Get compliant with ISO 9001:2015 and simplify compliance for your organisation.
This involves analysing the internal factors such as; structure, culture, and resources, as well as the external factors that can affect their operations and QMS.
By understanding the context of the organisation, businesses can determine the scope of the QMS and identify the interested parties that need to be considered when defining the QMS.
Interested parties are individuals or groups that have an interest in the organisation’s activities or products and can affect or be affected by the organisation’s QMS. These parties can include customers, suppliers, employees, shareholders, regulators, and other stakeholders.
This clause requires businesses to identify the interested parties that are relevant to their QMS and understand their needs and expectations.
This involves gathering information about the interested parties’ requirements, such as their expectations for product quality, delivery times, and customer service.
By understanding the needs and expectations of interested parties, businesses can develop a QMS that meets the needs of all stakeholders and improve customer satisfaction.
The scope of the QMS defines the boundaries of the QMS, including the products, services, and processes that it covers.
The scope of the QMS should be based on the organisation’s internal and external context, the needs and expectations of interested parties, and the organisation’s strategic objectives. By defining the scope of the QMS, businesses can ensure that their QMS covers all relevant areas and meets the needs of all stakeholders.
To determine the scope of their QMS, organisations would need to identify the products, services, and processes that the QMS will cover and ensure that they are consistent with the organisation’s internal and external context and the needs and expectations of interested parties.
By defining the scope of the QMS, businesses can ensure that their QMS covers all relevant areas and meets the needs of all stakeholders.
The organisation must create, use, and improve a quality management system that meets the requirements of this standard. To do this, the organisation must:
The organisation must keep records as needed to support its processes and to ensure they are carried out as planned. This includes: