This is a 4-day course providing the certification of attainment for the following units:
AU - Management System Auditingsee.. To attain registration as a QMS auditor, senior auditor, or lead auditor, attendees must pass the written examination, earn a passing grade (70% score) in-course assessments, and meet all prescribed professional requirements of attendance, participation, and learning objectives.
Learning Objectives:
Attendees will learn how to audit and lead an audit team including how to assess compliance with ISO 13485:2016. understanding how to plan, conduct, follow up on, and work with audited organizations to ensure efficient and effective audits. Students gain necessary auditing skills through formal class work, role-playing, group workshops, and open forum discussions.
At the end of this course, attendees will be able to:
1. Understand the development and deployment of the Quality Management System for medical devices
2. Understand all levels of documents required including interpretation of each clause of ISO 13485:2016
3. Understand the differences among FDA QSR, ISO 13485:2003, ISO 13485:2016, and ISO 9001:2015
4. By performing 20+ case studies and dynamic simulated workshop, learn how to audit and demonstrate conformity to the requirements.
5. Learn how to evaluate the effectiveness of the entire QMS, including the process approach
6. Learn how planning, process, and supporting activities can be evaluated effectively.
7. Understand the importance of leadership, risk-based auditing, management review, internal auditing, and the monitoring and measurement of the QMS.
8. Understand the audit process and responsibilities.
9. How to plan, perform, report, and follow-up on audits.
10. Describe the role and responsibility of the auditor, lead auditor, and the auditee at all stages.
Prerequisites:
QMS auditing background.
Note: All attendees need to study ISO 13485:2016: before attending this class.
Who Should Attend
This course is designed for first, second, or third-party auditors and professionals who may be leading ISO 13485:2016 compliance activities in their organizations. This is also training for those involved with corporate internal auditing activities who wish to broaden their knowledge of a total audit process. This course is also recommended to anyone involved with supply chain management or supplier quality control or assurance.
