MMD-105 Understanding the Requirements of ISO 14971:2019 - Risk Based
Thinking
A well-functioning quality management system, certified to ISO 14971, is a great start to building sustainable business performance.
ISO 14971:2019 risk based thinking training – increase your risk management awareness.
It can help you ensure on-time delivery, zero defects, and reduce waste, for example. An occupational health and safety system helps you to ensure worker safety, reduce sick-leave and cut the number of accidents in the workplace.
ISO 14971:2019 risk based thinking training – increase your risk management awareness.
It can help you ensure on-time delivery, zero defects, and reduce waste, for example. An occupational health and safety system helps you to ensure worker safety, reduce sick-leave and cut the number of accidents in the workplace.
The objective of this course is to provide participants with an introduction to risk management awareness aligned with ISO 14971:2019, provides learners with an overview of the purpose and requirements of a risk management system (RMS) based on the principles of ISO 14971.
- What is ISO 14971 and relation with Medical Device
- New ISO 14971:2019 the revised requirements : Identifying the changes
- Understanding the alignment of ISO 14971:2019 with MDR
- Type of medical device and it risk association
- Reference to ISO TR 24971 Guidance on application of ISO 14971
- Comparison of the clauses for version 2007 and 2019
- Annexes removed from the standard
- Additional Terms
- Briefing of ISO 14971 and Relation with Essential Principle of Safety and Performance
- Understanding risk related to Medical Device
- Type of medical device and it risk association
- Risk-Based Approach - Risk Management requirements to overall quality system requirements
- Risk Analysis method: FMEA
- Risk Analysis
- Risk Reporting
- Senior management
- Whom is responsible for transitioning their organization’s MD to meet the requirements
- Auditors and quality professionals
- Management Representatives
- For anyone working with quality management systems requiring an awareness of risk based thinking, this training course includes tutor led presentations and workshops.
This is a 1 or 2-days programme.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
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We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
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