Browsing Revista Politechnê by Author "Rodríguez, José"
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Comparison of the Quality System Requirements of Code of Federal Regulations Part 820 and International Standard ISO 13485
Figueroa, Yazmín (Polytechnic University of Puerto Rico, 2010)This paper compares the quality system requirements of the Code of Federal Regulations 21 CFR part 820 with the quality system requirements of the International Standard ISO 13485. The medical devices industry that distributes ... -
Improving Performance on Information and Technology Systems and Services at a Life Sciences Manufacturing Plant for the Graduate Programs at Polytechnic University of Puerto Rico
Delgado Velázquez, Arlene (Polytechnic University of Puerto Rico, 2010)The establishment of a continuous improvement program and culture at a Life Sciences company has giving them great business results. By using Lean ,Six Sigma and Team involvement methodologies areas like Information ...