ISO 9001:2015 Clause 8.5.5
What is ISO 9001:2015 Clause 8.5.5?
Clause 8.5.5 of ISO 9001:2015 pertains to how the organization shall meet the requirements for post-delivery activities associated with the products and services.
Key points outlined in Clause 8.5.5 include:
In determining the extent of post-delivery activities that are required, the organization shall consider:
- Statutory and regulatory requirements,
- The potential undesired consequences associated with its products and services,
- The nature, use, and intended lifetime of its products and services;
- Customer requirements and customer feedback.
How do companies comply with clause 8.5.5?
Establish a Change Control Procedure:
Develop documented procedures outlining how changes to production or service provision processes and the quality management system will be controlled.
Identification of Changes:
Implement a system to identify proposed changes effectively. This may include change request forms, regular review meetings, or electronic change management systems.
Evaluation of Changes:
Assess the potential impact of proposed changes on product or service quality, customer requirements, and conformity to quality management system requirements. Consider factors such as cost, time, resources, and risks associated with the change.
Authorization of Changes:
Designate authorized personnel responsible for reviewing and approving proposed changes. Ensure that only qualified individuals assess their impact and alignment with quality objectives before implementation.
Communication of Changes:
Ensure timely and effective communication of approved changes to relevant stakeholders within the organization, including employees, departments, suppliers, and customers. Use clear channels to convey the nature, rationale, and implications of the changes.
Implementation of Changes:
Execute approved changes in a controlled manner, following predefined procedures and protocols. Update relevant documentation, processes, and procedures to reflect the approved changes accurately.
Monitoring of Changes:
Establish mechanisms to monitor the implementation of changes and verify their effectiveness in achieving the desired outcomes. Monitor key performance indicators, customer feedback, and other relevant metrics to assess the impact of changes on product or service quality.
Review of Changes:
Periodically review the results of implemented changes to assess their effectiveness and identify opportunities for improvement. Capture lessons learned and incorporate them into future change management processes.
Documentation of Changes:
Maintain comprehensive records of all changes made to production or service provision processes and the quality management system. Ensure proper documentation and traceability of changes for documentation and audit purposes.
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Related Standards
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