IQAI International QA Institute - Official Website-

Profile of Officers

Akio Miura, CQA/CQE/CRE/CMQOE/CBA/CHA/CSSBB/CSQE, Honorary 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 ManualsContributor of ASQ Discussion Boards, Moderating the Board for Quality Standards
Professional
Qualifications:
ASQ Certified Quality Auditor (CQA), No. 02112ASQ Certified Quality Engineer (CQE), No. 37909ASQ Certified Manager for Quality and Organizational Excellence (CMQ/OE), No. 04808ASQ Certified Reliability Engineer (CRE), No. 04927ASQ Certified Bio-Medical Auditor (CBA), No. 54ASQ Certified HACCP Auditor (CHA), No. 00091ASQ Certified Six Sigma Black Belt (CSSBB), No. 161ASQ Certified Software Quality Engineer (CSQE), No. 1830RAB/IQA approved ISO Lead Auditor Training Course InstructorRAB/IATCA approved Senior Auditor until 2006ASQ 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, Chair

Business: QA/QM Consultant, Auditor and Course InstructorAssociate, SQA Services, Inc., USAAuditor of an ISO Registrar in JapanCourse 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, auditing on behalf of the client in USA and ISO registrars in Japan, and consulting for FDA inspection; 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).

Masakatsu Iwasa, Director ? Planning and Legal Matters

Business: Quality and Environmental Management Consultant,Representative Director, Green Enterprise Ltd.
Professional
Qualification:
IRCA QMS and EMS Lead AuditorEnvironment 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 IQAI2007 ? 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 Plant1980 ? 1990: Chief of the Electronic and Quality Control Sections at Sagami Plant1964: Entered Toyo Denki Seizo Co.BS Electrical Engineering

Naoyuki Kitami, CQE, Director ? Secretariat, Mailing List

Business: Quality Control Consultant
Professional
Qualification:
ASQ CQE (No. 46175)
Membership: ASQ Regular Member (No. 65006195)
Personal
Background:
2011 ? Present: Director of IQAI1995 ? 2011: TCE HP Certified Black Belt Hewlett-Packared Japan1985 ? 1994: TQC Promotion Center, Texas Instruments Japan BEng.Electronics, Tokyo University of Agriculture and Technology

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 IQAI2002 ? Present: Edwards Lifesciences Ltd. (in Tokyo)1997 ? 2002: Baxter Co. (in Tokyo)1996 ? 1997: Olympus Corporation BS Biomedical Science, Keio University

Miyuki?Sato, CQA/CQE, Director ? ASQ Certification Exam Promotion

Business: Boeing Japan KK
Professional
Qualification:
ASQ Certified Quality Auditor (No. 40871)
ASQ Certified Quality Engineer (No. 56808)
Membership: ASQ Regular Member (No. 64011450)
ISO TC69 SC5 Domestic TF Member
Personal
Background:
2012 – present: 2008 ? 2012: QMS Promotion,?Koito Industries Ltd.2006 – 2008: QA,?Photoscience Japan Co.1996 ? 2003:?Engineering and QA,?Japan Aviation Electronics Industry, Ltd. MS Electrical Engineering, Graduate school of Science and Technology, Nihon?University

Takako Hoshiyama, Director ? Accounting

Business: Management Consultant as the President of IE Tech
Professional
Qualification:
MBA at Aoyama Business School
Membership: ASQ Regular Member (No. 64093516)
Personal
Background:
2001: Studied chemical process engineering at University College London 2002? 2010: worked as Industrial Engineer and Process Engineer at several foreign-owned companies

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. atDuPont-Mitsui Fuluorochemicals Co., Ltd.Bachelor of Commerce, Keio University March 1961

Hidehisa Murashima, CQA, Auditor

Professional
Qualification:
ASQ Certified Quality Auditor
Membership: ASQ Regular Member