ISO 9001:2015 UPDATE: FDIS 9001 ISSUED
The publication of ISO/FDIS 9001 on July 9, 2015 is the latest stage in the ISO 9001 revision process. This is the last formal draft before final publication of the formal revised version (currently scheduled for September 2015).
F DIS 9001 positions the new version of the standard as an integral part of an organization’s efforts towards the broader aim of sustainable development and promotes it as a tool for improving an organization’s overall performance. It encourages more internal and external stakeholder focus as part of the adoption of a risk-based approach to quality management and emphasizes the importance of adopting a Quality Management System (QMS) as a strategic decision for an organization. In addition to renaming and repositioning some QMS activities, other significant new requirements have been introduced.
The ‘context’ of an organization (or its ‘business environment’) refers to the combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products and/or services. As a result, consideration of an organization’s context must now be an element of the QMS design and implementation process.
Risks and opportunities
A vital part of the planning and implementation of a QMS is a new requirement to identify the risks and opportunities that can potentially impact the operation and performance of the QMS, as well as the corresponding ‘proportionate’ actions to address them.
Top management are now required to demonstrate a greater direct involvement in the organization’s QMS, and the absence from the FDIS 9001 of the need for a specific ‘Management Representative’ is partly an attempt to ensure that ‘ownership’ of an organization’s management system is not simply focused on one individual. There is now a focus on ‘leadership’ rather than just management of the QMS.
The terms ‘documented procedure’ and ‘record’ used in ISO 9001:2008 have both been replaced throughout the FDIS 9001 by the term ‘documented information’. This is defined as information that is required to be controlled and maintained by an organization, though it is up to each organization to determine the level and type of documentation necessary to control its own QMS.
Other QMS requirements
There are also other changes to QMS requirements, including:
· Proposed specific requirements for organizations in relation to the execution of a process approach when planning, implementing and developing a QMS
· Identification of the competence necessary for personnel doing work that affects its quality performance
· Identification and maintenance of the knowledge needed to ensure that an organization can achieve conformity of products and services
A risk-based approach to ascertain the type and extent of controls suitable to all types of external provider
Structure and terminology
The FDIS 9001 adopts the clause structure specified in Annex SL, which is now the required framework for all new and revised ISO Standards. The stated intention behind this is to ensure that the final version of ISO 9001 is aligned with other management systems standards. By utilizing the Annex SL structure, it is intended to present QMS requirements in a more consistent, rational manner and not simply offer a template for the elements of an organization’s QMS.
It is important to note that for those organizations that already have an ISO 9001 compliant QMS, there will be no requirement to change their existing QMS procedure and document structure, or the terminology they use, to mirror that specified in FDIS 9001.
ISO 9001:2008 transition
Organizations which are already certified to ISO 9001:2008 will have three years from formal publication of ISO 9001:2015 in which to transfer to the new version of this standard. Based on the current publication schedule, this transition period would end September 2018.
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