Manajemen Mutu (QMS) 13 butir
ISO 9001:2015 Planning of Changes Checklist (Clause 6.3)
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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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