8.0 Operation

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8.5 Product and Service Provision

8.5.1 Control of Product and Service Provision

This requirement is comparable to the requirements from ISO 9001:2008 Clause 7.5.1 - Control of Production and Service Provision and Clause 7.5.2 Validation of Processes from Production and Service Provision. Clause 8.5.1 Control of Product and Service Provision requires your organization to control the manner in which products are produced and the services provided.

You should seek and record evidence that your organization has controlled the conditions by which products or services are provided, ensuring that:

  1. Documented information that defines the characteristics of the product or service is available;
  2. Documented information that defines the activities that need to be performed to produce the product or deliver the service is available, and that this specifies the results that are to be achieved;
  3. Monitoring and measurement takes place at appropriate points in the production process to ensure that both the processes themselves and the process outputs meet the organization’s acceptance criteria;
  4. The process environment and infrastructure are suitable;
  5. Suitable monitoring and measurement resources are made available;
  6. Personnel are competent and, where necessary, appropriately qualified;
  7. For processes where the results cannot be verified by subsequent monitoring or measurement,
  8. The process itself is initially validated and then periodically re-evaluated;
  9. Product and service release, delivery and post-delivery activities are implemented.

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