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Quality Management (QMS) 13 items

ISO 9001:2015 Planning of Changes Checklist (Clause 6.3)

A checklist to ensure changes to the quality management system are carried out in a planned manner, considering purpose, integrity, resources, and responsibilities per ISO 9001:2015 Clause 6.3.

ISO 9001:2015

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Change Identification

  • Has the need for the change to the quality management system been determined? *
  • Is the change being carried out in a planned manner rather than reactively? *
  • Is the scope of the QMS change and the affected functions clearly defined? *

Purpose & Consequences

  • Has the purpose of the change and its potential consequences been considered? *
  • Have risks and opportunities arising from the change been evaluated? *
  • Are potential impacts on customers and other interested parties considered?

System Integrity

  • Has the integrity of the quality management system been considered when planning the change? *
  • Have affected processes, documents, and interfaces been identified? *
  • Is a plan in place to update affected documented information after the change? *

Resources & Responsibilities

  • Has the availability of resources needed for the change been assessed? *
  • Have responsibilities and authorities for implementing the change been allocated or reallocated? *
  • Is documented information retained on the change decision and approval?
  • Change / project reference

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