KEY POINTS OF TRANSITIONING TO ISO 9001:2015
ISO 9001 2015
ISO 9001:2015 is undergoing a fundamental /significant change to both its structure and its contents which present new challenges for the quality management professionals.
We already know the changes arising mainly as a result of the adoption of Annex SL and it is these changes that we believe will have the most significant impact for both quality and audit professionals. We believe the quality management professional will need to revise their current thinking and work a different approach to maintain compliance and effectiveness. We intend to make a difference by giving you an approach that adds value to your compliance and will eventually deliver results that matter
Understanding the Context of the Organization
There are new requirements relating to the context of the organization requiring the explicit identification of internal and external issues , needs and expectations affecting the quality management system’s ability to deliver results
Depending on the system maturity, this may affect the culture of the organization as the basis for ISO 9001:2015. The change covers the change of mindset and behavior required of everyone connected within the quality management system. PDCA is very much alive in Clause .4 of the FDIS ISO 9001:2015 and operating at both a process level and an overall system level too.
The adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system has already been laid out – the effectiveness may vary from one organization to the next. The thrust to understanding its value towards effectiveness is enhanced in clause 4.4 of FDIS 9001:2015 setting out specific requirements designed to enforce its adoption.
Risk Assessment and Preventive Action
The core concept of identifying and addressing potential mistakes before they happen has strengthened the need for Preventive Action
FDIS 9001:2015 now talks in terms of risk and opportunities. Organizations must evidence that they have determined, considered and, where necessary, taken action to address any risks or opportunities that may impact (either positively or negatively) their quality management system’s ability to deliver its intended outcomes or that could impact customer satisfaction.