Standard Internal Audit
course objectives
• To enable trainees to understand the meaning of internal audits and the qualifications of internal auditors.
• Trainees will be able to interpret the requirements of ISO 13485:2016 to guide internal audits.
• Trainers understand the planning of the audit. to be used to create a program for internal audits
• Trainers understand how to prepare for an internal audit. To be used in the preparation of the audit list (Checklist)
• the participants understand to the technique of auditing for questioning, interviewing, sampling and gathering evidence in the audit
• Trainers can write Requests for Correction (CARs) showing facts and useful to those who are assessed
• Trainers can write a report audit for for executives to use in development and improve the efficiency and effectiveness of the management system Occupational Health and Safety
who should attend the training
• executive
• ISO 13485:2016 Working Group
• Management Representative
course content
• Management System Audit Guidelines according to ISO 13485:2016
• Application of the ISO 13485:2016 audit guidelines
• Planning, preparing, and executing audit activities
• Creating and Distributing Audit Reports
• Completion of audit operations and audit follow-up