Introduction to ISO 14155:2020

This international standard addresses good clinical practices for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the safety and performance of medical devices for regulatory purposes. It does not apply to in vitro diagnostic medical devices. This standard was developed by ISO technical committee ISO/TC 194. ISO 14155 was published in its second edition in February 2011. The third edition was released in July 2020.

The most recent ISO changes to 14155 were made to ensure that the standard keeps its global acceptance by regulatory authorities. Conducting clinical studies according to Good Clinical Practices (GCP) is important, not only to collect high-quality data under ethical conditions, but also to meet regulatory compliance. Also important to note is the acceptance by the U.S. Food and Drug Administration (FDA) of the ISO 14155:2020 standard for medical device trials and the acceptance of clinical data collected outside the U.S. under the condition that ISO14155-GCP has been followed.

Which Companies or Industries Does This Standard Apply To?

The ISO 14155 Standard addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.  ISO 14155 would benefit any company producing medical devices or their components.  Also benefiting from ISO 14155:2020 certification is any company conducting clinical trials for medical devices.

What are the benefits of being certified in this standard?

The 14155:2020 Standard introduces clarifications to facilitate compliance with other international clinical trial standards, such as the International Council for Harmonization Good Clinical Practice (ICH-GCP).

The main goal of the most recent ISO 14155 changes is to ensure that the standard keeps its global acceptance by regulatory authorities. Conducting clinical studies according to GCP is important, not only to collect high-quality data under ethical conditions, but also to meet regulatory compliance.

New requirements covering topics such as good clinical practice principles, risk management, and clinical investigation audits, will provide additional resources and requirements for manufacturers to include as part of their clinical evaluation and technical file submission.

The ISO 14155:2020 Standard ensures certified companies:

— protect the rights, safety and well-being of human subjects,

— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,

— define the responsibilities of the sponsor and principal investigator, and

— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

Key Requirements, Features of the Standard

The ISO 14155:2020 standard adopts the structure in the following breakdown:

Scope

Normative references

Terms and definitions

Ethical considerations

Clinical investigation planning

Clinical investigation conduct

Suspension, termination, and close-out of the clinical investigation

Responsibilities of the sponsor

Responsibilities of the principal investigator

Certification Process

The ISO certification process is a systematic approach that organizations follow to demonstrate their commitment to quality, efficiency, and compliance with international standards. It typically involves a series of steps to ensure that a company’s processes and practices meet the specific requirements of ISO 14155:2020.

The process to achieve certification often consists of the following steps:

Contacting a Certification Body:

• Contact an accredited certification body (also known as a registrar or certifying agency) that specializes in ISO 14155. Ensure they have the necessary expertise and accreditation to perform the certification.

Develop Documentation:

• Create or update the necessary documentation, including policies, procedures, work instructions, and forms, to align with the ISO 14155 requirements.
• Ensure that these documents are comprehensive, clear, and accessible to all relevant employees.

Conduct Internal Audits:

• Perform internal audits to assess your organization’s readiness for certification.
• Internal audits help identify non-conformities resulting in corrective actions, and opportunities for process improvement.
• Train your internal auditors or consider hiring external auditors to conduct these assessments.

Certification Audit (Stage 1):

• The certification body conducts a Stage 1 audit, which is typically a document review.
• They assess your documentation, policies, and procedures to ensure they meet the standard’s requirements.
• Any identified issues or concerns are communicated to you at this stage.

Certification Audit (Stage 2):

• The certification body conducts a Stage 2 audit, which is an on-site assessment of your organization’s operations.
• Auditors evaluate the effectiveness and implementation of your QMS to ensure it aligns with ISO 14155:2020.
• Non-conformities may be identified, and you’ll be required to address them.

Companies often hire expert consultants to simplify the ISO certification process and reduce the burden on existing management teams in leaning new standards, ensuring compliance, developing documentation and more. This ultimately makes it more cost effective for companies to hire consultants to support them through the process than pursuing it on their own.

Quality Systems Enhancement is the only company that offers guaranteed certification through our 10-Step Approach™ to ISO 14155 – 2020 certification. QSE ISO consultants emphasize developing simplified, documented Management Systems which meet or exceed the requirements of any ISO standard requirements. This 10-Step Approach™ has a built-in discipline to involve all employees, including top management, right from the beginning to achieve long-term, desired results. Our approach is so complete that we have helped over 800 companies obtain certification, of which, the majority have obtained certification with zero deficiencies.

Other Comparable Standards

ISO 13485:2016 – Quality management systems Requirements for regulatory purposes

ISO 14971:2019 – Application of risk management to medical devices

ICH-GCP – International Council for Harmonization Good Clinical Practice

Support Services Offered by QSE

Training:

• QSE offers comprehensive training programs to help organizations understand and implement the ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice effectively.
• Our training sessions are tailored to suit your specific needs, whether you are new to the standard or looking to enhance your existing knowledge.
• Our experienced trainers provide practical insights and real-world examples to make the learning process engaging and informative.

Consulting:

• QSE’s team of expert consultants specializes in guiding organizations through the process of achieving compliance with ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice.
• We offer customized consulting services that address your unique challenges and objectives.
• Our consultants work closely with your team to develop a tailored strategy for successful implementation and certification.

Auditing:

• QSE conducts thorough audits to assess your organization’s conformity with the ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice Our auditors have extensive experience in evaluating compliance and identifying areas for improvement.
• We provide detailed audit reports and actionable recommendations to help you continually improve your quality management system.

About QSE

Quality Systems Enhancement (QSE) was founded in 1992 by Baskar Kotte in Roswell, Georgia. Throughout the years, QSE has grown to include consultants from all over the world including the United States, Canada, Mexico, India, and more.

QSE has helped over 800 companies to achieve registration in very diverse industries such as automotive, aerospace, electronics, healthcare, packaging, telecommunications and more. QSE is also a certified Minority Business Enterprise (MBE) and a member of the National Minority Supplier Development Council (NMSDC) throughout the following states: Georgia, North Carolina, South Carolina, Alabama, Florida, and Kentucky.

Our proprietary 10-Step Approach™ to certification addresses each element in the standard and includes a mix of specialized training, consulting and auditing. We have used this approach successfully registering over 800 companies. Our approach has provided a one hundred percent success rate the first time through. Many of these successes were “zero deficiency” audits.

When utilizing this approach, we guarantee registration in as little as seven to eight months.

Of course, a variety of options are available to you based on your particular needs or budget requirements. We provide a no-obligation visit to assess your needs and offer a program that is customized to your company.

Documentation is at the core of every Quality System. We believe in a one-level documentation system as opposed to the two / three / four level documentation structures preferred by many others. Our documentation rarely exceeds 200 pages, including all attachments. One of the intangible benefits of our simplistic one-of-a-kind documentation is that it is easy to maintain – and that is a great advantage when it comes to maintaining your certification through surveillance audits. We guarantee that our documentation addresses all the requirements of the ISO standard and once implemented, will work for your company. Guaranteed!