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Quality Management (QMS) 13 items

ISO 9001:2015 Operational Planning & Control Checklist (Clause 8.1)

A checklist to verify operational planning and control of the processes needed to meet requirements for products and services under ISO 9001:2015 Clause 8.1.

ISO 9001:2015

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Requirements & Criteria

  • Have the requirements for the products and services been determined for each operational process? *
  • Are acceptance criteria for products, services, and processes established and documented? *
  • Are the resources needed to achieve conformity to product and service requirements identified? *

Process Control Implementation

  • Is control of the operational processes implemented in accordance with the established criteria? *
  • Is documented information maintained to have confidence the processes have been carried out as planned? *
  • Is documented information retained to demonstrate conformity of products and services to requirements? *
  • Is the output of operational planning suitable for the organization's operations? *

Control of Planned & Unintended Changes

  • Are planned changes controlled and their consequences reviewed before implementation? *
  • Is action taken to mitigate any adverse effects of unintended changes? *
  • Is documented information on changes reviewed and retained where required? *

Outsourced Processes

  • Has the organization ensured that outsourced processes are controlled? *
  • Are the type and extent of control applied to outsourced processes defined? *
  • List the outsourced processes covered by this review

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