ISO 10005:2018
Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018

ISO 10005:2018 6.11: Production and service provision

What does 6.11 require?

Production and service provision, with the monitoring and measurement that goes with it, usually makes up most of a quality plan. The processes differ with the kind of work, and process maps or flow charts are a good way to show how they connect. Production and service processes may need validating to show they can deliver the required output, above all where the output cannot be checked by later monitoring or measurement. The plan should identify what inputs, processes and outputs are needed for production and service provision, and the organization should use risk-based thinking to decide whether to include, or point to: the process steps; the relevant documented information; the tools, equipment, software, IT platform and methods used to meet the specified requirements, including particulars of any software application, material, product, service, process, validation or certification needed; the controlled conditions needed to meet planned arrangements and the ways of checking compliance with them, including any statistical or other process controls specified; competence or qualification requirements (see 6.7.3); criteria for accepting products, services and other process outputs; statutory and regulatory requirements that apply; industry codes and practices; measures to prevent human error; and arrangements for release, delivery and activities after delivery. Where installation or commissioning is required, the plan should explain the installation method and which characteristics need verifying and validating at that point. Where the case includes post-delivery activities such as maintenance, support or training, the plan should explain how conformity with applicable requirements will be assured, for example laws and regulations, the codes and practices of the industry, the competence of staff and trainees, and the availability of initial and continuing technical support for the agreed period. For projects, ISO 10006 gives guidance on the processes that deliver the product or service.

Maintained by Gerard Blokdyk

Other controls in Clause 6.9 to 6.17: Content of the quality plan, design to audits – ISO 10005:2018

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