With the 2018 deadline for transition fast approaching, it is time to start making the changes required to be ready for your audit to continue utilizing the benefits an ISO system brings with it.
ISO 9001:2015, the new version of the Quality standard offered by the International Organization of Standardization, has put forth a movement to push for more sustainable development, calculated decisions and promotes a toll for overall performance management. Continual Improvement is still at the forefront of the Quality Management System; however 2015 implements measure to ensure company management provides leadership for the system itself. We offer a multitude of solutions to help you make the transition from the current ISO 9001:2008 certification or compliant system to meet the requirements of ISO 9001:2015.
What has changed?
ISO 9001:2015 has renamed and re-positioning some QMS requirements, causing for a need to restructure some manuals; however, other significant new requirements have been introduced as well. We have compiled a ISO requirement checklist, but have provided a brief summary of the additions below.
Risks and Opportunities Management
From perspective of being proactive rather than reactive, the risk management process follows the same concept of quality, and has a distinct place in any ISO 9001:2015 quality system. The new requirement is to identify the risks and opportunities that can potentially impact the operation and performance of the overall QMS, as well as the actions needed to address them.
One of the new requirements of ISO 9001:2015 is that upper or top management is now required to demonstrate a greater direct involvement or leadership in the Quality Management System. The focus on leadership is a direct initiative to ensure that more people get involved in the system and its implementation.
Document Control Procedure
This procedure has not changed that much, but the terminology used is now different. "Documented Procedure" and "Record" used in ISO 9001:2008 have been replaced throughout the ISO 9001:2015 standard with "Documented Information". The defined of "Documented Information" refers to any information that is required to be controlled, protected, maintained and stored by an organization. Each individual organization is able to determine the types of documentation necessary to control, for the operation of the business.
Simple summaries and scope were required in the ISO 9001:2008 standards. The new ISO 9001:2015 standard whats consideration put into the organization’s context and responsibilities and be implemented into a organizations overall QMS.
The Quality Manual
While a manual is not required, it is still recommended for almost all companies for the purposes of due diligence and pre-qualification. For organizations that already have an ISO 9001 compliant Quality Manual, there will be no requirement to change their existing QMS procedures and document order to match to new standard. It is required to implement the additional requirements and ensure compliance.
The ISO 9001:2008 Transition
Organizations that are already certified to ISO 9001:2008 will have had three years from formal publication of ISO 9001:2015 from 2015. As a result, you must transfer to the new version of this standard by the deadline of September 2018. Because of the benefits that the certification will provide, it is worth making sure you are ahead of the curve and plan well ahead of the deadline.
Our team will work with clients to help transition an existing Quality System to ISO 9001:2015 compliance or to help with the creation of a brand new system, depending on what you currently have. We provide a full range of services related to your Quality System including implementation, management, auditing and process mapping.
If you have any questions related to the ISO transition, or implementing your overall Quality System, please contact us to receive more information on how we can help you out.