This is most frequently asked question that how to implement ISO 9001 2015 requirements. It becomes slightly important if organization is already certified with ISO 9001 2008 standard and it wants to upgrade its system from 2008 version to 2015 version.
if you look at structure of ISO 900 2008 & ISO 9001 2015, it is a huge change. ISO 9001 2015 has 10 clauses as per annexure SL guidelines.
ISO 9001 2015 standard implementation will follow sequence as listed below
- Starting point would be giving training to all concern persons about requirement of ISO 9001 2015 standard and changes with respect to ISO 9001 2008 if organization is ISO 9001 2008 certified.
- Top management / HODs shall made understood about requirement of clause 5 – leadership. There is a change in responsibility of Top management. Now Top management is overall accountable if Quality management system is not effective.
- The organization has to identify quality system processes. Organization has already identified these processes in ISO 9001 2008 version.
- If you look at ISO 9001 2015 clause 4.4 it asks for identification of inputs, determining expected outputs, determining performance indicators, evaluating risks and opportunities, monitoring and measuring processes, and implementing changes for improvement.
- All existing process shall pass through above requirements. Mainly risk assessment and performance indicator identification.
- Based on risk assessment of the process, preventive actions would be identified to prevent identified risks. Now these actions shall be integrated in the quality management system processes ( if organization has documented processes of each department which is not mandatory as per standard but recommended by us)
- Performance indicator of each process shall have target, action points for achievement of this indicator ( which may be termed as quality objective ), evaluation of performance indicator against target and implementation of corrective and preventive actions based on evaluation done.
- Quality objectives may be overall organizational or may be process wise. It shall be aligned with vision and strategy of the organization. Action plan for achievement of objective shall be prepared and implemented.
- internal audit and management review shall be implemented.
Above are few simple steps by which existing ISO 9001 2008 system can be upgraded to ISO 9001 2015 standard. However it requires lot’s of efforts and training to implement an effective ISO 9001 2015 quality management system standing on foundation of risk management and performance improvement.
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