MD-QMS ISO 13485:2016 Lead Auditor Training Course

Face to face Training5 DaysIntermediateVirtual Classroom

Achieve an internationally accepted CQI/IRCA (Charted Quality Institute - International Register of Certificated Auditors) registered certificate.

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 the ISO 13485 standard and applicable international regulatory standards in accordance with ISO 19011, ISO/IEC 17021.

It provides hands on training to ensure that participants thoroughly understands the role of an auditor and acquires the expertise needed or required to perform ISO 13485 QMS audits effectively. It is structured to provide an 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 the 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.

ISO 13485: 2016 (Medical Devices-Quality Management System-Requirements for Regulatory Purposes) specifies requirements for a management system for medical devices manufacturing organisations:

a) To demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

b) Aims to enhance customer satisfaction through the effective application of its MD-QMS, including processes for improvement of the system and assurance of conformity to the requirements of MD-QMS Requirement for Regulatory Purposes.

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.
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.
  • An 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.

Participants who 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.

  • Quality Professionals/ Consultants
  • Management Representatives/ Managers / Process owners
  • ISO13485 :2016 Coordinators
  • Auditors/ Lead Auditors
  • Internal auditors of MD-QMS & Other Management System Standards

Why do we need MD-QMS-Requirement for Regulatory Purposes?

To establish management system in order to;
  1. Identify the Role undertaken by the Organization Under applicable regulatory requirements;
  2. Identify the regulatory requirements that apply to its activities under these roles;
  3. Incorporate the applicable regulatory requirements within MD-QMS;
  4. Enhance customer satisfaction;
  5. Identify, Analyse and Mitigate Business, Product and Manufacturing process risks.

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
  • MDSAP Requirements
  • GHTF Requirements
  • 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 process
  • Surveillance audits
9. Exercises/ Role play (50 % of course Time)
10. Written Examination
  • Course delivered by one of TÜV SÜD's leading industry experts
  • Small class sizes enhance trainer-delegate relationship
  • Receive globally recognised TÜV SÜD certificate upon completion

There is a balance between knowledge-based presentation, discussions, exercises and case studies. 50% of the time is spent on activity based learning. A mock examination paper will be discussed throughout the course to help students to be familiar with the style of the question.

Upon completion you will also receive your globally recognised TÜV SÜD certificate of attendance on MD-QMS ISO 13485:2016 Lead Auditor.

Participants attending this course should have adequate knowledge of the ISO 13485 :2016 requirements. Having no prior knowledge may lead to unsuccessful completion of this course and the gaps in this knowledge may not be covered during this course.

TÜV SÜD additionally offers the opportunity to deliver this training as a dedicated in-house course, delivered solely to your organisation to meet your needs and requirements. To receive a quote and find out more information, please contact us at [email protected].

Net Price (excl. VAT)
from£ 2,250.00

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Book training course MD-QMS ISO 13485:2016 Lead Auditor Training Course
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From 07/10/24
Virtual Classroom
£ 2,250.00 add. VAT

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5 Days

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Virtual Classroom


Net Price
£ 2,250.00
plus VAT:
£ 450.00

Total Price (inc. VAT)
£ 2,700.00