11/06/2025

On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency. The version that is currently in effect; ISO 9001:2015, has seven sections that set the international standards for what a QMS is:

1. Context of the Organization: This section looks at the organization from a broad perspective, it identifies who the interested parties or stakeholders (customers, manufacturers, shareholders etc.) are and what they require or expect from the organization. It also takes into account the internal factors of an organization, such as performance, company culture, and values, as well external factors such as market-trends, technological advancements and social nuances, to determine the scope of a QMS.

2. Leadership: For those managing the QMS or “top management”, their role amongst other employees should be well defined and follow the organization’s established “Quality Policy” in order maintain order throughout the organization and avoid confusion when it comes to assigning tasks and responsibilities. Management should demonstrate effective leadership and commitment to maintaining a quality culture, provide support and resources where needed, and be accountable and transparent about how the QMS is being run especially when issues arise.

3. Planning: This section highlights actions to address risks and opportunities. Similar to planning a clinical trial, potential areas of risks should be identified as early as possible in order to stay ahead of any issues that may arise and mitigate their impact on the QMS function. Planning should also include planning for change, whether it be to factors identified in the context section, or in this case, changes to the standards and requirements for QMS.

4. Support: This section has 5 subsections that all need to be addressed to properly operate a QMS:

a. Resources: This includes knowing what resources the organization has and what resources are needed. Resources can include but are not limited to adequate staffing, equipment, and working conditions, all of which need to be routinely monitored and replenished when needed.

b. Competence: Each staff member needs to be competent in their specific roles and responsibilities. Routine training for all employees can help to make sure all responsibilities are being handled properly and additional training or reassignment of responsibilities may also be necessary for a QMS to operate.

c. Awareness: In addition to staff understanding their individual tasks and responsibilities, it is also essential that they are aware of the overarching policies and objectives that the organization sets such as those intended to promote a quality culture.

d. Communication: Like any other system, communication is essential for optimal functioning. Top management should strive to effectively communicate which tasks are assigned to who while staff should be encouraged to provide continuous reports of QMS efficiency and escalate any issues or deficiencies identified for swift resolution.

e. Documented Information: Adequate control over all documents and records should be established including version control over updates and changes, controls over who has access and alter information and where it is stored/archived.

5. Operation: This is the longest section that addresses all of the operational aspects of a QMS:

a. Operational Planning and Control

b. Requirements for Products and Services

c. Design and Development of Products and Services

d. Control of Externally Provided Processes, Products and Services

e. Production and Service Provision

f. Release of Products and Services

g. Control of Nonconforming Outputs

6. Performance Evaluation: Just like clinical trials, adequate oversight and close monitoring ensures that the project is being conducted as planned and any issues or deviations are quickly caught and addressed. Accurate evaluations should include a routine monitoring schedule as well as internal audits that will highlight any problematic areas or areas in which improvement is possible.

7. Improvement: In order to stay competitive in any market it is essential that an organization identify its shortcomings and come up with ways to adapt or improve.

The new ISO 9001:2026 is expected to retain the structure of 9001:2015 while improving and refining some of the language and terminology. In the leadership section, there is expected to be a more detailed emphasis on top management creating and maintaining a quality culture. Risk management will also see some changes, with more clear distinction between risks and opportunities as well as new management strategies that incorporates external factors. Inclusion of climate change is also expected, with an emphasis on sustainability within the quality culture and ethics of an organization and may include requirements that address climate change.

The new draft ISO will likely be finalized and published sometime in 2026 at which time the standard transition period will begin until 2029 where 9001:2015 will be fully retired. This will give companies and organizations time to review the changes and apply them to their internal processes and procedures. However, the sooner a QMS is up to standard, the smoother the transitionary period will be when the time comes. If you or your company could benefit from independent advice on your QMS, Clinical Pathways offer live training and consulting on QMS as well as other clinical trial subjects. For a full list of our services and to contact us, please visit our website and while you are there, sign up for our free newsletter and weekly blog to stay up to date on clinical trial related events such as this.

-The Clinical Pathways Team

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