Perancangan Analisis Risiko Sistem Manajemen Mutu ISO 9001 : 2015 di PT. X

Ricky Kurniawan, I Nyoman Sutapa

Abstract


PT. X is a company engaged in the field of bodybuilding. This study aims to design risk analysis and documents related to the interests to complete the requirements of ISO 9001: 2015 quality management system at PT. X. The preliminary quality review indicates compliance of 61% before designing for the ISO 9001: 2015 quality management system. The design of risk analysis for ISO 9001: 2015 quality management system using Failure Mode and Effect Analysis (FMEA) method. This research is still in the design stage and implemented on all departments in PT. X except the accounting and finance department. The result of risk analysis design with FMEA method shows that the biggest risk in PT. X is in the warehouse department, QC, production, and marketing. The final quality review after the design of the quality management system shows a suitability of 91% against the requirements of ISO 9001: 2015.

Keywords


quality management system ; ISO 9001:2015; risk analysis

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References


Stamatis, D.H (2015). The ASQ Pocket Quide to Failure Mode and Effect Analysis (FMEA). Milwaukee: ASQ Quality Press.

Besterfield, Dale. H (2003). Total Quality Management. Upper Saddle River, NJ.


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