BS EN ISO 15189-2022 + A11-2023 PDF

Full title and description

STB BS EN ISO 15189-2022 + A11-2023 — Medical laboratories — Requirements for quality and competence. This product page describes the international ISO 15189 fourth edition (published 2022) together with the European amendment A11:2023 as adopted in BS/EN national publications (consolidated as BS EN ISO 15189:2022 + A11:2023). The standard sets out management and technical requirements for medical laboratories, including requirements for point‑of‑care testing (POCT), clinical risk management, competence, quality assurance and accreditation readiness.

Abstract

ISO 15189:2022 defines the requirements for a medical laboratory's quality management system and technical competence to deliver reliable diagnostic testing and services that support patient care. The 2022 edition reorganises the structure to align with related ISO/IEC 17000-series standards, introduces a stronger patient‑centred risk approach and incorporates POCT requirements previously covered by ISO 22870. The European amendment A11:2023 (EN ISO 15189:2022/A11:2023) provides regional (CEN/EN) modifications and additions required for implementation and accreditation within Europe, including an Annex to support EU accreditation/regulatory relationships.

General information

• Status: Published (international standard and European amendment adopted in national standards).
• Publication date: ISO 15189:2022 — 6 December 2022; EN amendment A11:2023 — November 2023 (approved mid‑November 2023, effective in national adoptions thereafter).
• Publisher: International Organization for Standardization (ISO); European amendment published via CEN and adopted by national bodies; British national adoption available from BSI as BS EN ISO 15189:2022 + A11:2023 (national publishers may issue consolidated versions).
• ICS / categories: 03.120.10 (Quality management and quality assurance); 11.100.01 (Laboratory medicine in general).
• Edition / version: ISO 15189 — 4th edition (2022); consolidated with European amendment A11:2023 (EN ISO 15189:2022/A11:2023) and published as national adoptions (e.g., BS EN ISO 15189:2022 + A11:2023).
• Number of pages: ISO 15189:2022 — 62 pages (international text); Amendment A11:2023 — approximately 6 pages; consolidated national publications may present a slightly different page count.

Scope

This standard specifies requirements for quality and competence applicable to medical laboratories involved in examination of specimens for the purpose of medical diagnosis, management and treatment. It applies to laboratories of all sizes and complexity and covers the full examination process (pre‑examination, examination and post‑examination), including point‑of‑care testing (POCT). The standard is intended for use by laboratories implementing or maintaining quality management systems, by accreditation bodies assessing competence, and by regulatory authorities or laboratory users seeking to confirm laboratory competence.

Key topics and requirements

• Management requirements: leadership, governance, policies, objectives, documented information and continual improvement.
• Patient‑centred risk management: identification, assessment and control of clinical risks and the impact of laboratory services on patient safety.
• Technical requirements: personnel competence, equipment, reagent and consumable management, method validation and verification, and laboratory environment.
• Pre‑examination and post‑examination processes: sampling, sample receipt, transport, storage, reporting and result interpretation.
• Point‑of‑care testing (POCT): integrated POCT requirements now included within ISO 15189 (replacing separate ISO 22870 for accredited laboratories after the transition).
• Quality assurance and performance monitoring: internal quality control, external quality assessment (proficiency testing) and measurement uncertainty where applicable.
• Information management and data integrity: laboratory information systems, result security, confidentiality and record retention.
• Traceability and metrological requirements: calibration, reference materials and traceability to higher‑order references when applicable.
• Supplier and third‑party management: selection, evaluation and monitoring of external providers, including subcontractors.
• Requirements specific to European adoption (A11:2023): additions to support accreditation and regulatory alignment within the CEN/European framework (for example, Annexes to aid conformity assessment and national adoption requirements).

Typical use and users

Primary users are medical laboratory managers, quality managers, technical staff and laboratory directors preparing for or maintaining accreditation. Secondary users include national accreditation bodies, assessors, healthcare regulators, clinical governance leads, biomedical/clinical scientists, hospital administrators, diagnostic manufacturers and consultants who support implementation of quality systems in clinical laboratories.

Related standards

Commonly referenced and related standards include ISO/IEC 17025 (general competence for testing and calibration laboratories), ISO 22870 (POCT — now incorporated into ISO 15189:2022 for accredited settings), ISO 9001 (quality management principles), ISO 15190 (medical laboratory safety) and relevant national/adopted EN versions and amendments (for example EN ISO 15189:2022/A11:2023 as the European amendment).

Keywords

medical laboratory, ISO 15189, quality management, accreditation, competence, POCT, patient safety, risk management, laboratory competence, EN amendment A11:2023, BS EN ISO, clinical laboratory, quality assurance, validation, measurement traceability

FAQ

Q: What is this standard?

A: ISO 15189:2022 is an international standard that specifies quality management and technical requirements for medical laboratories. The A11:2023 item is a European amendment (EN ISO 15189:2022/A11:2023) incorporated into national adoptions such as BS EN ISO 15189:2022 + A11:2023.

Q: What does it cover?

A: It covers the entire laboratory testing process (pre‑examination, examination and post‑examination), personnel competence, equipment and method requirements, quality assurance, POCT, data management and a patient‑centred approach to risk and safety.

Q: Who typically uses it?

A: Medical laboratory managers and staff, accreditation bodies and assessors, regulators, clinical governance teams, diagnostic manufacturers and consultants involved in laboratory quality and accreditation use this standard.

Q: Is it current or superseded?

A: ISO 15189:2022 (published 6 December 2022) is the current international edition. The European amendment A11:2023 was approved in November 2023 and is part of the consolidated EN/BS national adoptions. A formal transition period was set for three years from publication of the 2022 edition: laboratories were expected to complete transition by 05 December 2025 (end of the three‑year transition period), after which accreditation to the older 2012 edition is no longer accepted by accreditation cooperative arrangements.

Q: Is it part of a series?

A: ISO 15189 sits within the family of laboratory and quality management standards and aligns with other ISO/IEC 17000‑series documents (such as ISO/IEC 17025). It also relates to ISO 22870 (POCT) whose requirements are incorporated into the 2022 edition, and to other complementary standards used in laboratory practice and accreditation.

Q: What are the key keywords?

A: Key keywords are: medical laboratory, quality management, accreditation, competence, POCT, patient safety, risk management, ISO 15189, EN amendment A11:2023, BS EN ISO.