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IQAI International QA Institute - Official Website - 特定非営利活動(NPO)法人「国際品質保証協会」-伝統と実績を誇る日本最初のQAプロ集団!-


Monthly Q&A

Monthly Q&A

  • January 2011  Attractive Quality vs. Ordinary Quality (PDF:269 KB))
  • December 2010  Reviewing Document and System upon Revision of ISO Standards (PDF:217 KB))
  • November 2010  Maintenance of Infrastructure (PDF:271 KB))
  • October 2010  Subject of Nonconformity Control(PDF:271 KB))
  • September 2010  Measure of Customer Satisfaction(PDF:295 KB))
  • August 2010  About Innovation(PDF:278 KB))
  • July 2010  How the Auditor Should Deal with the Auditee’s Expectation (PDF:400 KB)
  • June 2010  About Value-added Auditing (PDF:357 KB)

ASQ Certified People in Japan

(As of July 15, 2014)
Certification Number of Certified People
IQAI Member Non-member Total
(Certified Quality Engineer)
9 12
(3 Americans, 1 Indian,? 1 Mexican, 1 Greek)
(Certified Manager of Quality and
Organizational Excellence)
4 12
(6 Americans, 1 Kenyan, 1 Indian, 1 Saudi Arabia)
(Certified Reliability Engineer)
2 5
(1 from Korea, 1 American)
(Certified Quality Auditor)
22 12?(6 Americans, 1 Mexican) 34
(Certified Biomedical Auditor)
3 1 4
(Certified HACCP Auditor)
4 0 4
(Certified Six Sigma Black Belt)
3 10
(2 Indian)
(Certified Software Quality Engineer)
2 3?(1 Chinese) 5
(Certified Pharmaceutical GMP Professional)
2 1 3

Remarks: This is for 9 major items of certification only.


Name Certified in: Exam Site IQAI Membership
Ashish Chatterjee Dec. 1996 Tokyo Non-member
Akio Miura June 1998 Tokyo Member
Masaru Kuwahara June 1999 Tokyo Member
Shinya Kondo June 2000 Tokyo Member
Kotaro Morinaga June 2000 Tokyo Member
Munetaka Koda Dec. 2001 Tokyo Member
Nobuyuki Tateno Dec. 2002 Tokyo Member
Shawn Harris June 2003 Tokyo Non-member
Gary Wrightsman June 2005 Tokyo Non-member
Rintaro Tsuzuki June 2010 Tokyo Non-member
Miyuki Sato Dec.?2010 Tokyo Member
Eita Kinoshita Dec. 2011 Tokyo Non-Member
Alex Guzman Dec. 2011 Tokyo Non-Member
Gary R. Wrightsman Dec. 2011 Tokyo Non-Member
Antonios Lazaridis June 2012 Tokyo Non-Member
Toshihiko Oyabu Dec. 2012 Tokyo Non-Member
Yoko Shiohata Dec. 2012 Tokyo Non-Member
Takashi Shiino Dec. 2012 Tokyo Non-Member
Eiji Zenyoji June 2013 Tokyo Non-Member
Toru Mizumura Dec. 2013 Tokyo Member
Fumihiko Nobayashi Dec. 2013 Tokyo Member
Isao Tamura June. 2014 Tokyo Member

CMQ/OE (previous CQManager)

Name Certified in: Exam Site IQAI Membership
Akio Miura March 2000 Tokuyama Member
Shinya Kondo Oct. 2001 Tokyo Member
Yasaka Yamada Oct. 2001 Tokyo Member
Jeff Catron Oct. 2002 Tokyo Non-member
Flemming Kongsberg Oct. 2002 Tokyo Non-member
Christopher Stephens March 2003 Tokyo Non-member
Richard Forsberg March 2009 Tokyo Non-member
John P. Heinemann March 2009 Tokyo Non-member
Dan Macodiyo March 2009 Tokyo Non-member
Anandkumar Dhanaraj October 2009 Tokyo Non-member
Wail A. Al-Sabbali March 2011 Tokyo Non-member
Richard Wicks March 2011 Tokyo Non-member
Rintaro Tsuzuki October 2011 Tokyo Non-member
Kazunori Nakamura March 2014 Tokyo Non-member


Name Certified in: Exam Site IQAI Membership
Masaru Kuwahara Oct. 1999 Tokuyama Member
Akio Miura May 2000 Indianapolis, USA Member
Masaaki Tatsuta Oct. 2001 Tokyo Non-member
Won Jung March 2003 Tokyo
(from Korea)
Brian Landberg Oct. 2009 Tokyo Non-member
Rintaro Tsuzuki March 2010 Tokyo Non-member
Brian Landberg March 2013 Tokyo Non-member


Name Certified in: Exam Site IQAI Membership
Akio Miura Dec. 1990 New Jersey, USA Member
Mitsuko Nishihara June 1997 Tokyo Member
Kaoru Yoshida Dec. 1997 New Jersey, USA Member
Masaru Kuwahara Dec. 1998 Tokyo Member
Yasaka Yamada June 1998 Tokyo Member
Kiyoshi Yamada June 1998 Tokyo Member
Shinya Kondo June 1999 Tokyo Member
Munetaka Koda June 2001 Tokyo Member
Nobuyuki Tateno Dec. 2001 Tokyo Member
Paul Andersen Dec. 2002 Tokyo Non-member
Larry Leisure Dec. 2002 Tokyo Non-member
Noboru Fujiwara June 2004 Tokyo Member
Jerald L. Steinbach Dec. 2004 Tokyo Non-member
Takamasa Ishihara June 2005 Tokyo Member
Hiroshi Yamanaka Dec. 2005 Tokyo Non-member
Yoshihide Satoh Dec. 2008 Tokyo Member
Hisashi Habutsu Dec. 2009 Tokyo Non-member
Alex Guzman Dec. 2009 Tokyo Non-member
Miyuki Satou June 2010 Tokyo Member
Gary Wrightsman June 2010 Tokyo Non-member
Hidehisa Murashima Dec.?2010 Tokyo Member
Bill Whitesell Dec. 2010 Tokyo Non-member
Tamaki Masuda June 2011 Tokyo Non-member
Richard Wicks March 2012 Tokyo Non-Member
Dan Macodiyo Dec. 2012 Tokyo Non-Member
Teruhiro Goto Dec. 2012 Tokyo Non-Member
Atsushi Habutsu Dec. 2012 Tokyo Non-Member
Toru Mizumura Dec. 2012 Tokyo Member
Fumihiko Nobayashi June 2013 Tokyo Member
Long Su June 2013 Tokyo Member
Hitoshi Yasuoka June 2013 Tokyo Member
Seishi Otsuki Dec. 2013 Tokyo Non-Member
Kazunori Nakamura jun. 2014 Tokyo Non-Member
Gary Ray Wrightsman jun. 2014 Tokyo Non-Member

CBA(CQA Bio-medical)

Name Certified in: Exam Site IQAI Membership
Akio Miura March 2002 Tokyo Member
Shinya Kondo March 2002 Tokyo Member
Mitsuko Nishihara Oct. 2002 Tokyo Member


Name Certified in: Exam Site IQAI Membership
Mitsuko Nishihara Sept. 2000 Tokuyama Member
Kaoru Yoshida Sept. 2000 Tokuyama Member
Shinya Kondo Sept. 2000 Tokuyama Member
Akio Miura March 2001 Tokuyama Member


Name Certified in: Exam Site IQAI Membership
Akio Miura Oct. 2001 Tokyo Member
Hiroo Sugiura Oct. 2005 Tokyo Non-member
Koichi Ishida March 2008 Tokyo Non-member
Arindam Banerjee March 2009 Tokyo Non-member
Anandkumar Dhanaraj March 2010 Tokyo Non-member
Motoharu Fujikawa March 2011 Tokyo Non-member
Satoru Watanabe March 2012 Tokyo Non-Member
Yoko Shiohata Oct. 2012 Tokyo Non-Member
Christopher Cook March 2013 Tokyo Non-Member
Long Su March 2013 Tokyo Member
Satoshi Shinozaki March 2013 Tokyo Member
Toru Mizumura March 2014 Tokyo Member
Fumihiko Nobayashi March 2014 Tokyo Member


Name Certified in: Exam Site IQAI Membership
Shinya Kondo Dec. 2000 Tokyo Member
Tsutomu Tomizawa Dec. 2000 Tokyo Non-member
Akio Miura Dec. 2001 Tokyo Member
Mikio Shibata June 2008 Tokyo Non-member
Xiaoming Zhang Dec.?2010 Tokyo Non-member


Name Certified in: Exam Site IQAI Membership
Kaoru Yoshida June 2009 Tokyo Member
Toru Mizumura June 2013 Tokyo Member
Kazunori Nakamura June 2013 Tokyo Member

Prerequisites for IQAI Professional Qualifications

(1) Prerequisites for “IQAI Approved QA Auditors”

  • The candidate must:
  • ?be a Regular Member of IQAI;
  • ?be proficient in management system auditing techniques;
  • ?be well experienced in the quality assurance activities;
  • ?be the holder of internationally recognized professional qualifications, such as ASQ CQA, or considered equivalent to or above the level of CQA certificate holders;
  • ?be fully conscious of and observe the professional ethics based on the ASQ Code of Ethics;
  • ?complete the Quality Assurance/Management System Courses (both Theory and Advanced Courses) conducted by IQAI successfully, or considered having knowledge equivalent to or above the level of such courses;
  • ? pass the QA/QM consultant qualification examination to be conducted by IQAI.
  • Qualification and grading are to be made by the Qualification Panel using the criteria set by IQAI.

(2) Prerequisites for “IQAI Approved QA/QM Consultants”

  • The candidate must:
  • ? be an IQAI Approved QA Auditor;
  • ?be well experienced in and fully acquainted with the quality assurance and management;
  • ?have sufficient leadership;
  • ?be fully conscious of and observe the professional ethics based on the ASQ Code of Ethics;
  • ?complete the Course for Training Instructors and Professionals conducted by IQAI successfully;
  • ?pass the QA/QM consultant qualification examinations (including essay examination) to be conducted by IQAI.
  • Qualification and grading are to be made by the Qualification Panel using the criteria??set by IQAI.

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
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)
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)
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)
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.
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)
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
ASQ CQE (No. 46175)
Membership: ASQ Regular Member (No. 65006195)
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)
ASQ Certified Quality Auditor (No. 36977)
Membership: ASQ Regular Member (No. 63393460)
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
ASQ Certified Quality Auditor (No. 40871)
ASQ Certified Quality Engineer (No. 56808)
Membership: ASQ Regular Member (No. 64011450)
ISO TC69 SC5 Domestic TF Member
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
MBA at Aoyama Business School
Membership: ASQ Regular Member (No. 64093516)
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
IRCA registered Lead Auditor (A013261)
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

ASQ Certified Quality Auditor
Membership: ASQ Regular Member

Privacy Policy

Control and Use of Personal Information

International QA Institute (hereinafter referred to as IQAI) will carefully control, handle and use the personal information in accordance with its Personal Information Control System to protect them as appropriate to its purposes.

(1) Collection of personal information
Collection of personal information will be done only when needed for the following purposes:

  • ?for membership registration, and
  • ?for responding to inquiry addressed to IQAI.

(2) Use of personal information
IQAI will use the personal information for the following purposes:

  • ?to communicate with IQAI members, and
  • ?to respond to inquiries or requests addressed to IQAI.

(3) Disclosure of personal information
IQAI will not disclose or provide the personal information to any third party without having prior consent of the person concerned, except the following cases:

  • ?when requested by the government agencies such as police stations, law courts, based on laws or regulations,
  • ?when laws or regulations are enforced, or
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(4) Disclosure, Modification, and Deletion of Personal Information
This website will disclose, correct, amend, add, or delete the personal information, or refuse to use or provide such information, if IQAI receive and respond to such a request, but only if the request was confirmed to be the intent of the person concerned.

Security of Personal Information

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Compliance with Laws and Regulations

IQAI will comply with all applicable Japanese laws and regulations related to the security of personal information.

Contact for your questions and comments

If you have any questions or comments about our privacy policy, please email our Secretariat at welcome@iqai.org.