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Quality Management (QMS) 22 items

ISO 9001:2015 Design & Development Control Checklist

A checklist for controlling design and development of products and services against the planning, inputs, controls, outputs, and change requirements of ISO 9001:2015 Clause 8.3.

ISO 9001:2015

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Design & Development Planning (Cl. 8.3.2)

  • Have the stages and controls for design and development been determined considering the nature, duration, and complexity of the activities? *
  • Are required review, verification, and validation activities defined for each stage? *
  • Are responsibilities and authorities for the D&D process assigned? *
  • Have the internal and external resource needs for design and development been identified? *
  • Is the level of control expected by customers and other interested parties documented? *

Design & Development Inputs (Cl. 8.3.3)

  • Are functional and performance requirements determined as design inputs? *
  • Have applicable statutory and regulatory requirements been captured as inputs? *
  • Are standards or codes of practice the organization has committed to implement included? *
  • Have potential consequences of failure due to the nature of the products and services been considered? *
  • Are inputs adequate, complete, unambiguous, and free of conflict? *

Design & Development Controls (Cl. 8.3.4)

  • Are the results to be achieved by the design activity defined? *
  • Are reviews conducted to evaluate the ability of results to meet requirements? *
  • Is verification performed to ensure outputs meet input requirements? *
  • Is validation conducted to confirm products/services meet requirements for the specified application or intended use? *
  • Are actions taken on problems determined during reviews, verification, and validation retained as documented information? *

Design & Development Outputs (Cl. 8.3.5)

  • Do outputs meet the input requirements? *
  • Are outputs adequate for the subsequent processes for provision of products and services? *
  • Do outputs include or reference monitoring and measuring requirements and acceptance criteria? *
  • Do outputs specify characteristics essential for the intended purpose and safe and proper provision? *

Design & Development Changes (Cl. 8.3.6)

  • Are changes made during or subsequent to design and development identified, reviewed, and controlled? *
  • Is documented information retained on the changes, the results of reviews, authorization, and actions to prevent adverse impacts? *
  • Change reference / ECN number

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