![]() Key elements of our Risk Management Program include: ![]() Certification verifies that these standards are met by evaluating inputs and outputs throughout the entire product life cycle, from design and production to assessing customer satisfaction and informing necessary improvements.įor more information on these ISO certifications and to download the certificates, please refer to our Regulatory Support Page. These international standards developed by the independent, non-governmental International Organization for Standardization (ISO) define the requirements for operating a QMS for the design and manufacture of medical devices and related services. STEMCELL’s QMS is certified to ISO 13485:2016 Medical Devices and ISO 9001:2015. It helps coordinate and direct activities to meet customer and regulatory requirements, drives continuous improvement, and contributes to efforts to enhance customer satisfaction. Tissue and Cell Culture Dissociation ReagentsĪ quality management system (QMS) is a formal system of processes, procedures, and responsibilities for achieving quality policies and objectives.Work at STEMCELL View Current Opportunities >
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