ISO 13485 Courses
Course aims
The aim of this course is to provide delegates with the knowledge and skills required to perform an audit of part of a quality management system based on ISO 13485 and report on the effective implementation and maintenance of the management system in accordance with ISO 19011.
What will I learn?
- Interpretative skills in understanding the requirements of ISO 13485:2016
- Effective auditing techniques
- Practical knowledge of the Management System Approach
- Application of methods and techniques to conduct, and generate findings, on an ISO 13485:2016 audit.
- Core concepts and background on medical devices – Quality management systems in the supply chain.
- Review of common compliance problems and possible solutions.
- Application of methods and techniques to gather, evaluate & triangulate satisfactory objective evidence during an audit to determine the conformance of a system.
- Ability to generate accurate, appropriate, and comprehensive audit findings and conclusions.
This course will teach students the principles of ISO 13485:2016 and how to use tools as well as to teach students how to apply methods and techniques to plan and conduct an ISO 13485:2016 Audit.
Is this course right for me?
This course is aimed at:
- 3rd party ISO 9001 auditors converting to ISO 13485
- Key personnel from organisations that are currently implementing a QMS
- Managers and staff who are, or are about to become members of the organisation’s audit team
- Quality Managers, Regulatory / Compliance Managers, Internal Auditors and Consultants.