8.5 Production and service Provision (8.5.1)

8. OPERATION

8.5 Production and service Provision

8.5.1 Control of production and service provision

The organization shall implement production and service provision under controlled conditions.

Controlled conditions shall include, as applicable:

• a) the availability of documented information that defines: (via 8.1 & 8.2.2)
• 1) the characteristics of the products to be produced, the services to be provided, or the activities
• 2) be performed;
• 3) the results to be achieved;
• b) the availability and use of suitable monitoring and measuring resources (via 7.1.5);
• c) the implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met; (via 8.2.3)
• d) the use of suitable infrastructure (via 7.1.3) and environment for the operation of processes via 7.1.4);
• e) the appointment of competent persons (via 7.2), including any required qualification;
• f) the validation , and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement ;
• g) the implementation of actions to prevent human error;
• h) the implementation of release (via 8.6), delivery and post-delivery activities (via 8.5.5).

Cross reference
Clause 4.4.1 (QMS and its processes)
Clause 9.1.3 (Performance analysis and evaluation)
Clause 10.1 (Improvement)