The objective of this Course is to provide Learners with the knowledge and skills required for conducting internal audit against the ISO 13485:2016 and MDSAP requirements
Description
This course provides comprehensive steps to conduct effective Internal Audit against the requirements of ISO 13485:2016 and MDSAP.Prerequisite:
Prior knowledge of ISO13485 and MDSAP requirements is preferable. It is advisable for learners to have knowledge of Annex SL and MDSAP Audit Approach Document.
Objectives
- Understand how requirements are audited and interpreted
- Know and understand the requirements of ISO 13485:2016 and MDSAP
- Understand what auditors of the system will be looking for
- Gain skills to perform effective internal audits and be prepared to pass third party audits
- Learn, through interactive workshops, techniques for reviewing procedures /records, interviewing personnel and evaluating on site operations
Audience
- Internal auditors' managers
- Quality assurance
- Quality control or regulatory affairs managers
- Department supervisors
- Consultants
- Anyone interested in gaining insight into the techniques and procedures required to perform effective internal audits to ISO 13485:2016 and MDSAP
Virtual Course requirements:
To ensure your access to the virtual course and to gain the most out of this training we request all learners have:
- Reliable internet access (High speed)
- Computer with microphone and camera capabilities
Virtual Class 3 Days
83162150English