How different is the new 2015 Quality Management Standard?
The new ISO 9001:2015 version was finally released in September 2015. It has been many years in the development and review process. But finally it has arrived. The good news that the new 2015 version of the standard is not that different to the previous 2008 version, however there are some key changes.
In this Blog, I would like to highlight some of the main differences in the new standard and this will give you a good idea of what you will need to look for in either updating your existing Quality Management System (QMS) or how to plan the implementation of your new QMS.
1. Context of the Organization.
This is a completely new requirement and the organization will have to determine the internal and external context that affect the organization. For example the introduction in this standard refers to “interested parties”. The previous version was only focused on the customer.
2. Quality Management Manual
In the 2008 version there was a requirement to have a Quality Management Manual. This has been removed from the 2015 version. However, you still have a requirement to define and document the scope of the Quality Management System.
3. Risk Management
This is also a completely new requirement. When planning the Quality Management System, the organization will need to determine the risks and opportunities affecting the organization. This will need to be looked at in each and every process.
4. Management System Representative
In the 2008 Version you were required to appoint a Quality Management System Representative and this person was a senior within the organization. In the current version the new clause describes in more detail the roles and responsibilities and authorities within the Quality Management System and how this can be allocated to different people.
5. Preventative Action Process
Preventative action is core to the continual improvement process associated with Quality Management systems. The new standard has removed the words Preventative Action, however in clause 10.2 there is reference made to taking action to eliminate the causes of the non-conformity in order that is does not recur or occur elsewhere.
6. Quality Management Principals
The quality management principals have been reduced from eight to seven. The main change is the removal of the systems approach to management. In essence all the principals remain the same with minor adjustments. e.g. Involvement of People is now Engagement of People and Mutually beneficial supplier relationships has changed to relationship Management.
The new standard requires a more detail review of the organization and how it interacts with all stakeholders. The emphasis remains on customer focus, sound leadership, engagement of people and process approach with continual improvement being an integral part of the system.
If you need help in assessing your quality management system, or need to now how to implement an effective and compliant quality management system, drop me an email at firstname.lastname@example.org or visit the website www.isostandards.co.za and subscribe.