Laboratory Quality Management System: A Guide to ISO 15189 Accreditation

ISO 15189 is the international standard for quality and competence in medical laboratories. This article explains what the standard requires, how to build a laboratory quality management system that meets those requirements, and what the accreditation process involves. The content is written for laboratory students, technicians, researchers, and diagnostic professionals who need a practical roadmap for implementation.

At a Glance

Understanding ISO 15189 and Its Place in Laboratory Accreditation

ISO 15189 is an international standard that specifies requirements for quality and competence in medical laboratories. It was developed from earlier standards including ISO 9001 for quality management systems and ISO 17025 for testing and calibration laboratories, with additional requirements specific to medical laboratory services. The standard is intended for use across all recognized disciplines of medical laboratory services, and accreditation bodies use it as the basis for recognizing laboratory competence. The Japan Accreditation Board for Conformity Assessment and the Japanese Committee for Clinical Laboratory Standards jointly developed one of the early accreditation programs based on this standard, demonstrating how national bodies can apply it in practice. See the ISO 15189 medical laboratory accreditation report for details on the standard's structure and early implementation.

The standard has two main parts. Management requirements cover the administrative and organizational aspects of laboratory operation, including quality policy, document control, and continuous improvement. Technical requirements cover the scientific and technical aspects, including personnel qualifications, facilities, equipment, examination methods, and reporting. This structure means accreditation assesses both how the laboratory is managed and how it performs its technical work.

Accreditation differs from certification. Certification typically confirms that a quality management system meets a general standard such as ISO 9001. Accreditation goes further by confirming that the laboratory is technically competent to perform specific examinations. This distinction matters for medical laboratories because clinicians depend on accurate results for patient care decisions. The ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety article explains that ISO 15189 is increasingly recognized as the most appropriate standard for medical laboratory accreditation because it addresses all steps of the total testing process, including the extra-analytical phases that other standards may not cover.

Core Principles of a Laboratory Quality Management System

A laboratory quality management system is the coordinated set of policies, processes, and procedures that guide how the laboratory operates. The World Health Organization has published a Laboratory Quality Management System Handbook that provides detailed guidance on building such a system. The handbook covers the full range of quality system essentials, from organization and personnel to equipment, purchasing, process control, and information management.

The total testing process is a central concept. It divides laboratory work into three phases. The pre-analytical phase includes test ordering, patient preparation, sample collection, transport, and sample receipt. The analytical phase includes the actual examination of samples. The post-analytical phase includes result review, interpretation, reporting, and sample storage. Each phase has its own risks and quality control requirements.

Risk-based thinking is a key principle in the current version of the standard. Instead of applying identical controls to every process, the laboratory assesses where errors are most likely to occur and where they would cause the most harm. This approach allows the laboratory to allocate resources to the highest-risk areas. The IFCC recommendations on internal quality control describe how a risk-based approach applies specifically to internal quality control practices, including the selection of control materials, control frequency, acceptable limits, and statistical rules.

Management Requirements for ISO 15189 Accreditation

Organization and Quality Policy

The laboratory must define its organizational structure, including the responsibilities of management and technical staff. A quality policy statement should commit the laboratory to good professional practice, quality of examinations, and compliance with the standard. The policy must be communicated to all staff and reviewed periodically.

Laboratory management must provide evidence of commitment to the quality management system. This includes ensuring adequate resources, establishing quality objectives, and conducting management reviews. Management reviews should evaluate the effectiveness of the quality management system and identify opportunities for improvement.

Document Control

Document control is one of the most frequently cited challenges in accreditation. The Ghana public health laboratory study identified documentation as one of the challenges that most affected the acquisition of accreditation. The laboratory must control all documents that form part of the quality management system, including policies, procedures, instructions, and forms.

A document control system must ensure that approved documents are available at points of use, that obsolete documents are removed, and that changes are reviewed and approved by authorized personnel. Each document should have a unique identifier, version number, and effective date. Records differ from documents in that records provide evidence of activities performed and cannot be changed once completed.

Nonconformity Management and Corrective Action

The laboratory must have a process for identifying and managing nonconformities. A nonconformity is any failure to meet a requirement, whether from the standard, the laboratory's own procedures, or customer expectations. The process should include documenting the nonconformity, assessing its impact, and deciding on action.

Corrective action addresses the root cause of a nonconformity to prevent recurrence. The Double Helix model of quality monitoring study analyzed nonconformities from internal and external assessments in a medical laboratory. The most frequent root causes were training deficiencies and personnel negligence, and the most common corrective action was personnel training. This finding highlights the importance of linking corrective action to actual root causes instead of applying generic solutions.

Internal Audits and Management Review

Internal audits assess whether the quality management system conforms to the standard and is effectively implemented. Audits must be planned, conducted by trained auditors who are independent of the area being audited, and followed up with corrective actions for any findings.

Management review is a formal evaluation of the quality management system by laboratory leadership. Inputs include audit results, quality indicators, complaints, nonconformities, and resource requirements. Outputs include decisions on improvement actions and resource allocation.

Technical Requirements for ISO 15189 Accreditation

Personnel Competence and Training

The laboratory must define the education, qualifications, and competence required for each position. Personnel must be trained on the procedures they perform, and their competence must be assessed before they work independently. Ongoing competence assessment is required to ensure staff maintain their skills.

The Croatian laboratory professionals survey found that only 14 percent of respondents considered themselves completely familiar with ISO 15189:2012, and 68 percent felt that accreditation increased their workload, with excessive paperwork as the main contributor. The survey also found that technical staff felt their suggestions were taken into account only occasionally. These findings suggest that laboratories should invest in education about the standard for all staff levels and should actively involve technical staff in quality system decisions.

Facilities and Environmental Conditions

Laboratory facilities must support the correct performance of examinations. This includes adequate space, appropriate lighting, ventilation, and temperature control. Environmental conditions must be monitored and recorded where they affect result quality. The Laboratory Biosafety Manual from the World Health Organization provides guidance on the biosafety considerations that laboratories must address, including facility design, containment, and safe handling of biological materials.

Equipment Management

The laboratory must have a system for selecting, acquiring, and managing equipment. Each instrument should have a unique identifier, maintenance schedule, and calibration or verification records. Equipment must be checked before use and between examinations where appropriate.

The Manhiça Health Research Centre experience in Mozambique found that most findings from accreditation audits were related to personnel management, equipment, and reagents. This pattern suggests that equipment management is a common weakness that laboratories should address early in their preparation.

Examination Method Validation and Verification

Method validation and verification are critical technical requirements. Validation is required when a laboratory introduces a method it has developed or modified. Verification is required when a laboratory implements a method that has already been validated by the manufacturer or another laboratory.

The practical guide to validation and verification of analytical methods explains the difference between validation and verification and describes appropriate statistical tests for each. Precision and bias verification are required for quantitative procedures. Method comparisons use Bland-Altman plots and Passing-Bablok regression analysis. Qualitative procedures require 2x2 contingency tables and bubble charts. Linearity studies, analytical sensitivity and specificity, carry-over studies, and reference range confirmation are also addressed.

The Bioanalytical Method Validation Guidance from the U.S. Food and Drug Administration provides additional context on method validation principles, although it is written primarily for the pharmaceutical industry instead of medical laboratories.

Internal Quality Control

Internal quality control is the ongoing monitoring of examination procedures to ensure results are reliable. The IFCC recommendations on internal quality control provide practical guidance on implementing an IQC strategy that fulfills ISO 15189:2022 requirements. Key decisions include the selection and assessment of control materials, the definition of control frequency, the definition of acceptable limits, and the application of statistical rules.

Control materials should be as similar to patient samples as possible. The matrix of the control material should match the sample type being tested. Control frequency should be based on the risk of the examination and the stability of the analytical system. Acceptable limits should be based on the quality required for clinical decision-making instead of simply on what the instrument can achieve.

The occurrence management review notes that cost-effective in-house pooled patient sera can be used for quality control in resource-limited settings. This approach can reduce costs while still providing useful quality monitoring.

External Quality Assessment

External quality assessment, also known as proficiency testing, involves testing samples provided by an external organization and comparing results with those of other laboratories. Participation in EQA is a requirement of ISO 15189. The Bugando Medical Centre experience in Tanzania showed substantial improvements in EQA performance after ISO 15189 implementation. Parasitology improved from 45 percent to 100 percent, biochemistry from 50 percent to 95 percent, and microbiology from 48.1 percent to 100 percent.

EQA performance should be reviewed systematically. Poor performance requires investigation and corrective action. Consistent good performance provides evidence of technical competence.

Measurement Uncertainty

The laboratory must estimate measurement uncertainty for quantitative examinations. Measurement uncertainty describes the range within which the true value is expected to lie. It includes components from the analytical method, the equipment, the operator, and the sample.

The ISO 15189 medical laboratory accreditation report notes that the standard requires laboratories to implement uncertainty of measurement and traceability of measurements. The ISO 15189 Accreditation article identifies verification of examination procedures for imprecision, trueness, and diagnostic accuracy and estimation of measurement uncertainty as major issues in clinical laboratory accreditation.

The Accreditation Process

Gap Analysis and Preparation

The first step toward accreditation is a gap analysis. This assessment compares current laboratory practices with the requirements of the standard and identifies areas that need improvement. The Malawi-Liverpool Wellcome Research Programme experience describes how the laboratory conducted an initial gap analysis, appointed a quality officer, and provided staff training to establish core competencies.

The Tanzania QMS study found that out of 157 laboratories implementing QMS from 2007 to 2024, 81 laboratories were accredited. The proportion of accredited laboratories was significantly higher at tertiary level compared to other levels. Laboratories accredited through direct laboratory accreditation had a higher success rate than those using the SLMTA program, although the SLMTA program showed significant improvement over time.

Documentation Development

Documentation is a major component of accreditation preparation. The laboratory must develop a quality manual, standard operating procedures, forms, and records. The Ghana study identified documentation as one of the challenges that most affected the accreditation process, along with laboratory safety measures, management support, and reagent unavailability.

Documentation should be practical and used in daily work. Documents that exist only to satisfy auditors but are not followed in practice create risk instead of reducing it. The Croatian survey found that better process documentation was the main advantage of accreditation reported by staff, suggesting that well-designed documentation improves laboratory operations.

Application and Assessment

The laboratory applies to an accreditation body for assessment. The accreditation body reviews the application and documentation, then conducts an on-site assessment. The assessment team examines the laboratory's facilities, interviews staff, observes procedures, and reviews records.

The Manhiça experience describes a timeline where the accreditation process started in 2012 with a pre-assessment, application was made in 2014, and two audits were conducted in 2018 and 2019. Accreditation was obtained in 2020. This timeline illustrates that accreditation is a multi-year process requiring sustained commitment.

Addressing Findings and Achieving Accreditation

Assessment findings are classified as nonconformities or observations. The laboratory must address nonconformities with corrective actions and provide evidence that the actions are effective. Once all findings are resolved, the accreditation body grants accreditation for a defined scope of examinations.

Accreditation is not permanent. Laboratories must undergo periodic surveillance assessments and re-assessment to maintain accreditation. The Malawi-Liverpool experience emphasizes that ongoing periodic assessments are necessary to sustain the quality management system.

Point-of-Care Testing and ISO 15189

Point-of-care testing presents special challenges for accreditation. The POCT Accreditation ISO 15189 and ISO 22870 article explains that ISO 22870 specifies requirements for the quality and competence of point-of-care testing, intended for use in conjunction with ISO 15189. POCT characteristics include the availability of a large number of devices 24 hours per day, a variety of analytical methods, clinical settings inside and outside the hospital, and general non-laboratory staff operating the devices.

The article describes the experience of La Paz University Hospital, which has a complex multitest and multisite POCT network accredited since 2017. The crucial areas for POCT accreditation were method performance verification, internal and external quality assurance, staff training and competency, and continuous improvement. Laboratory medicine is charged with leading and coordinating POCT through a multidisciplinary committee.

Laboratory-Developed Tests and Regulatory Context

Laboratories sometimes develop their own tests when suitable commercial devices are not available. The ISO 15189 and laboratory-developed tests article discusses how ISO 15189 can cover requirements of the European In-Vitro Diagnostics Regulation for laboratory-developed tests for in-house use. These tests serve specific clinical needs, often for low-volume niche applications or the translational phase of new tests and treatments.

The article notes that documentary obligations, performance and safety specifications, and development and manufacture under an ISO 15189-equivalent quality system apply to laboratory-developed tests. The workload depends on which modifications to commercial tests turn them into laboratory-developed tests and on how national legislators handle new responsibilities.

Quality Indicators and Continuous Improvement

Quality indicators are measurable elements of laboratory performance that are used to monitor and improve quality. The ISO 15189 Accreditation article identifies quality indicators as a fundamental requirement of the standard. The Bugando Medical Centre experience provides examples of quality indicators in practice. Complaints were reduced from eight to two per week. Rejected samples were reduced from 7.2 percent to 1.2 percent. Turnaround time reached 92 percent of defined targets. Blood culture contamination decreased from 16 percent to 4 percent.

Quality indicators should cover all phases of the total testing process. Pre-analytical indicators might include sample rejection rate, labeling errors, and transport time. Analytical indicators might include internal quality control failure rate and external quality assessment performance. Post-analytical indicators might include turnaround time, critical result notification, and report correction rate.

The occurrence management review notes that laboratory errors are highly asymmetric, with up to 68.2 percent concentrated in the pre-analytical phase. Primary failure points include human-system interface lapses, manual transcription workflows, and cold-chain failures during power outages. This finding supports the emphasis on pre-analytical quality control in ISO 15189.

Common Failure Patterns in Accreditation Preparation

Documentation Without Implementation

A common failure is creating documents that do not reflect actual laboratory practice. Staff may follow verbal instructions instead of written procedures, or procedures may describe an ideal process that differs from what is done daily. Accreditation assessors detect this discrepancy during observations and staff interviews.

The solution is to involve the staff who perform the work in writing the procedures. Procedures should be tested against actual practice and revised when they do not match. The Croatian survey found that 89 percent of responders completely follow the prescribed protocols, suggesting that staff generally follow written procedures when they are clear and practical.

Training Without Competence Assessment

Another common failure is providing training but not verifying that staff can perform the procedure correctly. Training records show attendance at sessions, but competence assessment requires direct observation of performance, review of results, and monitoring of quality indicators.

The Ecuador study addresses unique training and compliance with ISO 15189 technical requirements in hospital clinical laboratories. The Croatian survey found that only 41 percent of responders considered competence assessment efficient, suggesting that many laboratories need to improve their competence assessment methods.

Equipment and Reagent Management Gaps

The Manhiça experience found that most audit findings were related to personnel management, equipment, and reagents. The Ghana study identified reagent unavailability as a major challenge. Equipment and reagent problems can cause result delays, quality failures, and patient safety risks.

Laboratories should establish preventive maintenance schedules, maintain inventory records, and verify reagent performance before use. Cold-chain management is critical for reagents that require temperature control. The occurrence management review identifies cold-chain failures during power outages as a primary failure point in resource-limited settings.

Inadequate Root Cause Analysis

When nonconformities occur, laboratories sometimes apply quick fixes without identifying the underlying cause. The Double Helix study found that training deficiencies were the most frequent root cause in external assessments, and personnel training was the most frequently implemented corrective action. However, if training is applied without addressing why the original training was inadequate, the nonconformity will recur.

Effective root cause analysis uses tools such as the five whys, fishbone diagrams, and process mapping. The analysis should examine contributing factors in the system, beyond individual errors. The occurrence management review recommends non-punitive just culture reporting policies to encourage incident reporting and error capture.

Safety and Regulatory Context

Laboratory safety is an integral part of the quality management system. The Laboratory Biosafety Manual from the World Health Organization provides guidance on biosafety practices, including risk assessment, containment principles, and safe handling of biological materials. The Ghana study identified laboratory safety measures as one of the challenges that most affected accreditation acquisition.

The ISO/IEC 15189 Implementation in Microbiology Laboratory article notes that a microbiology laboratory should be a safe and efficient environment. The standard is based on good laboratory practices and is oriented to support accurate clinical decisions. Trained and well-motivated laboratory staff are necessary to implement the system.

The Assay Guidance Manual from the National Center for Advancing Translational Sciences provides additional context on assay development and quality considerations that are relevant to laboratory-developed tests and method validation.

Professional Escalation Criteria

Laboratory professionals should escalate concerns when they identify conditions that could compromise result quality or patient safety. Escalation is appropriate when internal quality control fails repeatedly, when external quality assessment results indicate poor performance, when equipment malfunctions cannot be resolved, when staffing shortages affect the ability to perform examinations correctly, and when safety hazards cannot be controlled.

The IFCC recommendations describe strategies for handling nonconformities in internal quality control, including the identification of risks, mitigation through corrective actions, and implementation of improvements to prevent errors. When a nonconformity affects patient results, the laboratory must assess the impact, notify affected clinicians, and consider whether results need to be corrected or recalled.

Practical Implementation Steps

Step 1: Secure Management Commitment

Accreditation requires sustained commitment from laboratory leadership and the parent organization. The Ghana study identified laboratory management support as a critical factor. Management must allocate resources for training, documentation, equipment, and quality activities. The Tanzania QMS study recommends national strategic direction for laboratory accreditation and hospital and laboratory management support for the accreditation acquisition and maintenance processes.

Step 2: Conduct a Gap Analysis

Compare current practices with the requirements of the standard. Use a structured checklist that covers all management and technical requirements. Document the gaps and prioritize them based on risk and effort. The Malawi-Liverpool experience describes conducting an initial gap analysis as a key step in the implementation process.

Step 3: Appoint a Quality Officer

A dedicated quality officer is essential to oversee the implementation process. The Malawi-Liverpool experience describes appointing a quality officer supported by leadership engagement and staff training. The quality officer coordinates documentation development, training, internal audits, and corrective actions.

Step 4: Develop Documentation

Create the quality manual, standard operating procedures, forms, and records required by the standard. Involve technical staff in writing procedures for their areas. Review and approve documents through a formal process. The ISO 15189:2012 implementation checklists article provides a comparative analysis of checklists used by accreditation bodies, which can help laboratories understand what assessors will examine.

Step 5: Implement and Train

Train all staff on the quality management system and their specific procedures. Assess competence before staff work independently. The Ecuador study addresses unique training approaches for ISO 15189 technical requirements. The Croatian survey suggests that further efforts are needed in providing better education about ISO 15189 for technical staff.

Step 6: Establish Quality Monitoring

Implement internal quality control, enroll in external quality assessment programs, and establish quality indicators. The IFCC recommendations provide guidance on implementing and monitoring an IQC strategy. Quality indicators should cover all phases of the total testing process.

Step 7: Conduct Internal Audits

Train internal auditors and conduct audits of all areas of the laboratory. Document findings and track corrective actions. The Double Helix study analyzed nonconformities from internal and external assessments and found that internal assessments identified examination processes, personnel management, and document and record control as the top nonconformity categories.

Step 8: Apply for Accreditation

Select an accreditation body and submit the application. Prepare for the on-site assessment by reviewing all documentation, verifying that records are complete, and ensuring that staff are prepared for interviews. The Mexican experience provides an example of medical laboratory accreditation according to an earlier version of the standard.

Records and Measurements

Accreditation requires evidence that the quality management system is working. The laboratory must maintain records of personnel qualifications and training, equipment maintenance and calibration, internal quality control results, external quality assessment results, nonconformities and corrective actions, internal audits, management reviews, complaints, and quality indicators.

Records must be legible, complete, and retrievable. Electronic records require controls to ensure data integrity, including access controls, audit trails, and backup systems. The digital specimen tracking study notes that persistent paper-digital handoffs and heterogeneous IT landscapes can undermine data integrity in anatomic pathology.

The Malawi-Liverpool experience describes establishing quality indicators to monitor performance and participating in proficiency testing and internal quality control programs. The Bugando Medical Centre experience provides concrete examples of quality indicator measurements before and after implementation.

Limitations and Considerations

Accreditation does not guarantee perfect results. It provides assurance that the laboratory has a functioning quality management system and the technical competence to perform its accredited examinations. Laboratories must maintain the system through ongoing monitoring, audits, and improvement activities.

The ISO 15189 Accreditation article notes that the number of accredited laboratories varies largely between European countries and that major differences affect the approaches to accreditation promoted by national bodies. Some national accreditation bodies use fixed scopes while others promote flexible scopes. Laboratories should understand the approach used by their accreditation body.

The Ghana study found no difference in challenges identified between persons who worked in the laboratory before or after accreditation. This finding suggests that the challenges of maintaining accreditation are similar to those of achieving it. The study recommends sufficient technical assistance in the form of training and mentorship.

The Croatian survey found that 73 percent of responders prefer an online audit in times of COVID-19. This finding suggests that remote assessment methods may become more common, although on-site assessment remains the standard approach for most accreditation bodies.

Frequently Asked Questions

What is the difference between ISO 15189 and ISO 17025?

ISO 15189 is specific to medical laboratories and includes requirements for the total testing process, including pre-analytical and post-analytical phases. ISO 17025 is a general standard for testing and calibration laboratories. The ISO 15189 Accreditation article notes that ISO 15189 is increasingly recognized as the most appropriate standard for medical laboratory accreditation because it addresses all steps of the total testing process and focuses on technical competence in addition to quality systems.

How long does the ISO 15189 accreditation process take?

The timeline varies depending on the laboratory's starting point and resources. The Manhiça experience describes a process that started in 2012 with a pre-assessment and achieved accreditation in 2020. The Tanzania QMS study describes a seventeen-year national program from 2007 to 2024. Laboratories should plan for a multi-year process with sustained commitment.

What are the most common nonconformities found during ISO 15189 assessments?

The Double Helix study found that examination processes, document and record control, and personnel management were the top nonconformity categories in both internal and external assessments. Training deficiencies were the most frequent root cause. The Manhiça experience found that most audit findings were related to personnel management, equipment, and reagents.

How does ISO 15189 apply to point-of-care testing?

ISO 22870 specifies requirements for point-of-care testing and is intended for use in conjunction with ISO 15189. The POCT Accreditation article explains that crucial areas for POCT accreditation include method performance verification, internal and external quality assurance, staff training and competency, and continuous improvement. Laboratory medicine is charged with leading and coordinating POCT through a multidisciplinary committee.

What is the difference between method validation and method verification?

Validation is required when a laboratory introduces a method it has developed or modified. Verification is required when a laboratory implements a method that has already been validated by the manufacturer or another laboratory. The practical guide to validation and verification explains when to validate, when to verify, and which statistical tests are appropriate for each.

How should a laboratory handle internal quality control failures?

The IFCC recommendations describe strategies for handling nonconformities in internal quality control, including the identification of risks, mitigation through corrective actions, and implementation of improvements to prevent errors. When quality control fails, the laboratory must stop reporting patient results, investigate the cause, and take corrective action before resuming testing.

What is the role of external quality assessment in ISO 15189 accreditation?

External quality assessment, also known as proficiency testing, is a requirement of ISO 15189. The laboratory must participate in EQA programs appropriate to its scope of examinations. The Bugando Medical Centre experience showed substantial improvements in EQA performance after ISO 15189 implementation, demonstrating the value of the quality management system in improving technical competence.

How does ISO 15189 address laboratory-developed tests?

The ISO 15189 and laboratory-developed tests article discusses how ISO 15189 can cover requirements of the European In-Vitro Diagnostics Regulation for laboratory-developed tests for in-house use. Documentary obligations, performance and safety specifications, and development and manufacture under an ISO 15189-equivalent quality system apply to these tests.

Related Diagnostic Guides

• Quality Laboratory: Implementing a Quality Management System in Academic Research Labs
• Pre-Run Laboratory Checklist: Reagents, Instruments, Controls, and Documentation
• Quality Control in the Microbiology Laboratory: Key Practices for Reliable Results
• Laboratory Equipment Calibration: A Comprehensive Management Guide
• Calibration Laboratory Accreditation: What It Means and Why It Matters

References and Further Reading

• Laboratory Quality Management System Handbook. World Health Organization.
• Laboratory Biosafety Manual. World Health Organization.
• Assay Guidance Manual. National Center for Advancing Translational Sciences.
• Bioanalytical Method Validation Guidance. U.S. Food and Drug Administration.
• NCBI Literature Resources. National Center for Biotechnology Information.
• POCT Accreditation ISO 15189 and ISO 22870: Making the Point.. EJIFCC, 2021.
• Ensuring internal quality control practices in medical Laboratories: IFCC recommendations for practical applications based on ISO 15189:2022.. Clinica chimica acta, international journal of clinical chemistry, 2025.
• ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety.. Journal of medical biochemistry, 2017.
• Challenges with the pursuit of ISO 15189 accreditation in a public health laboratory in Ghana.. African journal of laboratory medicine, 2022.
• A practical guide to validation and verification of analytical methods in the clinical laboratory.. Advances in clinical chemistry, 2019.
• ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European In-Vitro-Diagnostics Regulation.. Clinical chemistry and laboratory medicine, 2023.
• [ISO 15189 medical laboratory accreditation].. Rinsho byori. The Japanese journal of clinical pathology, 2004.
• Laboratory professionals' attitudes towards ISO 15189:2012 accreditation: an anonymous survey of three Croatian accredited medical laboratories.. Biochemia medica, 2021.
• Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory - Mwanza, Tanzania.. 2018.
• The road map for ISO 15189-laboratory accreditation: The Experience of Manhiça Health Research Centre (CISM) laboratory, in southern Mozambique.. 2026.
• Implementing and Transitioning a Laboratory Quality Management System from ISO 15189:2012 to ISO 15189:2022: Experience from the Malawi-Liverpool Wellcome Research Programme, Blantyre.. 2026.
• The Quality Management System in Medical Laboratories: Seventeen Years of Strengthening Laboratory Management Towards ISO 15189 Accreditation in Tanzania. 2026.
• Strategies for effective occurrence Management in Resource-Limited Clinical Laboratories: Challenges and practical solutions.. 2026.
• Implementing and Transitioning a Laboratory Quality Management System from ISO 15189:2012 to ISO 15189:2022: Experience from the Malawi-Liverpool Wellcome Research Programme, Blantyre. 2026.
• Digital Specimen Tracking- and ISO 15189-Oriented Risk Management in Anatomic Pathology: A Qualitative Study of Expert Perspectives in Western Austria. Diagnostics, 2026.
• ISO/IEC 15189 Implementation in Microbiology Laboratory - General Concepts. 2020 IEEE International Workshop on Metrology for Industry 4.0 & IoT, 2020.
• ISO 15189: 2012 implementation : an applied guide for medical laboratories. 2013.
• Medical laboratories - Guidance on laboratory implementation of ISO 15189:2003. 2005.
• The ‘Double Helix’ model of quality monitoring: Risk mapping of quality management system during initial ISO 15189 Implementation in a medical laboratory. PLoS ONE, 2026.
• ISO 15189-accredited laboratories fulfill the JCI Hospital Accreditation Standard requirements for the use of referral laboratories: report of a consensus meeting. Accreditation and Quality Assurance, 2016.
• Unique training and compliance with ISO 15189 technical requirements in hospital clinical laboratories in Ecuador. Hacia La Promocion De La Salud, 2025.
• ISO 15189:2012 implementation checklists for conformity assessment by accreditation bodies: A comparative analysis. New Zealand Journal of Medical Laboratory Science, 2017.
• Medical laboratory accreditation according to ISO 15189:2003. The Mexican experience. Biochemia Medica, 2007.
• Conformity Evaluation of Afinion 2 Analyzer Maintainability: Compliance Practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation. Acta Medica Philippina, 2023.
• Requirements for quality and competence according to EN ISO 15189 for medical virological laboratory diagnostics. A field report. Laboratoriumsmedizin, 2007.

This article is educational and does not replace validated laboratory procedures, institutional biosafety review, manufacturer instructions, or professional interpretation.