ISO 9001:2015 Clause 8.5.6, titled "Control of Changes," addresses the need for organizations to manage and control changes to production and service provision processes in a systematic manner. This clause ensures that any alterations in how products and services are created, delivered, or supported do not adversely affect the quality or conformity to requirements. Understanding and implementing this clause is vital for maintaining the integrity of the quality management system (QMS) and ensuring continuous improvement. Here's a detailed look at this clause:
Purpose of Controlling Changes
The purpose is to ensure that changes, whether planned or unplanned, do not negatively impact the quality of products or services, customer satisfaction, or compliance with applicable requirements. It helps in mitigating risks associated with changes and ensures that all modifications are evaluated, reviewed, and implemented in a controlled manner.
Key Elements of Clause 8.5.6
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Identification of Changes:
- Changes can arise from various sources such as new technology, customer feedback, process reviews, or compliance with new regulations. Identifying the need for change is the first step in managing it effectively.
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Planning and Review:
- Before implementing a change, organizations must plan and review the change to assess its potential impact on the quality of products and services, including the effects on compliance with requirements. This planning should consider the scope of the change, resources needed, and any re-verification or re-validation activities required.
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Approval of Changes:
- Changes must be approved according to the organization’s established procedures before implementation. Approval should be granted based on a thorough review and understanding of the change’s potential impact.
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Implementation of Changes:
- Implementing changes in a controlled manner involves updating relevant documentation, communicating the changes to affected parties, and making necessary adjustments to processes and resources.
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Review of Changes:
- After implementing a change, organizations should review it to ensure that the desired objectives have been achieved without adversely affecting the quality of products or services. This review should also evaluate the effectiveness of the change management process.
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Documentation:
- Organizations must maintain documented information about changes, including descriptions of the changes, review outcomes, and authorization details. This documentation provides a traceable history of changes and supports continuous improvement efforts.
Implementing Control of Changes
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Change Management Process: Organizations should establish a formal change management process that includes steps for identifying, reviewing, approving, implementing, and reviewing changes.
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Risk Management: Integrating risk management practices into the change management process can help in assessing and mitigating potential impacts of changes.
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Communication: Effective communication with internal and external stakeholders is crucial throughout the change management process to ensure that all parties are aware of the changes and their implications.
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Training: Providing training and support to employees affected by the changes ensures a smooth transition and maintains process integrity.
Importance
Controlling changes is crucial for the sustainability and improvement of the QMS. It ensures that changes are made without compromising product or service quality and that the organization can adapt to new requirements, technologies, and market conditions in a controlled and effective manner.
In summary, ISO 9001:2015 Clause 8.5.6 emphasizes the importance of managing changes to production and service provision processes in a systematic and controlled way. This approach helps organizations to maintain quality standards, comply with requirements, and achieve continuous improvement while adapting to change.