ISO 9001:2015 QMS
ISO 9001 has always advocated mitigating and avoiding risk; it has implicitly addressed the issue. The new ISO 9001:2015 standard explicitly expects organizations to identify and address risks affecting product and service compliancy, resulting in improved customer satisfaction. Besides identifying the risks, the new ISO standard expects organizations to address opportunities for improvement based on the risk analysis. Although it does not require you to create a formal risk management system.
ISO 9001 is a quality management system (QMS) standard that requires an organization to meet its own requirements and those of its customers and regulators. It is based on the plan-do-check-act methodology, which helps organizations establish, implement, monitor and measure their processes to deliver results that align with the organization’s requirements and continually improve performance by taking appropriate action.
The ISO 9001:2015 standard has been restructured: chapter and subchapter titles, as well as the order of clauses and paragraphs, were completely revised.
- The standard is rewritten according to the HLS (High Level Structure)
- Risk management becomes a foundation of the standard
- A standard purposely open to the service industry
- No more quality manual
- Importance given to the context surrounding the certified organization and to its stakeholders.
- Knowledge is a resource like any other
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