Lead Auditor Training Program on Medical Devices - Quality Management System - Requirements for Regulatory Purposes

The comprehensive lead auditor course aims to impart sufficient knowledge and information on the Medical Device Quality Management System audit processes and techniques.

At the end of this course, participants will be able to attain:

• Explain the key concepts and principles of ISO 13485:2016
• Describe the purpose of ISO 13485:2016, including the interaction with appropriate medical device regulatory authority requirements, quality management systems standards, and third-party certification
• Explain the business benefits of a quality management system
• Explain the role and responsibilities of an auditor in planning, conducting, reporting, and following up on 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 conformance with ISO 13485:2016 and applicable medical device regulatory requirement documents in accordance with ISO 19011 and ISO/IEC 17021

In addition to the above, you will also gain an in-depth understanding of MD-QMS requirements for regulatory purposes (ISO 13495:2016).
This course is a key requirement in becoming a registered ISO 13485 lead auditor. Completing this course will prepare professionals to audit Medical Device Quality Management Systems and help organisations improve their quality performance.

This course will provide participants with the knowledge and skills necessary to audit Medical Device Quality Management Systems per ISO 13485:2016.

The ISO 13485 lead auditor course covers:

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 / Roleplay

10) Written examination

• Medical device quality management professionals who want to become lead auditors
• Individuals in organisations involved in the design, development, manufacturing, and distribution of medical devices
• Management representatives
• Quality directors, managers, and engineers
• Consultants

• Prior knowledge of the requirements of ISO 13485 and
• Implementation experience with the adoption of ISO 13485 standard or
• Internal audit experience of the ISO 13485 standard

• Conduct effective Medical Device Quality Management System audits in accordance with ISO 13485:2016, ISO 19011, and ISO/IEC 17021
• Recommend and monitor corrective actions
• Lead a team of auditors

• Lead auditor
• Quality manager
• Regulatory affairs manager
• MD-QMS Consultant

The course content and structure are designed by the domain experts from TÜV SÜD.

With immense experience and knowledge of the relevant standards, our team of product specialists and technical experts at TÜV SÜD developed the course content based on the current business landscape and market requirements.

The course will be conducted by our experienced lead auditors, who have audited numerous organisations.

There will be an online examination at the end of the course. A pass is required for certification to be awarded. This certificate is globally recognised and respected and will demonstrate your competence in ISO 13485:2016 lead auditing.

Evaluation Terms and Conditions

• 5% non-refundable amount to be paid now by placing the order on Singapore Academy E-store.
• Our team will contact you for the next steps to evaluate your eligibility for this course.
• On successful evaluation, you can proceed with the course enrollment by payment remainder 95% of the course fees.
• Payment link will be shared with you for 95% balance payment.
• Only after 100% payment, you will be assigned to course schedule which you select at the time of ordering on E-store.
• In case you are not eligible for the course, 5% amount paid while placing the order will not be refunded to you.

1. Besides attending the instructor-led ISO 13485 lead auditor course, can I also attend e-learning courses?
Yes, you can register for any e-learning course at TÜV SÜD.

2. How do I enroll for the ISO 13485 lead auditor training Course?
Please click “Buy now” to enroll and check out your cart.

3. What is the ISO 13485 lead auditor training course methodology?
The course is delivered through lectures, discussions, case studies, and group exercises.

4. Can I get a refund if I cancel my enrollment?

• If you communicate the cancellation to us by email within 14 days before the confirmed training date, we will not provide a refund for the training.
• If you communicate the cancellation to us by email more than 14 days before the confirmed training date, we will provide a 50 % refund for the training.

5. Are there any tests in the middle of the ISO 13485 lead auditor course?

• There is a closed-book exam at the end of the course. No study materials or other materials are allowed for reference.
• The passing score for the examination is 63%. Participants who score 70% or higher will receive a certificate of achievement. Participants who score lower than 70% will receive a certificate of attendance. To receive a certificate, candidates must have 100% attendance.

Note: In-house trainings are not applicable for manufacturers in medical device & healthcare industries.