SIRION Biotech achieves ISO-9001:2015 Certification

news-releasesSIRION Biotech GmbH
April 6th 2022

Martinsried, Germany: – Europe’s leading supplier of viral vector technologies, SIRION Biotech GmbH (SIRION), has been awarded full ISO 9001:2015 quality management certification, underlining and reinforcing its  ability to exceed the quality expectations and requirements of its customers.

ISO 9001 is the worlds most widely recognized standard for a quality management system (QMS). It enables companies to operate more effectively on several different levels, including the ability to focus on customer requirements and constantly finding ways in which to improve and become more resilient and sustainable.

Business benefits

SIRION’s ISO 9001:2015 certification follows inspection by Stuttgart-based DEKRA, Germany’s leading   inspection agency and the third-largest in the world. DEKRA’s main tasks include expert appraisals, safety inspections and the inspection of technical systems.

In addition to ensuring that SIRION Biotech customers receive consistent, high-quality products and services, ISO 9001:2015 confers other significant business benefits, including:

  • Homogenous, repeatable, and secure internal process execution
  • Creation of a platform for consistency during expansion
  • Improved client delivery services and customer satisfaction.

Customer satisfaction

SIRION Biotech Chief Operations Officer Dieter Lingelbach commented: “We are proud of our commitment to serving the scientific community, in particular cell and gene therapy developers, with the highest quality viral vectors.”

“Customer satisfaction is at the center of everything we do and this ISO certification assures our customers that we continue to prioritize quality, reliability, and consistency in our manufacturing and management system processes today and in the future.”

Quality Management Manual

SIRION Head of Quality Assurance, Katrin Becker, added:

“We created a Quality Management Manual that recognizes the significant role our employees play in the quality of all SIRION Biotech services. This QMM, along with an existing quality assurance structure, provided the foundation for our ISO 9001:2015 Certification, and includes all aspects of Service Delivery, Business Enablement, Infrastructure, Human Resources and Training, Finance and Accounting, and Business Growth. It gives us a clear, actionable, and thorough approach to the vital components of our business and is positions us well for ongoing growth.”

About SIRION Biotech

SIRION Biotech was founded in 2005 with the goal to spark a new generation of viral vector technologies for gene and cell therapy as well as vaccine development. SIRION evolves novel therapeutic viral vectors and uses proprietary technology platforms based on lenti-, adeno-, and adeno-associated viruses, to expedite its partners’ advances in drug development. To date SIRION has completed over 8000 projects of all sizes, working closely with over 600 independent customer groups from academia and industry. On August 31, 2021, SIRION was taken over entirely by PerkinElmer. For additional information, please visit


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