EN ISO 15189:2022/A11:2023

Overview

EN ISO 15189:2022/A11:2023 is a critical European amendment to the international standard ISO 15189, specifically tailored for medical laboratories. Published by the European Committee for Standardization (CEN) in November 2023, this standard defines the requirements for quality and competence in medical laboratories, ensuring reliable and accurate laboratory testing critical to patient care. It serves as a foundational framework facilitating laboratory accreditation, aligning with EU regulations such as Regulation (EC) No 765/2008 on accreditation and market surveillance.

This amendment (A11) to EN ISO 15189:2022 reflects the latest best practices and regulatory requirements, aiming to harmonize medical laboratory quality management systems across Europe. It was prepared under the mandate of the European Commission and the European Free Trade Association (EFTA) and is binding for the national standards bodies of 35 European countries, including the UK, Germany, France, and Italy.

Key Topics

• Quality and Competence Requirements - EN ISO 15189:2022/A11 sets out both the technical competence and quality management system essentials that medical laboratories must meet to achieve accreditation.
• Accreditation Compliance - The amendment supports conformity with EU Regulation (EC) No 765/2008, which governs accreditation and market surveillance of laboratories, providing presumption of conformity when this standard is applied.
• Structure and Resources - It specifies the structural and resource requirements necessary for medical laboratories, including personnel qualifications, equipment calibration, and environmental conditions.
• Process Requirements - The standard elaborates on the processes related to pre-examination, examination, and post-examination activities, emphasizing accuracy, traceability, and result integrity.
• Management System Requirements - EN ISO 15189:2022/A11 mandates laboratories to implement a robust quality management system that supports continuous improvement, risk management, and compliance with regulatory frameworks.

Applications

Medical laboratories adopting EN ISO 15189:2022/A11 benefit from:

• Enhanced Patient Safety - By following stringent quality and competence criteria, laboratories can deliver trustworthy diagnostic results crucial for effective treatment decisions.
• Regulatory Alignment - Laboratories operating in Europe align with EU accreditation requirements, simplifying market access and regulatory compliance.
• Improved Laboratory Operations - The structured framework fosters operational consistency, reduced errors, and optimized workflow management.
• International Recognition - Compliance signals adherence to globally recognized best practices, beneficial for labs engaged in cross-border collaborations or serving international clients.
• Support for In Vitro Diagnostic Devices - Given its preparation by Technical Committee CEN/TC 140 on in vitro diagnostic medical devices, the standard is highly relevant for labs working extensively with these devices ensuring their quality and competence.

Related Standards

• ISO 15189:2022 Medical Laboratories - Requirements for Quality and Competence – The base international standard to which this European amendment relates.
• Regulation (EC) No 765/2008 - Establishes the overarching accreditation framework that this standard helps to implement.
• EU Directive 2017/746 (IVDR) - Medical device regulation impacting laboratory in vitro diagnostic devices, referenced within this standard.
• ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories, complementary to the specific medical focus of ISO 15189.

For medical laboratories aiming to achieve or maintain accreditation within Europe, EN ISO 15189:2022/A11:2023 represents an indispensable standard ensuring quality, competence, and regulatory compliance. Adhering to these requirements promotes excellence in laboratory medicine, aligns with European regulatory frameworks, and ultimately supports improved patient outcomes worldwide.