Operational Controls for Products and Services Under ISO 9001

ISO 9001 Clause 8 - Operation Overview

Clause 8 is where the quality management system meets day-to-day operations. It covers the operational planning and control of products and services, customer requirements, design and development, externally provided processes, production and service provision, the release of products and services, and the control of nonconforming outputs. The clause splits into seven sub-clauses, each covered in its own article below.

Sub-clauses of ISO 9001 Clause 8

Clause 8.1 - Operational Planning and Control requires the organisation to plan, implement and control the processes needed to meet the requirements for the provision of products and services and to implement the actions determined in Clause 6.

Clause 8.2 - Requirements for Products and Services requires the organisation to determine, communicate and review requirements for products and services, including customer communication, requirements determination and changes to requirements.

Clause 8.3 - Design and Development of Products and Services requires the organisation to establish, implement and maintain a design and development process that is appropriate to make sure of the subsequent provision of products and services.

Clause 8.4 - Control of Externally Provided Processes, Products and Services requires the organisation to make sure externally provided processes, products and services conform to requirements, including the criteria for evaluation, selection, monitoring and re-evaluation of external providers.

Clause 8.5 - Production and Service Provision requires the organisation to implement production and service provision under controlled conditions, including the control of changes, identification and traceability, customer property and post-delivery activities.

Clause 8.6 - Release of Products and Services requires the organisation to implement planned arrangements at appropriate stages to verify that product and service requirements have been met before release.

Clause 8.7 - Control of Nonconforming Outputs requires the organisation to identify and control outputs that do not conform to their requirements to prevent unintended use or delivery, and to take appropriate action.