Course Description:
This comprehensive course is designed to equip participants with the knowledge and skills necessary to conduct first, second, and third-party audits of quality management systems for medical devices in accordance with ISO 13485:2016. Following ISO 19011 and ISO/IEC 17021-1 guidelines as applicable, participants will gain a deep understanding of effective audit practices specific to the medical device industry.
Course Objectives:
- Understand ISO 13485:2016 Requirements: Gain a detailed comprehension of the clauses and requirements specified in ISO 13485:2016.
- Audit Principles and Techniques: Master the principles, methodologies, and techniques essential for conducting effective audits.
- Audit Planning and Preparation: Develop skills in planning, executing, documenting, and following up on audits.
- Skills for Audit Execution: Acquire practical skills for executing audits efficiently in the medical device industry context.
- Audit Reporting: Learn how to document findings and prepare comprehensive audit reports specific to medical devices.
- Communication Skills: Enhance essential communication skills for effective auditing, including interviewing and active listening.
- Corrective Actions and Follow-Up: Understand the process of implementing corrective actions and conducting follow-up audits in medical device settings.
- Role of an Auditor/Lead Auditor: Gain insights into the responsibilities and roles of auditors and lead auditors within the medical device quality management context.
Course Agenda:
Day 1: Introduction to Medical Devices Quality Management Systems and ISO 13485
Day 2: Audit Principles, Preparation, and Launching of an Audit
Day 3: On-site Audit Activities
Day 4: Closing the Audit
Day 5: Revision and Examination
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Instructor Profile:
Experienced ISO 13485:2016 auditors and lead auditors with substantial industry expertise and teaching experience in medical devices quality management systems. |
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Learning Methods:
- Lectures and presentations by experienced industry professionals
- Interactive group discussions and workshops tailored for medical device audits
- Practical audit simulations and exercises with real-world medical device case studies
- Role-playing scenarios to simulate medical device audit scenarios
- Final examination to certify participants as ISO 13485:2016 auditors
Certification:
Participants who successfully complete the course and pass the final examination will receive a certificate of completion, recognized internationally.
Duration:
5 days (40 hours) including the final examination
Benefits of Attending:
- Become a certified ISO 13485:2016 lead auditor.
- Enhance your career prospects in the medical devices industry.
- Improve your organization’s quality management system for medical devices.
- Network with professionals and industry experts in medical device quality assurance and compliance.
Course Features
- Lectures 19
- Quiz 0
- Duration 30 hours
- Skill level Expert
- Language English
- Students 0
- Assessments Yes
Requirements
- Basic understanding of ISO 13485:2016 standards
- Prior experience in the medical device industry or quality management is beneficial but not mandatory
Target audiences
- Quality managers
- Quality auditors
- Regulatory affairs professionals
- Individuals aspiring to become certified ISO 13485:2016 auditors
- Professionals involved in implementing or auditing quality management systems for medical devices
