ISO 9001:2015, 8.1

Previous newsletter articles have described the ISO/DIS 9001:2015 planned requirements and changes for clause 4 (Context of the Organization), clause 5 (Leadership), clause 6 (Planning for the Quality Management System), and Clause 7 (Support).

Clause 8, Operation, has seven sub-clauses:

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

This article is on 8.1, Operational Planning and Control.

Requirements:

Plan, implement, and control the processes, as outlined in 4.4, needed to meet requirements for the provision of products and services and to implement the actions determined in 6.1:

a) determine product and services requirements;

b) establish criteria for the processes and for 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) retain documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements.

Prepare planning output that is suitable for the organization’s operations.

  • Control planned changes and review consequences of unintended changes.
  • Take action to mitigate any adverse effects, as necessary.
  • Ensure outsourced processes are controlled in accordance with 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
  • Planning of quality objectives is covered in 6.2