ISO 13485 Medical Devices Internal Auditor Training هذه الدورة تدرس باللغة الإنجليزية

تفاصيل الدورة

Who should attend?

Medical device quality professionals with knowledge of quality management systems and ISO 13485
Individuals interested in conducting first-party or second-party audits
Management representatives
Internal auditors
Managers
Consultants
This course does not detail the requirements of ISO 13485:2003 so some previous knowledge is required
"Very good to learn more on ISO 13485 clauses and internal auditor roles & responsibilities. Thanks for the course." – Mohankumar, Becton Dickinson Medical Products Pte Ltd
What will I learn?

On completion of this training, participants will be able to:
Explain the structure and scope of ISO 13485 management system standard and how it applies to the organization aiming for regulatory compliance worldwide
Identify the principles of auditing and auditor responsibilities
Plan an internal audit
Conduct informal opening and closing meetings
Conduct an audit based on process identification, sampling and questioning
Provide verbal and written feedback
Document concise nonconformities
Effectively report on an audit
Follow-up on corrective actions
What are the benefits?

Be better able to continue compliance with ISO 13485
Maintain and improve a global benchmark in quality standards
Be confident that your organization can rely on ISO certified internal auditors
Motivate colleagues through CPD and build customer confidence.
What is included?

Training course notes
Lunch
Refreshmensts
Pen