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Quality Systems
ISO 13485 / ISO 11137 / ASTM compliant procedures, audits, and testing.
Quality System Consultation Services
Quantum EBX provides comprehensive quality system services to help organizations establish and maintain effective quality systems for radiation sterilization processes.
Our services cover every aspect of quality system development and implementation, ensuring compliance with relevant standards and regulations.
Key Services:
Quality Systems
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ISO 13485 / ISO 11137 Compliant Sterilization Procedures
We develop comprehensive ISO 13485 / ISO 11137 compliant procedure sets tailored to the specific requirements of radiation processing and medical device sterilization.
-
ISO / ASTM Compliant Test and Measurement Procedures
We create ISO / ASTM compliant procedures for e-beam and x-ray testing, validation, and dosimetry system procedures.
-
Internal Quality Audits
We conduct internal quality audits with a focus on product sterilization requirements, ensuring compliance while identifying areas for improvement.
-
Supplier Quality Audits
Our comprehensive supplier quality audits evaluate the performance of suppliers and ensure the quality and reliability of procured materials and services.
-
Workforce Training
We provide comprehensive workforce training programs to equip personnel with the knowledge and skills required to implement and maintain sterilization quality system components effectively.
-
CAPA Process Implementation
We can assist in establishing and implementing a robust CAPA (Corrective and Preventive Action) process to address nonconformities and prevent their recurrence effectively.
Quality System Consultation Services
Quantum EBX provides comprehensive quality system services to help organizations establish and maintain effective quality systems for radiation sterilization processes.
Our services cover every aspect of quality system development and implementation, ensuring compliance with relevant standards and regulations.
Key Services
-
ISO 13485 / ISO 11137 Compliant Sterilization Procedures
We develop comprehensive ISO 13485 / ISO 11137 compliant procedure sets tailored to the specific requirements of radiation processing and medical device sterilization.
-
ISO / ASTM Compliant Test and Measurement Procedures
We create ISO / ASTM compliant procedures for e-beam and x-ray testing, validation, and dosimetry system procedures.
-
Internal Quality Audits
We conduct internal quality audits with a focus on product sterilization requirements, ensuring compliance while identifying areas for improvement.
-
Supplier Quality Audits
Our comprehensive supplier quality audits evaluate the performance of suppliers and ensure the quality and reliability of procured materials and services.
-
Workforce Training
We provide comprehensive workforce training programs to equip personnel with the knowledge and skills required to implement and maintain sterilization quality system components effectively.
-
CAPA Process Implementation
We can assist in establishing and implementing a robust CAPA (Corrective and Preventive Action) process to address nonconformities and prevent their recurrence effectively.
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