8.1 Operational planning and control

8. OPERATION

8.1 Operational planning and control

The organization shall plan, implement and control the processes (see 4.4 via 4.4.1 & 4.4.2) needed to meet the requirements for the provision of products and services, and to implement the actions determined in Clause 6 (via 6.1.1, 6.1.2, 6.2.1, 6.2.2 & 6.3), by:

• a) determining the requirements for the products and services;
• b) establishing criteria for:
• 1. the processes;
• 2. the acceptance of products and services;
• c) determining the resources needed to achieve conformity to the product and service requirements;
• d) implementing control of the processes in accordance with the criteria;
• e) determining and keeping documented information to the extent necessary:
• 1. to have confidence that the processes have been carried out as planned;
• 2. to demonstrate the conformity of products and services to their requirements.

NOTE “Keeping” implies both the maintaining and the retaining of documented information.

The output of this planning shall be suitable for the organization’s operations.

The organization shall control planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

The organization shall ensure that outsourced processes are controlled (see 8.4).



Reference for requirement
Clause 4.4.1 (QMS and its processes)
Clause 5.1.2 (Customer focus)
Clause 8.5.1 (Production Control)
Clause 8.5.5 (Post delivery activities)
Clause 9.1.3 (Performance analysis and evaluation)