Quality Management Systems


Your company's quality management system (QMS) can help optimize performance, achieve cost savings and improve customer satisfaction. We can assist you with all quality management issues and tasks worldwide. Through our involvement in ISO TC210/WG1 and decades of experience, we work with you to find the most efficient and secure regulatory solutions for your business. NSF Prosystem can assist you with: - Implementing a complete quality management system in accordance with ISO 13485:2016 and ISO 9001:2015 requirements. - Evaluation of your QMS with regard to regulatory and normative requirements (e.g. ISO 13485:2016, 21 CFR 820 Quality System Regulation, Medical Device Single Audit Program (MDSAP), ANVISA: RDC 16/2013 and Regulation (EU) 2017/745) - Process optimization and further development of existing processes in accordance with regulatory requirements - Conducting internal audits and supplier audits - Training and further education of your quality management representative/PRRC - Preparation, support and follow-up of inspections and audits
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