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ISO 13485:2003 · *This manual is to be used as a template in developing your 13485 Quality Manual. · Your Company developed and implemented a Quality Management 1(b). POL-001 is Medical Device Academy's template for a quality manual. It is the primary document meeting the applicable regulatory requirements for a QualityA quality manual is not just a requirement in ISO 13485; it helps companies manage their QMS and describe all the important elements in one place. This Quality Manual specifies requirements that Product Resources uses to address customer satisfaction, to meet customer and applicable regulatory and Introduction. Your Company developed and implemented a Quality Management System in order to document the company's best business practices, better satisfy 4 QUALITY MANAGEMENT SYSTEM. 4.1 GENERAL. The QMS is designed in accordance with the requirements of EN ISO 13485:2016 and. The Quality Management System of Exsurco meets the requirements of the international standards ISO. 13485 and U.S.QSR (21 CFR 820).