ISO 9001 Quality Management Systems

Clause 3 now includes a common set of terms and definitions directly in the document. The inclusion of the definitions in clause 3 are required to meet the harmonised structure requirements for management system standards issued by ISO, the International Organization for Standardization.  ISO 9000:2026 was released earlier this year and continues to be the normative reference standard for quality management terminology, providing addition definitions and fundamental concepts of quality management.  

Clause 4 of ISO 9001:2026 describes how the organisation must understand the external and internal factors that may affect its ability to achieve the intended results of the quality management system. In addition to the requirement to consider the potential impact of climate change, organisations are encouraged to consider a wide range of factors that can have positive or adverse effects on the organisation’s success.

Clause 5 of ISO 9001:2015 describes how the organisation’s leaders must commit to the success of the management system, providing sufficient resources, ensuring the quality policy and objectives are in place, and clearly communicating roles, responsibilities and authorities clear.

“Promoting quality culture and ethical behaviour” is added as a new entry under 5.1 (Leadership and commitment), with new guidance on how organizations can demonstrate this. The quality policy must now more explicitly reflect the organisation’s strategy and external context.

Clause 6 of ISO 9001:2015 describes how planning must address actions to address risks and opportunities; quality objectives and how to achieve them; and change management.

Clause 6.1 – Actions to address risks and opportunities. Risks and opportunities are now more clearly distinguished, with separate consideration of actions to address each — reorganizing what was previously a more combined treatment in 2015.

Clause 6.3 provides for a structured approach to change management. The requirement has been enhanced to include requirements for the organization to evaluate the effectiveness of changes along with a method to monitor the results of the change to ensure the desired result has been achieved.   

Clause 7 describes how the organisation must ensure sufficient resources are allocated to the quality management system, and carefully monitor their use and effectiveness. 

Clause 7.3 – Awareness. Organisational knowledge has been expanded to ensure the information needed to successfully operate the QMS is available to those who need it to perform their job functions. Awareness has been expanded to reflect the requirement for a quality culture and ethical behavior (clause 5) and the role each member of the organization plays in contributing to the achievement of organisation’s objectives.

Clause 8 of the standard describes how the organisation should plan, implement and control its processes to meet requirements for providing its products and services. The requirements in several of the clauses has been clarified however the overall intent is consistent with the 2015 version of the standard.

Clause 8.2.1 Customer communication has been modified to require  providing information related to contingency actions, when relevant, including any related to disruptions to the provision of products or services in an effort to ensure an uninterrupted source of products to the customer.

Clause 9 standard describes the monitoring, measurement and data analysis requirements the organization employees to provide relevant data needed to determine the overall effectiveness of the quality management system.  This information are key inputs into the management review process.

Clause 9.3.2 – Management review inputs. Additional guidance on continual improvement was incorporated, especially tied to Clause 5 leadership expectations, and inputs are expanded to include changing needs/expectations of interested parties.

The final clause of ISO 9001 requires a commitment to continual improvement of the QMS. The requirements for continual improvement from the 2015 version have been consolidated into one clause 10.1 which provide for a structured approach to identify and determine which improvement projects the organisation will pursue. Sources for identifying potential continual improvement opportunities are identified.

Annex A provides clarification of the requirements in ISO 9001. The inclusion of Annex A is a requirement of the harmonized structure for management system standards. 

Annex B from the 2015 version of ISO 9001, detailing the nature and application of additional quality management guidance standards to assist organizations in the development and operation of their QMS has been removed. The quality management guidance standards have been added to the bibliography of ISO 9001:2026.

Formal integration of climate-change considerations builds on the 2024 amendment rather than introducing it fresh.