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Our quality policy is comprised of four main objectives that govern our working practices. These are:

  • Comprehensive organization of co‑operation with partners and suppliers
  • Economic efficiency and avoidance of nonconformities
  • Clear and transparent instructions and operational sequences for the realization of customers' demands
  • Positive external effect and creation of total confidence in the company on the part of the customer

ISO 13485 Compliance

Bioline understands the importance of adhering to the ISO 13485 quality standards when developing and supplying custom reagents. Hence, all custom work is performed in accordance with ISO 13485. Our ISO certification confers the following benefits to our stakeholders:

  • Complete confidence in Bioline
  • Reassurance of risk definition & management
  • Order trail
  • Supply chain security
  • Materials traceability
  • Manufacturing consistency
  • Reproducible high standard of quality

Our adherence to the ISO quality standards not only confirms our commitment to being a reliable and technically competent partner, it also means that we have greater understanding of our customers and partners requirements and are committed to further developing our industrial partnerships.

“Business commitment for continuous improvement at Bioline is at the center of our innovation culture. Bioline recognizes that the implementation and use of internationally accepted standards of quality management provides assurance of our products performance and business processes. This has been accomplished through the implementation of ISO 9001 and ISO 13485 across our global operations.

Through the act of putting quality at the center of all we do, we aim to instill a high level of confidence with all our stakeholders and present Bioline as the company of choice. ”

Chris Weatherall, Senior Director Quality Assurance & Regulatory Affairs.


Bioline GmbH ISO 13485:2003 Certificate Bioline Reagents Limited ISO 13485:2012 Certificate Press Release - Bioline is Certified to the ISO 13485 Quality Standard

Click here to download a short summary of our quality control framework.

Click here if you would like to discuss our quality control, or any other needs you may have, with one of our experts.