ISO 22367-2020 PDF

Full title and description

St ISO 22367-2020 — Medical laboratories — Application of risk management to medical laboratories. This International Standard specifies a structured process for medical laboratories to identify, analyse, evaluate, control and monitor risks to patients, laboratory workers and service providers associated with medical laboratory examinations (pre‑examination, examination and post‑examination activities). It is intended to be used alongside laboratory quality management requirements such as ISO 15189.

Abstract

This standard defines a risk management cycle for medical laboratories including: establishment of a risk management plan; risk analysis (identification of hazards, estimation of probability and severity); risk evaluation (acceptability criteria); risk control (selection and verification of controls, assessment of residual risk and benefit–risk analysis); and risk monitoring and review. It does not set acceptable risk levels and does not cover clinical decisions made by healthcare providers or enterprise/business risks addressed by standards such as ISO 31000.

General information

• Status: Published.
• Publication date: February 2020 (Edition 1, 2020-02).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.100.01 — Laboratory medicine in general; developed by ISO/TC 212 (Clinical laboratory testing and in vitro diagnostic test systems).
• Edition / version: Edition 1 (2020).
• Number of pages: 82 pages.

Scope

Specifies requirements and guidance for a medical laboratory to establish and maintain a risk management process covering all stages of laboratory testing and related services including pre‑examination, examination, post‑examination and the accurate transmission of results to electronic medical records. Excludes acceptable risk level specification, risks from clinicians' post‑examination decisions, and enterprise/business risks covered by ISO 31000. The standard is applicable to medical laboratories of all types and sizes that perform examinations and report results.

Key topics and requirements

• Establishing a documented risk management policy and risk management plan tied into the laboratory quality management system (e.g., ISO 15189).
• Risk analysis: identification of hazards and hazardous situations, estimation of likelihood and severity, and documentation of analysis.
• Risk evaluation: defining risk acceptability criteria and deciding when controls are required.
• Risk control: selection and implementation of controls, verification of effectiveness, benefit–risk analysis and assessment of residual risk.
• Risk monitoring and review: ongoing surveillance, use of internal/external information (incidents, complaints, audits), and documented management review.
• Personnel qualifications and assignment of responsibilities for risk management tasks; record keeping and integration with existing quality records.
• Informative annexes offering examples, tools and guidance for estimating probability/severity, planning risk activities and evaluating residual risk.

Typical use and users

Intended for medical laboratory directors, quality managers, safety officers, risk managers, accreditation bodies, and technical staff involved in test design, validation and result reporting. Laboratories use the standard to implement a repeatable, documented risk management program that supports patient safety, reduces testing-related harm, and aligns with accreditation requirements (for example ISO 15189). The standard is also used by laboratories assessing in‑house developed tests, and by organisations seeking to integrate laboratory risk activities into enterprise quality and safety systems.

Related standards

Closely related to ISO 15189 (medical laboratories — requirements for quality and competence) and intended to be used alongside it. Also relates to ISO 15190 (medical laboratory safety), ISO 31000 (risk management principles) and standards/guidance for medical device/IVD risk management such as ISO 14971 and ISO/TR 24971 (guidance on benefit–risk and medical device risk management). ISO 22367:2020 replaces/revises ISO/TS 22367:2008.

Keywords

risk management; medical laboratory; patient safety; hazard identification; risk analysis; risk evaluation; risk control; residual risk; quality management; ISO 15189; laboratory accreditation.

FAQ

Q: What is this standard?

A: An ISO International Standard that specifies how medical laboratories should apply risk management to laboratory examinations and services to protect patients, staff and service providers.

Q: What does it cover?

A: The full risk management cycle for laboratory activities — planning, risk analysis (hazards, probability, severity), evaluation against acceptability criteria, selection and verification of controls, monitoring, and management review. It covers pre‑, intra‑ and post‑examination stages and transmission of results, but does not set acceptable risk levels or cover clinicians' decisions after reporting.

Q: Who typically uses it?

A: Laboratory leadership, quality and safety personnel, technical staff, and accreditation assessors; also useful to IVD/medical device developers and organisations linking laboratory risk management to broader safety and quality systems.

Q: Is it current or superseded?

A: ISO 22367:2020 is the current published edition (published February 2020). The standard is listed for periodic review and ISO has work indicated to develop an FDIS (final draft international standard) for a future revision, so users should check for any later revisions or replacements when implementing.

Q: Is it part of a series?

A: It is not a numbered series but it is part of ISO/TC 212’s suite of documents addressing medical laboratory quality and safety; it replaces the earlier ISO/TS 22367:2008. It is commonly implemented alongside ISO 15189 and related guidance documents.

Q: What are the key keywords?

A: Risk management, patient safety, laboratory quality, hazard identification, risk assessment, residual risk, risk control, ISO 15189.