ISO 9001:2015 Clause 8.3.3

What is ISO 9001:2015 Clause 8.3.3 about?

As of the 2015 version, Clause 8.3.3 of ISO 9001:2015 is related to the design and development of products and services. This clause specifically addresses the control of design and development changes. It outlines the requirements for organizations to manage changes that may occur during the design and development processes. This includes evaluating the effects of changes, ensuring that relevant personnel are aware of and understand the changes, and updating documentation as necessary.

What is the Goal of Clause 8.3.3?

The goal of Clause 8.3.3 is to ensure that any changes made during the design and development phase are controlled, documented, and communicated effectively to prevent unintended consequences and maintain the integrity of the quality management system.

Other ISO 9001:2015 Clauses:

How does a company comply with Clause 8.3.3?

Compliance with Clause 8.3.3 of ISO 9001:2015 involves establishing and maintaining a robust process for managing changes during the design and development of products and services. Here are steps that a company can take to comply with this clause:

Establish a Change Control Process:

• Define a formal process for controlling changes during the design and development phase.
• Clearly outline the steps involved in the change control process.

Identification of Changes:

• Establish criteria for identifying changes that require control.
• Ensure that all changes are assessed, including changes to specifications, drawings, processes, or any other relevant aspects of design and development.

Impact Assessment:

• Conduct a thorough impact assessment for each proposed change.
• Evaluate the potential effects on product or service requirements, quality, cost, delivery, and other relevant factors.

Documentation:

• Maintain documentation that describes the nature of the change, the reason for the change, and the potential impact on the product, process, or service.
• Update relevant documents, including specifications, drawings, and procedures, to reflect the approved changes.

Review and Approval:

• Establish a review and approval process for proposed changes.
• Involve relevant stakeholders, including those responsible for design and development, quality, and any other pertinent departments.

Communication:

• Communicate approved changes to all relevant personnel, ensuring that they are aware of and understand the modifications.
• Consider providing training if necessary to ensure effective implementation.

Monitoring and Measurement:

• Implement mechanisms to monitor and measure the effects of approved changes.
• Verify that the changes have been implemented as intended and that the desired results are achieved.

Records:

• Maintain records of all change control activities, including documentation of the change, the assessment, and the approval process.
• These records serve as evidence of compliance during audits.

Continuous Improvement:

• Periodically review the effectiveness of the change control process and identify opportunities for improvement.
• Implement corrective actions as needed to enhance the efficiency and effectiveness of the process.

Training:

Ensure that relevant personnel are trained on the change control process and are familiar with their roles and responsibilities.

By following these steps, a company can establish a systematic and well-documented approach to complying with Clause 8.3.3 of ISO 9001:2015, thereby effectively managing changes during the design and development of products and services.

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