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Company Quality Policy Statement
When it comes to the results in your laboratory, quality matters most. That's why laboratories across the globe rely on Microbiologics lyophilized microorganisms preparations to support their Quality Control and Assurance programs.
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 9001:2008
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Certifies a company's Quality Management System. The company must demonstrate that products and/or services are developed, produced and distributed in accordance with the Quality Management System.
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The Quality Management System involves official written procedures and training documentation. It also requires all complaints to be documented and corrective and/or preventative actions to be established.
Bottom Line: Assures customers that Microbiologics provides services and manufactures product in accordance with a sound Quality Management System.
ISO/IEC 17025:2005
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Examines a laboratories competence to perform tests. It involves standard methods within the defined scope.
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ISO/IEC 17025:2005 assesses a laboratories test methods, personnel competency and their ability to perform tests consistently.
Bottom Line: Provides official recognition that Microbiologics uses suitable test methods and procedures that produce accurate and consistent test results.
ISO Guide 34:2000
- 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.
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Certificate of Analysis includes additional data.
Bottom Line: ISO Guide 34:2000 provides the highest level of quality assurance; providing objective third-party recognition that Microbiologics is a qualified reference material producer.
Food and Drug Administration Establishment
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Applies to the facility, methods and controls used for the design, purchase, manufacture, packaging, labeling, storage and distribution of in-vitro medical diagnostic products.
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Ensures that finished products are safe, effective and in compliance with Federal Food and Drug and Cosmetic Act.
Bottom Line: Registration with the FDA provides evidence that Microbiologics adheres to all Current Good Manufacturing Practices (CGMP.)
CE Mark
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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.
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CE Marking is mandatory for products sold in the European Market.
Bottom Line: The CE Mark 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.
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