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Quality Management (QMS) 13 items

ISO 9001:2015 Organizational Knowledge Checklist (Clause 7.1.6)

A checklist to determine, maintain, and make available the organizational knowledge necessary for the operation of processes and conformity of products and services under ISO 9001:2015 Clause 7.1.6.

ISO 9001:2015

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Determining Knowledge

  • Has the organization determined the knowledge necessary for the operation of its processes? *
  • Is this knowledge sufficient to achieve conformity of products and services? *
  • Are the processes and roles for which knowledge is critical identified? *

Internal Knowledge Sources

  • Is knowledge gained from experience captured (e.g., lessons learned from successes and failures)? *
  • Is intellectual property and knowledge from internal projects and process improvements retained? *
  • Are results of improvements in processes, products, and services captured as knowledge? *

External Knowledge Sources

  • Is knowledge gathered from external sources such as standards, academia, conferences, and customers? *
  • Is knowledge from suppliers and external providers incorporated where relevant? *
  • Is customer and regulatory feedback used as a source of organizational knowledge?

Maintenance & Changing Needs

  • Is the organizational knowledge maintained and made available to the extent necessary? *
  • When addressing changing needs and trends, does the organization consider its current knowledge? *
  • Is there a defined method to acquire or access any necessary additional knowledge and required updates? *
  • Is knowledge retention addressed for critical roles at risk of loss (e.g., retirement, turnover)?

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