Planning Change in Management Systems: Insights from ISO 9001:2015

Changes can lead to uncertainty and confusion when not properly planned, and they are likely to have negative consequences if implemented without adequate foresight. ISO 9001:2015 stresses the importance of risk-based thinking, with change being a key area of risk that must be addressed proactively. Therefore, the change process should begin with a thorough review of the proposed change and its potential impact on the system and its outcomes.

Clause 6.3 of the standard focuses on planning for changes that affect the management system, while Clause 8.2.4 outlines requirements for changes in product and service specifications. Some may wonder how these two clauses should be applied within their organizations. In fact, they complement each other, ensuring a smooth transition when implemented together.

The planning of change involves a high-level review of the change, focusing on system-related risks, such as resource requirements, process adjustments, and tasks to be assigned to team members. The change requirements outlined in Clause 8.2.4, on the other hand, deal with a more granular scope, focusing on specific impacts. However, it is important to note that even small changes can have wide-reaching effects across the entire system. Therefore, when implementing changes in products or services, organizations should also refer to Clause 6.3 to assess the broader risks.

Here are some examples to illustrate these points:

Example of Product Change Affecting the Management System:

Imagine an automotive manufacturer decides to switch from conventional internal combustion engines to electric motors for one of its models. This is a significant change that impacts the entire production process, including resources, suppliers, materials, design, testing, tools, fixtures, employee training, and market review. The change would require extensive planning and control as part of a large-scale project, potentially taking years to complete. In this case, the product change leads to changes in every stage of the production line and supporting processes as well as after sale services.

Example of System Change:

Consider an organization facing financial difficulties, leading to a significant reduction in staff. While the scope of the management system remains unchanged in terms of the products produced, the reduction in resources may cause some supportive processes to lose personnel. For example, teams responsible for fixture repairs might be downsized, and their tasks could be merged with operators’ duties. In this scenario, the management system must be updated because the system designed for a larger organization may no longer be effective for a smaller one, which could lead to overlooked issues. New risks related to the quality of work must be identified, and the system should be adjusted accordingly. Careful planning is required before making any significant changes.

Example of a Product Change That Does Not Affect the Management System:

Suppose a product is improved by replacing a part, which may require small adjustments to the product and fixtures. These changes can typically be managed through an improvement project or action plan. For instance, if a switch on a machine is replaced, the holes for the new switch might need to be modified. The design team would review and update the drawings, while operators are trained on the new process. Although the risks associated with this change should be evaluated, the change would be limited to the product realization level and would not impact the overall system. The procedures would remain largely unchanged, and the adjustments could be documented as a corrective action or improvement project.

In conclusion, understanding the scope of the change and its potential impact on the system is essential. Whether the change is large and organizational in scale, or a small adjustment in a specific process, both need to be assessed for risks and appropriately planned and executed.

At Aumozition, we offer practical examples to help clients translate management system requirements into real-world applications. We also provide online self-paced management system audit courses to support their learning journey.