ISO 14971 risk management requires clear executive policy, useful guidance, and resource support in the form of human resources and training. You will need effective assessment methodologies appropriate to the product or service, and continual monitoring, assessment and improvement of the risk management process. Payback will take the form of dramatically improved efficiency and effectiveness of the organization's quality programs - previously invisible waste and inefficiencies become easy to identify and correct.
ISO 14971 risk management can be used to connect design control, quality planning, process control, measurements control and core problem solving processes. When this connection is made the interplay between them be-comes clear and potential problems can be prioritized and addressed in the most effective way at the lowest possible cost.
The entire organization and management team will benefit and feel a sense of satisfaction that they have, indeed, acted to benefit themselves, their organization and their society.
Date: 15th & 16th December 2021
Venue: Polytool Technologies Sdn. Bhd., Bayan Lepas, Penang
The two-day risk management course is intended to deliver the principles and concepts of risk management as defined in ISO 14971; the purpose of risk management as required by the regulatory authorities around the world; and provide a practical application that the attendees will use as a model of applying risk management to their own situation. Here are the learning objectives for the two days training program; after completing this program, partici-pants will be able to:
Understand the ISO 14971 guidelines for risk management
Explanation of the importance of risk management and risk analysis processes for medical devices.
Use appropriate approach to risk management, and its relationship to design control, quality planning, process control, measurements control and core problem solving processes.
Understand all major medical devices industry approaches to Risk Management and the variations in current use.
Who Should Attend:
Quality Managers, RA Managers, Auditors of Medical Device, Executives & Senior Management, Cross functional team members of implementation project, Suppliers to the organisation.
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