ISO 15378 documents provide a structured framework for organizations to establish and maintain a quality management system that meets both regulatory and industry standards. By integrating Good Manufacturing Practices (GMP) with ISO 9001:2015 principles, these documents help organizations ensure compliance, minimize risks, and enhance overall product quality.
- Standardized Documentation for Compliance
ISO 15378 documents, including quality manuals, SOPs, and procedures, offer a standardized approach to compliance. These structured documents help organizations maintain consistency in their operations, reducing the chances of errors and non-conformities.
- Risk Management and Process Control
The documentation kit includes risk assessment procedures and process control templates that help manufacturers identify potential risks, implement preventive actions, and ensure product safety throughout the production cycle.
- Efficient Internal Audits and Continuous Improvement
With an ISO 15378 audit checklist, organizations can conduct thorough internal audits, ensuring compliance with the standard’s requirements. The structured audit process helps in identifying gaps, driving corrective actions, and fostering a culture of continuous improvement.
- Simplified Training and Employee Awareness
The availability of standard operating procedures (SOPs) and process flow charts ensures that employees clearly understand their roles and responsibilities. This enhances training efficiency, improves workforce competence, and ensures consistency in quality practices.
- Cost and Time Savings in Documentation
Creating ISO 15378 documents from scratch can be time-consuming and complex. A pre-designed documentation kit saves valuable time and resources by providing ready-to-use templates that can be easily customized to suit an organization’s needs.
Content of ISO 15378:2017 Documentation Kit
For companies looking to implement ISO 15378 efficiently, Global Manager Group provides a comprehensive ISO 15378 Documentation Kit. These documents are designed to simplify compliance by offering ready-to-use templates that can be easily customized to suit an organization's specific needs.
- ISO 15378 Manual
The documentation kit includes an editable ISO 15378 manual, covering all essential aspects of QMS and GMP requirements. This manual serves as a reference guide for compliance with ISO 15378:2017.
- Mandatory Procedures
To ensure compliance, the kit includes ISO 15378 procedures that help organizations maintain control over various processes, ensuring smooth implementation and adherence to regulatory requirements.
- Exhibits
A set of sample exhibits provides comprehensive details on skill requirements and quality plans, aiding organizations in workforce training and competency management.
- Readymade Formats
With editable forms, organizations can efficiently maintain records and establish systematic control of their quality management system.
- Process Approach with Flow Charts
The documentation kit contains process approaches with flow charts, offering visual representation of key processes across different departments, ensuring better understanding and implementation.
- Standard Operating Procedures (SOPs)
A collection of standard operating procedures (SOPs) in editable formats define standardized operations as per ISO 9001 and GMP guidelines, ensuring consistency in manufacturing processes.
- ISO 15378 Audit Checklist
The audit checklist includes sample audit questions, covering clause-wise and department-wise requirements, providing an excellent reference for internal audits and ensuring compliance readiness.
Features of the ISO 15378 Documentation Kit
- User-friendly, making it easy to learn, customize, and implement.
- Available for instant download, including a FREE ISO 15378 DEMO for evaluation.
- Designed by experienced ISO 15378 consultants to ensure quality and compliance.
- Reduces excessive paperwork by offering a structured documentation approach.
- Ensures compatibility with GMP-based ISO 15378 documentation across global markets like the USA, UK, Europe, and Asia.
How This Documentation Kit is Useful
- Provides a complete set of manuals, procedures, process flow charts, templates, etc., ensuring confidence and improved quality system implementation.
- Users can modify the templates as per their organization's processes and quickly create customized documents for ISO 15378:2017 certification.
- Helps in fine-tuning internal processes and establishing better control over good manufacturing practices.
- Saves significant time and costs in document preparation.
- Offers excellent value for money, with a low payback period for investment in documentation.
- Ensures accuracy and minimizes repetitive work, increasing efficiency in documentation and compliance efforts.
Get Your ISO 15378 Documentation Kit Today!
If your organization is seeking ISO 15378 certification for medicinal product packaging materials, the ISO 15378 Documentation Kit from Global Manager Group is the most reliable solution. With a well-structured set of documents, your company can ensure compliance, reduce audit stress, and enhance overall quality management.
For more details, visit: Global Manager Group - ISO 15189 Documents page and take the next step towards achieving ISO 15378 certification effortlessly.
