Management system guidance
8.5 Production and service provision
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8.5.1 Control of production and service provision
This requirement is unchanged in ISO 9001:2026. It continues ISO 9001:2015 clause 8.5.1, which brought together ISO 9001:2008 Clause 7.5.1 - Control of Production and Service Provision and Clause 7.5.2 Validation of Processes for Production and Service Provision. If you need a procedure and forms to help control your business's product and service provision process, click here.
Clause 8.5.1 requires your organization to carry out production and service provision under controlled conditions. You should seek and record evidence that, as applicable:
- Up-to-date documented information is available and used that defines the characteristics of the products or services, the activities to be performed and the results to be achieved;
- Suitable monitoring and measuring resources are available and used;
- Monitoring and measurement takes place at appropriate stages to confirm that the criteria for controlling processes and their outputs, and the acceptance criteria for products and services, have been met;
- The infrastructure and process environment are suitable;
- Personnel are competent and, where necessary, appropriately qualified;
- Processes whose results cannot be verified by subsequent monitoring or measurement are validated, and periodically revalidated, to confirm they can achieve the planned results;
- Actions are taken to prevent human error (for example mistake-proofing, checklists, automation and clear work instructions);
- Release, delivery and post-delivery activities are implemented.
Businesses should develop, conduct, control and monitor production processes to ensure parts manufactured conform to specifications. This includes documented instructions that define the production activities, approval of processes and equipment and any changes to those processes and equipment, monitoring and control of process parameters, and component characteristics during production.
Making use of documented procedures, work instructions, specifications, drawings, reference materials, suitable equipment and specific monitoring and measurement devices; where the absence of such could affect quality, your organization should employ process controls, which are consistent and appropriate for the operations being conducted.
Your organization should ensure adequate equipment is available and adequate for the manufacture of products to meet specifications. This includes ensuring equipment is maintained periodically, documenting activities performed and by whom and when the activities are performed.
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