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Quality Systems

Our industry-leading quality system reflects our ability to consistently design, develop, and deliver biological controls of the highest quality.

Company Quality Policy Statement

Microbiologics has received numerous certifications and accreditations to formally recognize the quality of our customer service, manufacturing processes and products. We want you to purchase our products with 100% confidence, knowing they are manufactured to the highest possible standards. Here's a brief explanation of each of our quality credentials and how they benefit you.


ISO 13485:2016

  • Represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
  • The principal standard for manufacturers of medical products, devices and components.
  • A testament to the manufacturer's quality management system and their ability to consistently design, develop, produce and distribute in-vitro microorganism preparations of the highest quality.
Microbiologics ISO 13485:2016 Certificate


ISO/IEC 17025:2005

  • Examines a laboratories competence to perform tests. It involves standard methods within the defined scope.
  • ISO/IEC 17025:2005 assesses a laboratories test methods, personnel competency and their ability to perform tests consistently.
  • Provides official recognition that Microbiologics uses suitable test methods and procedures that produce accurate and consistent test results.
Microbiologics ISO 17025:2005 Certificate


ISO 17034:2016

  • Certifies the competence of a manufacturer as a reference material producer. Methods used to produce certified reference material are evaluated and validated to be proven acceptable.
  • Certificate of Analysis includes additional data.
  • The highest level of quality assurance, provides objective third-party recognition that Microbiologics is a qualified reference material producer.
Microbiologics Reference Material:
  • Epower™
  • EZ-Accu Shot™
  • EZ-Accu Shot™ Select
  • EZ-CFU™
  • EZ-CFU™ One Step
  • EZ-PEC™
  • EZ-SPORE™
  • KWIK-STIK™
  • KWIK-STIK™ Plus
  • LYFO DISK™
  • UV-BioTAG™
Microbiologics Certified Reference Material:
  • Epower™ CRM
  • Lab-Elite™ CRM
Microbiologics ISO 17034:2016 Certificate


Food and Drug Administration Registered Establishment

  • Applies to the facility, methods and controls used for the design, purchase, manufacture, packaging, labeling, storage and distribution of in-vitro medical diagnostic products.
  • Ensures that finished products are safe, effective and in compliance with Federal Food and Drug and Cosmetic Act.
  • Provides evidence that Microbiologics adheres to all Current Good Manufacturing Practices (CGMP.)

CE Mark

  • Microbiologics reference stock culture products such as LYFO DISK® and KWIK-STIK™ fall under the category of In-Vitro Diagnostics Medical Devices Directives for CE Mark Conformity. Products must conform to the criteria for placing in vitro diagnostics on the European Market.
  • CE Marking is mandatory for products sold in the European Market.
  • Indicates conformity with the essential requirements set forth in European Directives. It also verifies the performance of the product and constancy of the production process.