​IRCA Medical Devices Quality Management Systems Certification Scheme

Who the scheme is for

• Medical device professionals intending to demonstrate their core competence in audit management performance.  

• Medical device manufacturers and distributors who possess an understanding and knowledge of MD-QMS issues, and who are competent to participate in MD-QMS audits. 

• Medical Device Quality Management System auditors and consultants. 

• Suppliers or importers of medical devices.  

• Lead, Principal, Internal and Associate Auditors. 

Auditing Key Standards

This scheme is based on ISO13485:2016.

Requirements

In addition to the general experience identified in the main body of this standard ISO 13485 Auditors are required to demonstrate the following knowledge, skills, experience, and education or training:  

Education: For the grades of Lead Auditor, Principal Auditor, and Auditor, applicants must be educated to degree level in medical science, or a related field of study (e.g. medicine, biology, microbiology, chemistry, biochemistry, medical sciences, physiology, pharmaceutical, or an engineering or computer science discipline directly related to medical device applications. 

Experience: For the grades of Lead Auditor, Principal Auditor, and Auditor, applicants must demonstrate a minimum of 4 years of experience in full-time employment in medical devices or a related sector(s). 

Training: For the grades of Lead Auditor, Principal Auditor, and Auditor, applicants must successfully complete a CQI and IRCA Certified ISO 13485 Lead Auditor (40-hour) training course (PR369). 

For auditors who have already successfully completed a CQI and IRCA Certified Lead Auditor training course in another management system discipline, they can satisfy this requirement by completing: 

• a CQI and IRCA Certified ISO 13485 Auditor Conversion (24-hour) training course (PR370) and- a CQI and IRCA Certified ISO 14971 Foundation (8-hour) (Medical Device – Application of risk management to medical devices) training course (FD133 or CQI and IRCA recognised equivalent). 

For the grades of Internal Auditor and Associate Auditor, applicants must successfully complete:  

• a CQI and IRCA Certified ISO 13485 Foundation (FD132) training course and a CQI and IRCA Certified ISO 13485 Internal Auditor (PT264) training course 

or 

• a CQI and IRCA Certified ISO 13485 Lead Auditor (PR369) training course or a CQI and IRCA Certified ISO 13485 Auditor Conversion (PR370) training course. 

Technical Competence

Successful applicants must understand: 

• audit techniques, vocabulary and management of audits in the medical device sector, including audits that may be required specific to regulatory requirements and not only ISO13485. 

• the application software data management techniques and the validation of software used in medical device manufacture and use. 

• the importance of labelling and traceability in relation to medical devices. 

• the responsibilities of manufacturers, suppliers, and importers when offering a device to the market.  

• regulatory requirements affecting product manufacture and acceptance, how these requirements may vary around the world and what part (if any) ISO 13485 can play in supporting regulatory obligations. 

• manufacturing processes used in the medical device industry. 

• medical device grading and their applicable risk controls.  

• the application of ISO 14971 with regard to risk identification and management and the need to review arrangements for risk management in the audit.  

Successful applicants must be able to: 

• review the impact and effectiveness of top management on quality systems.  

• interpret the medical device design management process and its management. 

Acceptable alternative standards

We may accept audits to alternative standards not listed on the IRCA certification scheme. To find out more please visit the Acceptable Alternative Standards page.