ISO 22367 Certification Service

ISO 22367:2020 Certification – Risk Management in Medical Laboratories

Overview
ISO 22367:2020 is an internationally recognized standard that provides guidelines for the application of risk management in medical laboratories. It is designed to help laboratories identify, evaluate, and manage risks that could affect the quality and safety of medical examinations. This standard aligns with the principles of ISO 15189 and promotes a proactive approach to risk, enhancing patient safety and improving the reliability of laboratory outcomes. ISO 22367:2020 emphasizes a systematic process for managing risks associated with all aspects of medical laboratory services, including pre-examination, examination, and post-examination processes.

What is ISO 22367:2020?
ISO 22367:2020 is titled "Medical laboratories — Application of risk management to medical laboratories. " This standard outlines a risk management framework specific to the medical laboratory environment. It supports laboratories in making informed decisions that minimize errors and enhance patient care. The standard guides laboratories to implement a continuous risk identification and control process, fostering a culture of quality, accountability, and safety.

Why ISO 22367:2020?
The healthcare industry demands a high degree of accuracy and safety, especially in diagnostic laboratories. Implementing ISO 22367:2020 helps laboratories manage uncertainties that can impact test results, patient diagnosis, and overall healthcare outcomes. This standard is particularly important for laboratories seeking to improve clinical reliability, meet accreditation requirements, and ensure compliance with international best practices. ISO 22367:2020 supports laboratories in mitigating legal, operational, and reputational risks, while also fostering trust among patients and stakeholders.

Benefits of ISO 22367:2020 Certification

• Establishes a proactive risk management system tailored for medical laboratories

• Enhances patient safety by reducing the likelihood of diagnostic errors

• Aligns laboratory operations with ISO 15189 and other healthcare standards

• Improves staff awareness and engagement in risk-aware practices

• Strengthens laboratory quality systems and decision-making capabilities

• Demonstrates commitment to international quality and safety standards

• Boosts confidence among patients, healthcare providers, and regulatory bodies

Certification Process

1. Gap Analysis: A preliminary review is conducted to assess the current risk management practices in comparison to ISO 22367:2020 requirements.

2. Documentation Review: All relevant documents, including risk assessment plans, mitigation strategies, and incident records, are evaluated for compliance.

3. Implementation Audit: The medical laboratory’s risk management system is examined to ensure effective implementation of policies and procedures.

4. Certification Audit: A formal audit is conducted by a recognized certification body to verify conformity with ISO 22367:2020.

5. Issuance of Certificate: Upon successful audit, the laboratory receives ISO 22367:2020 certification, valid for a specific period with periodic surveillance audits.