Learn how to audit the processes of an ISO 13485:2016 Quality Management System (QMS). This course provides guidance and practical experience in planning, executing, reporting and audit follow-up of an internal audit when monitoring the effectiveness and conformity of a ISO 13485:2016 compliant QMS.
Participants Receive:-
- Slides including exercises
- ISO 13485:2016 standard
- Certificate of course completion post exam on the 2nd day
Course Facilitators:-
All course facilitators are highly qualified and experienced both in training and assessment of Medical Devices Quality Management Systems. We strongly believe that the experience in Environment Management Assessment and Training skills is a right combination to deliver a practical training course. They are selected on their ability to make BSCIC courses both practical and enjoyable.
Who should attend?
Medical device quality professionals with knowledge of quality management systems and ISO 13485:2016, as well as individuals interested in conducting first-party or second-party audits, management representatives, internal auditors and consultants.
Learning objectives:-
You will learn about:
- Explain the structure and scope of ISO 13485:2016 and how it applies to the organization seeking regulatory compliance
- Identify the key principles of auditing and auditor responsibilities
- Plan an internal audit
- Conduct an effective audit based on process identification, sampling and questioning
Eligibility?
No specific knowledge or experience is required.
Course Content and Structure:-
The course of ISO 13485:2016 includes a series of presentations, Examples, Exercises involving group activities, Brain Storming, Case Studies, Readings and Sharing of Practical Experiences.
Duration:-
2 Days