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Total Documentation for Laboratory System Certification

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Laboratory System- ISO/IEC 17025, ISO 15189, ISO 35001

ISO/IEC 17025 Certification

ISO 17025 is key standard for an analytical laboratory. It is the single most important quality standard for calibration and testing laboratories around the world. In India it is known as NABL Accreditation, is a procedure by which an authoritative body gives formal recognition of technical competence for specific tests / measurements, based on third party assessment based on ISO/IEC 17025 standard. Laboratories that are ISO/IEC 17025 Accredited have demonstrated that they are technically competent and able to produce precise and accurate test and/or calibration data.


ISO 15189 Certification

The international standard ISO 15189:2022 - Medical Laboratories outlines the standards for proficiency and quality in medical lab settings. It is essentially a standard that mandates that in order for labs to demonstrate their competence, they must create a solid, trustworthy quality management system (QMS). The ISO 15189 certification guarantees that testing and diagnostic services are performed in laboratories that adhere to strict criteria for accuracy, dependability, and efficiency. A laboratory's adherence to ISO 15189 demonstrates its dedication to providing excellent results, upholding patient safety, and continuously enhancing its operations. This certification is beneficial for increasing trust in laboratory services, encouraging laboratory interoperability, and making test results more widely recognised globally.


ISO 35001 Certification

The ISO 35001 biorisk management system defines the fundamental components of a framework for a biorisk management system that should be integrated into the overall governance, strategy and planning, management, reporting processes, policies, values, and culture of a laboratory or other related organisation. It also describes a thorough biorisk management process that mitigates biorisks, including biosafety and biosecurity risks. The ISO 35001 biorisk management system is advantageous for any laboratory or associated facility handling, storing, shipping, or disposing of biologically hazardous items.

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