ISO 9001 2015 focuses on change management at many places of the standard. ISO 9001 2008 standard was also has this element. However 2015 version is emphasizing on change management more than earlier version. Any change may be it is in process, manpower, machinery, instruments, technology, raw materials, suppliers, customer requirements, legal requirements etc…. shall be go through a defined change management process.
Change management process would include
- change to be done
- changes initiated by
- reason for change
- changes reviewed by
- evaluation of change for consequences / effects on overall performance of quality system and further actions to be taken to resolve such effects
- resources required to make change
- skills required to make change
- final decision for change approval
- change in documents as per change to be implemented.
ISO 9001 2015 clause 6.3, 8.1, 8.3.6 & 8.5.6 requires change management process as above.
Changes in organization shall take place in such a way that integrity of quality management system does not get affected.