ISO 14155
ISO 14155:2020 is an internationally accepted standard that specifies general requirements for the planning, conduct, recording, and reporting of clinical investigations carried out in human subjects to assess the safety or performance of medical devices. It is aligned with Good Clinical Practice (GCP) principles and is crucial for organizations involved in clinical trials of medical devices. At Quality Asia Certification, we certify medical device manufacturers and clinical research organizations to ISO 14155 to ensure global regulatory compliance and ethical research practices.
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What is ISO 14155?
ISO 14155:2020 is the latest version of the standard titled “Clinical investigation of medical devices for human subjects — Good clinical practice.” It outlines how clinical investigations must be conducted ethically, scientifically, and in compliance with regulatory frameworks. This standard applies to all medical device manufacturers and organizations that perform or manage clinical investigations involving human subjects, including hospitals, CROs, and device testing institutions.
Why is ISO 14155 important?
With growing international scrutiny and strict regulatory requirements from authorities such as the European Commission (MDR), U.S. FDA, and other global bodies, adhering to ISO 14155:2020 is now essential. It demonstrates your organization’s commitment to:
- Patient safety and ethical research conduct
- Regulatory readiness and international market access
- Reliable and traceable clinical investigation processes
ISO 14155 certification by Quality Asia Certification reflects the integrity of your device trials and builds stakeholder trust globally.
What are the benefits of ISO 14155?
- Ensures protection of human subjects involved in clinical trials
- Aligns with international regulations, including MDR and FDA
- Provides structured methodology for trial planning and execution
- Enhances the scientific validity and credibility of clinical data
- Reduces trial-related risks and ensures documentation traceability
What kind of businesses can benefit from ISO 14155?
Obtaining ISO 14155:2020 certification from Quality Asia Certification offers numerous business advantages:
- ✅ Global Market Access – Meet global regulatory expectations and gain faster entry into EU, US, and other regulated markets.
- ✅ Competitive Advantage – Showcase a commitment to ethical and compliant research, attracting stakeholders and investors.
- ✅ Reduced Compliance Risk – Minimize the chances of regulatory audits, penalties, or trial rejections.
- ✅ Improved Stakeholder Confidence – Build trust with patients, sponsors, regulators, and healthcare professionals.
- ✅ Efficient Trial Management – Implement standardized procedures, leading to reduced errors and smoother trial operations.
- ✅ Support for CE Marking – Strengthen documentation for conformity assessment under MDR 2017/745.
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.
