In Focus

摘要

Probably the most significant change to ISO 9001:2015—Quality management systems—requirements concerns integrating risk-based thinking as part of the quality management system (QMS) and decision-making processes. While risk management concepts are nothing new to ISO 9001, previous versions were more reactionary and primarily focused on detection after the fact, root cause analysis, corrective actions and preventing the failure's recurrence. ISO 9001:2015 emphasizes considering risk up front (prevention) and having a solid approach to address risk in planning, managing and driving actions. Failure mode and effects analysis (FMEA) can be effectively applied to address the standard's risk-based requirements. Note, however, that FMEA is only one of many tools that can be used to address risk.