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  • ISO 13485 Medical Devices Quality Management System

The ISO 13485 course is designed for professionals managing quality in the medical devices sector. It covers the implementation of a Quality Management System (QMS) adhering to ISO 13485 standards. The course addresses regulatory requirements, risk management, and ensuring product safety and efficacy. Certification demonstrates proficiency in maintaining high-quality standards for medical devices.

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ISO 13485 Medical Devices Quality Management TrainingCourse

Curriculum

Master ISO 13485 for Medical Devices Quality Management. Learn compliance, risk management, and quality assurance to advance your career in the medical device industry.

Ratings

( 4.5 Ratings )

Live Online Classes starting on 01 January, 1970

ISO 13485 Medical Devices Quality Management System

The ISO 13485 Lead Auditor course is designed for individuals seeking to master the audit of Medical Devices Quality Management Systems (MDQMS) using the ISO 13485 standard. Through this comprehensive 13485 lead auditor training, learners will understand the course objectives, structure, and the relevant standards and regulatory frameworks. They will learn about the certification process and the fundamental principles of MDQMS.

Participants will gain expertise in Audit principles, preparation, initiating, and conducting both Stage 1 and Stage 2 audits. The course delves into On-site audit activities, communication during the audit, and the creation of audit findings and reports. It also covers the closing of the audit, evaluating action plans, managing an internal audit program, and the competence and evaluation of auditors.

Upon completion of the modules, learners will undertake a Certification Exam to validate their knowledge and skills in auditing MDQMS. This 13485 lead auditor course equips learners with the proficiency to perform and lead MDQMS audits effectively, ensuring compliance with ISO 13485 standards.

 

Why Should You Attend?

The ISO 13485 Lead Auditor training course equips you with the skills required to perform audits of Medical Devices Quality Management Systems (MDQMS) effectively. You will learn to apply recognized audit principles, procedures, and techniques essential for conducting both internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification processes.

The course includes practical exercises designed to help you master audit techniques, manage audit programs and teams, communicate effectively with clients, and resolve conflicts. Upon completing the course and passing the exam, you can apply for the “PECB Certified ISO 13485 Lead Auditor” credential, which validates your expertise in auditing MDQMS based on best practices.

 

Who Should Attend?

  • Auditors seeking to perform and lead MDQMS certification audits

  • Managers or consultants aiming to master the MDQMS audit process

  • Individuals responsible for ensuring conformance with MDQMS requirements

  • Technical experts preparing for MDQMS audits

  • Expert advisors in Medical Devices Quality Management

 

Learning Objectives

By the end of this training course, you will be able to:

  • Understand MDQMS Operations: Comprehend the operations and requirements of a Medical Devices Quality Management System based on ISO 13485.

  • Relate Standards: Recognize the correlation between ISO 13485 and other relevant standards and regulatory frameworks.

  • Auditor’s Role: Understand the auditor’s responsibilities to plan, lead, and follow up on audits in accordance with ISO 19011.

  • Audit Leadership: Learn to lead an audit and manage an audit team effectively.

  • Interpret Requirements: Interpret ISO 13485 requirements within the context of an MDQMS audit.

  • Audit Competencies: Develop competencies to plan audits, lead audits, draft reports, and follow up on audits in line with ISO 19011.

 

Educational Approach

  • Theory and Best Practices: The training integrates theoretical knowledge with best practices used in MDQMS audits.

  • Case Studies and Examples: Lectures are illustrated with practical examples and case studies.

  • Practical Exercises: Engage in practical exercises, including role-playing and discussions based on real-world scenarios.

  • Exam Preparation: Participate in practice tests designed to mirror the certification exam format.

 

Course Outline

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

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) 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

(4.5 Ratings)

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