Lead Auditor Training Program on Medical Devices Quality Management System

Based on ISO 13485:2016


15th to 17th and 22nd & 23rd Jan. 2022: ISO 13485 Lead Auditor Training Program I Duration: 5 Days I Time: 9:30 am to 6:30 pm

What you'll gain by enrolling for this course?

  • An internationally accepted CQI/IRCA (Charted Quality Institute - International Register of Certificated Auditors) registered certificate
  • In-depth understanding of MD-QMS requirements for regulatory purposes
  • Knowledge and skills required to assess the OH&S management system of an organisation
  • Understand the role of an auditor and acquire the requisite expertise needed to perform the audits effectively


This ISO 13485 quality management system lead auditor course has been made in-line with international registers and guidelines. It aims to provide learners with the knowledge and skills required to perform first, second and third-party audits of medical device quality management systems against ISO 13485 standard and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021. It provides hands on training to ensure that auditor thoroughly understands the role of an auditor and acquires the expertise needed or required to perform the ISO 13485 qms audits effectively. It is structured to provide in-depth understanding of ISO 13485 medical device quality management system requirements for regulatory purposes. With this medical device ISO 13485 training, participants will gain knowledge and skills required to assess the OH&S management system of an organisation. This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. It is a participative ISO 13485 training, which uses case studies, role plays, exercises, workshops and group discussions for improving the overall understanding of the participants. 


5 Days


  • Medical Device Manufacturers
  • Quality Professionals
  • Regulatory Professionals
  • Internal and external Auditors
  • Consultants and anyone involved with the implementation of the standard


On completion of this ISO 13485 lead auditor training, successful learners will have the knowledge and skills to:

  • Explain the purpose of a medical device quality management system (MD-QMS), interaction with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of an effective quality management system
  • Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021
  • Plan, conduct, report, and follow-up an audit of a medical device quality management system to establish conformity (or otherwise) with ISO 13485 and  applicable medical device regulatory requirement documents in accordance with ISO 19011, ISO/IEC 17021


A basic understanding of MD QMS and other related standards including ISO 62304, PD ISO/TR 80002-2-2017, IEC/ISO 60601, ISO 14937, ISO 14644 and ISO 14698-1. Having knowledge about relationship between GHTF, IMDRF and MDSAP would also be beneficial while attending this ISO 13485 certification training program. 

Examination and Certification

In order to satisfactorily complete the ISO 13485 certification course, each trainee must: 
1. Complete/attend all elements of the course 
2. Pass the continuous assessment 
3. Pass the written examination

Evaluation parameters
1) Continuous Assessment: Punctuality, presentation skills, interactive approach, involvement, role-play, daily tests etc. 
2) Written examination: (Closed book) at the end of the ISO 13485 lead auditor certification course
There are 04 Sections
*Study materials and other materials will not be allowed during the exam for reference. 
Unmarked Copy of ISO 13485 will be allowed to be referred.
            Total Marks for Examination: 90 Marks 
             Passing Criteria 1: 70% of 90 Mark – 63 Marks
             Passing Criteria 2: 50 % in each of the 04 sections

TÜV SÜD South Asia as an Approved Training Partner of CQI IRCA and the organisation fulfills all compliances of the course PR369: MD-QMS ISO 13485:2016 Lead Auditor (Medical Device – Quality Management System). Participants who will score 70% and above in both the continuous assessment and written examination will be issued an CQI IRCA (Charted Quality Institute - International Register of Certificated Auditors) registered certificate of successful completion of the course, which is renowned in certification and carries worldwide acceptance.

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