ISO 9001:2015 Quality management systems - requirements

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ISO 9001:2015 Quality management systems - requirements


ISO 9001:2015 Quality management systems - requirements: The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. Consistently meeting requirements and addressing future needs and expectations poses a challenge for organizations in an increasingly dynamic and complex environment. To achieve this objective, the organization might find it necessary to adopt various forms of improvement in addition to correction and continual improvement, such as breakthrough change, innovation and re-organization.

Abbreviation: ISO 9001:2015


MitoPedia O2k and high-resolution respirometry: Oroboros QM 

Publicly available informative sections of standards

Quality management principles
The quality management principles are:
β€” customer focus;
β€” leadership;
β€” engagement of people;
β€” process approach;
β€” improvement;
β€” evidence-based decision making;
β€” relationship management.
Plan-Do-Check-Act cycle
The PDCA cycle can be briefly described as follows:
β€” Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies, and identify and address risks and opportunities;
β€” Do: implement what was planned;
β€” Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;
β€” Act: take actions to improve performance, as necessary.
Risk-based thinking
Opportunities can arise as a result of a situation favourable to achieving an intended result, for example, a set of circumstances that allow the organization to attract customers, develop new products and services, reduce waste or improve productivity. Actions to address opportunities can also include consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not all positive effects of risk result in opportunities.
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