Resit – Examination Auditor/Lead Auditor program on Medical Devices - Quality Management System - Requirements for Regulatory Purposes based on ISO 13485:2016

This MD QMS Lead Auditor course 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 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021. The success of an organisation, the penetration of its products and services in the market, efficient internal procedures, and a healthy economic status essentially depends on how MD-QMS requirements and requirements for regulatory purposes are consistently ensured, maintained, and improved. The ISO 13485 Lead Auditor training program fulfils these requirements. 

1)     MD-QMS Introduction and Process Approach 

• Purpose and benefits of MD-QMS-Requirements for Regulatory Purposes including understanding of the basic MD-QMS principles
• Terms, Fundamentals and Principles 
• Process Approach with PDCA 
• Mandatory documents for regulatory purposes
• Difference between compliance and conformance
• Relationship between IMDRF and GHTF
• Principles of IMDRF
• MDR European Union Regulations 
• MD-QMS Requirements (Clause 1 to 8)

2)     Auditing Principle 

• Auditing objectives
• Types of audits
• Audit life cycle
• Terms and Definition
• Principle of Auditing
• Annex A – Guidance of Auditors

3)     Role and Responsibilities of Auditor

• Audit Programme objectives
• The auditees' responsibilities
• The lead auditors’ responsibilities
• Auditors’ qualification and certifications

4)     Role Planning an Audit 

• Pre-Audit planning
• Reviewing documentation
• Developing an audit plan
• Preparing checklists or working documents
• Communication factors

5)     Conducting an Audit 

• Opening meeting
• Collecting objective/audit evidence 
• Effective interviewing techniques
• Identifying and recording nonconformities
• Preparing for the closing meeting

6)     Reporting Audit Results 

• Conducting the closing meeting 
• Preparing the audit report
• Distributing the audit report 

7)     Corrective Actions 

• Corrective action responsibilities
• Follow up scheduling
• Monitoring corrective action 

8)     ISO 13485: 2016 Registration 

• The registration processes
• Surveillance audits 

9)     Exercises/ Role play (50 % of course Time) 

10)  Written Examination

The participant who attended the 5-days training but failed or missed the first attempt exam, are eligible to appear for a Resit examination

The participant who attended a 5-day course but failed or missed the first attempt, is eligible to appear for a Resit examination within 12 months of their first examination attempt.

To satisfactorily complete the 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 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.

1. When can I get the certificate?

MD-QMS ISO 13485:2016 Lead Auditor certification will be issued within 21 working days from the examination date.

2. When can I get the training material and invite?

One day before the commencement of the training program.

3. How do I pay the fees for training and examination?

Online mode

4. What are the benefits of the MD-QMS ISO 13485:2016 Lead Auditor Program?

• Understand how to describe the goal of a quality management system, its standards, management system auditing, and third-party certification.
• Understand an auditor's responsibilities in planning, conducting, reporting, and following up on a quality management system audit in accordance with ISO 13485:2016.
• Demonstrate knowledge and basic abilities to conduct and lead a management systems audit.

5. Do you offer support for ISO 13485 2016 lead auditor training course?

Yes, at TÜV SÜD, we offer support for ISO 13485 2016 lead auditor training course through a comprehensive course that 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 and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

6. Is ISO 13485 lead auditor course useful?

The ISO 13485 lead auditor course is indeed useful and essential as they are among the most valuable and recognised credentials that can boost your career.

7. Is there any refund policy for the paid fees?

Please check Cancellation and Refund Policy page.