LEAD AUDITOR TRAINING PROGRAM ON MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEM - Based on ISO 13485: 2016
COURSE OVERVIEW: ISO 13485 LEAD AUDITOR TRAINING
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 organization, the penetration of its products and services in the market, efficient internal procedures, and a healthy economic status depends essentially 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.
MD-QMS CONCEPTS AND BENEFITS
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
COURSE OBJECTIVES
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 organization.
WHO SHOULD ATTEND THIS ISO 13485 TRAINING COURSE?
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 utilizing ISO 13485, a prior understanding of ISO 13485 and its implementation within a Medical Device business and internal audit experience is recommended.
WHAT'S INCLUDED IN THIS ISO 13485 TRAINING COURSE?
- On completion of the ISO 13485:2016 Lead Auditor Training course, delegates will be able to describe the goal of a quality management system, its standards, management system auditing, and third-party certification.
- The ISO 13485 Lead Auditor course explains an auditor's responsibilities in planning, conducting, reporting, and following up on a quality management system audit in accordance with ISO 13485:2016.
- Passing the necessary IRCA test and skills assessment after completing this IRCA approved QMS Lead Auditor course, you will demonstrate knowledge and basic abilities to conduct and lead a management systems audit.
Our high impact accelerated learning technique as a part of the ISO 13485 lead auditor course improves knowledge retention and skill application. This activity-based training results in a deeper knowledge of the topic and a larger influence on work performance.
CONTENTS OUTLINE: ISO 13485 LEAD AUDITOR
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
EXAM DETAILS (DURATION, PATTERN)
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
TRAINING DURATION
5 Days consecutively (40 hours)
Course Venue/Mode
Courses are held through ABC Academy / online
CERTIFICATION
• ABC CERTIFICATION certified training partner for Exemplar Global
• Participants who receive 70% and above in both continuous evaluation and written examination will receive exemplar Global certification to successfully complete the course, which is recognized worldwide. Lead auditor course is prepared in line with international records and guidelines.
