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ISO 15189: Definition, Requirements, Implementation, and Accreditation

Published: June 16, 2025

Updated: June 30, 2025

ISO 15189 is an internationally recognized standard that defines quality management system (QMS) requirements specifically for medical laboratories. The core requirements of ISO 15189 are detailed in Clauses 4 through 8, addressing topics such as impartiality, confidentiality, structural and resource management, operational processes, and continual quality monitoring.

ISO 15189 emphasizes documented procedures, risk-based thinking, and traceability across all phases of the diagnostic workflow, from pre-examination to post-examination. ISO 15189 also mandates internal audits, corrective and preventive actions (CAPA), complaint handling, personnel competence, and continuous improvement.

Implementation of ISO 15189 involves a thorough understanding of the standard, conducting gap analysis, creating compliant QMS documentation, training staff, and applying standardized procedures throughout laboratory operations. The ISO 15189 accreditation process includes selecting a recognized accreditation body, undergoing assessments, resolving nonconformities, and participating in ongoing surveillance evaluations.

Medical laboratory QMS software, such as SimplerQMS, supports ISO 15189 compliance by automating QMS functions including document control, CAPA workflows, training, audit management, and more. SimplerQMS offers a cloud-based platform, fully validated according to GAMP5, that helps ensure regulatory compliance and audit readiness in medical laboratories.

What Is ISO 15189?

ISO 15189 is an international standard established by the International Organization for Standardization (ISO) that outlines specific requirements for ensuring quality and competence in medical laboratories. The core objective of ISO 15189 is to deliver accurate, timely, and reliable laboratory results that enhance patient care and foster confidence in diagnostic services.

Although ISO 15189 focuses on laboratory testing, such as blood banks, immunology, and microbiology laboratories, it can also be applied to other diagnostic services, including imaging and respiratory therapy. ISO 15189 includes targeted provisions for point-of-care testing (POCT). Initially introduced in 2003 by ISO (International Organization for Standardization) and developed collaboratively by Technical Committee ISO/TC 212 and CEN/TC 140, the standard underwent its fourth revision in 2022. This 2022 edition aligns structurally with ISO/IEC 17025:2017 and incorporates the requirements of the ISO 22870 standard to offer a fully integrated approach to POCT.

ISO 15189 builds upon the foundational principles of ISO 9001, which sets generic quality management requirements applicable across industries. ISO 15189 also incorporates and adapts the technical competence requirements of ISO/IEC 17025, traditionally used for testing and calibration laboratories, to the context of medical diagnostics.

The 2022 version of ISO 15189 introduces significant amendments such as integrating risk-based thinking and structured risk management practices aligned with ISO 22367 (Medical laboratories — Application of risk management to medical laboratories) and ISO 35001 (Biorisk management for laboratories and other related organizations). The 2022 version also clarifies critical operational roles, including the responsibilities of laboratory directors. Additionally, the QMS requirements have been reorganized to the end of the document, mirroring the layout of ISO/IEC 17025 for consistency.

ISO 15189 is widely embraced by key stakeholders, including regulators, insurers, and the World Health Organization (WHO). According to Boursier et.al., in France and Hungary, ISO 15189 accreditation is mandatory for all medical laboratories. Other countries have implemented partial mandates, for example, Belgium requires it for molecular biology tests, Ireland for immunohematology and blood transfusion services, and Lithuania for biochemistry and hematology.

Despite its global adoption, ISO 15189 is not recognized by the Food and Drug Administration (FDA) as equivalent to Clinical Laboratory Improvement Amendments (CLIA) certification. Consequently, the CLIA, under 42 CFR Part 493, remains the obligatory framework in the U.S.

Why Is ISO 15189 Important?

ISO 15189 is essential for medical laboratories as it defines stringent quality and technical competence requirements, directly influencing patient safety, diagnostic accuracy, and institutional credibility. The ISO 15189 standard mandates verification and validation of examination procedures, measurement accuracy, and traceable results, thereby minimizing diagnostic errors that could delay treatment or cause harm. Accuracy in test results is achieved through rigorous verification and validation of methods, equipment calibration, defined sample handling procedures, and competent staffing, supported by internal quality control and external quality assessment.

By conforming to ISO 15189, laboratories enhance their credibility and signal adherence to regulatory, clinical, and quality norms through ISO 15189 accreditation. Moreover, the standard promotes personnel safety by enforcing environmental controls against biological, chemical, and physical hazards, covering aspects like layout, ventilation, and contamination control. ISO 15189 also supports harmonizing practices across healthcare systems, enabling reliable and consistent test results regardless of location.

What Is the Organizational Structure of ISO 15189?

The organizational structure of ISO 15189 is divided into eight (8) distinct clauses that outline specific requirements for medical laboratories. ISO 15189 has three (3) annexes to provide POCT requirements and comparative tables to ISO 9001 and ISO 17025. Each clause addresses different areas of quality and competence needed to ensure reliable laboratory operations.

The 8 different clauses of ISO 15189 are listed below.

Clause 1 Scope: Clause 1 defines the standard’s purpose as specifying the requirements for quality and competence in medical laboratories, including those performing POCT. The standard applies to all aspects of laboratory operations impacting patient care, diagnostics, and compliance with health sector regulations.
Clause 2 Normative References: Clause 2 identifies essential references that provide the interpretive framework for ISO 15189. These normative references ensure alignment with international best practices in laboratory quality and competence management.
Clause 3 Terms and Definitions: Clause 3 defines standardized terminology essential for consistently interpreting and applying requirements across laboratory systems.
Clause 4 General Requirements: Clause 4 states that laboratories must maintain impartiality and ensure the confidentiality of patient information. Clause 4 includes implementing policies and controls to prevent conflicts of interest, establish secure access controls for patient data, and maintain professional integrity in examination processes and result reporting.
Clause 5 Structural and Governance Requirements: Clause 5 establishes the need for defined legal status, designated laboratory directors, and documented organizational responsibilities. Governance frameworks must include qualified authorized signatories and clear lines of accountability.
Clause 6 Resource Requirements: Clause 6 requires laboratories to ensure that all personnel are competent and adequately trained. Required resources include calibrated and maintained equipment, suitable facilities, and controlled environmental conditions that support the integrity of testing processes as well as the health and safety of personnel.
Clause 7 Process Requirements: Clause 7 focuses on implementing robust processes across the diagnostic cycle: pre-examination, examination, and post-examination. Clause 7 includes verification and validation of testing methods, defined procedures for sample handling, result reporting, complaint management, and data traceability, underpinned by risk-based quality assurance.
Clause 8 Management System Requirements: Clause 8 describes how to establish, implement, maintain, and improve a quality management system (QMS), including risk management, corrective actions, and internal audits.

The 3 annexes from ISO 15189 are described below.

Annex A Additional Requirements for Point-of-Care Testing (POCT): Annex A provides additional mandatory requirements for tests performed near or at the site of patient care.
Annex B Comparison between ISO 9001:2015 and ISO 15189:2022: Annex B provides a clause-by-clause comparison and alignment table that maps the structure and requirements of ISO 15189:2022 to those of ISO 9001:2015.
Annex C Comparison between ISO 15189:2012 and ISO 15189:2022: Annex C offers a detailed clause-by-clause comparison to highlight structural and procedural updates from the previous 2012 version.

What Are the Key ISO 15189 Requirements?

The key ISO 15189 requirements in Clauses 4 to 8 define the essential elements medical laboratories must implement to ensure quality management and technical competence.

The key ISO 15189 requirements are listed below.

Impartiality and Confidentiality: Medical laboratories must establish and document procedures to avoid conflicts of interest and protect patient information.
Laboratory Governance and Responsibility: The roles of the laboratory director and personnel must be clearly defined in organizational documents.
Personnel Competence: Staff must be qualified, trained, and assessed regularly for competence in their assigned tasks.
Facilities and Environmental Conditions: Laboratories must maintain controlled environments that safeguard patient safety and ensure the reliability of clinical results.
Equipment and Calibration: All equipment must be selected for suitability, calibrated, maintained, and monitored for metrological traceability.
Sample Handling Processes: Procedures must be documented for sample collection, transportation, storage, acceptance, and rejection.
Examination Procedures: All laboratory examination methods must be verified or validated for their intended use.
Quality Assurance: Laboratories shall implement both internal quality control (IQC) and external quality assessment (EQA) schemes, which must be used to monitor performance and result accuracy.
Result Reporting: Reports must be clear, timely, and include all necessary patient and test information, including critical results and interpretation when applicable.
Complaint Handling: Ensures that complaints are acknowledged, evaluated, resolved, and documented as part of a robust QMS.
Nonconforming Work Management: Processes must be in place to identify, document, and correct nonconformities that could affect test reliability or patient safety.
Management System Implementation: A documented QMS must include the laboratory’s quality policies, objectives, document control, risk management, internal audits, management reviews, and continuous improvement efforts.

Clause 4 General Requirements

Clause 4 of ISO 15189, ‘General requirements’, outlines comprehensive general requirements emphasizing impartiality, confidentiality, and patient-focused obligations. Clause 4 requirements ensure that medical laboratories act ethically, protect personal and clinical data, and prioritize patient rights and safety.

Clause 4 further governs organizational ethics and patient-centered practices across all laboratory operations, mandating transparency, fairness, and privacy in service delivery. Together, these principles foster trust and accountability in medical laboratory services.

Impartiality

Impartiality, as defined by ISO 15189 under clause 4, is a core principle requiring medical laboratories to operate free of bias and conflicts of interest. This ensures that all diagnostic results and clinical services are delivered objectively and consistently.

To maintain impartiality, laboratories must do the following.

Ensure freedom from commercial, financial, or other pressures that could influence results.
Monitor relationships and activities that might threaten objectivity.
Take action to mitigate identified risks to impartiality.

Confidentiality

Confidentiality, as stipulated in ISO 15189 under clause 4, is a critical requirement to safeguard patient and clinical information across all laboratory activities.

Laboratories must protect all patient-related information by doing the following below.

Management of Information: Secure and manage all patient data using enforceable agreements; only disclose information publicly with patient/user consent.
Release of Information: Notify patients when legally required to share confidential data; maintain discretion in handling third-party sources.
Personnel Responsibility: Ensure all personnel, including contractors and committee members, always uphold confidentiality obligations.

Requirements Regarding Patients

‘Requirements regarding patients’ are outlined under Clause 4 of ISO 15189 and refer to the establishment of robust requirements, emphasizing the integration of patient-centered care across all laboratory services.

Laboratory management must do the following.

Enable patient/user input in selecting methods and interpreting results.
Provide access to the examination process and cost information.
Periodically review tests for clinical relevance.
Disclose incidents with potential harm and resulting mitigations.
Handle patients, samples, and remains with care and respect.
Obtain informed consent when required.
Preserve sample and data accessibility and integrity during lab closure, acquisition, or merger.
Ensure equitable care and uphold patient rights.

Clause 5 Structural and Governance Requirements

Clause 5 structural and governance requirements of ISO 15189 outlines the structural and governance requirements for medical laboratories. Clause 5 details how laboratories should be organized, specifies who holds authority, and mandates the clear assignment and documentation of responsibilities.

Clause 5 emphasizes the necessity of competent leadership and robust quality governance, reinforced by risk-based management strategies. The purpose is to ensure legal accountability and maintain consistent, high-quality, regulatory-compliant laboratory operations.

Legal Entity

‘Legal entity’, under clause 5, requires the laboratory to operate as a legally accountable organization. This legal accountability ensures that the laboratory can be held responsible for all its activities, affirming its obligation to meet regulatory, ethical, and professional requirements in every aspect of its service.

Laboratory Director

Under Clause 5, the laboratory director plays a pivotal role and must possess the qualifications, technical knowledge, and authority necessary to manage and lead effectively.

Subclauses under the laboratory director include the following.

Laboratory Director Competence: The laboratory director shall demonstrate documented competence through relevant qualifications, technical and scientific knowledge, and experience appropriate to the scope of services provided. The laboratory director must possess the decision-making authority, leadership skills, and resources necessary for clinical laboratory governance.
Laboratory Director Responsibilities: The laboratory director is responsible for implementing and maintaining the laboratory’s QMS. Responsibilities include identifying and managing potential risks to patient care as well as recognizing opportunities for improvement.
Delegation of Duties: The laboratory director may assign operational tasks to qualified personnel, but he/she will retain full legal and regulatory accountability for laboratory performance and outcomes.

Laboratory Activities

Clause 5 of ISO 15189, ‘Laboratory activities’, requires that all laboratory activities be structured, documented, and controlled under a comprehensive quality management system. These laboratory activities must span the full diagnostic workflow: pre-examination, examination, and post-examination. The scope ensures that each process is compliant with regulatory and clinical benchmarks.

Subclauses under laboratory activities include the following.

General: The medical laboratory shall define, document, and communicate the complete scope of diagnostic services. This includes in-house testing, off-site laboratory activities, and POCT. All these services must be integrated into the laboratory’s QMS.
Conformance with Requirements: All laboratory activities must comply with the requirements of ISO 15189, meet applicable regulatory requirements, and align with user expectations. Conformance with requirements also includes maintaining traceability, quality control, and documentation across all testing environments to ensure the reliability and validity of results.
Advisory Activities: The laboratory must provide ongoing expert consultation services, including guidance on appropriate test utilization, clinical interpretation of results, and guidance on the effective use of laboratory services. These activities support patient care through interdisciplinary collaboration and should be embedded in stakeholder communication protocols within the QMS.

Structure and Authority

Clause 5, ‘Structure and authority’, mandates that laboratories establish a well-defined organizational structure to ensure the effective execution of laboratory activities.

To detail the structure and authority under clause 5, it has been divided into 2 subclauses below.

General: The medical laboratory must define and document its position within any parent organization, including a visual or written description of the governance structure. The laboratory hierarchy, interdepartmental relationships, and internal communication pathways should be outlined to ensure accountability, traceability, and role clarity. The laboratory must also establish procedures to ensure consistent execution of laboratory activities and reliability of results.
Quality Management: Laboratory personnel shall be assigned clearly defined responsibilities and authorities to maintain, improve, and report on the QMS. Responsibilities include identifying and addressing deviations, initiating corrective actions, and ensuring the effectiveness of laboratory operations.

Objectives and Policies

The laboratory must set measurable objectives and policies under clause 5, aligned with user needs and ISO 15189 compliance. These objectives and policies must be systematically integrated throughout the organization to promote consistent performance, regulatory adherence, and a culture of continual improvement.

Risk Management

Risk management under clause 5 requires the laboratory to implement a comprehensive risk management approach that includes identifying and evaluating risks related to patient safety. The laboratory must establish processes to detect potential issues proactively and take corrective or preventive actions to address them.

Risk management aims to minimize harm and promote continual improvement in diagnostic quality and patient outcomes.

Clause 6 Resource Requirements

Clause 6 of ISO 15189 details the resource requirements that medical laboratories must meet to ensure the accuracy, reliability, and safety of examinations.

Clause 6 defines essential criteria for operational resources, including personnel competence. Other criteria include equipment control and maintenance, appropriate environmental conditions, and dependable supply chain systems. Clause 6 also ensures laboratories have the infrastructure and qualified staff needed to support all testing activities safely and effectively.

General

Clause 6, ‘General’, outlines the requirement for laboratories to ensure the availability of sufficient, competent personnel, suitable facilities, equipment, materials, and reliable support services.

Personnel

Personnel under clause 6 have subclauses listed below.

General: All personnel involved in laboratory processes must be competent, act in accordance with documented ethical conduct policies, and operate with impartiality. All personnel should remain aware of the laboratory’s QMS requirements, user expectations, and regulatory responsibilities.
Competence Requirements: Laboratories shall establish role-specific competency requirements that define the required qualifications, education, experience, and skills for each position. Competency assessments must be performed at defined intervals and documented to ensure alignment with ISO 15189 and applicable healthcare regulations.
Authorization: Personnel must be formally authorized to perform specific activities such as method validation, result review, and accessing or modifying patient data.
Continuing Education: Ongoing continuing professional development (CPD) is mandatory. Laboratories must provide structured training programs to maintain and enhance competence, adapt to changes in technology or regulations, and promote a culture of quality improvement.
Personnel Records: Laboratories shall maintain comprehensive personnel qualification records, including evidence of education, training, competency assessments, and individual authorizations.

Facilities and environmental conditions

Facilities and environmental conditions under clause 6 include sections as listed below.

General: Laboratory facilities must be designed, operated, and maintained to ensure that environmental conditions do not compromise the validity of diagnostic results or the safety of personnel, patients, and visitors.
Facility Controls: Laboratories shall implement facility control systems such as limiting access to authorized personnel, contamination risk zoning, ensuring adequate ventilation, and providing essential safety equipment such as fire protection and eyewash stations. Environmental monitoring protocols must be in place where contamination risk affects test accuracy.
Storage Facilities: Medical laboratories must provide storage conditions that preserve the integrity of samples, equipment, materials, and records; and prevent cross-contamination and deterioration of patient samples. Medical laboratories should also ensure appropriate storage and disposal of hazardous and biological waste.
Personnel Facilities: The laboratory must provide appropriate staff amenities, including toilets, rest areas, and designated PPE storage zones.
Sample Collection Facilities: Sample collection facilities must be designed to protect sample integrity and ensure the quality of examinations, while also meeting patient needs for privacy, accessibility, and safe collection. They should include distinct areas for reception and collection, along with appropriate first-aid resources for both patients and staff.

Equipment

Equipment requirements, as outlined in clause 6, are listed below.

General: Laboratories shall ensure that all equipment used within the medical laboratory infrastructure is subject to a complete lifecycle management program.
Equipment Requirements: Equipment must be selected based on its ability to meet defined performance specifications, and it must be traceable through unique identification codes. All devices must support accurate and reproducible diagnostic results.
Equipment Acceptance Procedure: New or repaired equipment must undergo documented acceptance testing against predefined performance and functionality criteria before routine use. The results of this validation must be reviewed and approved by qualified personnel.
Equipment Instructions for Use: The laboratory must ensure that both manufacturer-provided instructions and operating procedures are readily accessible to all authorized users of equipment, who should be trained and competent. Controls should be in place to prevent unauthorized modification of equipment.
Equipment Maintenance and Repair: All equipment shall have a documented preventive maintenance schedule, supported by safety protocols for proper handling during service. Maintenance tasks must be performed by qualified personnel and logged for traceability, documenting any deviations. Defective equipment must be clearly marked and removed from service. Where applicable, equipment must be decontaminated before servicing or decommissioning.
Equipment Adverse Incident Reporting: The laboratory must ensure any adverse incidents or accidents linked to equipment are thoroughly investigated and reported to manufacturers, suppliers, and appropriate regulatory authorities, as required. The laboratory should also establish procedures for responding to manufacturer recalls or notifications and implementing appropriate corrective actions.
Equipment Records: The laboratory shall maintain detailed and up-to-date equipment records for each piece of equipment that affects test results. Records of equipment shall include identification details, manufacturer instructions, calibration history, preventive maintenance actions, service activities, and performance verification outcomes. These records must be retained as part of the QMS for internal review and external audits.

Equipment calibration and metrological traceability

‘Equipment calibration and metrological traceability’, covered under clause 6, has 3 subsections listed below.

General: Laboratories shall implement and maintain documented systems to ensure calibration and traceability of all equipment used in measuring or monitoring diagnostic activities.
Equipment Calibration: The laboratory must have procedures for calibrating equipment that impacts examination results, including conditions for use, traceability records, verification of accuracy, documentation of calibration status, and calibration schedule. Others include updating correction factors and managing out-of-control calibration events to minimize service risks.
Metrological Traceability: Laboratories must ensure that all measurement results are traceable to the International System of Units (SI) or other internationally recognized references. Reference materials and calibration standards must have valid certification of traceability. When required, measurement uncertainty (MU) must be calculated, documented, and considered in diagnostic interpretations. Where traceability is not technically possible, the laboratory must provide suitable alternative evidence of result reliability, such as the use of certified reference materials.

Reagents and consumables

Reagents and consumables, as outlined in clause 6, are governed by 7 sections listed below.

General: Laboratories must implement procedures for the selection, verification, handling, and control of reagents and consumables to ensure they meet specified quality and performance requirements.
Reagents and consumables — Receipt and Storage: Reagents and consumables must be inspected and stored upon delivery in accordance with supplier instructions, including temperature, humidity, and light exposure controls, as applicable. A receipt verification record should be generated for each lot received.
Reagents and consumables — Acceptance Testing: Before use, each critical reagent or consumable that may impact the quality of tests must undergo documented acceptance testing using internal quality control procedures. Laboratories must verify the certificate of analysis (CoA) data and issue lot release authorization only after performance acceptance criteria are met.
Reagents and consumables — Inventory Management: Laboratories must maintain physical and documented segregation between untested, accepted, expired, or unacceptable materials.
Reagents and consumables — Instructions for Use (IFU): Manufacturer-provided instructions and laboratory-specific SOPs for all reagents and consumables must be readily accessible in a controlled instructions repository.
Reagents and consumables — Adverse Incident Reporting: Any adverse incidents or accidents linked to reagents or consumables must be investigated, documented, and reported to suppliers, regulatory authorities, and relevant oversight bodies, as applicable. The laboratory should also establish procedures for responding to manufacturer recalls or notifications and implementing appropriate corrective actions.
Reagents and consumables — Records: Laboratories must keep complete records of reagents and consumables used for testing, including batch numbers, receipt dates, acceptance testing, storage conditions, expiry dates, and usage details. These records must be retained per the QMS retention policy and made available for audit or investigation.

Service agreements

Clause 6, ‘Service agreements’ comprises two main sections as listed below.

Agreements with Laboratory Users: Laboratory user agreements must define documented responsibilities, service requirements, and, where applicable, referral arrangements. Any changes that may impact examination results must be communicated to users, and records of reviews and revisions must be retained.
Agreements with POCT Operators: Agreements with POCT operators shall specify defined responsibilities, governance structures, and oversight roles. These POCT agreements must ensure operator competence, ongoing monitoring, and alignment with documentation and quality control protocols.

Externally provided products and services

Externally provided products and services under clause 6 has 3 subsections listed below.

General: Laboratories must establish documented procedures for the qualification, approval, and ongoing monitoring of external suppliers whose products or services impact the quality of laboratory testing.
Referral Laboratories and Consultants: Laboratories must clearly communicate requirements to referral laboratories and external consultants, covering procedures, reporting, critical result management, and required technical competence.
Review and Approval of Externally Provided Products and Services: Laboratories must have a defined procedure for the review and approval of external products and services, which should include assessing and monitoring supplier performance against defined acceptance criteria, evaluating any potential risks, and ensuring conformity before use.

Clause 7 Process Requirements

Clause 7 of ISO 15189 sets forth the process requirements that regulate the full scope of medical laboratory operations. Clause 7 includes every stage of the workflow, from receiving a patient request to delivering final results and managing complaints.

Clause 7 details essential operational components such as sample management, test execution, data processing, and user communication.

General

The ‘General’ requirements under clause 7 require laboratories to actively identify and manage risks and opportunities relating to patient care throughout the entire diagnostic workflow, including the pre-examination, examination, and post-examination stages.

Pre-examination processes

Clause 7, ‘Pre-examination processes’ includes the sections below.

General: Laboratories must have accessible, documented procedures for all pre-examination activities.
Laboratory Information for Patients and Users: Provide patients and users with clear information, including details of the laboratory’s services, sample collection procedures, result turnaround times, advisory services, consent requirements, and how to raise complaints.
Requests for Providing Laboratory Examinations: Laboratory examination requests must be complete with sufficient patient information to ensure traceability and enable clinical advice. Procedures must also be in place to manage oral requests when applicable.
Primary Sample Collection and Handling: Ensure primary samples are collected and handled correctly, including accurate labeling, correct volume collection, and preservation methods that conform to ISO 15189 quality system requirements.
Sample Transportation: Transport samples under controlled conditions that maintain integrity and comply with documented transport protocols.
Sample Receipt: Define and document acceptance or rejection criteria, and ensure that all samples are logged upon receipt to maintain traceability and sample integrity.
Pre-examination Handling, Preparation, and Storage: Protect samples from degradation, define permissible storage durations, and outline preparation procedures to support additional tests.

Examination processes

‘Examination processes’, outlined under clause 7, includes the sections listed below.

General: Laboratories must implement examination methods that are validated, clinically relevant, and appropriate for supporting accurate diagnostic decisions.
Verification of Examination Methods: Standard examination methods must undergo verification to confirm they perform reliably and meet intended analytical outcomes within the lab’s operational context.
Validation of Examination Methods: Non-standard, modified, or laboratory-developed methods require full validation, including performance characteristics such as accuracy, precision, and detection limits, to ensure fitness for clinical use.
Evaluation of Measurement Uncertainty (MU): Quantitative tests must include documented estimation of measurement uncertainty (MU) to assess reliability and support clinical interpretation.
Biological Reference Intervals and Clinical Decision Limits: Define, document, and periodically review biological reference intervals and clinical decision limits based on current scientific evidence and population relevance.
Documentation of Examination Procedures: Maintain examination procedures in a clearly written, accessible format that aligns with ISO 15189 documentation control and staff competency requirements.
Ensuring the Validity of Examination Results: Ensure the validity of results through internal quality control (IQC), external quality assessment (EQA), and comparability checks across instruments, locations, and personnel.

Post-examination processes

‘Post-examination processes’, covered under clause 7, includes the following.

Reporting of Results: Result reporting must be clear, complete, accurate, and traceable, with critical values promptly communicated for patient safety and decision-making.
Post-examination Handling of Samples: Laboratories must establish and document criteria for post-examination sample storage, retention periods, and disposal to comply with ISO 15189 traceability and biosafety requirements.

Nonconforming work

‘Nonconforming work’, included under clause 7, mandates that laboratories must have clear procedures in place to manage nonconforming work. Nonconforming work includes detecting deviations in processes or test results, evaluating their impact, documenting findings thoroughly, and implementing corrective actions. These measures are vital for maintaining result integrity, ensuring patient safety, and driving continuous quality improvement.

Control of data and information management

‘Control of data and information management’ outlined under clause 7, has sections listed below.

General: Laboratories must implement procedures to protect data integrity, accuracy, and confidentiality.
Authorities and Responsibilities for Information Management: Clearly define and assign roles and responsibilities for managing laboratory information systems (LIS) and manual records to ensure accountability and regulatory alignment.
Information Systems Management: Electronic LIS must be validated, while manual processes must be documented, controlled, and verified. All laboratory information systems must be secured and maintained to guarantee data accessibility, reliability, and traceability.
Downtime Plans: Laboratories must develop and regularly test downtime procedures to ensure operational continuity and availability during LIS or power outages.
Off-site Management: When using external data providers or cloud services, laboratories must verify that these entities meet the requirements of ISO 15189, including data security, confidentiality, and system performance requirements.

Complaints

‘Complaints’, covered under clause 7, includes the following.

Process: Laboratories must establish and document a structured process to receive, investigate, and resolve complaints.
Receipt of Complaint: Upon receiving a complaint, assess its relevance, record the details, acknowledge receipt, and communicate the outcome to the complainant.
Resolution of Complaint: The complaint investigation and resolution process must be performed objectively to ensure impartiality and should not result in any discriminatory actions.

Continuity and emergency preparedness planning

Continuity and emergency preparedness planning, outlined in clause 7, requires laboratories to implement continuity and emergency preparedness plans that safeguard essential services during unexpected disruptions.

Strategies must be regularly tested to verify their effectiveness and ensure that the laboratory can maintain critical functions, protect patient safety, and uphold service reliability in emergencies.

Clause 8 Management System Requirements

Clause 8 of ISO 15189 outlines the management system requirements that medical laboratories must fulfill to ensure consistent quality and compliance.

Clause 8 provides a framework for establishing, implementing, maintaining, and continuously improving a QMS that integrates all operational aspects covered in ISO 15189. Clause 8 encompasses requirements for governance, documentation control, internal evaluations, corrective actions, and improvement initiatives.

Moreover, clause 8 emphasizes the importance of top management involvement in overseeing QMS performance.

General requirements

The general requirements captured under clause 8 are detailed within 3 sections as listed below.

General: Laboratories must operate under a structured quality management system that consistently complies with ISO 15189 general and technical requirements.
Fulfillment of Management System Requirements: The laboratory shall establish a QMS that ensures the effective implementation of policies, procedures, and quality objectives across all operational areas.
Management System Awareness: All personnel must be aware of and understand the quality management system, including their specific responsibilities.

Management system documentation

‘Management system documentation’, covered under clause 8, includes the following.

General: ISO 15189 requires that quality policies and measurable objectives are formally documented and effectively communicated across all levels of the organization to ensure alignment and deployment.
Competence and Quality: Documentation must support the consistent delivery of competent testing and quality outcomes, reinforcing standardized practices and staff accountability.
Evidence of Commitment: Leadership shall provide documented evidence of commitment to the QMS, including the allocation of resources and active participation in quality improvement.
Documentation: The QMS must include or reference all procedures, records, and systems essential for laboratory operations.
Personnel Access: All personnel must have timely access to the QMS documents applicable to their roles to ensure informed and compliant performance of assigned duties.

Control of management system documents

‘Control of management systems documents’ includes the sections below.

General: Laboratories must establish documented procedures for managing and controlling internal and external documents.
Control of Documents: All documents must be formally approved prior to use, regularly reviewed for accuracy, clearly identified with version control, and safeguarded against unauthorized access or modification.

Control of records

Subclauses under the control of records under clause 8 includes the following.

Creation of Records: Records must be generated concurrently with the performance of each laboratory activity to ensure accuracy, traceability, and real-time documentation and provide evidence of conformity to requirements.
Amendment of Records: Any changes made to records must be documented, traceable to the individual making the change, and not obscure the original entry.
Retention of Records: Laboratories must define record retention periods based on legal, clinical, and quality requirements, ensuring that all records remain legible, retrievable, and protected from unauthorized access or deterioration.

Actions to address risks and opportunities for improvement

‘Actions to address risks and opportunities for improvement’, as outlined under clause 8, includes the following.

Identification of Risks and Opportunities for Improvement: Laboratories must proactively identify risks and opportunities for improvement that could impact examination results, patient safety, or quality system performance.
Acting on Risks and Opportunities for Improvement: Identified risks and opportunities must be evaluated, prioritized, and addressed through documented actions integrated into the QMS and monitored for effectiveness.

Improvement

Clause 8, ‘Improvement’, includes the following sections.

Continual Improvement: Laboratories must continually improve the effectiveness of the QMS by using data from audits, risk assessments, performance metrics, and feedback mechanisms.
Laboratory Patients, User, and Personnel Feedback: Input from patients, users, and staff must be collected, reviewed, and used to drive improvements and support patient-centered care.

Nonconformities and corrective actions

‘Nonconformities and corrective actions’, covered under clause 8, is governed by 3 sections listed below.

Actions When Nonconformity Occurs: When a nonconformity occurs, laboratories must take immediate action to correct and contain the issue, investigate the root cause, implement corrective measures to prevent recurrence, and monitor their effectiveness.
Corrective Action Effectiveness: The effectiveness of corrective actions must be evaluated and monitored over time to confirm the resolution of the issue and prevent systemic failure.
Records of Nonconformities and Corrective Actions: All nonconformities, corrective actions, investigations, and evaluations of effectiveness must be thoroughly documented and retained as part of the laboratory’s QMS.

Evaluations

‘Evaluations’, covered under clause 8, includes 3 main sections listed below.

General: Laboratories must periodically evaluate the QMS and laboratory activities to ensure that the requirements of the standard and patients’ needs are met.
Quality Indicators: Quality indicators must be established and continuously monitored, analyzed, and used to assess laboratory performance in critical operational and clinical areas.
Internal Audits: Internal audits must be planned and conducted at regular intervals to confirm the effective implementation of QMS processes and to identify opportunities for corrective actions and improvement.

Management reviews

Clause 8, ‘Management reviews’ includes the sections listed below.

General: Top management must review the QMS at planned intervals.
Review Input: Review inputs must include results from internal and external audits, complaints, customer and personnel feedback, quality indicators, non-conformities, and overall performance data.
Review Output: The review must result in documented decisions and action plans related to QMS improvement, resource allocation, and enhancements in laboratory service quality and patient care outcomes.

Additional Requirements for Point-of-Care Testing (POCT)

Annex A of ISO 15189 provides supplemental requirements for POCT, covering diagnostic procedures conducted in close proximity to patients. These diagnostic procedures include clinics, emergency departments, and bedside environments.

The purpose of these requirements is to ensure that POCT achieves the same level of accuracy, quality control, and regulatory adherence as central laboratory testing.

The annex outlines the expectations listed below.

Governance: The organization’s governing body is responsible for monitoring POCT accuracy and quality. Service agreements must define responsibilities between the laboratory and POCT sites.
Quality Assurance Program: A qualified person must be appointed to oversee POCT quality. This role includes ensuring compliance with ISO 15189 requirements as applied to POCT.
Training Program: A designated individual must manage POCT personnel training and competency assessments. The training program must include both theoretical knowledge and practical skills.

What Are the Benefits of Implementing ISO 15189?

The benefits of implementing ISO 15189 are listed below.

Improve Diagnostic Accuracy: Standardized procedures ensure reliable testing, reducing the risk of incorrect results and enhancing patient care quality.
Enhance Laboratory Credibility: Operate within internationally recognized ISO 15189 quality and competence requirements to build trust among stakeholders and accrediting bodies.
Achieve International Recognition: Leverage ISO 15189 certification to gain global acceptance of laboratory results, enabling cross-border patient care and regulatory interoperability.
Implement Effective Risk Management: Identify, assess, and control risks to patients, staff, and the environment to enhance safety and minimize legal exposure.
Align with Regulatory Requirements: Use ISO 15189 as a framework to meet national and regional compliance obligations and strengthen accreditation readiness.
Optimize Operational Efficiency: Define workflows, roles, and controls to reduce errors, retests, and delays, improving cost-effectiveness and service speed.
Foster a Continual Improvement Culture: Apply audits, feedback, and quality indicators to drive ongoing enhancements in laboratory performance and service quality.
Maintain Competent and Qualified Staff: Provide structured training, authorize responsibilities, and conduct regular competence evaluations.
Increase Patient and Customer Satisfaction: Deliver timely, accurate, and confidential results that enhance trust, communication, and patient-centered service.
Reduce Waste and Retesting Costs: Preventing test failures and corrective rework leads to measurable long-term savings and more sustainable operations.

How to Implement ISO 15189?

To implement ISO 15189, the recommended steps are listed below.

Understand the Standard Requirements: Study ISO 15189:2022 in detail to learn the specific clauses and expectations covering quality, competence, risk, and documentation.
Conduct a Gap Analysis: Compare current laboratory practices against ISO 15189 requirements to identify areas that need changes or improvements.
Prepare a Project Plan: Develop a structured implementation plan with a timeline, assign responsibilities, and define milestones to guide the step-by-step alignment with ISO 15189.
Establish a Quality Management System (QMS): Create or update the QMS to align with ISO 15189, including documented procedures, policies, records control, and quality objectives.
Train Personnel: Ensure all staff understand their responsibilities, the requirements of the ISO 15189 standard, and how their work affects quality and compliance.
Validate and Verify Laboratory Methods and Equipment: Perform method verification or validation and confirm equipment calibration and traceability to ensure reliable testing.
Implement Internal Audits: Conduct regular audits to evaluate compliance, identify nonconformities, and measure system effectiveness.
Perform Management Review: Review inputs such as performance data, audit results, complaints, and improvement actions to confirm system suitability and effectiveness.
Correct Identified Issues: Address audit findings and non-conformities with corrective actions, document root causes, and resolutions, and verify effectiveness.
Prepare for Accreditation Assessment: Choose an accreditation body and complete all necessary documentation and readiness activities for the external evaluation.

1. Understand the Standard Requirements

Understanding the standard requirements means thoroughly reviewing ISO 15189 to grasp the structure, scope, and intent behind each clause. This foundational step ensures the laboratory knows precisely what is expected for compliance, covering quality management, technical competence, risk management, and patient safety.

Misinterpretations can result in implementation errors, audit failures, and compromised diagnostic outcomes. Hence, proper implementation of step 1 is essential.

Practical tips to implement step 1 include the following.

Read the entire ISO 15189 standard, not just summaries or checklists.
Use the official clause structure, from Clauses 4 to 8 and Annex A, to guide internal discussions and training.
Refer to annexes for comparisons with previous versions and related standards (e.g., ISO 9001, ISO/IEC 17025).
Use cross-functional teams such as quality, technical, IT, and admin to interpret requirements and map processes.

2. Conduct a Gap Analysis

Conduct a gap analysis by comparing your current laboratory practices, processes, and documentation against the requirements outlined in ISO 15189. This step identifies where your operations fall short and what needs to be developed, changed, or improved to achieve compliance.

Performing a gap analysis is essential because it creates a clear roadmap for implementation. It prevents wasted effort by focusing only on areas that require attention and helps allocate resources more effectively.

Strategic ways for conducting a gap analysis are the following.

Break down ISO 15189 requirements into a checklist format grouped by clauses 4 to 8, and Annex A (if applicable).
Involve staff from quality, technical, and administrative roles to gather accurate information.
Score compliance levels (e.g., compliant, partially compliant, not compliant) to prioritize actions.
Document supporting evidence for each area assessed to track progress over time.

Laboratories fail when gap analysis excludes cross-functional teams and produces incomplete assessments. Treating all gaps equally dilutes the focus on patient safety, diagnostic accuracy, and legal compliance. Gap analysis requires regular updates to reflect changes in laboratory processes or quality management systems.

3. Prepare a Project Plan

Prepare a project plan by outlining the specific actions, responsibilities, deadlines, and resources needed to address the gaps identified during your analysis and achieve ISO 15189 compliance. The plan should define the sequence of implementation steps, assign accountable personnel, and include monitoring mechanisms.

This step is crucial because structured planning helps coordinate efforts across departments, keeps implementation on schedule, and ensures nothing is overlooked. Laboratory risk misalignment, resource shortages, and delays in reaching accreditation readiness can occur without a plan.

Tips on how to prepare a project plan effectively are listed below.

Use a Gantt chart or task management tool to track tasks, owners, and timelines.
Group actions by ISO 15189 clauses to ensure full coverage.
Set clear milestones for major deliverables (e.g., QMS documentation, training, internal audits).
Include buffer time for staff training, equipment validation, and corrective actions.

Common mistakes to avoid include creating only a fixed plan with no built-in review checkpoints or progress tracking. Another is underestimating the time and resources needed for documentation and validation work. Lastly, failing to assign clear ownership for each task leads to accountability gaps.

4. Establish a Quality Management System (QMS)

Establishing a QMS requires implementing documented processes, policies, responsibilities, and records aligned with ISO 15189 requirements. The QMS must address all laboratory operations, including impartiality, sample handling, examination processes, documentation, risk management, and continual improvement.

QMS structure ensures consistent, traceable, and high-quality outcomes across laboratory functions. ISO 15189 compliance depends on QMS integration to support patient safety, diagnostic reliability, and regulatory compliance.

Common strategies to carry out laboratory QMS establishment include the following.

Use ISO 15189 Clause 8 as a structural guide for QMS documentation. Define Quality Policy and measurable quality objectives.
Define standard operating procedures (SOPs) for each key process, from pre-examination to examination and post-examination to support services.
Include document control, record retention, nonconformity handling, and internal audit procedures.
Assign a QMS coordinator to oversee development, maintenance, and staff access to QMS materials.
Consider implementing electronic QMS (eQMS) software to automate document control, training records, and CAPA tracking.

Common mistakes during QMS establishment include using generic QMS templates without adapting them to laboratory-specific processes, which causes misalignment and inefficiency. Overcomplicated documentation reduces clarity, usability, and relevance, thereby limiting its practical application.

5. Train Personnel

Training of personnel ensures staff understand their roles in ISO 15189 implementation and perform tasks in compliance with the QMS. Training includes awareness of requirements, internal procedures, safety protocols, quality, confidentiality, and impartiality responsibilities.

Laboratory quality and competence depend on accurate and consistent staff performance. Well-trained staff help reduce errors, increase efficiency, and directly support compliance and patient safety.

The following are practical ways to implement effective personnel training.

Create role-specific training modules focused on tasks, procedures, and regulatory obligations.
Include initial onboarding, periodic refresher training, and updates when procedures change.
Document all training activities, dates, attendance, and outcomes for audit readiness.
Assess competence through observation, quizzes, or supervised task performance.

Common mistakes to avoid include treating training as a one-time event instead of an ongoing requirement. Another mistake is focusing only on technical skills while neglecting ISO 15189 awareness or quality responsibilities. Failure to evaluate training effectiveness or update records accordingly can also be overlooked.

6. Validate and Verify Laboratory Methods and Equipment

Validate and verify laboratory methods and equipment by confirming that all examination procedures and instruments perform reliably and produce accurate, clinically meaningful results under actual operating conditions. This process includes method validation or verification, equipment calibration, and metrological traceability as required by ISO 15189.

Method validation establishes the performance characteristics of a laboratory-developed, modified, or non-standard method and confirms that it is fit for its intended purpose. Method verification ensures that an established or validated method (typically a standard method) works as expected in a specific laboratory setting.

Step 6 is critical because unvalidated or unverified methods, or poorly calibrated equipment, can lead to erroneous results, compromising patient safety and undermining laboratory credibility. Proper validation and verification ensure testing is fit for intended use, supports clinical decision-making, and meets accreditation requirements.

Practical tips to implement step 6 include the following.

Verify standard methods to confirm the lab can reproduce the manufacturer’s stated performance.
Validate non-standard, modified, or lab-developed methods using objective performance criteria.
Perform routine calibration and function checks on equipment and maintain traceable calibration records.
Document validation and verification results, including performance specifications, data analysis, and reviewer approval.

Laboratories must avoid validation and verification errors to comply with ISO 15189. Using outdated or unvalidated methods without documentation, relying solely on manufacturer data, and failing to revalidate or reverify methods after changes compromises accuracy and safety. Avoiding these issues preserves the integrity of validation and verification processes and supports accreditation readiness.

7. Implement Internal Audits

Implement internal audits by systematically reviewing laboratory processes, documentation, and compliance with ISO 15189. Audits must be planned and cover all QMS areas, including pre-, post-, and examination phases, support services, and management activities.

Internal laboratory audits detect nonconformities early, guide corrective actions, and verify effective QMS implementation. Audits also demonstrate ongoing compliance with accreditation bodies and show the laboratory’s commitment to quality and patient safety.

A strategic approach for implementing internal audits includes the following.

Create an audit schedule covering all ISO 15189 clauses over a defined cycle (typically 12 months).
Use trained, competent auditors who are independent of the area being audited.
Document findings clearly with references to specific clauses and supporting evidence.
Track corrective actions through completion and assess their effectiveness.

Common internal laboratory audit mistakes include treating audits as checklist exercises rather than comprehensive performance evaluations. Another mistake is ignoring minor nonconformities that may indicate systemic issues and failing to close findings or verify the resolution of root causes. Biased audits by auditing one’s own work are also a common mistake. These practices weaken audit effectiveness and risk noncompliance.

8. Perform Management Review

Perform management review by evaluating the QMS at planned intervals to confirm suitability, adequacy, and effectiveness in line with ISO 15189 requirements. The review must include input from audits, quality indicators, nonconformities, complaints, identified risks, feedback, and the outcomes of previous reviews. Management review outputs must be documented and include strategic decisions, action items, and follow-up requirements.

Management review enables leadership to decide on resources, improvements, and strategies. Management review ensures active top management involvement in compliance and continual improvement.

Tips on how to perform a management review effectively are listed below.

Use a structured agenda aligned with ISO 15189 Clause 8.9 to ensure all required inputs and outputs are addressed.
Prepare a summary report that includes decisions, assigned actions, timelines, and follow-up items.
Involve technical, quality, and administrative representatives to provide comprehensive strategies.
Schedule reviews at appropriate intervals (at least annually and more frequently if significant changes or issues arise).

Common mistakes include treating management review as a superficial paperwork exercise without meaningful analysis or action follow-up, omitting input data like EQA results, audits, or complaints, and failing to document and share outputs with relevant personnel.

9. Correct Identified Issues

Correct identified issues by addressing nonconformities found through audits, complaints, or daily operations, including determining root causes, applying corrective and preventive actions, and verifying effectiveness to prevent recurrence.

Unaddressed issues pose serious risks to patient safety, diagnostic accuracy, and regulatory compliance. By rigorously managing corrective actions, laboratories uphold quality standards, reinforce their quality management system, and drive ongoing improvement.

Common ways to correctly identify issues include the following.

Use a structured approach for root cause analysis (e.g., 5 Whys or fishbone diagrams) on issues identified before deciding on actions.
Prioritize issues based on clinical risk, regulatory impact, and frequency.
Track each issue from detection to closure with documented evidence of actions taken.
Check the effectiveness of corrective actions over time.
Integrate corrective action and preventive action (CAPA) management into your QMS software to ensure traceability and accountability.
Treat each nonconformity as an opportunity to improve, not just as a compliance obligation.
Analyze recurring issues to identify system-level weaknesses, not just isolated incidents.

Laboratories must avoid surface-level solutions that fail to address root causes, as this can lead to issue recurrence. Excluding relevant personnel from the resolution process risks overlooking critical factors. Furthermore, prematurely closing corrective actions without verifying effectiveness compromises compliance and quality system integrity.

10. Prepare for Accreditation Assessment

Prepare for accreditation assessment by organizing documentation, verifying ISO 15189 implementation, and ensuring staff readiness for external evaluation. Preparation includes a final internal review, resolution of pending issues, and confirmation that all QMS elements function correctly.

Accreditation assessment confirms compliance, reliability, and competence. A successful assessment secures formal recognition, credibility, and international acceptance of results.

The following provides a practical course of action for accreditation assessment preparation.

Conduct a mock audit using ISO 15189 criteria, simulate assessor interviews, and check for gaps.
Prepare a summary binder or digital folder of key documents for assessors (e.g., organization chart, quality manual, audit plan, SOPs, and records).
Assign a coordinator to communicate with the accreditation body and oversee on-site logistics.
Brief staff on potential questions and expectations during interviews, focusing on operational processes.
Confirm that corrective actions from previous internal audits or management reviews are closed and documented.

Common mistakes to avoid during accreditation assessment preparation include waiting until the last minute to review documentation or resolve issues. Do not focus solely on documents – assessors evaluate implementation and staff understanding. Involve all departments and rehearse the assessment process to ensure full readiness instead of concentrating only on 1-2 departments.

What Is the ISO 15189 Accreditation Process?

The typical 15189 accreditation process is outlined below.

Submitting the Application: Initiate the ISO 15189 accreditation process by submitting an official application and attachments required to a recognized accreditation body.
Undergoing Document Review: The accreditation body evaluates the submitted materials, such as SOPs, quality manuals, audit reports, and performance indicators, against ISO 15189 documentation and control requirements.
Participating in a Pre-Assessment (Optional): An optional pre-assessment helps identify system implementation and readiness gaps, offering laboratories early insights to strengthen compliance before formal evaluation.
Completing the On-Site Assessment: Trained assessors perform a structured site visit, using checklists to observe laboratory operations, interview staff, and review compliance across ISO 15189 clauses.
Addressing Nonconformities: Laboratories must submit a documented corrective action plan with root cause analysis, resolution evidence, and action completion within a specified timeline if any nonconformities are found.
Receiving the Accreditation Decision: Once corrective actions are accepted, the accreditation body issues a formal ISO 15189 certificate confirming that the laboratory operates under internationally accepted quality and competence requirements.
Maintaining Accreditation: Laboratories must undergo regular surveillance assessments, demonstrate ongoing compliance, and continuously improve their QMS, personnel competence, and documentation practices to retain accreditation.

What Is the Difference Between ISO 15189 and ISO/IEC 17025?

The main difference between ISO 15189 and ISO/IEC 17025 lies in their focus. ISO 15189 is specifically designed for medical laboratories, while ISO/IEC 17025 applies to testing and calibration laboratories across all industries.

ISO 15189 sets requirements for quality and competence in medical laboratories that perform tests on human samples to diagnose, treat, and prevent disease. ISO 15189 emphasizes clinical relevance, patient-centered processes, confidentiality, and the provision of advisory services.

In contrast, ISO/IEC 17025:2017 outlines general requirements for the competence of testing and calibration laboratories. It applies to labs in manufacturing, food safety, engineering, environmental testing, and other non-clinical fields, focusing on technical accuracy and traceability.

Key differences between ISO 15189 and ISO 17025 are summarized in the table below.

Aspect	ISO 15189	ISO/IEC 17025
Patient Care	Included (focuses on diagnostic accuracy and impact on patient outcomes)	Not included (no direct link to patient care)
Medical Ethics and Confidentiality	Included (emphasizes patient confidentiality and ethical obligations)	Not included (not applicable to medical context)
Clinical Advisory Roles	Included (defines responsibilities for clinical consultation)	Not relevant (no provision for clinical roles)
Applicability	For medical laboratories	For testing and calibration laboratories across all industries

What Is the Difference Between ISO 15189 and ISO 9001?

The main differences between ISO 15189 and ISO 9001 are their focus and scope of application. ISO 15189 is tailored to medical laboratories with a focus on quality, competence, and patient safety, while ISO 9001 provides a general quality management framework applicable across industries, including those without healthcare-specific requirements.

ISO 15189 defines quality and competence requirements for medical laboratories, focusing on the accuracy of patient test results, laboratory competence, risk management, and clinical effectiveness. ISO 15189 includes technical procedures and patient-related processes such as sample handling, result reporting, and staff qualifications.

On the other hand, ISO 9001 specifies requirements for a general QMS to ensure consistent product or service quality and customer satisfaction. ISO 9001 does not include any sector-specific or technical laboratory requirements.

Key differences between ISO 15189 and ISO 9001 are summarized in the table below.

Aspect	ISO 15189	ISO 9001
Scope	Specific to medical laboratories and diagnostic services	General, applicable to all industries (non-sector-specific)
Patient safety and clinical risk	Explicitly covered, including clinical validity and risk to patients	Not covered; focuses on product/service quality and customer satisfaction
Use in accreditation	Used for medical laboratory accreditation	Used for general QMS certification

How Does Quality Management Software Support ISO 15189 Compliance?

Quality management software for laboratories supports ISO 15189 compliance by automating, standardizing, and documenting all required quality processes. From document control to risk management, an eQMS centralizes activities and supports real-time decision-making, ensuring alignment with ISO 15189 clauses across the entire laboratory operation.

The benefits of medical laboratory QMS software are listed below.

Centralize Document Control and Version Management: Ensure SOPs, policies, and records are controlled with approval workflows, version control logs, and audit trails.
Automate Training and Competency Tracking: Implement a training matrix linked to employee roles, tracking training assignments, completions, and assessments.
Manage Internal Audits and Accreditation Preparation: Use built-in templates and scheduling tools to conduct internal audits, generate real-time audit trails, and prepare evidence for external accreditation assessments.
Streamline Nonconformance and CAPA Processes: Enable laboratories to report nonconformities, assign root cause investigations, and monitor corrective and preventive actions (CAPAs).
Enable Risk-Based Decision Making: Integrate tools to support risk identification, assessment, and mitigation and ensure compliance with ISO 15189 risk management principles.
Ensure Personnel Role-Based Access and Traceability: Assign document and task access based on user roles, maintaining data integrity and traceability.
Support Continual Improvement and Performance Monitoring: Track quality indicators, trends, and recurring issues to support a continuous improvement loop enhancing service delivery and system reliability.

SimplerQMS offers comprehensive medical laboratory QMS software tailored for medical laboratories aiming to achieve and maintain ISO 15189 compliance. SimplerQMS integrates essential QMS functions, including documentation control, training, audit management, risk management, and CAPA processes, into a unified, cloud-based platform. SimplerQMS is fully validated according to GAMP5 requirements. SimplerQMS ensures regulatory readiness and supports scalability, making it a reliable solution for laboratories of varying sizes and complexity.