title: [Nine-Year Experience after ISO 15189 Acquisition, How Successful was It? Focusing on the Results of Interviews and Questionnaires].
abstract: Our laboratory, for the purpose of Quality Management System (QMS) improvement, acquired ISO 15189:2003 accreditation 9 years ago and completed the renewal to ISO 15189:2012 last year. In this study, we reviewed the efficacy of ISO 15189 based on an analysis of laboratory director's and managers' opinions. We could realize QMS improvement through the proactive implementation of preventive and corrective actions, and also the continuous implementation of education and delivery by means of reviewing the interview records of ISO 15189:2012 renewal with the laboratory director. All answers to the questionnaire obtained from managers with regard to the advantages of ISO 15189 acquisition agreed with the purpose of ISO 15189. From these results, we concluded that ISO 15189 acquisition was successful for QMS improvement. [Review].
authors.forename: Kazumitsu
authors.initials: K
authors.lastname: Fujimoto
authors.forename: Noriaki
authors.initials: N
authors.lastname: Asai
authors.forename: Yoshinaga
authors.initials: Y
authors.lastname: Nakajima
authors.forename: Kaoru
authors.initials: K
authors.lastname: Inoue
mesh_terms: D000068:Accreditation; D064790:Clinical Laboratory Services / Q000592:standards*; D058996:Quality Improvement / Q000592:standards*; D011787:Quality of Health Care / Q000592:standards*; D011795:Surveys and Questionnaires; D013997:Time Factors