ISO 13485 medical device COURSE

Classroom Based Courses

International Associates Limited (IAL)

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.