IQAI International QA Institute - Official Website-

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

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)
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.
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.
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.
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
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)
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
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)
Membership: WWF Japan,
Non-Profit Organization “Network Chikyu-Mura”, and
Japanese Society for Quality Control