ISO 9001:2015 sets out the new criteria for a quality management system and is the only standard in the family that can be certified to. It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
Interesting now is that the new standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. And one of the key changes in the 2015 revision is the establishment of a systematic approach to risk, rather than treating it as a single component of a quality management system. In previous editions of ISO 9001, a clause on preventive action was separated from the whole. Now risk is considered and included throughout the standard.
By taking a risk-based approach, an organization becomes proactive rather than purely reactive, preventing or reducing undesired effects and promoting continual improvement. Preventive action is automatic when a management system is risk-based. Via the High Level Structure it is now connected with ISO 31000 Risk Management, which also is in revision. PRIMO will study how to proceed on this in advising their members.
These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits. >>
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