7. 引用先

 

[1]“MBTIとは”.一般社団法人日本MBTI協会. http://www.mbti.or.jp/what/ (参照2019-03-24)

[2]Carl, G Jung.; PSYCHOLOGISHE TYPEN. タイプ論. 林道義訳. みすず書房, 1987, 644p.

[3]“Japan-APTについて”. Japan Academia for Psychological Type. http://www.japan-apt.org/ (参照2019-03-24)

[4]“トレーニング講座”.一般社団法人日本MBTI協会. http://www.mbti.or.jp/training/ (参照2019-03-24)

[5]“Über SMP GmbH”. SMP GmbH. https://smp.smpgmbh.com/geschichte.html

[6]“会社概要”. SMP Laboratories Japan Co.,Ltd. https://www.smplabjapan.com/blank-3

[7]“ISO 9001:2015 Quality management systems -- Requirements”. International Organization for Standardization.https://www.iso.org/standard/62085.html

[8]“ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories”. International Organization for Standardization. https://www.iso.org/standard/66912.html

[9]“Qualitätsmanagement ISO 9001 | DIN EN ISO 17025, DEKRA Zertifikat”. SMP GmbH, Qualitätsmanagement. https://smp.smpgmbh.com/qualitaetsmanagement.html

[10]“Notified bodies, What the notified bodies do”. Notified body, The single market and standards, European commission. https://ec.europa.eu/growth/single-market/goods/building-blocks/notified-bodies_en

[11]“ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes”. International Organization for Standardization. https://www.iso.org/standard/59752.html

[12]“ISO 17664:2017 Processing of health care products -- Information to be provided by the medical device manufacturer for the processing of medical devices”. International Organization for Standardization. https://www.iso.org/standard/62952.html

[13]“Medical device Directive 93/42/EEC”. Medical devices, The single market and standards, Internal Market, Industry, Entrepreneurship and SMEs, European commission. https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

[14]“Regulation (EU) 2017/745, The new Regulations on medical devices, Regulatory framework”, Regulatory framework, Medical devices, Sectors, Internal Market, Industry, Entrepreneurship and SMEs, European commission. https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

[15]The European parliament and the council of the European union, Regulation(EU) 2017/745 of The European parliament and the council of the European union of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. 2017, p8(60).

[16]International Organization for Standardization; Quality management principles. ISO. 2015, p1.

[17]平成16年12月17日厚生労働省令第169号;医療機器及び体外診断用医薬品の製造管理及び品質管理の基準に関する省令,https://www.mhlw.go.jp/web/t_doc?dataId=81aa6618&dataType=0&pageNo=1

[18]“QMS適合性調査業務”.独立行政法人医薬品医療機器総合機構. https://www.pmda.go.jp/review-services/gmp-qms-gctp/qms/0003.html

[19]DGKH, DGSV and AKI; Leitlinie von DGKH, DGSV und AKI für die Validierung und Routineüberwachung maschineller Reinigungs- und thermischer Desinfektionsprozesse für MedizinprodukteGuideline 5 Auflage 2017.mph verlag, 2017.

[20]“統計的管理手法の歴史”.日本科学技術連盟. http://www.juse.or.jp/statistical/history/(統計管理手法参照)

[21]Deming, W.E. 1986.Out of the Crisis. MIT Press. Cambridge, MA, p88.

[22]Deming, W.E. 1993.The New Economics. MIT Press. Cambridge, MA. p135.

[23]Boyd, John R.1976. Destruction and Creation (PDF). U.S. Army Command and General Staff College.

[24]Kent B.2018. Observe, Orient, Decide, Act: A Subjectivist Model of Entrepreneurial Decision Making. JOURNAL OF MANAGERIAL ISSUES Vol. XXX. p349.