ISO 22367
ISO 22367:2020 is an international standard that outlines a systematic approach to managing and mitigating risks in medical laboratories. It supports organizations in the health sector in identifying, assessing, and addressing potential risks that can compromise the quality of medical services and patient safety. At Quality Asia Certification, we provide end-to-end ISO 22367:2020 certification services to help your medical laboratory implement robust risk management practices, ensuring global compliance, operational excellence, and patient trust.
Our certification process aligns with international regulatory expectations and healthcare quality standards, making your organization credible, competitive, and future-ready.
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What is ISO 22367?
ISO 22367:2020 – Medical Laboratories – Application of Risk Management to Medical Laboratories is a standard developed by the International Organization for Standardization (ISO) to support medical laboratories in applying risk management principles to improve diagnostic accuracy, laboratory safety, and service continuity.
It provides a framework for:
- Identifying and evaluating risks related to laboratory operations.
- Implementing controls to prevent, reduce, or monitor risks.
- Enhancing decision-making, patient safety, and laboratory reliability.
ISO 22367 is especially relevant for organizations already certified to ISO 15189 and wishing to strengthen their risk management capabilities.
Why is ISO 22367 important?
In today’s healthcare environment, patient safety and diagnostic reliability are paramount. Errors or delays in medical laboratory testing can have life-threatening consequences. Implementing ISO 22367:2020 helps medical laboratories proactively manage such risks and meet global best practices.
By choosing ISO 22367, your organization:
- Reduces the likelihood of diagnostic errors and accidents.
- Builds trust among healthcare providers and patients.
- Enhances compliance with international regulatory bodies and accreditation schemes.
- Ensures preparedness for emergency situations and service disruptions.
With ISO 22367:2020 certification from Quality Asia Certification, you assure your stakeholders of your lab’s commitment to safe, accurate, and continuous healthcare service delivery.
What are the benefits of ISO 22367?
Implementing ISO 22367:2020 delivers measurable improvements in quality, safety, and compliance. Key benefits include:
- Proactive Risk Identification: Detect risks before they escalate into failures.
- Improved Laboratory Performance: Optimize operations through risk-aware decision-making.
- Strengthened Patient Safety: Minimize diagnostic and procedural errors.
- Regulatory Alignment: Fulfill risk-based compliance requirements from global and national regulators.
- Integrated Risk Management: Combine ISO 22367 with ISO 15189 or ISO 9001 for a comprehensive quality approach.
- Internal Culture of Safety: Foster accountability and awareness among staff and stakeholders.
What kind of businesses can benefit from ISO 22367?
By achieving ISO 22367:2020 certification through Quality Asia Certification, your medical laboratory or diagnostic center can:
✅ Gain a competitive edge by showcasing internationally recognized risk management compliance.
📈 Improve operational reliability and reduce costly service disruptions or errors.
🔍 Enhance trust and reputation among patients, doctors, hospitals, and regulators.
📑 Facilitate smoother audits and accreditations, such as NABL or CAP.
💡 Support continuous improvement through ongoing risk assessments and controls.
🛡️ Strengthen legal protection by documenting due diligence in risk management.
🌍 Expand business opportunities globally by meeting international standards.
Top Tips on making ISO 9001 effective for you.
#1
Top management commitment while practicing and accomplishing the standard is the key to success.
#2
Keeping staff informed about the ongoing practices, a well-communicated plan would increase the motivation and zeal of working in them.
#3
Making sure that the various departments of the organization work as a team for the benefit of the organization and customers as well.
#4
Review systems, policies, processes, and procedures for a smooth working of QMS.
#5
Speaking to customers & suppliers while getting feedback & working on improvements.
#6
Training staff carrying out the internal audits with the opportunity for improvement.
#7
Celebrate your achievement and use the QualityAsia Assurance Mark on your literature, promotional material, and website.
#8
Ensure continuous improvement by regularly reviewing and updating your quality management practices.
#9
Promote a culture of quality by encouraging innovation, accountability, and employee involvement at every level of the organization.
Why QualityAsia?
QualityAsia always vanguard in the auditing and governing of internationally acclaimed standards practices. At QualityAsia, we focus on driving the success of our clients through creating excellence with our trained professional auditors. The content of our service provision, comply with international certification rules defined by the accreditation bodies without burning a hole in your pocket. We will take you through the journey of audits with our best kept audit practices, viz.:
Initial Certification – Stage 1 (Preparatory Phase)
- Thorough documented information review.
- Exchange of information with staff through online or onsite presence.
- Identification of key performances, processes & objectives as per the standard requisites.
- Analysis of facilities, infrastructure, systems and processes in regard with the requested certification scope with a resource allocation review.
Initial Certification – Stage 2 (On-site Audit)
- Measurement, reporting & reviewing the performances against key performances objectives.
- Reviewing the suitability of the system meeting the legal, regulatory & contractual requirements.
- Operational control of processes, internal audits & management reviews while understanding the responsibilities for the policies.
- Conclusion based on prescriptive requirements, policy, performance objectives, staff skill, operations, procedures, internal audits, etc.
Surveillance & Certification Renewal
Drawing out the scrutiny on various aspects of the previously done audits on effectiveness while reviewing the various processes and control of the operations in the QMS and finally going for the recertification.
