Lead Auditor Training Program on Medical Devices - Quality Management System - Requirements for Regulatory Purposes based on ISO 13485:2016

The ISO 13485 Lead Auditor certification training course can be attended by medical device quality testing professionals interested in conducting first-party, second-party, and third-party audits.

• Management representatives.
• Quality directors, managers, and engineers.
• Consultants.

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 caliber of an auditor is crucial to the performance of companies and ultimately to the success of the management system. This comprehensive ISO 13485 Lead Auditor course provides hands-on training to ensure that the auditor thoroughly understands the role of an auditor and acquires the expertise needed or required to perform the audit effectively.

On completion of the ISO 13485:2016 Lead Auditor training course, successful learners will have the knowledge and skills to:

Knowledge

• 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 the 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.

Skills

• 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.

This intensive ISO 13485 Lead Auditor course is a key requirement in becoming a registered Lead Auditor. The ISO 13485:2016 Lead Auditor training is a participative training course, which uses case studies, role-plays, exercises, workshops, and group discussions.

The ISO 13485 Lead Auditor course is structured to provide an in-depth understanding of MD-QMS Requirements for regulatory purposes (ISO 13495: 2016) knowledge and skills required to assess the OH&S management system of an organisation.

TÜV SÜD has achieved Exemplar Global Accreditation as a Recognized Training Provider. This accreditation confirms our commitment to providing the highest quality services and demonstrates our expertise in our industry.

As a professional, it's important to have recognition for your skills and knowledge. Exemplar Global Accreditation provides this recognition, giving you a competitive edge in the marketplace. With over 30 years of experience building certification programs, Exemplar Global is the leading authority in accreditation for the conformity community.

As a student of an Exemplar Global Recognized Training Provider (RTP) course, you are eligible to receive:

• Access to Exemplar LINK
• 12-months of exclusive benefits including:
  • One self-coaching assessment
  • Extended learning content
  • Complimentary access to online events, online magazine, newsletters, and low-cost professional liability insurance
  • Access to an exclusive LinkedIn Community
  • The chance to look into alternatives for employment and career advancement
• A TÜV SÜD / Exemplar Global Graduate Certificate

At TÜV SÜD, we believe in maximizing your career and providing you with the tools you need to succeed. Our Exemplar Global Accreditation is a testament to our commitment to excellence and our commitment to helping you succeed.

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This is an instructor-led training in a virtual classroom. There is a balance between knowledge-based presentation, discussions, exercises and case studies. 50% of the time is spent on activity-based learning.

• 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

Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.

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

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

In order 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.

• Participants who score 70% and above in both the continuous assessment and written examination will be issued a certificate of successful completion of the course. The Lead Auditor course is made in line with international registers and guidelines.
• Unsuccessful candidates will be issued a certificate of attendance.

Learners must obtain a copy of the ISO standard to be referenced during the course. The standard may be purchased through the American National Standards Institute (ANSI) (www.ansi.org) and/or American Society for Quality (ASQ) (www.asq.org).

As the ISO 13485 Lead Auditor training covers auditing concepts utilising ISO 13485, a prior understanding of ISO 13485 and its implementation within a Medical Device business and internal audit experience is recommended.

MD -QMS

• MD -QMS Terms and definitions
• MD -QMS Requirements
• ISO 9000 – Terms and Definitions

Other related standards

• IEC 62304
• PD ISO/TR 80002-2-2017
• IEC/ISO60601
• ISO14937
• ISO14644
• 14698-1

Relationship With

• GHTF
• IMDRF
• MDSAP