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ISO 15189

ISO 15189:2022 is an international standard developed and published by the International Organization for Standardization (ISO) that specifies requirements for quality and competence in medical laboratories.^[1] It provides a framework for laboratories to establish and maintain management systems that ensure accurate, reliable, and timely diagnostic services, applicable to all types of medical laboratories including those performing point-of-care testing (POCT).^[1] The standard is used not only for internal development and self-assessment but also by laboratory users, regulatory authorities, and accreditation bodies to confirm or recognize a laboratory's competence.^[1] The development of ISO 15189 began under ISO Technical Committee 212 (ISO/TC 212), with the first edition published in 2003, followed by revisions in 2007 and 2012, and the current fourth edition in December 2022.^[1] It integrates quality management principles from ISO 9001 with technical competence requirements from ISO/IEC 17025, adapted specifically for the unique needs of medical laboratories to address patient safety and clinical outcomes.^[2] By 2013, the standard had been adopted by medical laboratories in over 60 countries; as of 2025, it is implemented in over 100 countries through accreditation bodies signatory to the International Laboratory Accreditation Cooperation (ILAC), with thousands of laboratories accredited worldwide.^[3]^[4] Key requirements in ISO 15189:2022 are organized into eight main clauses, beginning with general requirements for impartiality and confidentiality, followed by structural and governance aspects such as the role of the laboratory director and organizational setup.^[5] Clause 6 addresses resource requirements, including personnel qualifications, equipment validation, and facility conditions to ensure competent operations.^[5] Process requirements in Clause 7 cover the full lifecycle of laboratory activities—from pre-examination (e.g., sample collection and handling) through examination (testing and analysis) to post-examination (reporting and release of results)—with an emphasis on risk-based approaches.^[5] Finally, Clause 8 mandates a comprehensive quality management system (QMS), including internal audits, management reviews, and continual improvement to mitigate risks and enhance efficiency.^[5] Accreditation to ISO 15189 verifies a laboratory's integrity, impartiality, and technical competence across disciplines such as clinical biochemistry, hematology, microbiology, histopathology, immunology, genetics, andrology, and histocompatibility & immunogenetics.^[6] This accreditation process, conducted by bodies like the United Kingdom Accreditation Service (UKAS), demonstrates compliance through rigorous assessments and supports the delivery of reliable test results essential for diagnosis, treatment monitoring, and public health.^[6] Ultimately, adherence to the standard fosters confidence in laboratory services, reduces errors, and aligns with international regulations to improve patient safety and healthcare outcomes.^[7]

Overview

Definition and Purpose

ISO 15189 is the international standard titled "Medical laboratories — Requirements for quality and competence," developed by Technical Committee ISO/TC 212 of the International Organization for Standardization (ISO).^[1]^[8] This standard specifies requirements that medical laboratories must meet to demonstrate their competence in performing examinations on materials derived from the human body, such as for diagnosis, screening, monitoring, or treatment of disease, or for assessing health status.^[1]^[9] The primary purpose of ISO 15189 is to promote the welfare of patients and satisfaction of laboratory users by building confidence in the quality and competence of medical laboratories.^[10] It establishes criteria for laboratories to integrate quality management systems (QMS) that ensure reliable test results, thereby supporting patient safety and positive clinical outcomes.^[1] Key objectives include fostering consistent laboratory practices worldwide to enhance accurate diagnostics and patient care, while incorporating risk-based thinking to identify and mitigate potential issues in laboratory processes.^[11]^[1] At its core, ISO 15189 is based on the quality management principles of ISO 9001 and the competence requirements of ISO/IEC 17025, but it is specifically tailored to the medical laboratory context.^[12] This adaptation emphasizes aspects unique to healthcare, such as ethical considerations in patient interactions, the clinical relevance of test results, and the full continuum of pre-examination, examination, and post-examination processes.^[1] By aligning with these frameworks, the standard enables laboratories to develop robust systems for self-assessment and external recognition of their competence.^[13]

Scope and Applicability

ISO 15189 specifies requirements for quality and competence in medical laboratories, applicable to all such facilities regardless of size, number of personnel, or the extent of their testing scope.^[1] This includes laboratories in health facilities, clinics, or those associated with other healthcare organizations, encompassing specialties such as clinical chemistry, hematology, microbiology, pathology, and immunology.^[6] The standard covers the full spectrum of laboratory activities, including pre-examination processes (such as specimen collection and handling), examination procedures (testing and analysis), and post-examination phases (result reporting and release).^[1] The standard is intended for medical laboratories that perform examinations on human samples to provide information for health assessment, diagnosis, prevention, or treatment of disease, including the management of in vitro diagnostic activities and non-conformities.^[1] It supports the development of management systems, self-assessment of competence, and external confirmation of competence by users, regulatory authorities, and accreditation bodies.^[1] Point-of-care testing (POCT) sites are explicitly included, ensuring consistent quality across decentralized testing environments.^[1] ISO 15189 does not apply to non-medical testing laboratories, such as those focused on environmental, food, or industrial analysis, nor to non-laboratory medical services like imaging or surgery.^[13] Globally, accreditation to ISO 15189 is recognized under the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement, enabling mutual acceptance of laboratory results across signatory bodies and promoting international trade and patient safety.^[14]

History

Initial Development

The development of ISO 15189 originated in the late 1990s through the efforts of the International Organization for Standardization's Technical Committee 212 (ISO/TC 212), focused on clinical laboratory testing and in vitro diagnostic test systems, which was proposed and established in 1995 by the National Committee for Clinical Laboratory Standards (now Clinical and Laboratory Standards Institute, CLSI) to promote global harmonization of laboratory practices.^[15]^[8] This initiative responded to the increasing globalization of healthcare, where standardized quality assurance in medical laboratories became essential to ensure consistent, reliable diagnostic services across borders amid rapid technological advancements in testing methodologies.^[15]^[16] The primary motivations for creating ISO 15189 were to bridge limitations in broader standards like ISO 9001:2000, which addressed general quality management systems, and ISO/IEC 17025:1999, tailored to testing and calibration laboratories, by integrating medical laboratory-specific requirements such as the protection of patient rights, ethical considerations in sample handling, and the clinical validity of test results to directly support patient care outcomes.^[16] These gaps highlighted the need for a dedicated framework that not only ensured technical competence but also aligned with regulatory demands, client expectations, and the unique ethical imperatives of healthcare environments, fostering trust in laboratory results worldwide.^[16]^[15] Key milestones included the commencement of drafting under ISO/TC 212's Working Group 1 on quality management in the clinical laboratory around the late 1990s, with intensive international collaboration leading to the standard's approval by December 2000.^[17]^[15] The first edition, ISO 15189:2003, was published in February 2003, emphasizing requirements for quality management systems and competence specifically for medical laboratories.^[18] This document was developed with contributions from international experts, including those affiliated with CLSI (a WHO Collaborating Center since 1985) and regional accreditation organizations, to achieve broad harmonization and applicability.^[15]^[16]

Major Revisions

The ISO 15189 standard has undergone several revisions since its initial publication to address evolving needs in medical laboratory quality and competence. The 2007 edition represented a minor technical update aimed at enhancing alignment with the contemporaneous ISO/IEC 17025:2005 standard for testing and calibration laboratories.^[19] This revision clarified requirements for personnel competence, including verification of qualifications and ongoing training, and introduced initial guidance on risk management to support laboratory decision-making processes.^[20] These changes were driven by the need for greater harmonization across ISO standards, ensuring consistency in competence assessment without major structural overhauls.^[21] A more substantial revision occurred with the 2012 edition, which marked a major overhaul to adopt a high-level structure compatible with ISO 9001:2008 for quality management systems and ISO/IEC 17025:2005.^[13] This restructuring emphasized a process approach to laboratory operations, integrating management and technical requirements more fluidly, and expanded coverage of pre- and post-examination phases to better encompass the full laboratory workflow.^[12] Enhancements to personnel training requirements included explicit provisions for continuing education and competency evaluation, reflecting user feedback on the need for robust staff development in clinical settings.^[22] The update was motivated by harmonization efforts with broader ISO frameworks and responses to practical implementation challenges identified by laboratories worldwide.^[23] The most recent edition, ISO 15189:2022, published on December 6, 2022, as the fourth edition, further refined the standard over a four-year development process involving global stakeholders such as laboratory managers, regulators, and accreditation experts.^[24] Key emphases include patient-centered care, the integration of point-of-care testing (POCT) requirements previously outlined in the separate ISO 22870:2016 standard, and a stronger focus on risk-based thinking to identify and mitigate opportunities and threats throughout laboratory processes.^[25] Updates to clauses 4 through 10 address modern challenges, such as the incorporation of digital tools for data management and cybersecurity risks within equipment and information system controls.^[1] These revisions were propelled by user feedback, technological advances like the growth of POCT and automation, and the need for alignment with updated ISO standards including ISO 9001:2015 and ISO/IEC 17025:2017.^[26] Laboratories accredited under prior editions typically have a transition period of 2 to 3 years to adopt the new version, with the current cycle extending until December 2025 to facilitate compliance.^[27]

Structure and Requirements

Overall Framework

ISO 15189:2022 follows a structure aligned with ISO/IEC 17025:2017, comprising 8 main clauses that integrate quality management with technical competence for medical laboratories, while incorporating requirements from ISO 22870:2016 for point-of-care testing (POCT). Clauses 1 through 3 cover the scope, normative references, and terms and definitions, establishing the foundational elements of the standard. Clauses 4 through 8 then address the core requirements: general requirements (Clause 4), structural and governance requirements (Clause 5), resource requirements (Clause 6), process requirements (Clause 7), and management system requirements (Clause 8). This structure ensures a systematic approach to quality management while emphasizing technical competence in laboratory operations.^[1] The normative sections of the standard, specifically Clauses 4 to 8, are mandatory for achieving compliance and form the backbone of the quality management system (QMS). These clauses require laboratories to integrate QMS principles with technical processes, such as risk-based planning, resource allocation, operational controls, and ongoing evaluation, to ensure reliable and competent medical testing services. By mandating this integration, the framework promotes a unified system where management responsibilities support and enhance technical performance, reducing silos and fostering accountability across the laboratory.^[1]^[28] In addition to the main clauses, ISO 15189:2022 includes Annex A (normative), which provides additional requirements for point-of-care testing (POCT) to address unique challenges in decentralized testing environments. Informative Annex B offers a comparative table between ISO 15189:2022 and ISO 9001:2015 to aid in understanding overlaps with general quality management principles. Risk management, aligned with ISO 22367, is integrated into Clauses 5.6 and 8.5, while metrological traceability of measurements, including references to validation processes for ensuring measurement accuracy and reliability, is required in Clause 6.5.^[1]^[29] The overall integration approach in ISO 15189:2022 combines a robust QMS with demonstrable technical competence through a process-based model. This model encourages continual improvement via the Plan-Do-Check-Act (PDCA) cycle, embedded across the clauses, allowing laboratories to identify risks, monitor performance, and adapt to changing needs in healthcare delivery. By structuring requirements this way, the standard supports laboratories in delivering high-quality results that enhance patient safety and trust in diagnostic services.^[1]^[30]

Management Requirements

The management requirements of ISO 15189:2022, detailed primarily in Clauses 4, 5, and 8, establish the foundational elements of a quality management system (QMS) for medical laboratories, emphasizing organizational structure, leadership, governance, and management system operations to ensure impartiality, ethical conduct, and sustained quality in patient care. These clauses require laboratories to demonstrate commitment to objectivity and confidentiality while addressing the needs of interested parties, such as patients and clinicians, through systematic processes that integrate feedback and risk mitigation.^[1]^[29] Clause 4 focuses on general requirements, mandating impartiality, confidentiality, and specific considerations for patients, including clear information, informed consent, patient rights, and feedback mechanisms such as complaint handling. Laboratories must implement safeguards against conflicts of interest and ensure personnel are trained on legal and ethical responsibilities for data protection.^[29]^[31] Clause 5 addresses structural and governance requirements, including the laboratory's legal entity status, the role and competence of the laboratory director (who holds ultimate responsibility for QMS and risk management), organizational structure and authority, objectives aligned with interested parties' needs, and policies promoting ethical conduct and continual improvement. The director may delegate tasks but must oversee risk mitigation to protect patient safety.^[29] Clause 8 outlines management system requirements, including documentation, control of documents and records, actions to address risks and opportunities, improvement processes, handling of nonconformities and corrective actions, evaluations (such as internal audits at planned intervals by impartial auditors, prioritizing high-risk areas), and regular management reviews using inputs like audit results, patient feedback, and performance indicators to ensure QMS suitability and drive continual improvement. Nonconformity handling requires immediate response, root cause analysis, and risk-proportional corrective actions, with records maintained for trend analysis.^[29]^[31] Support mechanisms in Clause 6.1 and planning in Clause 5.6 further bolster these by requiring resources for personnel competence, awareness, communication, and documented information, with ongoing training on ethical practices and integration of patient feedback into risk-based planning.^[29]

Technical Requirements

The technical requirements of ISO 15189:2022, outlined in Clauses 6 and 7, establish operational standards to ensure the competence, accuracy, and reliability of medical laboratory activities, focusing on resources and processes that directly impact patient care. These requirements emphasize risk-based approaches to pre-examination, examination, and post-examination phases, integrating quality assurance measures to minimize errors and maintain traceability. Clause 6 addresses resource elements such as personnel, premises and equipment, while Clause 7 details the core laboratory processes; performance evaluation, including internal quality control and external quality assessment, is integrated in Clause 7.3.7 and broader evaluations in Clause 8.8.^[1]^[32] Personnel qualifications and training, specified in Clause 6.2, require laboratories to employ sufficient staff with appropriate education, experience, and demonstrated competence for their roles, including ongoing training to address evolving needs. Competence must be assessed through methods like direct observation and record review, with authorization limited to qualified individuals and records maintained for all training and evaluations.^[33] Premises and environmental conditions under Clause 6.3 must support laboratory operations without compromising result validity or safety, including monitoring of factors like temperature, ventilation, and lighting, as well as controls for biological hazards such as containment systems and decontamination protocols.^[34] Equipment validation and maintenance in Clause 6.4 mandate selection based on specifications, initial verification testing, and regular calibration traceable to national or international standards, with documented schedules for preventive maintenance and incident reporting to prevent failures. Clause 6.5 specifically requires metrological traceability for measurements.^[29] Pre-examination processes in Clause 7.2 cover sample collection, receipt, identification, and initial handling to preserve integrity, requiring documented procedures for transportation, storage conditions, and patient instructions, including consent for collection. Examination procedures in Clause 7.3 require validation of non-standard methods and verification of standard ones to confirm suitability for clinical use, including estimation of measurement uncertainty for quantitative assays and ensuring metrological traceability of results to the International System of Units (SI) or certified reference materials where applicable. Quality assurance during examination incorporates method selection aligned with clinical needs and ongoing monitoring to detect systematic errors.^[5] ^[35] Post-examination processes in Clause 7.4 focus on result release and storage, mandating timely, secure reporting with clear identification of the patient, test, and interpretive comments where relevant, along with protocols for notifying critical values to authorized recipients. Laboratories must define retention periods for records and samples based on regulatory and clinical requirements, ensuring retrievability and protection against loss or unauthorized access. Additional process elements in Clause 7 include handling nonconforming work (7.5), data and information management (7.6), complaints (7.7), and continuity/emergency planning (7.8).^[31] Competence assurance relies on performance evaluation integrated throughout, particularly through internal quality control (IQC) in 7.3.7 to monitor examination precision using control materials and statistical tools like standard deviation indices, and external quality assessment (EQA) or proficiency testing to compare results with peers and verify accuracy. These measures ensure result reliability by identifying and correcting deviations, with participation in relevant EQA programs required unless unavailable, in which case alternative comparisons must be used. Broader evaluations, including internal audits, are covered in Clause 8.8.^[36] ^[37]

Accreditation and Implementation

Accreditation Bodies and Process

Accreditation bodies for ISO 15189 are independent organizations that evaluate and recognize the competence of medical laboratories against the standard's requirements. These bodies must themselves comply with ISO/IEC 17011, which outlines general requirements for their operations, ensuring impartiality and consistency in assessments.^[14] Internationally, they are recognized through the International Laboratory Accreditation Cooperation (ILAC) and its Mutual Recognition Arrangement (MRA), while regionally, networks such as the Asia-Pacific Accreditation Cooperation (APAC, formerly APLAC) and the Inter American Accreditation Cooperation (IAAC) facilitate harmonized practices.^[38]^[39] Representative examples include the American Association for Laboratory Accreditation (A2LA) in the United States, the United Kingdom Accreditation Service (UKAS) in the UK, and the National Association of Testing Authorities (NATA) in Australia, each offering ISO 15189 accreditation programs tailored to medical testing laboratories.^[40]^[6]^[41] The accreditation process begins with a laboratory's application to a recognized body, followed by a document review to verify compliance with ISO 15189 clauses 4 through 8, which cover general, structural, resource, process, and management requirements. An on-site assessment then occurs, involving audits by qualified assessors who examine the laboratory's operations, personnel, equipment, and procedures to confirm competence in delivering accurate results.^[42] Any identified nonconformities must be addressed through corrective actions, after which the accreditation body grants accreditation if satisfied, defining the scope to specific tests, methods, or services such as point-of-care testing (POCT) or comprehensive laboratory analyses.^[43] Post-accreditation, ongoing surveillance ensures continued compliance, typically involving annual or biennial monitoring audits that review selected aspects of the laboratory's quality management system and technical operations.^[44] Full re-assessments occur every three years, encompassing a comprehensive evaluation similar to the initial process to renew accreditation and update the scope as needed.^[45] The ILAC MRA enables global mutual recognition among signatory accreditation bodies, meaning results from ISO 15189-accredited laboratories are accepted internationally without further verification, thereby supporting cross-border healthcare delivery and reducing redundant testing.^[14] This arrangement, involving over 100 signatories, promotes trust in medical laboratory outcomes worldwide by confirming the equivalence of accreditation processes.^[46]

Compliance Steps

Achieving ISO 15189 compliance requires laboratories to undertake a structured internal process to align their operations with the standard's requirements for quality and competence. The preparation phase begins with a comprehensive gap analysis, where the laboratory assesses its current practices against the clauses of ISO 15189:2022 to identify discrepancies in areas such as management systems, resource allocation, and process controls.^[5]^[47] This analysis is typically conducted by a cross-functional team, including laboratory leadership and quality personnel, to ensure a thorough evaluation. Following the gap analysis, laboratories develop a quality management system (QMS) policy and set measurable objectives that reflect the standard's emphasis on continual improvement and patient safety. Responsibilities are then assigned, often designating a quality manager to oversee the integration of these elements into daily operations.^[5]^[43] Implementation involves documenting procedures that cover all relevant clauses, ensuring that every aspect of laboratory activities—from pre-examination to post-examination processes—is addressed with clear, standardized protocols. Staff training is essential, focusing on competency assessment, ethical considerations, and the use of validated methods to maintain accuracy and reliability in testing.^[5]^[47] Laboratories must validate processes, such as method verification for analytical equipment, and incorporate risk assessments to mitigate potential errors. Internal audits are conducted to verify adherence, followed by management reviews that analyze performance data, including key performance indicators (KPIs) like turnaround times and error rates, to drive refinements. Pilot testing of procedural changes allows laboratories to identify and resolve issues before full rollout.^[43]^[48] The entire implementation timeline typically spans 6 to 18 months, influenced by the laboratory's size, existing infrastructure, and complexity of operations; smaller facilities may achieve readiness in 6-12 months, while larger ones require up to 18 months for thorough integration.^[49]^[5] Maintenance of compliance demands ongoing vigilance through continual monitoring using KPIs to track QMS effectiveness and promptly address non-conformities via root cause analysis and corrective actions. Regular internal audits and management reviews ensure sustained adherence, with laboratories preparing for periodic external evaluations as part of their internal cycle. Transitioning to new editions of the standard, such as from ISO 15189:2012 to 2022, generally occurs within a 2-3 year window to allow for systematic updates to policies and procedures.^[5]^[29]^[28]

Impact and Comparisons

Benefits and Challenges

Adopting ISO 15189 accreditation offers several key benefits to medical laboratories, primarily by enhancing operational efficiency and reliability. The standard promotes improved accuracy in diagnostic testing and faster turnaround times through standardized processes that minimize variability in pre-analytical, analytical, and post-analytical phases.^[50] For instance, implementation of ISO 15189 has been shown to streamline workflows, reducing delays in reporting results and enabling more timely clinical decisions.^[51] A core advantage is the enhancement of patient safety via substantial error reduction. Accreditation fosters a culture of risk management and continual improvement, which directly lowers the incidence of laboratory errors that could lead to misdiagnoses or inappropriate treatments. Studies evaluating external quality assessment results in accredited laboratories have demonstrated significant declines in error rates; for example, one long-term analysis of immunohaematology testing in Austria found errors dropping from 1.3% to 0.7% following ISO 15189 implementation, representing a roughly 46% reduction.^[52] This aligns with broader evidence that accreditation systems like ISO 15189 reduce error rates in various testing domains, thereby safeguarding patient outcomes.^[50] ISO 15189 also boosts staff competence and morale by mandating structured training programs, proficiency assessments, and a non-punitive approach to error reporting. These elements empower laboratory personnel with clear roles, ongoing professional development, and a sense of contribution to quality goals, leading to higher engagement and reduced burnout.^[53] Furthermore, the standard facilitates regulatory compliance by aligning laboratory practices with national and international legal requirements, while conferring global credibility that supports cross-border recognition of test results.^[54] In regions where accreditation is mandatory, such as France and Hungary, it ensures seamless integration with healthcare systems and enhances trust among stakeholders.^[5] Despite these advantages, implementing ISO 15189 presents notable challenges, particularly for resource-constrained facilities. High initial costs for training, documentation, and system upgrades pose a significant barrier, encompassing consultant fees, staff development, and process redesign.^[55] Small laboratories and point-of-care testing (POCT) sites face amplified difficulties due to limited infrastructure, high workloads, and insufficient personnel, making full compliance resource-intensive and potentially disruptive to daily operations.^[56] Ongoing audit requirements add to the burden, requiring regular internal reviews and external assessments that demand dedicated time and expertise, often straining staff in under-resourced settings. Resistance to change in established legacy systems is another common obstacle, as shifting from informal practices to a formalized quality management system can encounter pushback from personnel accustomed to traditional workflows.^[57] In developing contexts, such as Ethiopian government hospitals, challenges like inadequate management support and training gaps further complicate adoption.^[58] Globally, ISO 15189 has seen widespread adoption, with accreditation programs active in over 80 countries as of 2025, contributing to improved clinical outcomes such as fewer misdiagnoses through enhanced diagnostic reliability.^[59] This broad implementation underscores its role in elevating laboratory standards worldwide, though challenges like costs and audits can be mitigated via phased rollouts that prioritize critical areas before full integration.^[53] ISO 15189 serves as a specialized adaptation of ISO/IEC 17025, which establishes general requirements for the competence of testing and calibration laboratories across various fields.^[60] While ISO/IEC 17025 focuses on technical proficiency in testing and calibration without sector-specific emphases, ISO 15189 tailors these principles to medical laboratories by incorporating elements such as ethical considerations for patient care, clinical correlation of results, and comprehensive coverage of pre-examination, examination, and post-examination processes.^[7] Notably, ISO/IEC 17025 does not explicitly address pre- and post-examination phases or prioritize point-of-care testing (POCT), whereas ISO 15189 mandates requirements for these to ensure continuity in patient safety and operational efficiency.^[7] ISO 15189 builds upon the quality management system (QMS) foundation of ISO 9001, integrating its core principles while adding technical competence criteria unique to medical laboratories, such as validation of examination procedures and personnel qualifications for clinical relevance.^[60] It also integrates risk management practices from ISO/TS 22367, a technical specification for reduction of error through risk management in medical laboratories, by requiring laboratories to identify, evaluate, and mitigate risks throughout the testing process to protect patients and ensure result reliability.^[61] Additionally, ISO 15189 complements ISO 22870, a standard specifically for POCT requirements, which was designed for use in conjunction with ISO 15189 to address decentralized testing environments; the 2022 edition of ISO 15189 has now incorporated these POCT elements directly, replacing ISO 22870.^[62] For harmonization across standards, ISO 15189:2022 adopts the high-level structure outlined in Annex SL of the ISO/IEC Directives, aligning its clauses with those in ISO 45001 for occupational health and safety management systems, which facilitates integrated implementation in laboratories handling multiple compliance needs.^[63] In the United States, ISO 15189 is often used alongside guidelines from the Clinical and Laboratory Standards Institute (CLSI), which provides practical harmonization for quality control, risk assessment, and laboratory operations under ISO/TC 212 oversight.^[64] In summary, ISO 15189 distinguishes itself by prioritizing clinical relevance, including stricter rules for personnel training in result interpretation and ethical patient interactions, over the general testing focus of ISO/IEC 17025, thereby enhancing synergies with complementary standards for comprehensive laboratory quality assurance.^[60]

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A2LA's Clinical Testing Program combines ISO 15189 & CLIA requirements for quality. Explore our clinical testing laboratory accreditation services here.
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Human Pathology ( ISO 15189 ) Laboratory Accreditation - NATA
ISO 15189 is an international standard for medical lab quality, ensuring testing validity. Accreditation covers all pathology testing areas, including pre, ...
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9 Steps to A2LA Accreditation: ISO 15189:2022
Jul 8, 2024 · In this infographic, we've broken down the process of achieving A2LA ISO 15189:2022 accreditation into 9 steps. Learn more here.Missing: regional network
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CAP 15189 Accreditation Process | College of American Pathologists
Dec 6, 2022 · The CAP 15189 process includes application, desk review, internal audit, gap assessment, on-site assessment, addressing nonconformances, and ...
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Maintaining ISO 15189:2022 Accreditation – Surveillance Visits
Oct 17, 2025 · A surveillance visit is your accreditation body's way of checking that your laboratory is still doing what it promised to do when it earned its ...
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After initial certification, organizations must undergo annual surveillance audits in years one and two, followed by a complete recertification audit in year ...
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Signatory Search - International Laboratory Accreditation Cooperation
Use this directory to find an accreditation body in the economy where you require the calibrations, testing or inspections to be carried out.<|control11|><|separator|>
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ISO 15189: Everything You Need to Know | SafetyCulture
May 17, 2024 · How to Get ISO 15189 Certification · Step 1: Develop and Implement a QMS · Step 2: Read More About the ISO Standard · Step 3: Perform Gap Analysis.What is ISO 15189? · What are the Benefits of... · How to Get ISO 15189...<|control11|><|separator|>
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Homepage | Laboratory Quality Stepwise Implementation tool
Phase 1: Ensuring that the primary process of the laboratory operates correctly and safely · Phase 2: Controlling and assuring quality and creating traceability ...Questions on how it works? · Download · User Instructions · Roadmap Phase 1
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ISO 15189 2022 Accreditation Timeline: How Long It Takes and Why
Sep 24, 2025 · Q1: How long does ISO 15189:2022 accreditation really take from start to finish? A: For most labs, between 6 and 12 months—depending on your ...
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Accreditation of Medical Laboratories – System, Process, Benefits ...
The accreditation of labs improves facilitation of accurate and rapid diagnostics, efficiency of treatment and reduction of errors in the laboratory process.
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(PDF) Evidence for the positive impact of ISO 9001 and ISO 15189 ...
Apr 20, 2023 · Statistically significant error reductions were seen upon ISO 9001/ISO 15189 implementation (1.3% before vs. 0.7% after; p=0.0468).Missing: studies | Show results with:studies
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International Organization for Standardization (ISO) 15189 - PMC
It applies to all divisions of a medical laboratory, regardless of the services it provides or the way it is organized; the standard is as relevant in a full- ...
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Feb 14, 2023 · ISO 15189:2022 – Medical Laboratories is an international standard that specifies the requirements for quality and competence in medical lab environments.
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The Hidden Laboratory Setup Cost: A Comprehensive Guide
Jan 4, 2025 · Example: ISO 15189 annual renewal fees in the US can range from $2,000 to $5,000, depending on the laboratory size and scope. Audits and ...
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Barriers to Implementation of Quality Management Systems in ...
Jun 20, 2024 · Knowledge of LQMS by laboratory staff and laboratory management, infrastructure, workload, and management support were potential barriers to the successful ...
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Top Challenges Faced by Labs Seeking Accreditation
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Survey-Defined and Interview-Elicited Challenges That Faced ...
Jul 10, 2018 · The survey and interviews specified nine major challenges for Ethiopian government hospital laboratories that seriously obstruct meeting ISO 15189 demands.
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Jun 2, 2016 · ISO 15189 is the medical laboratory version of ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories).
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Mar 17, 2020 · ... 14971 for risk management in medical ... It is also a key requirement of ISO 15189 for the quality and competence of medical laboratories.
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ISO 22870:2016 - Point-of-care testing (POCT) — Requirements for ...
ISO 22870:2016 gives specific requirements applicable to point-of-care testing and is intended to be used in conjunction with ISO 15189.
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ISO15189:2022 | Medical laboratories - Requirements for ... - CLSI
ISO. Add to Cart. $155.00. Sign into view exclusive member pricing. CLSI EP19. A Framework for Using CLSI Documents to Evaluate Medical Laboratory Test Methods.