The common management system framework introduced by Annex SL, ISO 9001:2015 contains a number of changes including standardized terms and definitions as well as a 10 clause structure.
ISO 9001:2015 contains an expanded focus on Leadership; requirements relating to the role top management plays in creating and supporting an effective QMS have been enhanced, including –
- Promoting awareness of the process approach
- Driving the integration of QMS requirements into the organizations’ business processes
- Ensuring the QMS achieves its intended results
- Ensuring that the policies and processed are effectively communicated, understood and applied by the entire organization.
- Encouraging relevant management roles to demonstrate their leadership
Increasing the focus on Leadership in ISO 9001:2015 requires top management to demonstrate a clear understanding of the business context, assessing and ameliorating risks and opportunities, and greater accountability tied closer to links between the management system and actual product/service quality.
Going forward, assessors will challenge the top management of an organization to understand its business strategy and objectives in relation to ISO 9001:2015. This involvement must be demonstrable through internal oversights such as internal audits, which remains an integral part of the assessment. There’s an expectation that top management will be active participants in the ISO 9001:2015 Internal Audit process.
Assessors will actively engage with top management and be capable of communicating the ISO technical requirements in a way that relates to business – effectively bridging the gap between the boardroom and the shop floor.
The independent impartial external view is vital for continued effective operations.
For the top management this represents a requirement for their direct involvement with both the Internal and 3rd party external Auditors and the ability to demonstrate their active involvement and commitment to their system.
The management system can longer be simply delegated to the Quality Manager; requiring the integration of the QMS with the business processes automatically demands the involvement of all process owners.
Change is inevitable. Embracing positive change is critical for the survival of any organization. These revisions of ISO 9001:2015, along with the focus on top management engagement, will ensure that organizations will benefit from having an effective and performance-based management system that deliver a synergy of business benefits and real competitive advantages.