ISO 13485 Standard Internal Auditing Course
Do you work with medical devices and quality management? Strengthen your expertise with our ISO 13485 Standard Internal Auditing Training — designed to give you the knowledge and practical skills to perform internal audits confidently within your own organization.
ISO 13485:2016 is a globally recognized management system standard for manufacturers of healthcare devices and supplies, as well as other operators in the field. The standard ensures that the regulatory and customer requirements for healthcare devices and supplies are fulfilled at every stage of a product’s lifecycle. Internal auditing is utilized as a tool for developing the quality system, and it is also one of the requirements of the ISO 13485 standard.
In this two-day course, you will gain fundamental knowledge of the concept of auditing, its scope, and procedures, as well as the skills and qualifications to function as an internal auditor in accordance with the ISO 13485:2016 standard within your own organization.
You will learn:
- The fundamentals of auditing and significance of auditing as a tool for developing your Quality Management System (QMS)
- How to perform an internal audit in compliance with ISO 13485:2016 requirements
- How to incorporate MDR/IVDR requirements into internal audits
- How to audit subcontractors
The training includes hands-on, interactive exercises and an audit assignment in your own organization. The course is led by Leena Raunio, a highly experienced QA/RA professional and certified ISO 13485 & MDSAP lead auditor.
This course is ideal for quality managers, internal auditors, and professionals working with devices and responsible for maintaining or developing the QMS.
The course will be held online on 17 March & 28 April. Book your spot today! Learn more and register
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