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.