ISO 13485:2016 certificate establishes the requirements of a Medical device/equipment Quality Management System that consistently meets Customer and applicable regulatory requirements. Such organizations may be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation or servicing of medical devices/equipment.

ISO 13485 is generally aligned with ISO 9001 and the basic difference is that ISO 9001 requires Organizations to demonstrate continuous improvement whereas ISO 13485 requires Organizations to demonstrate a quality management system for medical devices that is implemented and maintained effectively.

What are the benefits of implementing ISO 13485 Training In Medical Industries ?

The medical device industry is currently undergoing a massive regulatory change. In the European Union, the implementation of the new regulations – the Medical Device Regulation (MDR) and the In vitro Device Regulation (IVR), has given the industry some new challenges. The implementation deadlines are approaching fast. At the core of these regulations is ISO 13485:2016, the mandatory standard. Thus, Training and Competency development of the standard will help industries meet their compliance goals. In this article, learn more about how to perform ISO 13485 training and awareness.

What are the ISO 13485:2016 requirements?

Under ISO 13485:2016, all personnel dealing with quality processes and specialized tasks need to have the necessary skills and competency to execute their roles. Competency can be gained through education, training, skills development and experience. The standard requires the following:

  • The process of establishing competency for each person must be documented. Next, training needs are to be identified, the relevance of the training needs must be provided. The frequency of training and how awareness is to be generated should also be documented. These are new requirements of the 2016 version of the standard.
  • The records of all training programs that an individual goes through are to be maintained. Typically, these records are managed as employee files along with certificates. The competency of the trainer is also documented.
  • Training effectiveness should be assessed.
  • Each individual involved in a critical process needs to be fully aware of the relevance and importance of his/her work and its impact on product quality and quality objectives.
  • Training is periodically required to maintain a high level of competency in the organization.

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