ISO 9001:2015 Clause 8.1 is titled "Operational Planning and Control." This clause is part of the larger section on "Operation," which is focused on the execution processes that an organization needs to deliver products and services. Clause 8.1 establishes the general requirements for operational planning and control to ensure that the products and services meet the requirements and the quality management system (QMS) processes are carried out effectively. Here’s a summary of the key points:
-
Consistency with the QMS: Organizations must plan, implement, and control the processes needed to meet the requirements for providing products and services, and to implement the actions determined in Clause 6 (Planning), in a manner consistent with the requirements of the QMS.
-
Determination of Requirements: It involves determining the requirements for the products and services, establishing criteria for processes and for the acceptance of products and services, and determining the resources needed to achieve conformity to product and service requirements.
-
Control of Processes: Organizations are required to control the processes in accordance with the criteria, and to keep documented information to the extent necessary to have confidence that the processes have been carried out as planned.
-
Control of Outsourced Processes: There is also a requirement to control externally provided processes, products, and services in accordance with the requirements of the QMS. Organizations need to apply a risk-based approach to determine the type and extent of controls appropriate to particular external providers and outsourced processes.
Overall, Clause 8.1 emphasizes the importance of careful planning and control of operational processes to ensure product and service quality, including when these processes are outsourced. It underlines the need for a systematic approach to managing operations, from planning through to control, to achieve the intended outcomes and enhance customer satisfaction.