ISO 9001:2015 Clause 8.5.6

What is ISO 9001:2015 Clause 8.5.6?

Clause 8.5.6 of ISO 9001:2015 is titled “Control of Changes.” This clause outlines requirements for organizations to establish processes to control and manage changes within their quality management system (QMS).

Key points outlined in Clause 8.5.6 include:

General Requirement:

Organizations must establish, implement, maintain, and continually improve processes to control and manage changes within their QMS.

Review of Changes:

Organizations must review and evaluate changes before implementation to ensure that they do not have an adverse impact on the QMS’s integrity.

Authorization of Changes:

Changes must be authorized by relevant personnel before implementation.

Communication of Changes:

Organizations must communicate relevant changes to the appropriate personnel and functions affected by the change.

Review of Consequences:

Organizations must review the consequences of changes, including their effects on constituent parts of the QMS, to ensure their integrity is maintained.

Traceability of Changes:

Organizations should maintain traceability of changes, including the rationale for the changes and any necessary approvals.

Documentation of Changes:

Organizations must update relevant documentation to reflect approved changes. Overall, this clause emphasizes the importance of managing changes effectively within the QMS to maintain its integrity, ensure conformity to requirements, and continually improve the organization’s processes.  

Other ISO 9001:2015 Clauses:

How do companies comply with clause 8.5.6?

Compliance with Clause 8.5.6 of ISO 9001:2015 requires a systematic approach to managing changes within the quality management system (QMS). Here are the steps a company can take to comply with this clause:

Establish a Change Control Process:

Develop a documented procedure that outlines the process for initiating, reviewing, approving, implementing, and verifying changes within the QMS. This process should be tailored to the organization’s size, complexity, and specific needs.

Identify Change Triggers:

Determine what types of changes require formal control and establish criteria for identifying and categorizing changes. This could include changes to processes, procedures, documents, equipment, facilities, personnel, suppliers, or organizational structure.

Change Review and Evaluation:

Implement a mechanism for reviewing proposed changes to assess their potential impact on the QMS, including risks to product/service quality, regulatory compliance, customer satisfaction, and other relevant factors.

Authorization and Approval:

Define roles and responsibilities for authorizing and approving changes. Establish criteria for determining who has the authority to approve changes based on their significance and potential impact.

Communication and Training:

Ensure that relevant stakeholders are informed about proposed changes and their potential impact. Provide necessary training to personnel who will be affected by or involved in implementing the changes.

Documentation and Recordkeeping:

Maintain documentation of all change requests, including the rationale for the change, the review and approval process, and any associated actions taken. Ensure that records are updated to reflect approved changes.

Implementation and Monitoring:

Implement approved changes according to the established process and monitor their effectiveness. Establish mechanisms for tracking the progress of change implementation and addressing any issues or deviations that arise.

Review and Continuous Improvement:

Periodically review the effectiveness of the change control process and make adjustments as necessary to improve its efficiency and effectiveness. Continually seek opportunities to enhance the organization’s ability to manage changes within the QMS. By following these steps and integrating change control practices into their QMS, companies can effectively comply with Clause 8.5.6 of ISO 9001:2015 and ensure that changes are managed in a systematic and controlled manner.  

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