Discussing corporate sustainability and social responsibility from the perspective of the new quality management system requirements
With the release of the new ISO 9001 quality management system in September 2015, other ISO standards have also been revised. With the exception of ISO 13485, which has slightly different requirements for medical device quality management systems, most standards share common elements such as "organizational context analysis," "ISO 9001:2015 integration," "adoption of the High-Level Scale (HLS) framework," "introduction of risk-based thinking and risk management," and "strengthening the responsibilities of organizational leaders." The "organizational context analysis" section specifically emphasizes "4.1 Understanding the organization and its context" and "4.2 Understanding stakeholder needs and expectations," requiring that internal and external issues affecting the organization be the starting point for establishing, implementing, and maintaining a quality management system, emphasizing the connection between the quality management system and the organization's internal and external environment. Therefore, in the operation of the new version of ISO management system, the focus is no longer just on the implementation results of the project scope corresponding to each standard, but is more closely integrated with the overall operation management and even performance of the enterprise. Just like through the application of SWOT analysis tools, when planning the enterprise operation strategy, the opportunities, threats, strengths, weaknesses and other issues faced by the corresponding projects of each standard are included. Then, risk assessment and response measures are carried out to "leverage strengths" or "prevent problems before they occur"; so that the enterprise operation can obtain appropriate risk control and effectively improve performance, so as to achieve the result of sustainable profit and operation. However, simply conducting S through "understanding the organizational background" is not enough.