ISO 15378 documents play a crucial role in ensuring quality management for primary packaging materials. This standard outlines a series of mandatory procedures designed to maintain consistency, compliance, and continuous improvement throughout an organization. Below is an overview of the 18 mandatory procedures required by ISO 15378:2017, with detailed insights on a core processes.

Core Quality Processes in ISO 15378 Documents

Procedure for Management Review
This process empowers top management to regularly evaluate the performance of the quality system. It covers the review of performance metrics, resource allocation, and strategic alignment, ensuring that operational objectives remain consistent with the organization’s vision.

Procedure for Document and Data Control
A critical component for maintaining compliance, this procedure details how documents and data are created, reviewed, approved, and archived. It guarantees that all relevant personnel have access to accurate, up-to-date information, reducing errors and enhancing overall process efficiency.

Procedure for Internal Audit
Regular internal audits are essential to validate adherence to ISO 15378 requirements. This procedure defines the audit scope, frequency, and methods, as well as the process for reporting findings and implementing necessary corrective measures.

Procedure for Corrective and Preventive Action (CAPA)
Focused on continuous improvement, the CAPA procedure involves identifying non-conformities through root cause analysis, implementing corrective measures, and taking proactive steps to prevent recurrence. This systematic approach is vital for mitigating risks and maintaining high-quality standards.

Procedure for Risk Management
Risk management in ISO 15378 involves identifying potential threats to product quality and safety. This procedure provides a framework for continuous risk evaluation, ensuring that appropriate strategies are in place to minimize adverse impacts on processes and outcomes.

In addition to the core processes outlined above, ISO 15378 documents require adherence to the following procedures:

• Procedure for Control of Records
• Procedure for Training
• Procedure for Control of Monitoring and Measuring Equipments
• Procedure for Control of Monitoring of Work Environment
• Procedure for Validation of Sterilization Process
• Procedure for Monitoring and Measurement of Processes
• Procedure for Analysis of Data
• Procedure for Customer Satisfaction Survey
• Procedure for Purchasing
• Procedure for Control of Non–Conforming Products
• Procedure for Identification of Products
• Procedure for Traceability
• Procedure for Preservation

Conclusion

Adopting these mandatory procedures as part of your ISO 15378 documents not only ensures regulatory compliance but also builds a robust framework for quality management and continuous improvement. Organizations implementing these guidelines can achieve better control over their processes, improve operational efficiency, and deliver higher-quality products to the market. Whether detailed or simply listed, each procedure plays a vital role in maintaining the integrity of the overall quality management system.

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