ISO 9001:2015, 8.1

Clause 8, Operation, has seven sub-clauses:

8.1 Operational Planning and Control
8.2 Requirements for Products and Services
8.3 Design and Development of Products and Services
8.4 Control of Externally Provided Processes, Products, and Services
8.5 Production and Service Provision
8.6 Release of Products and Services
8.7 Control of Nonconforming Outputs

This article is on 8.1, Operational Planning and Control.

Requirements:

Plan, implement, and control the processes (see 4.4) needed to meet the requirements for the provision of products and services, and to implement the actions determined in clause 6:

a) determine product and services requirements;

b) establish criteria for:
1) the processes;
2) the acceptance of products and services;

c) determine the resources needed to achieve conformity to product and service requirements;
d) implement control of the processes in accordance with the criteria;

e) determine, maintain, and retain documented information to the extent necessary:
1) to have confidence that the processes have been carried out as planned
2) to demonstrate conformity of products and services to their requirements.

Provide planning output that is suitable for your operations.

Control the planned changes and review the consequences of unintended changes, taking action to mitigate any adverse effects, as necessary.

Ensure that outsourced processes are controlled (see 8.4).

Changes:

  • Replaces 7.1 on planning for product realization
  • Extends to control of processes and planned changes
  • Adds reviewing consequences and mitigating adverse effects
  • Refers to 8.4 for control of “outsourced” processes
  • Planning of quality objectives is covered in 6.2