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The quality manual outlines the policies, procedures and requirements of the Quality. Management System. The system is structured to comply with the conditions THE ULTIMATE GUIDE TO ISO 13485:2016 QUALITY MANAGEMENT SYSTEM FOR. MEDICAL DEVICES. If you see no issues with this approach and your opinion is that a QMS A major update of the QMS was introduced in 2018 to meet the updated requirements of EN. ISO 13485:2016 ”Medical devices – Quality management systems – Unlike ISO 9001:2015, the ISO 13485:2016 standard requires that manufacturers establish a quality manual. This requirement is found in clause 4.2.1(b).This Quality Manual specifies requirements that Product Resources uses to address customer satisfaction, to meet customer and applicable regulatory and e) other documentation specified by applicable regulatory requirements. 4.2.2 Quality manual. The organization shall document a quality manual that includes:. The point of the Quality Manual · It offers a medium for the organization to present its commitment and approach to quality management. · It's a good place to