EN 14136:2004
(Main)Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to:
- scheme design and organisation;
- identification of procedures (IVD MDs) used by the participant;
- classification and evaluation of data.
NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs.
This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.
Verwendung externer Qualitätssicherungsprogramme bei der Bewertung der Durchführung von Untersuchungsverfahren in der In-vitro-Diagnostik
Diese Europäische Norm gilt für externe Qualitätssicherungsprogramme, nachfolgend als EQAS (External Quality Assessment Schemes) bezeichnet, die in ihre Funktionen die Beurteilung und Bewertung der Leistung bestimmter in vitro diagnostischer Verfahren (einschließlich der In vitro Diagnostika, nachfolgend als IVD bezeichnet) einbeziehen. Sie legt die Anforderungen dar, die erforderlich sind, damit die EQAS diese Funktion in Beziehung auf Folgendes erfüllen können:
¾ die Struktur und die Organisation des Programms;
¾ die Identitätsfestlegung der vom Teilnehmer verwendeten Verfahren bzw. IVD;
¾ die Gliederung und Bewertung der Daten.
ANMERKUNG Die entsprechend diesen Kriterien gewonnenen externen Qualitätssicherungsdaten helfen Herstellern, Anwendern oder zuständigen Behörden, die Leistung von IVD nach deren Markteinführung unabhängig zu überwachen.
Diese Europäische Norm legt weder die Art und Weise fest, nach denen die EQAS ihrerseits organisiert werden, noch wie die einzelne oder gemeinsame Leistung klinischer Laboratorien bewertet wird.
Utilisation des programmes d'évaluation externe de la qualité dans l'évaluation de la performance des procédures de diagnostic in vitro
La présente Norme européenne s'applique aux programmes d'évaluation externe de la qualité, désignés ci-après PEEQ, qui incluent dans leurs fonctions l'évaluation de la performance de procédures spécifiées de diagnostic in vitro (y compris les dispositifs médicaux de diagnostic in vitro, désignés ici DM DIV). Elle établit les exigences nécessaires pour permettre aux PEEQ de remplir cette fonction, relatives à :
¾ la conception et l'organisation du programme ;
¾ l'identification des procédures (DM DIV) utilisées par le participant ;
¾ la classification et l'évaluation des données.
NOTE Les données d'évaluation externe de la qualité générées selon ces critères peuvent aider les fabricants, les utilisateurs et les autorités compétentes à contrôler de manière indépendante la performance post-commercialisation des DM DIV.
La présente Norme européenne ne précise pas la manière dont les PEEQ sont eux-mêmes organisés, ni comment la performance individuelle ou collective des laboratoires d'analyses de biologie médicale est évaluée.
Uporaba shem zunanje ocene kakovosti za oceno delovanja postopkov diagnostičnih preiskav in vitro
General Information
Overview
EN 14136:2004 is a European Standard developed by CEN focusing on the use of External Quality Assessment Schemes (EQAS) in evaluating the performance of in vitro diagnostic examination procedures (IVD MDs). This standard sets out essential requirements for EQAS to effectively assess and monitor the post-marketing performance of specific in vitro diagnostic medical devices. It emphasizes scheme design, proper identification of diagnostic procedures, and robust data classification and evaluation.
By following EN 14136:2004, EQAS organizations can support manufacturers, users, and regulatory authorities in independently monitoring IVD MDs. However, the standard does not dictate how EQAS are organized nor how clinical laboratories' performance is evaluated collectively or individually.
Key Topics
Scope and Purpose
EN 14136:2004 applies to EQAS that evaluate specific in vitro diagnostic procedures and devices. The goal is to provide independent performance data to ensure the ongoing quality and reliability of diagnostic tests.Scheme Design and Organization
The standard highlights the importance of well-planned EQAS designs, including frequency of surveys (recommended at least six times per year), usage of survey samples closely simulating clinical specimens, and requirements for rapid data processing and clear reporting.Identification of Diagnostic Procedures
EQAS must be able to clearly identify the specific IVD medical devices used by participants and distinguish device-related performance from user-related factors. This enables targeted evaluation of analytical procedures.Data Classification and Evaluation
Statistical methods appropriate for the diagnostic property being tested must be applied. EQAS organizations should report central tendencies, dispersion measures, and provide performance interpretation based on manufacturer claims, applicable metrological standards, and medical relevance.Performance Assessment
Assessment must consider appropriate criteria reflecting medical needs and state-of-the-art diagnostic capabilities. Traceability to reference measurement procedures and adherence to manufacturer protocols ensure reliability of evaluations.Quality Management and Independent Operation
EQAS organizations are required to maintain a quality management system and operate independently without commercial or conflicting interests to guarantee impartiality in performance assessments.
Applications
EN 14136:2004 serves as a valuable framework for:
Manufacturers of IVD Medical Devices
Facilitates ongoing post-marketing surveillance of device performance, helping identify issues that may not be apparent during initial validation phases.Clinical Laboratories and Healthcare Providers
Supports participation in quality schemes that promote high standards in laboratory diagnostics and support clinical decision-making.Regulatory Authorities and Competent Bodies
Provides a standardized basis for monitoring and evaluating the analytical quality of diagnostic devices across Europe, supporting compliance with EU regulations such as Directive 98/79/EC.External Quality Assessment Organizations
Offers guidance on designing EQAS that yield meaningful and actionable data related to both laboratory performance and the diagnostic devices themselves.
Related Standards
EN 14136:2004 integrates and complements several key standards including:
- EN ISO 17511 – Metrological traceability of values assigned to calibrators and control materials for IVD devices
- EN ISO 18153 – Metrological traceability for catalytic concentration values of enzymes
- EN 12286 – Presentation of reference measurement procedures for biological samples
- EN ISO 15195 – Requirements for reference measurement laboratories in laboratory medicine
- ISO/IEC Guide 43-1 – General principles for proficiency testing by interlaboratory comparisons
These standards collectively support the establishment of robust quality assurance frameworks for in vitro diagnostics, ensuring accuracy, traceability, and reliability across the diagnostic testing lifecycle.
Keywords: EN 14136:2004, External Quality Assessment Scheme, EQAS, in vitro diagnostic medical devices, IVD MD, post-marketing surveillance, diagnostic procedure evaluation, quality management system, metrological traceability, laboratory quality assurance, clinical laboratory quality, European Standard, CEN, performance assessment
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Verwendung externer Qualitätssicherungsprogramme bei der Bewertung der Durchführung von Untersuchungsverfahren in der In-vitro-DiagnostikUtilisation des programmes d'évaluation externe de la qualité dans l'évaluation de la performance des procédures de diagnostic in vitroUse of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures11.100.10In vitro diagnostic test systemsICS:Ta slovenski standard je istoveten z:EN 14136:2004SIST EN 14136:2004en,fr,de01-november-2004SIST EN 14136:2004SLOVENSKI
STANDARD
EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 14136May 2004ICS 11.100English versionUse of external quality assessment schemes in the assessmentof the performance of in vitro diagnostic examination proceduresUtilisation des programmes d'évaluation externe de laqualité dans l'évaluation de la performance des procéduresde diagnostic in vitroVerwendung externer Qualitätssicherungsprogramme beider Bewertung der Durchführung vonUntersuchungsverfahren in der In-vitro-DiagnostikThis European Standard was approved by CEN on 2 March 2004.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,Slovenia, Spain, Sweden, Switzerland and United Kingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2004 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 14136:2004: ESIST EN 14136:2004
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Frequently Asked Questions
EN 14136:2004 is a standard published by the European Committee for Standardization (CEN). Its full title is "Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures". This standard covers: This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: - scheme design and organisation; - identification of procedures (IVD MDs) used by the participant; - classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.
This European Standard applies to external quality assessment schemes, hereafter called EQAS, that include in their functions the assessment and evaluation of the performance of specified in vitro diagnostic procedures (including in vitro diagnostic medical devices, hereafter called IVD MDs). It sets out the requirements that are necessary to enable EQAS to fulfil this function relating to: - scheme design and organisation; - identification of procedures (IVD MDs) used by the participant; - classification and evaluation of data. NOTE External quality assessment data generated according to these criteria will help manufacturers, users or competent authorities to monitor independently the post-marketing performance of IVD MDs. This European Standard does not specify ways in which EQAS themselves are organised, nor how the individual or collective performance of clinical laboratories is evaluated.
EN 14136:2004 is classified under the following ICS (International Classification for Standards) categories: 11.100 - Laboratory medicine. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14136:2004 is associated with the following European legislation: EU Directives/Regulations: 98/79/EC; Standardization Mandates: M/252. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
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La norme EN 14136:2004 est un document essentiel pour l’utilisation des schémas d’évaluation de la qualité externe (EQAS) dans l’évaluation de la performance des procédures d’examen diagnostique in vitro. Son champ d'application est clairement défini, s'appliquant aux EQAS qui incluent l’évaluation et l’analyse des performances des procédures diagnostiques in vitro, incluant les dispositifs médicaux de diagnostic in vitro (IVD MDs). Parmi ses forces, cette norme établit des exigences spécifiques qui permettent aux EQAS de réaliser leur rôle de manière efficace. Elle couvre des aspects essentiels tels que la conception et l’organisation des schémas d’évaluation, l’identification des procédures utilisées par les participants, ainsi que la classification et l’évaluation des données collectées. Ces éléments sont cruciaux pour garantir que les EQAS puissent fournir une évaluation précise et pertinente des performances des IVD MDs. De plus, la norme souligne l’importance des données issues des EQAS, qui sont non seulement bénéfiques pour les fabricants et les utilisateurs, mais aussi pour les autorités compétentes. Ces données permettent un suivi indépendant de la performance des IVD MDs après leur mise sur le marché, ce qui est essentiel pour assurer la sécurité et l'efficacité des dispositifs utilisés dans le diagnostic in vitro. En matière de pertinence, cette norme répond à un besoin croissant dans le secteur des diagnostics médicaux, contribuant à l’amélioration continue de la qualité et de la fiabilité des procédures diagnostiques. Ainsi, la norme EN 14136:2004 se positionne comme un outil crucial pour le maintien de standards élevés dans l'évaluation de la performance des dispositifs médicaux diagnostiques. Il est à noter que cette norme ne définit pas la manière dont les EQAS doivent être organisés ni comment évaluer la performance individuelle ou collective des laboratoires cliniques, ce qui laisse une certaine flexibilité dans leur mise en œuvre. Toutefois, les exigences énoncées fournissent une base solide pour garantir la qualité des évaluations et des données produites par ces schémas.
Die Norm EN 14136:2004 behandelt die Anwendung externer Qualitätssicherungssysteme (EQAS) zur Bewertung der Leistungsfähigkeit von In-vitro-Diagnoseverfahren (IVD). Sie definiert den Umfang und die Anforderungen, die notwendig sind, um sicherzustellen, dass EQAS ihre Funktion zur Beurteilung und Auswertung der Leistung spezifischer IVD-Verfahren ordnungsgemäß erfüllen können. Ein wesentliches Merkmal dieser Norm ist die klare Struktur in Bezug auf die Gestaltung und Organisation von EQAS. Dies ermöglicht eine einheitliche Durchführung und Transparenz in den Verfahren, was für Teilnehmer von großer Bedeutung ist. Die Norm legt auch fest, wie die verwendeten Verfahren (IVD-MDs) von den Teilnehmern identifiziert werden sollen, was die Vergleichbarkeit der Ergebnisse erhöht. Zudem beschreibt sie die Kriterien für die Klassifizierung und Bewertung von Daten, was für die Validierung und Überwachung der Leistung von IVD-MDs von entscheidender Bedeutung ist. Ein weiterer Vorteil der EN 14136:2004 liegt in ihrer Relevanz für Hersteller, Anwender und zuständige Behörden. Die externe Qualitätssicherung, die über diese Norm implementiert wird, trägt dazu bei, die Marktbewertung der IVD-MDs unabhängig zu überwachen. Die Norm bietet somit nicht nur einen Rahmen zur Qualitätsbewertung, sondern unterstützt auch die kontinuierliche Verbesserung und Anpassung der IVD-Verfahren an sich ändernde Anforderungen und Standards im Gesundheitswesen. Zusammenfassend bietet die Norm EN 14136:2004 eine wertvolle Grundlage für die Einrichtung und den Betrieb von EQAS, indem sie klare Anforderungen und Richtlinien bereitstellt, die eine effektive Beurteilung der Leistungsfähigkeit von In-vitro-Diagnoseverfahren ermöglichen. Die Implementierung dieser Norm ist für die Gewährleistung der Qualität und Sicherheit von IVD-MDs von zentraler Bedeutung und wird von verschiedenen Akteuren im Bereich der diagnostischen Medizin als unerlässlich erachtet.
The EN 14136:2004 standard is a pivotal document in the domain of external quality assessment schemes (EQAS) for evaluating in vitro diagnostic examination procedures. Its primary scope centers on the structured assessment and evaluation of the performance of specified in vitro diagnostic procedures, which encompasses in vitro diagnostic medical devices (IVD MDs). One of the key strengths of this standard lies in its comprehensive framework that delineates the essential requirements for EQAS to effectively carry out their roles in assessing diagnostic procedures. By articulating the design and organization of EQAS, as well as facilitating the identification of IVD MDs utilized by participants, the standard ensures that the processes are not only systematic but also transparent. This clarity is critical for stakeholders who rely on EQAS to maintain high standards in diagnostic accuracy and reliability. Furthermore, the classification and evaluation of data mandated by the EN 14136:2004 standard empower manufacturers, users, and competent authorities to independently monitor the post-marketing performance of IVD MDs. This independent monitoring is crucial, as it aids in ensuring that diagnostics remain reliable and meet quality assurance expectations over time. Moreover, the standard highlights that while it provides a framework for EQAS, it does not dictate how these schemes should be organized or how the performance of clinical laboratories should be evaluated. This flexibility allows for the adaptation of the standard across various jurisdictions and institutional contexts, making it relevant for a broad audience. In summary, EN 14136:2004 serves as an essential guide for EQAS in the assessment of IVD MDs. Its structured approach not only enhances the reliability of diagnostic procedures but also strengthens the overall quality assurance processes within the healthcare sector. The relevance of this standard in the current landscape of in vitro diagnostics cannot be overstated, as it ensures ongoing effectiveness in monitoring and enhancing diagnostic capabilities.
SIST EN 14136:2004 표준은 체외 진단 검사 절차의 성능 평가를 위한 외부 품질 평가 체계(EQAS)의 사용에 관한 유럽 표준으로, 특정 체외 진단 절차(IVD MD 포함)의 성능 평가 및 평가 기능을 포함하는 EQAS에 적용됩니다. 이 문서는 EQAS가 이러한 기능을 수행할 수 있도록 보장하는 데 필요한 요구 사항을 명시하고 있습니다. 이 표준의 주요 강점 중 하나는 EQAS의 설계 및 조직, 참여자가 사용하는 절차(IVD MD의 식별), 데이터의 분류 및 평가와 같은 포괄적인 요구 사항을 설정함으로써, 평가의 신뢰성을 높이고 체계적인 접근 방식을 제공합니다. EQAS에 의해 생성된 외부 품질 평가 데이터는 제조업체, 사용자 또는 적격 기관이 IVD MD의 시장 출시 이후 성능을 독립적으로 모니터링하는 데 도움을 주며, 이는 품질 관리와 안전성을 보장하는 데 필수적입니다. SIST EN 14136:2004 표준은 임상 실험실의 개별 또는 집합 성능이 어떻게 평가되는지에 대한 구체적인 방법을 명시하지 않지만, 외부 품질 평가 체계의 기능적 설계를 통해 고품질 진단 장비의 사용을 촉진하고, 체외 진단 의료기기와 관련된 기술적 요구 사항을 충족할 수 있도록 합니다. 이러한 점에서, 해당 표준은 체외 진단 분야에서 매우 중요한 역할을 하며, 현재와 미래의 진단 검사 절차의 신뢰성과 효율성을 보장하는 데 기여합니다.
EN 14136:2004は、体外診断検査手順のパフォーマンス評価における外部品質評価スキーム（EQAS）の使用に関するヨーロッパ標準であり、非常に重要な役割を果たしています。この標準の適用範囲は明確で、特定の体外診断手順（IVD MDs）のパフォーマンスを評価するために必要なEQASの機能を定義しています。 この標準の強みは、EQASの設計と組織の要件、参加者が使用する手順（IVD MDs）の特定、データの分類と評価に関する詳細な指針を提供している点です。これにより、製造業者や使用者、または適切な権限が、IVD MDsの販売後のパフォーマンスを独立して監視できるような基盤が整えられています。外部品質評価データは、臨床検査の精度向上に寄与するための重要な情報源となります。 また、EN 14136:2004は、EQAS自体の組織方法や、臨床検査室の個別または集合的なパフォーマンス評価の具体的な方法については指定していませんが、この柔軟性が各国のニーズに応じた適用を可能にしています。したがって、この標準は、体外診断検査手順に関わるすべての関係者に対して高い関連性を持ち続けています。 全体として、EN 14136:2004は、体外診断分野における品質保証の向上に貢献するための重要な構造を提供しており、業界標準としての本質を維持しています。これにより、体外診断製品の信頼性と安全性が向上し、最終的に患者の健康に寄与することが期待されます。
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