Outcome
This ISO 13485 Medical Device Quality Management System Lead Auditor course aims to provide participants 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 (Guidelines for auditing management systems) and ISO 17021.
 
TÜV SÜD will guide participants through the entire audit process using a step by step approach, from initiating the audit through to conducting audit follow-up. Participants will acquire the skills to plan, conduct, report and follow-up a MD QMS audit that establishes conformity and enhances overall organizational performance.
 
The course provides hands on training to ensure that participants thoroughly understand the role of an auditor and acquires the expertise needed or required to perform ISO 13485 MD QMS audits effectively. It is structured to provide an in-depth understanding of ISO 13485 medical device quality management system requirements for regulatory purposes.
 
This intensive ISO 13485 lead auditor course is a key requirement for becoming a registered Lead Auditor. Achieve an internationally accepted CQI/IRCA (Charted Quality Institute - International Register of Certificated Auditors) registered certificate.
 
Content
 
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 MD QMS purposes
• Difference between compliance and conformance
• Relationship between IMDRF and GHTF
• Principles of IMDRF
• 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 process
• Surveillance audits

Methodology
The course consists of knowledge-based presentation, case studies, role plays, exercises, workshops and group discussions. 50% of the time is spent on activity based learning resulting in deeper understanding of the material and a greater impact on job performance. A mock examination paper will be discussed throughout the course to help participants to be familiar with the style of the question.
 
Examination and Certification
In order to satisfactorily complete the course, each participant 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, 2 hours duration (physical pen and paper):

• The examination consists of 4 sections
• Closed book examination, study materials and other materials will not be allowed during the examination for reference
• An unmarked copy of ISO 13485 will be allowed to be referred
• Total marks of examination: 90 marks
• Passing criteria 1: 70% of 90 mark – 63 marks
• Passing criteria 2: 50 % in each of the 4 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.
 
In addition, upon completion participants will also receive a course certificate issued by Medicoindustrien and TÜV SÜD.
 
Who should attend
The training is relevant for: 

• Quality professionals
• Consultants
• Management representatives, Managers or Process owners
• ISO 13485:2016 Coordinators
• Auditors/ Lead Auditors 

Knowledge of ISO 13485 and its application within a medical device organization is strongly recommended together with experience with conducting internal or supplier audits.
 
Prerequisites
Participants are expected to have adequate knowledge of the requirements of ISO 13486:2016. Having no prior knowledge may lead to unsuccessful completion of this course and the gaps in this knowledge may not be covered during the course.
 
Trainer
TÜV SÜD Tutor, Balakrishnan Babu