Internal Auditor ISO 13485:2016 Training Course
Level of Difficulty
Basic (A very basic knowledge of the topic but no professional usage).
Strong auditing skills are essential in the medical device industry. Delegates will gain the knowledge of how to assess compliance with ISO 13485:2916 after successfully completing this course.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support)
This practical and interactive 2-day ISO 13485:2016 internal auditor training course enables delegates to interpret the requirements of the ISO 13485 medical devices standard from an auditing perspective, and to conduct effective audits. Delegates will learn the principles and practices of effective quality management systems (QMS) process audits in accordance with ISO 19011:2018.
ISO 19011:2018 provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits, as well as guidance on the evaluation of competence of individuals involved in the audit process.
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