Requires an organization initially to determine and then subsequently provide the resources necessary to establish, implement, maintain and continually improve its quality management system.
This requires an organization to provide those people necessary for the effective operation of its quality management system and its processes in order that it can consistently meet customer, statutory and regulatory requirements.
Requires an organization to identify, provide and maintain the infrastructure necessary to enable processes to operate effectively.
7.1.4 Environment for the operation of processes
Requires an organization to “determine, provide and maintain” a suitable environment for the operation of processes.
7.1.5 Monitoring and measuring resources
Where an organization uses monitoring or measuring to demonstrate that its products and services conform to requirements, it must make sure that it provides the necessary resources to ensure that its monitoring and measuring results are valid.
7.1.6 Organizational knowledge
This requires an organization to ensure that it has or obtains the knowledge resources necessary to respond to changing business environments, changing customer and interested party needs and expectations and, where applicable, related improvement initiatives.
The organization must determine the competency requirements for those people performing work under its control. Once these competency requirements have been determined, the organization must then ensure that those people possess the necessary competencies, either on the basis of their education, training or experience.
The requirements apply to all “persons doing work under the organization’s control”. People doing work under the organization’s control are to be aware of the organization’s quality policy, any quality objectives that are relevant to them, how they are contributing to the effectiveness of the QMS and the implications for not conforming to the QMS requirements
An Organization must determine how it wishes to communicate on QMS matters, to whom it will communicate and when such communications will be made.
7.5 Documented information
An Organization’s quality management system should include documented information required by the standard and that identified by the organization as being necessary for the effective operation of their quality management system.
7.5.2 Creation and updating
When documented information is created or updated, the organization must ensure that it is appropriately identified and described and reviewed and approved for suitability and adequacy.
7.5.3 Control of documented information
An Organization is required to control documented information in order to ensure that it is available where needed and that it is suitable for use.
The organization must determine how it will distribute, access, retrieve and use documented information.