ISO 13485:2016 Internal Auditor Training Course - UK

Participants will learn how audits can support the implementation and improvement of a management system and will develop audit skills and techniques to evaluate the conformance and effectiveness of processes.

Who should attend the ISO 13485:2016 Internal Auditor Training Course?

• internal quality management system auditors
• supplier auditors
• medical device professionals
• quality, audit, compliance, and/or regulatory affairs managers
• auditees preparing for certification audits

What are the objectives of the ISO 13485:2016 Internal Auditor Training Course?

Through lectures, discussions and workshops, you will be able to:

• Learn the principles and practices of the quality management systems (QMS);
• Understand the interpretation of ISO 13485:2016 Standard, the quality management system and its application to Medical Devices;
• Develop skills in planning, preparing and performing value-added ISO 13485:2016 audits; preparing audit reports and conducting follow-up verification audits

What will you learn from the ISO 13485:2016 Internal Auditor Training Course?

By the end of this course ISO 13485 Internal Auditor training course, participants will be able to:

• explain the purpose, structure and content of ISO 13485:2016 Medical Devices
• outline the content of EU MDR and the USA FDA requirements for medical devices and their relationship with ISO 13485
• describe the roles and responsibilities of an auditor
• plan, conduct, report and follow up an internal audit in accordance with ISO 13485
• evaluate conformance of processes to ISO 13485 and related internal and regulatory requirements

Style of delivery and course leaders: ISO 13485:2016 Internal Auditor Training Course

Our course leaders have extensive experience across a wide range of sectors including manufacturing, service and professional organisations including Local, National and International Government. This wide experience enables them to make the course more interesting by using their relevant examples and case studies during workshop discussions.

Their team of staff has extensive experience of working across cultural boundaries, through their work in Europe, Africa, Middle East, Asia and the Americas.

Will I get a Certificate after completing the ISO 13485:2016 Internal Auditor Training Course?

Delegates successfully completing the course will be awarded a certificate from SAI Global.

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