When you are assessing your suppliers, it is critical to examine the objective evidence, which demonstrates top management commitment and dedication to the QMS. In ISO 9001:2015, there are new requirements for change. Specifically, there are 4 6.3 Planning of changes, 8.1 Operational planning and control, 8.3.6 Design and development changes and 8.5.6 Control of changes. Once a QMS and processes are established in an organization, there may be changes necessary to mitigate risk as well as implement continuous improvement. The mechanism in which change is assessed and implemented must be carried

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Managing risk Within the framework of ISO 9001:2015 what do we really need to do with risk? The ISO/TC 176 quality management and quality assurance committee presented the 2015 revision as having neutral impact to organizations with quality management systems (QMS) using the 2008 version of the standard. The assumption here is that risk assessment of the QMS processes were intuitive, and the requirement is now more overt than covert in the standard. If proper preventive actions and management reviews were being performed, and the P in the plan-do-check-act (PDCA) cycle was robust, then ris

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