It has been revised to not only ensure it continues to provide a consistent foundation for the future, but to ensure it reﬂects the needs of all relevant interested parties.
With the introduction of Annex SL, the new high-level structure for all new and revised management system standards, ISO 9001:2015 also ensures easy integration with other management system standards, such as ISO 14001:2015, also published in September 2015.
Originally, ISO 9001 was aimed more at manufacturing organisations, but as industry has developed, ISO 9001 was being used by organisations in all industry sectors; after all, most organisations want to deliver a quality service that meets customer expectations, whether that be for a service or product. ISO 9001, therefore, needed to change to become more compatible with service organisations and non-manufacturing users.
With the ever complex environments organisations now operate in, there is a clearer understanding that ‘one size does not ﬁt all’. ISO 9001 now expects a stronger emphasis on an organisation’s context. Organisations must now determine what the relevant external and internal issues are and then demonstrate these are relevant or aligned with the organisations strategic direction.
Greater emphasis is on leadership where top management are now directly responsible and therefore, accountable for the management system. Top management can no longer delegate the responsibility to a management systems representative.
As with the 2008 standard, there is a focus on a process-based approach, but ISO 9001:2015 has strengthened this focus and it has become more explicit.
Concept of preventive action has now been addressed throughout the standard by risk identiﬁcation and mitigation and there has been an increased emphasis on seeking opportunities for improvement.
Although the structure has changed to ISO 9001:2015, the Plan-Do-Check-Act (PDCA) cycle is still very much at the heart of the management system standard.
This article provides some practical guidance and advice for those who are responsible for implementing a quality management system to ISO 9001:2015 requirements.
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