The new ISO9001:2015 standard has arrived. It focuses on a process-based approach with the aim to produce a desired outcome. Several changes have occured from the 9001:2008 version: The process approach strongly emphasises that the Quality Management System has to be woven into and fully aligned with an organisation’s strategic direction.
The PDCA (plan-do-check-act) methodolody is overlaid on the system of processes, which apply both to individual processes as well as the Quality Management System as a whole. A strong focus on risk-based thinking is required now! It is aimed at “preventing unfavourable outcomes,” such as non-conforming products and services.
The standard has now been published, there is a transition period of 3 years to make the necessary changes, do you have a plan on how you will tackle it?