the clause that most reflects the continuous improvement philosophy in ISO 15189. It requires that whenever there is a nonconformity—significant QC problems, audit findings, clinician complaints—there is a documented process to: identify root causes; take actions that address those root causes (not just the symptoms); verify the effectiveness of the actions; and document the entire process.
What distinguishes laboratories that truly internalize this clause: they use CAPA as a tool to grow—every problem is an opportunity to make the system better. Those that only meet formalities use CAPA as a document that needs to exist for an audit—created after a problem occurs, filed, and forgotten.
An Audit is Not an Exam — It is a Confirmation
"If your QA is running well—there is no need to fear an audit. The auditor is only confirming what you have already done."
This sentence is simple but contains an important philosophy. Fear of an audit is a signal that there is a gap between what should be happening and what is actually happening. A laboratory that does not fear an audit is a laboratory where the gap is very small—because its QA system runs every day, not just when an auditor is present.
This also means that preparing for accreditation should not be a sprint before an audit—it is the consequence of a marathon that is run every day. Documentation exists because it is always created. SOPs are followed because they are always followed. ATLMs are competent because they are always trained and evaluated.
Empirical evidence also supports this: a long-term study of transfusion hematology laboratories in Austria comparing the performance of ISO 9001/ISO 15189 certified labs with non-certified ones found consistently lower error rates in laboratories with an accredited quality system. This shows that accreditation, when carried out with substance (not just formality), truly correlates with a decrease in laboratory error rates.
Laboratories that reach this state not only find it easier to maintain accreditation—they also experience far fewer QC problems, fewer clinician complaints, and most importantly: they provide much more reliable results to patients.
For Laboratories That Are Not Yet Accredited
Although this discussion revolves around ISO 15189, readers working in non-accredited laboratories—such as community health centers (Puskesmas) or small clinics—can still derive very practical value from this, in line with the spirit of Minister of Health Regulation No. 43 of 2013 on Good Clinical Laboratory Practice, which establishes basic quality standards for all clinical laboratories in Indonesia, regardless of their accreditation status.
ISO 15189 clauses are essentially the formalization of known good practices—scheduled calibration, trained ATLMs, documented procedures, implemented corrective actions. All of these are not just accreditation requirements; they are fundamental quality components for any laboratory, anywhere.
The difference lies only in the level of formality and documentation expected. A small laboratory may not need a documentation system as complex as a tertiary hospital—but the same principles remain: equipment is calibrated, ATLMs are trained, and problems are resolved down to the root cause. Quality indicators covering the entire examination process—from pre-analytical, analytical, to post-analytical phases—are fundamental tools for quality and patient safety, regardless of the laboratory's accreditation status.
Conclusion
ISO 15189 is not a book of rules handed down from the sky to make life difficult for laboratories. It is a codification of the global medical laboratory community’s collective experience regarding what is necessary to consistently produce reliable results.
Every clause exists because a lesson was learned—from errors that occurred, from preventable patient safety incidents, and from research showing that certain components make a significant difference in the quality of results.
Understanding why each clause exists—not just what it demands—is the difference between running an accreditation system and understanding it. That understanding is what makes QA not a burden, but an investment.