Swift Biosciences announces ISO 13485:2016 Certification
Ann Arbor Michigan (January 7, 2019) - Swift Biosciences, Inc. a manufacturer of precision next-generation sequencing (NGS) solutions, announces it has received International Organization Standardization (ISO) 13485:2016 certification for design, development, production, and distribution of molecular biology and related reagents in both standard and custom formats has been assessed and approved by National Quality Assurance, USA with zero conformances, the best result possible.
The ISO 13485:2016 certificate was issued to Swift Biosciences by the National Quality Assurance Global Certification body on January 2, 2019. Swift Biosciences’ Quality Management System will assure the quality and efficacy of its products and services in accordance with applicable regulatory and statutory requirements.
The standard contains specific requirements for manufacture, installation, and servicing and calls for:
- Implementation of Quality Management System with several enhancements.
- Risk Management approach to product development and product realization.
- Validation of processes.
- Compliance with statutory and regulatory requirements.
- Effective product traceability and recall systems.
Nathan Wood, CEO, stated “Swift Biosciences goal is to provide the highest quality products in the NGS space. By becoming ISO certified our customers can be confident that our products are the most accurate, reliable and cost-effective for their work. We are proud to have so many new and legacy customers that depend on us and our products. We will continue to innovate and provide new solutions and products in the NGS market.”
For more information, visit SwiftBioSci.com and follow Swift Biosciences on Twitter (@SwiftBioSci)
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