SN EN ISO 22367:2020 Definition

SN EN ISO 22367:2020 is a standard published by the International Organization for Standardization (ISO) that outlines a structured risk management process specifically for medical laboratories. It aims to enhance patient safety, laboratory staff safety, and the protection of service providers during medical examinations.

Purpose and objectives

The primary objective of SN EN ISO 22367:2020 is to provide a comprehensive framework for risk management in medical laboratories. This standard emphasizes the importance of identifying, assessing, evaluating, and controlling risks associated with laboratory activities. By following this structured approach, laboratories can enhance the quality of their services, ensure patient safety, and comply with regulatory standards. Additionally, the standard promotes continuous risk monitoring and the integration of risk management into laboratory operations, aligning with the broader ISO 31000 risk management framework.

Scope: who must comply

SN EN ISO 22367:2020 applies to all medical laboratories, regardless of their size or type. This includes laboratories that perform diagnostic tests, research, and development, as well as those involved in the transfer of test results to healthcare providers. Compliance with this standard is essential for any organization operating within the Healthcare Technology sector that aims to ensure safety and quality in their laboratory processes. By adhering to the guidelines set forth in this standard, laboratories can effectively manage risks to patients, laboratory personnel, and service providers, thereby improving overall service quality and patient outcomes.

How SN EN ISO 22367:2020 relates to other standards

SN EN ISO 22367:2020 is closely related to several other standards:

• ISO 15189: This standard specifies requirements for quality and competence in medical laboratories, complementing the risk management processes outlined in ISO 22367.
• ISO 31000: Provides general principles and guidelines on risk management applicable across various industries, establishing a foundation for the risk management framework used in ISO 22367.
• ISO 9001: Focuses on quality management systems, supporting the integration of risk management into broader quality practices within medical laboratories.

Revision history and current status

SN EN ISO 22367:2020 was published by ISO in 2020, marking its first edition. This revision introduced updated methodologies for risk assessment and management, reflecting the latest practices and technologies in the medical laboratory field. The standard aims to ensure that laboratories can effectively manage risks in a constantly evolving healthcare environment, promoting higher standards of patient safety and service quality.