Auditor/Lead Auditor Training Course on Medical Devices - Quality Management System - Requirements for Regulatory Purposes based on ISO 13485:2016 (CQI IRCA)

This 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 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

As the ISO 13485 Lead Auditor training in India 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

• 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.

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.
            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

Certification

TÜV SÜD South Asia as Approved Training Partner of CQI IRCA fulfills all compliances of the course PR369: MD-QMS ISO 13485:2016 Lead Auditor (Medical Device – Quality Management System). 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. The Lead Auditor course is made in line with international registers and guidelines. Unsuccessful candidates will be issued a certificate of attendance from TÜV SÜD South Asia.

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 refer to Cancellation and Refund policy page.