- Risk is the possibility of events or activities impeding the achievement of an organization’s strategic and operational objectives.
- With ISO 9001:2015, the organization must consider the risks and opportunities in optimizing the Quality Management System (QMS)
- SBS offers several tools to implements Risk assessment in QMS:
–The SBS FMEA database
- A stand-alone tool for analyzing processes or items for failure mechanisms and implementing actions to improve the process and reduce overall risk
–The SBS Quality Database
- Containing tools for Failure Modes and Effects Analysis (FMEA), SWOT analysis, and Preventive Actions.
–The Q-Med Database
- Containing tools for Failure Modes and Effects Analysis (FMEA), SWOT analysis, and Preventive Actions.
- Ideal for FDA regulated industries