7. Citation

[1] “What is MBTI”. Japan MBTI Association. Http://www.mbti.or.jp/what/ (Reference 2019-03-24)

[2] Carl, G Jung .; PSYCHOLOGISHE TYPE N.  Type theory.  Translated by Michiyoshi Hayashi.  Misuzu Shobo, 1987, 644p.

[3] “About Japan-APT”. Japan Academia for Psychological Type. Http://www.japan-apt.org/ (Reference 2019-03-24)

[4] “Training course”. Japan MBTI Association. Http://www.mbti.or.jp/training/ (Reference 2019-03-24)

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

[6] “Company Profile”. 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 / regulation-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] December 17, 2004 Ministry of Health, Labor and Welfare Ordinance No. 169; Ministerial Ordinance on Manufacturing Control and Quality Control Standards for Medical Devices and In Vitro Diagnostic Drugs, https://www.mhlw.go.jp/web/t_doc ? dataId = 81aa6618 & dataType = 0 & pageNo = 1

[18] “QMS Conformity Survey Business”. Pharmaceuticals and Medical Devices Agency. 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 Routine überwachung maschineller Reinigungs- und thermischer Desinfektionsprozesse für Medizinprodukte Guideline 5 Auflage 2017.mph verlag

[20] “History of statistical management methods”. Union of Japanese Scientists and Engineers. Http://www.juse.or.jp/statistical/history/ (Refer to statistical management methods)

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

[22] Deming, WE 1993.The New Economics. MIT Press. Cambridge, MA. P135.

[23] Boyd, John R. 1976. Destruction and Creation (PDF). US 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.