DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "ISO 13485 2016-Quality management systems - Requirements for regulatory purposes - Webinar" webinar to their offering.
All life science businesses are required to maintain their Quality Management System training (QMS) processes in a state of control, via controlled documents and objective evidence in the form of record keeping requirements.
Medical device designers and manufacturers are required to follow ISO 13485 training, and will be expected to implement the 2016 revision changes. They will have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOP training, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.
The webinar will first present the key differences between ISO 13485 2016 versus ISO 13485 2003.
Next, the speaker will provide an overview of the updated standard.
Overview of ISO 13485 2016:
- Systemic Requirements
- Management Requirements
- Resource Requirements
- Realization Requirements
- Remedial Requirements
For more information visit http://www.researchandmarkets.com/research/lkmts6/iso_13485