Laboratory Quality Management Systems: Key Components and Implementation Strategies

A laboratory quality management system (QMS) is the coordinated set of policies, processes, and procedures that governs how a diagnostic laboratory plans, performs, monitors, and improves its testing services. For laboratory managers, students, technicians, and diagnostic professionals, the QMS is the operational backbone that connects every step from sample collection to result reporting. This article explains the core components of a QMS under ISO 15189 and CLIA frameworks, provides a phased implementation roadmap, and includes a gap analysis template you can adapt to your laboratory's scope and resources.

What a Quality Management System Does in a Diagnostic Laboratory

A QMS transforms laboratory work from isolated technical tasks into a managed system where every action is documented, every process is verified, and every result is traceable. The World Health Organization's Laboratory Quality Management System Handbook describes the QMS as the framework that addresses all aspects of laboratory operations, including organization, personnel, equipment, purchasing and inventory, process control, information management, documents and records, occurrence management, assessment, process improvement, customer service, and facilities and safety. The handbook serves as a practical reference for laboratories at any stage of QMS development, from those just beginning to those preparing for accreditation.

The central purpose of a QMS is to ensure that laboratory results are reliable, reproducible, and fit for their intended clinical use. This requires more than purchasing good instruments or hiring skilled staff. It requires a system that catches errors before they reach the patient, that documents corrective actions when errors occur, and that continuously evaluates whether the laboratory is meeting its quality objectives.

For clinical laboratories, the most relevant international standard is ISO 15189. This standard is specifically designed for medical laboratories and recognizes the importance of all steps of the total testing process, including the extra-analytical phases before and after the actual measurement. According to a 2017 review in the Journal of Medical Biochemistry, ISO 15189 is increasingly recognized as the most appropriate standard for accreditation of medical laboratories because it addresses technical competence in addition to quality systems and focuses on customer needs. The review notes that while some countries still use ISO 9001 for quality systems or ISO 17025 for testing laboratories, only ISO 15189 covers the complete testing pathway.

In the United States, the Clinical Laboratory Improvement Amendments (CLIA) establish federal regulatory requirements for all clinical laboratories that test human specimens. CLIA focuses on certification and compliance, while ISO 15189 accreditation is voluntary but demonstrates a higher level of quality management and technical competence. Many laboratories pursue both, using CLIA as the regulatory baseline and ISO 15189 as the quality excellence framework.

At a Glance: QMS Components and Implementation Overview

Core Components of a Laboratory QMS

Organization and Personnel

The organizational structure of a laboratory must define who is responsible for what, how authority flows, and how accountability is maintained. ISO 15189 requires the laboratory to have a quality manager who oversees the QMS and a technical manager who oversees the scientific and technical operations. In smaller laboratories, one person may hold both roles, but the responsibilities must be clearly documented.

Personnel management includes defining job descriptions, establishing qualification requirements, and verifying that each staff member has the education, training, and experience needed for their assigned tasks. Training must be documented and assessed, not simply completed. Competency assessments should be performed at defined intervals and after any change in duties or procedures.

The experience of the Malawi-Liverpool Wellcome Research Programme demonstrates that appointing a dedicated quality officer, supported by leadership engagement and staff training, is a critical early step in QMS implementation. Their transition from ISO 15189:2012 to ISO 15189:2022 involved a second gap analysis that emphasized risk-based thinking and alignment with patient-centered requirements.

Documents and Records

Document control ensures that only current, approved versions of procedures are available at the point of use. Every document must have a unique identifier, a version number, an effective date, and an approval signature. Obsolete documents must be removed from circulation and archived according to the laboratory's retention policy.

Records are different from documents. Documents tell staff what to do, while records provide evidence of what was done. Records include test results, quality control data, maintenance logs, training files, and complaint investigations. The ISO 15189:2003 requirements, as discussed in Clinical Chemistry and Laboratory Medicine, stress the importance of evidence, document control, and control of records and clinical material. The standard requires that records be legible, retrievable, and stored under conditions that protect them from damage, loss, or unauthorized access.

Process Control: Pre-analytical, Analytical, and Post-analytical

The total testing process is divided into three phases, and each phase has distinct quality risks. A study from Ehime University Hospital Clinical Laboratory found that when the incongruent rate was assessed in each inspection process under the QMS, the process before the inspection accounted for 47 percent of the total. This finding highlights that pre-analytical processes, including sample extraction, inspection, reception, and processing, require particular management attention.

Pre-analytical quality controls include patient preparation instructions, specimen collection procedures, transport conditions, and sample acceptance and rejection criteria. The laboratory must define what constitutes an unacceptable sample and document the actions taken when such samples are received.

Analytical quality controls include internal quality control (IQC) materials run with each batch of patient samples, method verification before a new test is introduced, and participation in external quality assessment (EQA) or proficiency testing programs. The Assay Guidance Manual from the National Center for Advancing Translational Sciences provides detailed guidance on assay development and validation, including considerations for accuracy, precision, sensitivity, and specificity that apply to laboratory-developed tests.

Post-analytical quality controls include result review, reference interval verification, result reporting, and sample retention. According to a 2021 article in Advances in Laboratory Medicine, ISO 15189:2012 requires laboratories to define and document the duration and conditions of sample retention and to design an internal quality control scheme to verify whether post-analytical activities attain expected standards. The standard also requires a contingency plan to ensure communication of laboratory results if the primary reporting system fails.

Equipment and Information Management

Equipment management covers selection, installation, calibration, maintenance, and decommissioning of all instruments used in the testing process. Each instrument must have a maintenance schedule based on manufacturer recommendations and usage patterns. Calibration must be traceable to reference standards, and calibration records must be maintained.

Laboratory information management includes the laboratory information system (LIS), data entry and retrieval, result reporting, and data security. ISO 15189 requires laboratories to design a contingency plan for communicating results when the LIS is unavailable. The standard also addresses the correct use of accreditation labels in laboratory reports, which is a post-analytical requirement that affects how results are presented to clinicians.

Occurrence Management and Continual Improvement

Occurrence management covers the identification, documentation, investigation, and resolution of non-conformities. A non-conformity is any failure to meet a requirement, whether that requirement comes from the standard, the laboratory's own procedures, or a customer's expectations. Each non-conformity must be investigated to determine its root cause, and corrective actions must be implemented to prevent recurrence.

Preventive actions address potential problems before they occur. This requires the laboratory to analyze trends in quality data, customer complaints, and process performance to identify risks and take action before failures happen.

Continual improvement is a formal requirement of ISO 15189. The standard requires the laboratory to evaluate its processes through internal audits, external assessments, and management review. The ISO 15189:2003 requirements, as discussed in Clinical Chemistry and Laboratory Medicine, present evaluation and continual improvement in relation to internal audit and external assessment, non-conformity, corrective and preventive action, and management review.

Regulatory Frameworks: ISO 15189 and CLIA

ISO 15189: The International Standard for Medical Laboratories

ISO 15189 is the international standard for quality and competence in medical laboratories. It was first published in 2003 and has been revised multiple times, with the current version being ISO 15189:2022. The standard specifies requirements for quality management and technical competence that are particular to medical laboratory services.

A 2017 review in the Journal of Medical Biochemistry describes ISO 15189 accreditation as a valuable resource for clinical laboratories and notes that the development of an international standard for their accreditation represented a milestone on the path toward improved quality and safety in laboratory medicine. The review emphasizes that ISO 15189 recognizes the importance of all steps of the total testing process, including extra-analytical phases, and requires a focus on technical competence in addition to quality systems.

The 2022 revision of ISO 15189 introduced a stronger emphasis on risk-based thinking. Laboratories must identify risks to the quality of their services and take actions to mitigate those risks. This represents a shift from purely procedural compliance to a more proactive, risk-aware approach to quality management.

CLIA: The US Regulatory Baseline

CLIA establishes quality standards for all laboratory testing performed on human specimens in the United States. CLIA regulations cover personnel qualifications, quality control, proficiency testing, and quality assurance. Laboratories must obtain a CLIA certificate based on the complexity of the tests they perform, ranging from waived tests to high-complexity testing.

CLIA and ISO 15189 are complementary instead of competing frameworks. CLIA provides the regulatory floor, while ISO 15189 provides a more comprehensive quality management framework. Laboratories that achieve ISO 15189 accreditation typically exceed CLIA requirements in areas such as document control, internal auditing, and management review.

Laboratory-Developed Tests and Regulatory Considerations

Laboratory-developed tests (LDTs) are tests that are designed, manufactured, and used within a single laboratory. These tests play a decisive role in diagnostic process chains, ensuring state-of-the-art diagnostics and patient care, according to a 2025 comparative review in ESMO Open. The review notes that the implementation and use of such in-house tests must be quality assured and meet regulatory and legal requirements.

The regulatory landscape for LDTs varies by jurisdiction. A 2026 analysis in Health Policy found that the European Union's transition from the In Vitro Diagnostic Directive to the In Vitro Diagnostic Regulation established a risk-based classification and stricter requirements for LDTs. In the United States, the FDA rescinded its 2024 Final Rule on LDTs in 2025 following a federal court ruling, restoring primary authority to CLIA. The analysis notes that the newly issued ISO 5649:2024 provides internationally recognized specifications for LDT design, validation, and quality management.

A 2023 article in Clinical Chemistry and Laboratory Medicine discusses how ISO 15189 can serve as a sufficient instrument to guarantee high-quality manufacture of laboratory-developed tests for in-house use under the European In-Vitro Diagnostics Regulation. The article notes that documentary obligations, performance and safety specifications, and development and manufacture under an ISO 15189-equivalent quality system apply to LDTs. The authors discuss appropriate interpretation of ISO 15189 to cover IVDR requirements and present selected cases illustrating LDT implementation that addresses medical needs with commensurate management of risk.

Phased Implementation Roadmap for Your Laboratory

Phase 1: Preparation and Commitment

The first phase establishes the foundation for the entire QMS. It begins with leadership commitment. The laboratory director and senior management must understand that QMS implementation requires ongoing resources, staff time, and organizational change. Without visible leadership support, the QMS will fail regardless of how well the technical work is done.

During this phase, the laboratory should:

1. Define the scope of the QMS, including which tests, locations, and services are covered
2. Appoint a quality manager and define their authority and responsibilities
3. Establish a QMS implementation team with representatives from each laboratory section
4. Conduct initial training on QMS concepts and the requirements of the chosen standard
5. Secure budget for training, documentation, and any needed equipment or software

The experience from Bugando Medical Centre Clinical Laboratory in Mwanza, Tanzania, demonstrates that mentorship is necessary during this phase and should be performed by professional laboratory mentors trained in quality management systems. Their implementation process used a gap analysis based on the Southern African Development Community Accreditation system checklist, which detected several non-conformances that guided subsequent work.

Phase 2: Gap Analysis

The gap analysis is the formal assessment of the laboratory's current state against the requirements of the chosen standard. This analysis identifies what is already in place, what is missing, and what needs improvement. The output is a prioritized action plan that guides the implementation effort.

The WHO Laboratory Quality Management System Handbook provides a framework for conducting a gap analysis. The quality stepwise implementation tool, described in a 2015 study of the National Reference TB Laboratory of Iran, uses a quality control form containing 334 quality questions that determine 12 main organizational blocks of the laboratory. These blocks include facilities and safety, organization and personnel, documents and records, management reviews, client management and customer service, equipment, internal audit, purchasing and inventory, information management, process control and internal and external quality management, corrective actions, and incident management and process improvement.

The Malawi-Liverpool Wellcome Research Programme conducted an initial gap analysis as part of their QMS implementation and then conducted a second gap analysis during their transition to ISO 15189:2022. The second analysis emphasized risk-based thinking and alignment with patient-centered requirements, reflecting the changes in the updated standard.

Gap Analysis Template

Use this template to assess your laboratory's current state against QMS requirements. For each item, rate your laboratory as Not Started, In Development, Partially Implemented, or Fully Implemented, and record the evidence that supports your rating.

Phase 3: Documentation Development

Documentation is the visible evidence of the QMS. The documentation hierarchy typically includes four levels: the quality manual, procedures, work instructions, and records and forms.

The quality manual is the top-level document that describes the laboratory's quality policy, organizational structure, and how the laboratory meets the requirements of the chosen standard. Procedures describe the sequence of activities for a process, such as sample handling or result reporting. Work instructions provide detailed steps for specific tasks, such as operating an instrument or preparing a reagent. Records and forms capture the evidence that activities were performed.

The experience from Bugando Medical Centre shows that system and technical procedures must be developed, approved, and communicated. Their implementation established quality indicators to measure laboratory improvement and to identify issues requiring immediate and preventive actions.

During documentation development, the laboratory should:

1. Inventory existing documents and identify what needs to be created or revised
2. Assign document authors with appropriate technical expertise
3. Establish a document numbering and version control system
4. Define the review and approval process for new and revised documents
5. Train staff on the use of controlled documents
6. Implement a process for periodic document review

Phase 4: Implementation and Training

Once documentation is developed, the laboratory must put the QMS into practice. This phase requires staff training on new procedures, implementation of quality controls, and establishment of monitoring systems.

Training should be role-specific and competency-based. Staff must demonstrate that they can perform their assigned tasks correctly before they are authorized to work independently. Training records must document the training content, the trainer, the date, and the assessment method and result.

The Bugando Medical Centre experience demonstrates the measurable impact of QMS implementation. After implementation, their external quality assessment performance increased across multiple departments, including Parasitology from 45 percent to 100 percent, Molecular Biology from no records to 100 percent, Biochemistry from 50 percent to 95 percent, Tuberculosis Microscopy from 60 percent to 100 percent, and Microbiology from 48.1 percent to 100 percent. Complaints were reduced from eight to two per week, rejected samples were reduced from 7.2 percent to 1.2 percent, and the proportion of contamination in blood cultures decreased from 16 percent to 4 percent.

Phase 5: Monitoring and Internal Audit

Monitoring is the ongoing collection and analysis of data to verify that the QMS is working as intended. Quality indicators are the specific measurements used for this purpose. ISO 15189 requires quality indicators as a fundamental component of the standard, according to the 2017 review in the Journal of Medical Biochemistry.

Common quality indicators include:

• Sample rejection rate
• Turnaround time for each testing phase
• External quality assessment performance
• Internal quality control failure rate
• Customer complaint rate
• Corrected report rate
• Blood culture contamination rate

The Malawi-Liverpool Wellcome Research Programme established quality indicators to monitor performance during their QMS implementation. The Bugando Medical Centre tracked turnaround time, which reached 92 percent of defined targets after implementation.

Internal audits are systematic, independent examinations of the laboratory's activities to determine whether they conform to the QMS and the chosen standard. Internal audits must be conducted at planned intervals, by trained auditors who are independent of the area being audited. The audit findings must be documented, and corrective actions must be tracked to completion.

A 2013 article in Annales de Biologie Clinique discusses the internal audit process in medical laboratories and the means of control needed for an effective audit process. The article addresses how audits should be planned, conducted, and followed up to ensure they add value to the laboratory.

Phase 6: Management Review and Continual Improvement

Management review is the formal evaluation of the QMS by the laboratory's leadership at defined intervals. The review considers audit results, quality indicators, customer feedback, complaint data, non-conformities, and opportunities for improvement. The output of the management review is decisions and actions related to QMS improvement, resource allocation, and changes to the quality policy or objectives.

A 2009 article in Accreditation and Quality Assurance provides a management review checklist for ISO/IEC 17025 and ISO 15189 quality-management systems. The checklist helps laboratories ensure that all required inputs are considered and that the review is comprehensive and effective.

Continual improvement is the ongoing effort to enhance the QMS and the laboratory's performance. This requires a culture that encourages staff to identify problems and suggest improvements, a system for evaluating improvement opportunities, and a process for implementing and verifying changes.

Common Failure Patterns in QMS Implementation

Documentation Without Implementation

The most common failure is creating documents that describe ideal processes but are not followed in practice. Staff may continue to use old habits, or the documented procedures may not match the actual workflow. This creates a disconnect between what the QMS says and what the laboratory does. The solution is to involve the people who perform the work in writing the procedures and to verify through observation and audit that documented procedures are followed.

Pre-analytical Process Neglect

The Ehime University study found that pre-analytical processes accounted for 47 percent of incongruent rates in inspection processes. Laboratories often focus their quality efforts on the analytical phase because that is where instruments and quality control materials are most visible. However, the pre-analytical phase, including sample collection, transport, and processing, is where many errors originate. Laboratories should track pre-analytical quality indicators and invest in training and process improvement for sample handling.

Incomplete Training Records

Training that occurs but is not documented is treated as not having occurred. Laboratories must maintain complete training records that document the training content, the trainer, the date, and the assessment method and result. This is a common finding in internal audits and external assessments.

Quality Control Without Action

Running quality control materials and recording the results is not sufficient. The laboratory must have defined rules for interpreting quality control results, procedures for investigating failures, and documentation of corrective actions taken. Quality control data must be reviewed regularly to detect trends before they become failures.

Siloed Quality Activities

Quality management can become the responsibility of the quality manager alone, with other staff viewing quality as someone else's job. This creates a system that exists on paper but does not influence daily practice. The QMS must be integrated into the work of every staff member, with quality responsibilities defined in every job description.

Records and Measurements That Matter

Quality Indicators to Track

The laboratory should select quality indicators that are meaningful for its scope and patient population. Each indicator should have a clear definition, a measurement method, a target value, and a designated owner. Indicators should be reviewed at defined intervals, and trends should trigger investigation and action.

The Bugando Medical Centre experience shows the value of tracking indicators such as rejected samples, complaints, turnaround time, and blood culture contamination. These indicators provided measurable evidence of improvement after QMS implementation.

External Quality Assessment Performance

External quality assessment (EQA) or proficiency testing is the independent assessment of the laboratory's performance on unknown samples. Participation in EQA programs is required by ISO 15189 and CLIA. EQA performance should be tracked over time to identify systematic problems with specific tests or methods.

A 2026 study in Frontiers in Molecular Biosciences examined the commutability of erythropoietin control materials for external quality assessment schemes. The study found that most control materials remained within the range of the clinical sample bias distribution across paired method correlations, but some control materials exceeded the limits, including native frozen pooled serum. The study also found that dilution and lyophilization affected inter-method bias to varying degrees. This research highlights the importance of understanding the limitations of EQA materials and interpreting EQA results in the context of commutability.

Sigma Metrics for Analytical Performance

Sigma metrics provide a quantitative framework to assess and enhance laboratory performance. A 2025 study in PubMed describes how sigma metrics are calculated using the coefficient of variation from internal quality control results and the bias from proficiency testing results, compared against total allowable error from biological variation databases. The study found that 28 to 33 parameters on different instruments showed a sigma value below 3, indicating poor performance. The study also noted that several parameters lack total allowable error values in the CLIA database, preventing their inclusion in assessments of acceptability.

Laboratories can use sigma metrics to design tailored quality control plans. Parameters with high sigma values may require less frequent quality control, while parameters with low sigma values require more intensive monitoring and process improvement.

Biosafety and Quality Management Integration

Biosafety is an integral component of laboratory quality management. The WHO Laboratory Biosafety Manual provides guidance on risk assessment, facility design, personal protective equipment, and safe handling of biological materials. Biosafety considerations affect multiple QMS components, including facilities and safety, personnel training, equipment management, and process control.

The laboratory's biosafety program should be aligned with its quality management system. Biosafety risk assessments should inform the development of standard operating procedures, and biosafety training should be documented in personnel records. The QMS should include procedures for incident reporting and investigation, including biological exposure incidents.

The WHO Laboratory Quality Management System Handbook includes facilities and safety as one of the 12 quality system essentials. This integration ensures that biosafety is not treated as a separate activity but as part of the overall quality framework.

Digital Pathology and Evolving Technologies

Digital pathology systems are being deployed in an increasing number of clinical pathology departments. A 2019 article in the Journal of Clinical Pathology describes the approach taken by Leeds Teaching Hospitals NHS Trust, which has been scanning 100 percent of histology slides since September 2018. The article provides practical advice on what types of procedures and documentation are necessary for ISO inspection of digital pathology services, including risk assessment, standard operating procedures, validation and training, calibration and quality assurance.

The article emphasizes that the continuous quest for quality and safety improvements should underpin all pathology operations, including digital pathology. Departments deploying digital pathology systems must validate the technology, train reporting pathologists, and maintain quality assurance procedures that meet or exceed the standards applied to conventional microscopy.

Total laboratory automation is another evolving area that affects QMS implementation. A 2026 article on collaborative robotics, mobile platforms, and total laboratory automation in clinical diagnostics addresses how automation changes workflow, quality control, and information management. Laboratories implementing automation must update their QMS to address new risks and new quality control requirements.

Quality Management in Research and Non-Clinical Laboratories

While ISO 15189 is designed for medical laboratories, the principles of quality management apply to research laboratories and other testing facilities. The Malawi-Liverpool Wellcome Research Programme is an example of a research laboratory that implemented ISO 15189 to achieve technical competence and consistent delivery of valid results.

The Assay Guidance Manual from the National Center for Advancing Translational Sciences provides guidance on assay development and validation that is relevant to both clinical and research laboratories. The manual covers topics such as assay design, reagent qualification, and data analysis that are essential for producing reliable results.

The Next-Generation Sequencing: Standardization of Clinical Testing (Nex-StoCT) workgroup developed principles and guidelines for assuring the quality of next-generation sequencing in clinical laboratory practice. A 2012 article in Nature Biotechnology describes how the workgroup identified and addressed gaps in quality practices that could compromise the quality of clinical laboratory services. The guidelines address four topics: test validation, quality control procedures, independent assessment of test performance through proficiency testing or alternative approaches, and reference materials.

Professional Escalation Criteria

Laboratory professionals should know when to escalate quality issues beyond their level of authority. The following situations warrant escalation to the quality manager, laboratory director, or other appropriate authority:

1. A quality control failure that cannot be resolved through the defined corrective action procedure
2. A result that may have caused patient harm or that requires immediate clinical notification
3. Evidence of fraud, falsification of records, or intentional non-compliance
4. A safety incident involving exposure to biological, chemical, or radiological hazards
5. A regulatory or accreditation finding that requires immediate corrective action
6. A complaint from a customer that cannot be resolved at the laboratory level
7. A resource limitation that prevents the laboratory from meeting quality requirements
8. A change in test methodology, equipment, or personnel that requires validation or reverification

The laboratory should have a defined escalation pathway that specifies who to contact, how to document the escalation, and what information to provide. Escalation should be timely and should not be delayed by concerns about blame or accountability.

Frequently Asked Questions

Who is responsible for the quality management system in a laboratory?

The laboratory director has overall responsibility for the QMS, but the quality manager has the day-to-day responsibility for implementing, maintaining, and improving the system. Every staff member has quality responsibilities defined in their job description. The Malawi-Liverpool Wellcome Research Programme appointed a quality officer to oversee the implementation process, supported by leadership engagement and staff training to establish core competencies.

What is the difference between ISO 15189 and CLIA?

ISO 15189 is an international standard for quality and competence in medical laboratories that is used for voluntary accreditation. CLIA is the US federal regulatory framework that establishes minimum quality standards for all clinical laboratories. ISO 15189 is more comprehensive in its coverage of the total testing process, including extra-analytical phases, and requires a focus on technical competence in addition to quality systems. Many laboratories pursue both, using CLIA as the regulatory baseline and ISO 15189 as the quality excellence framework.

How long does it take to implement a quality management system?

Implementation time varies based on the laboratory's starting point, scope, resources, and the standard being pursued. The experience from Bugando Medical Centre and the Malawi-Liverpool Wellcome Research Programme shows that implementation is a multi-year effort that requires ongoing commitment. A realistic timeline for a laboratory starting from minimal QMS infrastructure is 18 to 36 months to reach accreditation readiness, depending on the complexity of the testing menu and the availability of dedicated quality staff.

What is a gap analysis and why is it important?

A gap analysis is a formal assessment of the laboratory's current state against the requirements of the chosen standard. It identifies what is already in place, what is missing, and what needs improvement. The output is a prioritized action plan that guides the implementation effort. The WHO Laboratory Quality Management System Handbook provides a framework for conducting a gap analysis, and the quality stepwise implementation tool uses a quality control form with 334 questions covering 12 organizational blocks of the laboratory.

How often should internal audits be conducted?

Internal audits must be conducted at planned intervals, with the frequency determined by the laboratory's risk assessment and the requirements of the chosen standard. Most laboratories conduct full internal audits annually, with targeted audits of high-risk areas more frequently. The audit program should cover all elements of the QMS and all laboratory activities within a defined cycle.

What are quality indicators and how are they selected?

Quality indicators are specific measurements used to monitor the performance of the laboratory's processes. ISO 15189 requires quality indicators as a fundamental component of the standard. Indicators should be selected based on their relevance to the laboratory's scope, their ability to detect problems, and their feasibility of measurement. Common indicators include sample rejection rate, turnaround time, external quality assessment performance, and customer complaint rate.

How does ISO 15189 address laboratory-developed tests?

ISO 15189 can serve as a sufficient instrument to guarantee high-quality manufacture of laboratory-developed tests for in-house use under the European In-Vitro Diagnostics Regulation. The standard covers documentary obligations, performance and safety specifications, and development and manufacture under an ISO 15189-equivalent quality system. The newly issued ISO 5649:2024 provides internationally recognized specifications for LDT design, validation, and quality management.

What is the role of management review in the QMS?

Management review is the formal evaluation of the QMS by the laboratory's leadership at defined intervals. The review considers audit results, quality indicators, customer feedback, complaint data, non-conformities, and opportunities for improvement. The output is decisions and actions related to QMS improvement, resource allocation, and changes to the quality policy or objectives. A management review checklist can help ensure that all required inputs are considered.

Related Diagnostic Guides

• Quality Laboratory: Implementing a Quality Management System in Academic Research Labs
• Quality Control in the Microbiology Laboratory: Key Practices for Reliable Results
• Laboratory Equipment Calibration: A Comprehensive Management Guide
• Laboratory Results Template: How to Present Data Clearly and Reproducibly
• Procedure for Quality Control: Step-by-Step Implementation in a Molecular Lab

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.
• ISO 15189:2003--quality management, evaluation and continual improvement.. Clinical chemistry and laboratory medicine, 2006.
• ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety.. Journal of medical biochemistry, 2017.
• 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 So Far and in the Future -Effects of Quality Assurance and Management System Using ISO 15189-].. Rinsho byori. The Japanese journal of clinical pathology, 2016.
• Integration of the ISO 15189 quality management system in the undergraduate internship teaching of medical laboratory technology.. Medicine, 2026.
• Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory - Mwanza, Tanzania.. African journal of laboratory medicine, 2018.
• Maintaining quality diagnosis with digital pathology: a practical guide to ISO 15189 accreditation.. Journal of clinical pathology, 2019.
• Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management.. Advances in laboratory medicine, 2021.
• Beyond compliance: How accreditation can strengthen trust in science and research infrastructure.. 2026.
• Regulation of laboratory-developed tests and in-house in vitro diagnostic medical devices in the United States and the European Union-a comparative overview.. 2025.
• Impact of the manufacturing process on the commutability of erythropoietin control materials for external quality assessment schemes.. 2026.
• Comparative analysis of in vitro diagnostic medical devices and laboratory-developed tests: Insights from global regulation.. 2026.
• Collaborative Robotics, Mobile Platforms, and Total Laboratory Automation in Clinical Diagnostics. 2026.
• Enhancing Laboratory Quality: A Comprehensive Sigma Metric Analysis for Diverse Biochemical Parameters.. 2025.
• 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. Wellcome Open Research, 2026.
• Laboratory quality stepwise implementation tool: National reference TB laboratory of Iran. 2015.
• Assuring the quality of next-generation sequencing in clinical laboratory practice. Nature Biotechnology, 2012.
• Implementation of Good Laboratory Practices (NIT-DICLA-035, Inmetro) in a technological platforms network: the Fiocruz experience. Accreditation and Quality Assurance, 2012.
• Experience in establishing a quality management system at a plant diagnostic laboratory in Fiji. Accreditation and Quality Assurance, 2020.
• [Internal audit in medical laboratory: what means of control for an effective audit process?].. Annales de Biologie Clinique, 2013.
• Implementing Quality Management System in Pharmaceutical Laboratories. 2016.
• Implementation and monitoring of a quality management system based on the standard UNE-EN-ISO 15189 in a urine culture unit. Clinical Biochemistry, 2012.
• Management review checklist for ISO/IEC 17025 and ISO 15189 quality-management systems. Accreditation and Quality Assurance, 2009.
• [From the position of a private sector hospital: ISO 15189 acquisition by a clinical laboratory, and quality management system deployment in the whole hospital].. Rinsho Byori the Japanese Journal of Clinical Pathology, 2012.

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