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Clause 4.4.1(f)
Address the risks and opportunities as determined in accordance with the requirements of 6.1.
New version of QMS includes risk based thinking, so first of all you have to conduct the business risk assessment of each unit/department and have to do it documented and communicated. After which you have to distribute/assign responsibilities regarding control measures raised in risk assessment. This whole will have to be modified in context of the organization. Further more other things are almost same...
There was nothing added in 2008, but it was more precise about the interpretation of the standard in version ISO 9001:2015. In the new version, organization are strongly encouraged as an to use risk analysis in order to decide which challenges you see in the management of your business processes. ISO 9001:2015 has ten clauses instead of eight. The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onwards. The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act)
On a broader perspective, the main changes between 2008 standard and 2015 standard is
* context - the capability of the organization to be clearly defined.
* Org knowledge - every organisation should have a mechanism to collect data and learn from them.
The above changes really promote to the betterment of the Quality Management System.
The 9001:2015 also has 4.2 Needs and expectations of interested parties.
Implementation of Risk Assessment for each process and the specific role of Management Representative is no longer specified.
ISO 9001 is internationally recognized as providing a framework for quality management system that can be easily interpreted for all areas of industry and commerce. iSO 9001 provides a framework for monitoring and measuring process performance and operations ensuring increased efficiency and improved customer satisfaction. now demanded by many "Blue-Chip" companies and government department. ISO 9001 certification provides these organization and your existing customers with confidence that you should be able to provide a consistent and improving quality product or service
as a ISO consultant since 2004 i will say that iso revised after three clauses remaining seven clauses which is not so much new for us it only description of some points which they realized after so many years we already worked on them
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