Profile of Officers
Akio Miura, CQA/CQE/CRE/CMQOE/etc., Chairman
Business: | Quality Assurance/Management Consultant (to ISO9000/13485/14000, ISO/TS16949, ASME B&PV Code, API Spec Q1, FDA cGMP, HACCP, CE Marking, etc.) Consultant on Product Liability Prevention, including development of Instruction Manuals Contributor of ASQ Discussion Boards, Moderating the Board for Quality Standards |
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Professional Qualifications: |
ASQ Certified Quality Auditor (CQA), No. 02112 ASQ Certified Quality Engineer (CQE), No. 37909 ASQ Certified Manager for Quality and Organizational Excellence (CMQ/OE), No.04808 ASQ Certified Quality CRE (No.04927 ASQ Certified Quality CBA (No.54 ASQ Certified HACCP Auditor (CHA), No.00091 ASQ Certified Six Sigma Black Belt (CSSBB), No.161 ASQ Certified Software Quality Engineer (CSQE), No.1830 RAB/IQA approved ISO Lead Auditor Training Course Instructor RAB/IATCA approved Senior Auditor until 2006 ASQ CQA Refresher Course Instructor (qualified by the Audit Division, ASQ March 2001) Instructor, 1st Level Technical English Proficiency by the University of Michigan |
Membership: | ASQ Fellow (Member #125908) |
Publications: | Books: ? “Guide to Preparation of Quality Manuals” (JSA, May, 1992) ? “Guide to ISO9000 with Illustration”(Ohm-sha, July 1994) ? “Quality Assurance Program Evaluation” (translation with comments, LMJ-J, December 1995) Articles published: ? “Don’t Suffer through Bad Manual” in “Quality Progress” of ASQ December 1989 ? “About Audit Sampling” in “Informed Outlook” February 2004 ? “MIL-Q-9858A, the Origin of ISO 9001” in “Tech Journal” of ASQ September 2004 ? “QA for Product Liability Prevention” (JSA Magazine in Japan, November 1991) ? Series Articles “Points of QA Manual Preparation” (JSA Magazine, January to June 1992) |
Personal Background: |
1990 ? Present:Quality Management Consultant at IQS, IQAI, etc. covering all of ISO 9001, cGMP, ASME B&PV Codes, API Spec Q1, etc., acting also as Senior Consultant of N. C. Kist & Associates, Inc. in IL, USA 1990 thru 2000, and Partner of JP Russell in some of his courses since 1999; 1959 ? 1990:Worked mainly for Plant Construction Projects and developed and established a unique quality assurance and management system meeting all of ANSI Z 1.15, GMP, MIL-Q-9858A, ASME Codes, and BS5750, and used it successfully in management, internal auditing and subcontractor control while working as a CEO for a plant equipment manufacturer since 1978 through 1984. |
Mitsuko Nishihara, CQA/CHA/CBA, Executive Director ? R&D, Deputy Chair
Business: | QA/QM Consultant, Auditor and Course Instructor Associate, SQA Services, Inc., USA Auditor of an ISO Registrar in Japan Course Instructor, Global Techno Co. (FDA-related Course) |
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Professional Qualification: |
ASQ Certified Quality Auditor (CQA) (No. 16910) ASQ Certified Bio- Medical Auditor (CBA) (No. 00083) ASQ Certified HACCP Auditor (CHA) (No. 00057) QMS Lead Auditor, RABQSA International (No. QI03518) EMS Auditor, RABQSA International (No. E051809) |
Membership: | ASQ Senior Member (No. 1051902) ASME Regular Member (No. 4692810) |
Publications: | Keeping So-so Relations with ISO Standards” (March 2007 “ISOS” Magazine, System Kikaku) “Essence and Effect of ISO 9001 ? Continuing Universal Validity of QA from the Past to the Future” (November 2005, Global Techno) “Correct Interpretation of ISO 9001 in English Language (“ISOMS” Magazine, September 2003 through August 2004, Global Techno) Auditing in New Age (July 1999 “ISOS” Magazine, System Kikaku) |
Personal Background: |
1995 ? Present:Deputy Chair of IQAI; 1987 ? Present:Consulting in QA/QM system establishment and maintenance, and auditing on behalf of the client in USA and ISO registrars in Japan; 1976 ? 1986:Management Representative for management system operations for overseas projects and Coordinator for ASME B&PV Code construction projects, at Tokki Ltd.; 1970 ? 1976:Coordinator at Kasado Works, Hitachi Ltd. for overseas chemical plant construction projects (meeting ASME B&PV Codes). |
Wataru Tsuchihira, CQA, Director ? Board Meeting
Business: | Senior Field Quality Engineer, ALTERA Japan, Ltd. |
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Professional Qualification: |
ASQ Certified Quality Auditor (No. 15980), Ex IRCA-registered Lead Auditor |
Membership: | ASQ Senior Member (No. 01014351) |
Personal Background: |
2008 ? Present:ALTERA Japan, Ltd., Director of IQAI 2007 ? 2008:Maxim Japan Co., Ltd. 2004 ? 2007:NuCORE Technology, Co., Ltd., 1985 ? 2004:Intel K.K. BS Physics, Nagoya University |
Masakatsu Iwasa, Director ? Planning and Public Relations
Business: | Quality and Environmental Management Consultant, Representative Director, Green Enterprise Ltd. |
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Professional Qualification: |
IRCA QMS and EMS Lead Auditor Environment Counselor (No. 1997113060, by Japanese government) Green Advisor (No. 06-112, by Japanese government) |
Membership: | Japanese Society for Quality Control |
Publications: | Books related to Environmental Management for small business: “Guidance for Implementation of ECO Action 21 for Medium and Small Sized Organizations” (2003, All Japan Environmental Protection Association (AJEPA)) “Introduction to ECO Action 21 for each industry” (2002, AJEPA) |
Personal Background: |
2008 ? Present:Director of IQAI 2007 ? 2008:Director for Quality and Environment at Toyo Denki Seizo Co. 2004 ? 2007:Quality Management Manager (At Headquarters and Plant) 1985 ? 2004:Chief of the Electronic and Quality Control Sections at Sagami Plant 1980 ? 1990:Chief of the Electronic and Quality Control Sections at Sagami Plant 1964:Entered Toyo Denki Seizo Co. BS Electrical Engineering |
Noboru Fujiwara, CQA, Director ? Training Courses
Business: | Associate system consultant, Mitsubishi UFJ Research & Consulting Co. |
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Professional Qualification: |
ASQ CQA (No.30717) |
Membership: | ASQ Regular Member (No. 01312196) |
Personal Background: |
2008 ? Present:Director of IQAI 1994 ? 1999:Director at ALCOA Chemical Co. 1987 ? 1993:Production Control Manager at Moralco Co. 1964 ? 1986:Mitsubishi Chemical Industries, Ltd. BS Metallurgy, Akita University |
Kurao Inoue, Director ? Secretary General and Accounting
Business: | Auditor for Management System and Operating Certification of Persons |
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Professional Qualification: |
IRCA registered Auditor (A011245) |
Membership: | ASQ Senior Member (No. 63346121) |
Personal Background: |
2007 ? Present:Director of IQAI 2000 ? 2003:Development Researcher in NASDA 1998 ? 2000:QA Manager at IHI Inspection and Measurement 1983 ? 1998:QA Manager at IHI 1965 ? 1983:QA Division and Chemical Plant Division at IHI BS Chemical Engineering, Gunma University |
Yoshihide Sato, CQA, Director ? Secretariat
Business: | QA Supervisor for Medical Devices at Edwards Lifesciences Co. (in Tokyo) |
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Professional Qualification: |
ASQ Certified Quality Auditor (No. 36977) |
Membership: | ASQ Regular Member (No. 63393460) |
Personal Background: |
2008 ? Present:Director of IQAI 2002 ? Present:Edwards Lifesciences Ltd. (in Tokyo) 1997 ? 2002:Baxter Co. (in Tokyo) 1996 ? 1997:Olympus Corporation BS Biomedical Science, Keio University |
Yoshio Nagasawa, Auditor and Secretary ? Membership
Business: | QMS Lead Auditor at LRQA |
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Professional Qualification: |
IRCA registered Lead Auditor (A013261) |
Personal Background: |
Admin. Mgr., Human Resource Mgr., and Quality Assurance Mgr. at DuPont-Mitsui Fuluorochemicals Co., Ltd. Bachelor of Commerce, Keio University March 1961 |
Nagayuki Watanabe, Auditor
Professional Qualification: |
IRCA approved QMS Lead Auditor (1192101) IRCA approved EMS Lead Auditor (1192101) |
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Membership: | WWF Japan, Non-Profit Organization “Network Chikyu-Mura”, and Japanese Society for Quality Control |