ISO 9001:2015 Launched
After seven years, ISO released a major update to its Quality Management System (QMS) standard, ISO 9001. This revision reflected developments in quality management practices, regulatory expectations, and the need for greater integration with other ISO management system standards. The main changes in this revision include the addition of two new clauses, a new high-level structure, a heavier focus on risk-based thinking and new documentation formats.
ISO 9001:2008 vs ISO 9001:2015 — what’s changed?
With seven years between updates, there were significant changes that affected certified companies:
New clauses
The structure was revised to better align with the Plan-Do-Check-Act (PDCA) cycle. Two new clauses were introduced to strengthen planning and evaluation, making PDCA a core organizing principle of the standard.
High-level structure
ISO 9001:2015 adopted the Annex SL framework.This high-level structure allowed for greater integration across standards. With unified core elements across the certification family, organizations could more simply implement multiple standards that followed the Annex SL structure, including ISO 14001, ISO 45001, and ISO 27001.
Greater focus on process inputs and outputs
The 2015 revision required companies to monitor the materials and information involved in the production process and regularly assess the quality of the outputs generated by these processes.
Risk-based thinking
The new revision introduced a greater emphasis on risk-based thinking throughout the QMS. This proactive approach replaced the previous focus on preventative measures – a key component of the standard.
Context of the organization
Previously, the standard didn’t require users to build their Quality Management System based on their organization’s specific context. The 2015 revision introduced a requirement for organizations to determine the expectations of relevant interested parties.
Increased interested parties
With the 2015 revision, the focus expanded beyond just the customer. Suppliers, personnel, society as a whole and internal customers had to now be considered as interested parties in the implementation of the standard.
More leadership involvement
The new standards placed greater emphasis on managers’ and business leaders’ active involvement in aligning the quality standard with business strategy and taking direct responsibility for the standard’s effectiveness. Unlike before, when a single authority acted as a management representative, quality became a shared responsibility across the whole organization.
Documentation changes
Reflecting evolving methods of information management and access, the 2015 revision allowed for greater flexibility in how documented information is presented. The 2015 revision removed the explicit requirement for a quality manual, allowing greater flexibility in how documented information is presented. Information can be shared in many different ways.
