<![CDATA[PT. XYZ is a manufacture company which specializes in producing Machine-Glazed paper. The purpose of this research is to design the analysis of risk and related documents in order to complete the requirements of Quality Management System ISO 9001: 2015 in PT. XYZ. Early quality review showed 59% suitability before risk analysis of quality management system ISO 9001: 2015 was implemented. Designing risk analysis of quality management system ISO 9001: 2015 uses Failure Mode and Effect Analysis (FMEA) method. This research is currently in designing phase and will be implemented in all departments of PT. XYZ, such as; HRD & GA, Production, Technical, Warehouse, PPC, Quality Control, Purchasing, Marketing, and Shipment. The result of risk analysis with FMEA method suggest that the biggest risks in PT. XYZ are bad paper quality, returned commodity from consumer, and shipment delay of finished goods. Designing quality management system ISO 9001: 2015 is equipped with commission of SOP, IK, SWOT analysis, Job Description, and Competency Matrix. The final quality assessment after designing quality management system shows 84% suitability with ISO 9001: 2015 requirements]]>
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