ISO 9001:2015 – Clause 7


7.1 Resources

7.1.1 General
Requires an organisation initially to determine and then subsequently provide the resources necessary to establish, implement, maintain and continually improve its quality management system.

7.1.2 People
This requires an organisation 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.

7.1.3 Infrastructure
Requires an organisation 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 organisation to “determine, provide and maintain” a suitable environment for the business to operate.

7.1.5 Monitoring and measuring resources

Where an organisation 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 Organisational knowledge
This requires an organisation to ensure that it has or obtains the knowledge necessary to respond to changing business environments, changing customer needs and expectations and, where applicable, related improvement initiatives.

7.2 Competence

The organisation must determine the competency levels necessary for those people performing work under its control. Once these competency levels have been determined, the organisation must then ensure that those people possess the necessary competencies, either on the basis of their education, training or experience.

7.3 Awareness

The requirements apply to all “persons doing work under the organisation’s control” – this can include contractors. People doing work under the organisation’s control are to be aware of the organisation’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

7.4 Communication

An Organisation 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

7.5.1 General
An Organisation’s quality management system should include documented information required by the standard and that identified by the organisation 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 organisation 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 Organisation is required to control documented information in order to ensure that it is available where needed and that it is suitable for use.
The organisation must determine how it will distribute, access, retrieve and use documented information.