Overview
ISO/TS 23824:2024 - Medical laboratories - Guidance on application of ISO 15189 in anatomic pathology - provides targeted guidance for implementing a management system in anatomic pathology (AP) laboratories to meet the quality and competence requirements of ISO 15189:2022. It clarifies how ISO 15189 applies to AP workflows (histopathology, cytopathology, frozen sections, gross examination and ancillary techniques) and offers examples of process actions and risks specific to AP. The Technical Specification does not add new requirements beyond ISO 15189, and national or regional regulations can also apply.
Key topics and requirements
- Scope and definitions tailored to AP terms (anatomic pathology, cytopathology, primary sample, gross examination, frozen section).
- General requirements for AP laboratories including impartiality, confidentiality and the variety of laboratory users (patients, surgeons, clinicians).
- Structure and governance: design of a management system, roles and responsibilities specific to AP.
- Resource requirements: personnel management, competence, and staffing considerations for pathologists, cytotechnologists and technical staff.
- Process requirements: workflow guidance for macroscopic and microscopic examinations, specimen handling, and ancillary testing (IHC, molecular tests, imaging/AI tools).
- Management system requirements: risk management, managing nonconforming work, internal auditing, corrective actions and management review aligned with ISO 15189.
- Examples of process actions and risks: tables provide AP‑specific examples to help translate ISO 15189 clauses into practical lab procedures.
Practical applications
- Helps AP laboratories design or adapt their quality management system to meet ISO 15189 accreditation expectations.
- Supports development of SOPs for specimen handling, grossing, slide preparation, reporting, and frozen‑section workflows.
- Guides risk assessments for unique AP risks such as non‑repeatable specimens, orientation/margin issues, and interpretive variability.
- Advises integration of emerging tools (image analysis, AI, molecular testing) into existing quality frameworks while identifying new risk points.
Who should use this standard
- Pathologists, laboratory directors and AP section heads
- Quality managers and compliance officers in hospital and private pathology labs
- Cytotechnologists, biomedical scientists and technical staff involved in AP workflows
- Accreditation bodies and auditors assessing ISO 15189 conformance for AP services
Related standards
- ISO 15189:2022 - Medical laboratories - Requirements for quality and competence (normative reference)
- Work prepared by ISO/TC 212 (Medical laboratories and in vitro diagnostic systems)
This document is a practical bridge between ISO 15189 requirements and the specific operational realities of anatomic pathology laboratories, helping teams improve patient safety, diagnostic reliability and accreditation readiness.
