The new ISO 9001: 2015 introduces three new requirements: the organization context, the interested parties and the risk. Regarding the purpose of the rule, it is unchanged: product compliance and customer satisfaction.
There are many changes that characterize the new ISO 9001: 2015, a key objective is to have a simpler, more applicable standard, a common format and language even for small enterprises.
The main changes of the new ISO 9001:2015 are summarized as follows:
- Greater focus on the customer
- policies and objectives aligned with the strategies of the organization
- Risk-based thinking
- Greater flexibility in regards with documentation
One of the innovative aspects that the new ISO 9001:2015 has developed is the expansion of the concept from customer to "interested parties". In particular, new points are introduced, which require the Organization to understand their external and internal environment, in order to examine needs and expectations of stakeholders that may impact on the quality management system (QMS). On this basis the Organization will have to develop policies and objectives in line with the strategies of the organization.
With "risk-based approach" it is meant the will to determine and assess opportunities and risks to be addressed in order to ensure the efficiency of the quality management system (QMS), by preventing and reducing the undesirable effects, in favor of a continuous improvement. The concept of "preventive action" is then turned into a risk-based approach.
QSA.net is introducing new features able to provide methodological and operational support in the implementation of these important changes.
The increased flexibility regarding the documentation can be summarized in a "bureaucratic" simplification of the system documentation. It is provided a greater flexibility for enterprises, which are free to choose depth and detail they wish to use for their written documentation, a choice that can be made based on various factors, such as the complexity of the processes and the expertise of staff.
This simplification will allow a real computerization of processes for a more efficient and effective management system.
The new ISO 9001:2015 will ask all certified organizations to review its quality management system in order to introduce new requirements and improve the management of organizational processes, ensuring effectiveness, efficiency and control capabilities.
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