ISO 9001:2015 – Clause 8


8.1 Operational Planning & Control

Requires an organisation to plan, implement and control processes identified in clause 4.4 in order to meet requirements for the delivery of their products and services and to put into place the actions determined as a result of risk assessment.

8.2 Determination of requirements for products & services

Requires an organisation to put processes in place to enable communication with clients on matters relating to their products and services. To put in place processes to ensure product or service requirements are known and that any statutory and regulatory requirements including customer requirements are also known. To review the requirements related to their products and services and those specified by their customer, including any statutory and regulatory requirements.

8.3 Design and development of products and services

Requires an organisation who designs and develops their own products and services to implement a design and development process, plan and control the design and development of products or services, determine specific inputs into its design and development process, apply controls to design and development process, ensure that outputs from design and development process meet input requirements and that changes to the design and development input or output must be controlled

8.4 Control of externally provided products and services

Requires an organisation to ensure that externally provided products and services meet specified requirements; they shall decide the type and extent of controls it wishes to apply and the information it needs to give to external providers.

8.5 Production and service provision

Requires an organisation to control the way they supply their products and services, to be able to identify and trace their product and service, if necessary, to take care of property belonging to customers or external providers and to preserve its product. It also requires an organisation decide on the extent of post-delivery activities and to control of changes made to the provision of their product or service.

8.6 Release of products and services

Requires an organisation carry out checks to ensure its products and services are correct and meet all necessary requirements before release to their customers.

8.7 Control of nonconforming process outputs, products and services

Requires an organisation to ensure that any issues or problems with their products and services are identified and controlled so that they are not used or delivery to customers. Actions will be taken to correct any problems this includes where the product or service has been delivered.


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