Short answer: A laboratory quality management system is the coordinated set of policies, processes, records and responsibilities a laboratory uses to direct and control quality. Most laboratories build one around the 12 quality system essentials and map it to ISO 15189:2022, which typically takes 9 to 18 months.
- The 12 quality system essentials give you a complete checklist of what a QMS must cover.
- ISO 15189:2022 groups requirements into governance, resources, processes and the management system.
- Write procedures that describe what you actually do, then improve the practice.
- Assessors look for evidence that the system runs, not just for documents.
What is a laboratory quality management system?
A laboratory quality management system (QMS) is the coordinated set of activities, documents and responsibilities that a laboratory uses to direct and control its work so that every result is accurate, reliable and timely.
It covers far more than quality control on the analyser. A QMS governs how samples are requested, collected and transported, how staff are trained and assessed, how equipment is maintained, how errors are recorded and corrected, and how results reach the clinician. Laboratory results feed into a large share of clinical decisions, so a failure anywhere in that chain reaches the patient.
The model most widely used in Africa comes from the WHO and CLSI, described in the WHO Laboratory Quality Management System handbook. It organises everything into 12 quality system essentials that apply to every phase of testing.
What are the 12 quality system essentials?
The 12 quality system essentials are organisation, personnel, equipment, purchasing and inventory, process control, information management, documents and records, occurrence management, assessment, process improvement, customer service, and facilities and safety.
Each essential is a building block. If one is missing, the others cannot fully compensate. The table shows what each covers and the evidence an assessor will typically ask to see.
| Quality system essential | What it covers | Evidence an assessor will look for |
|---|---|---|
| Organisation | Leadership commitment, structure, quality policy, objectives, roles and authority | Organogram, signed quality policy, job descriptions, named quality manager, quality objectives with targets |
| Personnel | Recruitment, orientation, training, competency assessment, continuing education | Personnel files, training records, competency assessments for each examination, CPD evidence, current practice licences |
| Equipment | Selection, installation, calibration, maintenance, repair and retirement | Equipment inventory, calibration certificates, maintenance logs, service records, out-of-use labels |
| Purchasing and inventory | Supplier evaluation, ordering, receiving, storage and stock control | Approved supplier list, stock cards, receipt and acceptance checks, lot verification records, expiry monitoring |
| Process control | Pre-examination, examination and post-examination processes, method verification, QC and EQA | Sample acceptance criteria, verification reports, QC charts and rules, EQA results and reviews |
| Information management | Patient data, request forms, reports, LIS, confidentiality and data integrity | LIS validation, access controls, report templates, backup records, confidentiality agreements |
| Documents and records | Creating, approving, issuing, reviewing and archiving documents; retaining records | Master document list, version control, review dates, retention schedule, controlled copies at the bench |
| Occurrence management | Detecting, recording and investigating errors, near misses and nonconformities | Occurrence log, root cause analyses, corrective action records, trend reviews |
| Assessment | Internal audits, external assessments, EQA and quality indicators | Audit programme, audit reports, quality indicator data, follow-up of findings |
| Process improvement | Using data to improve, corrective and preventive action, PDCA cycles | Improvement projects, CAPA effectiveness checks, management review decisions |
| Customer service | Understanding and meeting the needs of patients and clinicians, complaints and advice | Satisfaction surveys, complaint register, turnaround time monitoring, user handbook |
| Facilities and safety | Workspace, environmental conditions, biosafety, waste and emergency preparedness | Risk assessments, temperature logs, safety training, spill kits, waste segregation records |
How does the QMS map to ISO 15189:2022?
The 12 essentials cover the same ground as ISO 15189:2022, but the standard organises its requirements differently, into general, structural and governance, resource, process and management system requirements.
At a high level, ISO 15189:2022 is organised into five requirement clauses:
- Clause 4, general requirements: impartiality, confidentiality and requirements regarding patients. This links to organisation and customer service.
- Clause 5, structural and governance requirements: legal entity, laboratory director, laboratory activities, structure and authority, objectives and policies, and risk management. This maps mainly to organisation.
- Clause 6, resource requirements: personnel, facilities and environmental conditions, equipment, calibration and metrological traceability, reagents and consumables, service agreements and externally provided products and services. This maps to personnel, equipment, purchasing and inventory, and facilities and safety.
- Clause 7, process requirements: pre-examination, examination and post-examination processes, ensuring the validity of results, nonconforming work, control of data and information management, complaints, and continuity and emergency preparedness. This maps to process control, information management, occurrence management and customer service.
- Clause 8, management system requirements: documentation, control of documents and records, actions to address risks and opportunities, improvement, nonconformities and corrective action, evaluations including internal audit, and management review. This maps to documents and records, assessment and process improvement.
The older idea of “management requirements” versus “technical requirements” from the 2012 edition no longer fits neatly. In practice, build with the 12 essentials and then cross-check every clause of the 2022 standard so nothing is missed. The 2022 edition also brings point-of-care testing requirements into ISO 15189, so include POCT in your design if your laboratory oversees it.
How do you build a laboratory QMS step by step?
You build a laboratory QMS in six phases: secure commitment, assess gaps, design and document, implement and train, monitor and audit, then review and improve. Most laboratories need 9 to 18 months, depending on size, scope and starting point.
- Phase 1: Commitment and leadership (month 1). Management agrees the scope, appoints a quality manager with protected time and authority, and signs the quality policy.
- Phase 2: Gap assessment (months 1 to 2). Your team compares current practice with the 12 essentials and ISO 15189:2022, using the standard or the ASLM SLIPTA checklist, and turns the gaps into a prioritised action plan.
- Phase 3: Design and documentation (months 2 to 6). Write the quality policy, objectives, procedures, work instructions and forms. Set up document control first, so everything you write afterwards is controlled.
- Phase 4: Implementation and training (months 4 to 12). Train staff on the new procedures, assess competency, start the occurrence log, verify methods, and run QC and EQA with documented review.
- Phase 5: Monitoring and internal audit (months 9 to 15). Track quality indicators, run a full internal audit with trained auditors (a mock audit is useful here), and close findings with root cause analysis.
- Phase 6: Management review and improvement (months 12 to 18). Hold a formal management review using real data, set new objectives and decide whether you are ready to apply for accreditation.
Phases overlap, and the timeline varies. A laboratory with existing SOPs and EQA can move faster; one with high staff turnover may need longer. For the accreditation steps that follow, read our ISO 15189 accreditation process roadmap.
What mistakes should you avoid when building a QMS?
The most common mistake is building a QMS on paper that does not match daily practice, which assessors detect quickly by talking to bench staff.
- Copying SOPs from another laboratory. Borrowed documents describe other equipment and other workflows. Use templates for structure, but write the content yourself.
- Weak corrective action. “Staff retrained” is not a root cause. Use structured root cause analysis and check that the action worked.
- Poor document control. Uncontrolled photocopies and outdated versions at the bench are among the easiest findings for an assessor to raise.
- Confusing training with competency. Attendance proves someone was in the room. Competency assessment proves they can do the task.
- Ignoring the pre- and post-examination phases. Most laboratory errors arise in sample collection, labelling, transport and reporting, not inside the analyser.
- Skipping management review. Without it, nobody with authority acts on what audits and indicators reveal.
- Leaving it all to one person. A QMS that depends on the quality manager alone will not survive their leave or departure.
Which documents does a laboratory QMS need?
ISO 15189:2022 no longer explicitly requires a document titled quality manual, but you still need documented policies and procedures that cover every requirement and are controlled, current and available to staff.
Many laboratories keep a quality manual anyway because it gives assessors and new staff a single overview. Whatever you call it, the typical document set includes:
- Quality policy and measurable quality objectives
- Organisational chart, job descriptions and authorisations
- Procedures for document control, records, occurrence management, corrective action, internal audit, management review, complaints and risk management
- Examination procedures (SOPs) for every test in scope, plus pre- and post-examination procedures
- Equipment, calibration, maintenance and QC procedures
- A user handbook or sample collection manual for clinicians and phlebotomists
- Records: training and competency, QC and EQA, verification reports, maintenance logs, audit reports and management review minutes
Is your laboratory ready for an accreditation assessment?
Your laboratory is ready when the system has run long enough to produce records, a full internal audit and a management review are complete, and staff can explain their procedures without notes.
| Readiness check | Ready when |
|---|---|
| Document control | Every document at the bench is current, approved and on the master list |
| Records | At least three to six months of QC, EQA, maintenance and occurrence records exist |
| Competency | Every person has a documented competency assessment for each examination they perform |
| Method verification | Verification or validation reports exist for every examination in scope, including measurement uncertainty |
| EQA | Results are reviewed and unacceptable results have documented investigations |
| Internal audit | A full audit covering all clauses is complete and findings are closed |
| Management review | Minutes show data reviewed, decisions made and actions assigned |
| Staff interviews | Bench staff can describe what they do and where the procedure is |
What training does your team need to build and run a QMS?
Your quality lead needs in-depth QMS training, your internal auditors need audit training, and everyone who handles errors needs to know how to record and investigate them.
Elmenta’s 5-day Establishing and Maintaining a Laboratory QMS course works through all 12 quality system essentials. Quality managers leading accreditation also take the ISO 15189:2022 Lead Implementer course, internal auditors take ISO 15189:2022 Internal Audit Training, and supervisors who handle nonconformities benefit from Laboratory Occurrence Management. Courses run every quarter, in person in Nairobi and live online, can be delivered in-house for a whole team, and include the first month of Elmenta Lab Pro mentorship free. Participants receive a certificate of completion. See the training calendar for dates, and our guide to choosing training for your lab team if you are planning for several people.
Building your QMS from the ground up? The 5-day QMS course takes your quality team through every essential, with a focus on applying each one in your own laboratory.
Explore the Establishing and Maintaining a Laboratory QMS course
Frequently asked questions
Who should be the quality manager in a medical laboratory?
The quality manager should be a senior, respected member of staff with good knowledge of laboratory work, trained in ISO 15189 and the quality system essentials, and given protected time and direct access to laboratory management. In small laboratories the role may be combined with other duties, but responsibilities and authority must be written down and the person must have time to do the work.
Can we use QMS software instead of paper records?
Yes. ISO 15189:2022 does not require paper. Electronic document control, training records and occurrence logs are acceptable if the system is validated for its intended use, access is controlled, changes are traceable and records are backed up. Many laboratories start on paper or shared drives and move to software once their processes are stable.
How often should a laboratory do internal audits?
ISO 15189:2022 requires internal audits at planned intervals, and most laboratories cover the whole management system and all examination areas at least once a year, often split into smaller audits through the year. Areas with recent problems, new methods or high risk should be audited more often. Check your accreditation body's guidance on expectations.
What are quality indicators in a laboratory?
Quality indicators are measures the laboratory tracks to monitor performance across the testing process, such as sample rejection rate, turnaround time, EQA performance, critical result notification times, and complaint numbers. ISO 15189:2022 expects you to select indicators, set targets, review them regularly and act on trends, usually as part of management review.
Is a QMS only needed if we want accreditation?
No. A QMS improves the reliability of results and patient safety whether or not you apply for accreditation. Many laboratories build their QMS first for internal improvement or for SLIPTA, then pursue ISO 15189 accreditation once the system is stable. Regulators and clients increasingly expect evidence of a working quality system regardless.
