ISO 13485 Internal Auditor Training Course

الموضوعات والوحدات الرئيسية

• Medical device QMS
• Regulatory interfaces
• Process audit planning
• Evidence sampling
• Audit reporting
• Practical workshop: developing the medical device QMS internal audit checklist

الفئة المستهدفة

• Quality managers
• Internal auditors
• Laboratory managers
• Process owners
• Quality engineers

القطاعات ذات الصلة

Medical device manufacturing, In-vitro diagnostic manufacturing, Medical device servicing, Medical device distribution

القيمة في مكان العمل

• Provide teams with a medical device QMS internal audit checklist to support consistent decisions and clearer handovers.
• Strengthen review of evidence sampling and audit reporting using the course exercises and documented findings.
• Support performance follow-up through a defined measure: device quality audit findings linked to applicable criteria.

اعتبارات التقييم والالتحاق

الالتحاق والاعتراف: The proposed duration covers BEMCON learning delivery. It does not establish an external qualification, personnel certification or operating licence.