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Awareness Training Program on Medical Devices Certification

ISO 13485


ISO 13485 Quality Management System standard for medical devices. The Internal Auditing Course provides delegates with the skills to be able to plan, prepare and perform Internal Audits to ensure the Quality Management System focusing on Medical devices is implemented effectively and that the system is successful in helping the company of maintaining and controlling its own Quality Policy, System/related Regulatory requirements for managing the risk environment encountered which highly affect to product quality and customer/user confidence.

Awareness Training Program on Medical Devices is a very practical awareness and comprises 2 days in total, the first two days being theory presentations and workshops focusing on exercising communication and team management skills as well as skills focusing on analysis and logic. The third day involves a simulated internal audit which is conducted through case studies and by giving participants the opportunity to carry out an actual live Audit on the premise.

By the end of the course, the participants will:

• Overview of Quality Management Systems for Medical Devices

• Purpose of Auditing

• Overview of ISO 13485 : 2003 Requirements

• Audit scheduling/planning

• Conducting the Audit

• Audit Conclusion Reporting audit results

• Corrective action/Follow-up and Close-out


• All food business operators including hotels, retailers, caterers.
• Manufacturers of equipment for food processing.
• Food related packaging material/chemicals.
• Management system Auditor and consultants.
• Representatives from authorities.


• Anyone with a basic understanding of ISO 9000 or other quality management system standards wishing to be capable of conducting internal audits of an ISO 13485 Quality Management System for Medical devices.

• Anyone with the basic knowledge of the Quality system documentation requirement.


A certificate of completion will be issued to successful participants based on performance during the course as well as the examination which will be conducted on the final day of the course.


This means it is under no external financial or shareholder pressure and can present itself to the market as a truly independent body. MSP‘s objective is to “Providing Value Added Services For Safeguarding Life, Property & Environment”.

All management system certificates are not equal. MSP offers more than a ticket to trade. When partnering with MSP, you begin a journey toward business improvement, and ultimately business excellence.

We facilitate certification process for various standards by leading agencies & authorities like Det Norske Veritas (DNV), Intertek, B.V.Q.I, T.U.V. etc.

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