Table of contents
Short biography
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Mark Kaganov was born and raised in Moscow, Russia. He graduated from Moscow University of Radio-electronics and Automation where he earned his Bachelor and Master's degrees in design and technology of electronic equipment. While attending the university, he worked for
Institute of Plastics, the former USSR's leading organization in
research and development of plastic materials. Mr. Kaganov designed plastic
materials and developed test equipment and processing methods for automotive, aerospace,
medical, agricultural, consumer and other industries. In the late
1970s he was an active member of the group representing the USSR on the ISO Technical Committee
(TC) 61 that developed test methods for plastics for ISO standards.
In 1981, Mr. Kaganov immigrated to the US and continued his professional career in Quality Assurance and Research and Development in the plastics, electronics, and medical device manufacturing industries. He has worked for major
international corporations such as Capitol Records, RCA, COBE Laboratories,
Medtronic and British Standards Institution (BSI). During his professional career, Mr. Kaganov has published a number of technical articles in the areas of
research of plastics, the economics of manufacturing,
ion-selective electrode technology and quality and environmental
management systems. He has also authored numerous international patents.
Since 1990, as a
Director of Operations, Mr. Kaganov manages Quality Works. The company
specializes in providing businesses with consulting and
publications in the areas of
development and implementation of quality
management systems (QMS), environmental management systems (EMS), optimization of manufacturing and service
processes and design of custom software.
From 1996 to 2006, Mr. Kaganov
worked for British Standards Institution (BSI), Inc., TUV America,
Inc., Intertek and other leading registrars and notified bodies as
a Client Manager and a
Lead Auditor. His qualifications include ISO 9001,
ISO 14001, ISO 13485, Medical Device Directive 93/42/EEC for CE marking
and Canadian Medical Device Regulations. In early 1998, Mr. Kaganov led an assessment for the first registration in North America to the ISO 13485 standard. Working in the registration arena, Mr. Kaganov has assisted
dozens of North American, European and Asian companies in
registering their quality and environmental systems.
Mr. Kaganov is a certified QMS Lead Auditor with the
International Register of Certificated Auditors (IRCA), England
and EMS Lead Auditor with Registrar Accreditation Board (RAB),
USA (1998-2007).
Mr. Kaganov has over 20 years
of experience in the development, implementation and management of quality
and environmental management systems. His industrial experience covers numerous
fields such as plastics, electronics, optics, defense and
medical equipment manufacturing.
Mr. Kaganov is a
public speaker
and a contributor of numerous articles to conferences and professional publications.
In
January 2005 Mr. Kaganov joined WSI as an
Internet
Business Consultant. In this capacity he
provides Internet
consulting, education and Internet business solutions to small and medium size
businesses. He offers companies economical results-oriented Internet
solutions including, Website development, advanced promotional programs to
generate high site traffic, economical hosting, on-line audio, video and
multimedia, secure e-commerce, e-learning and full service consulting and
education in the area of e-business.
Professional experience
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QUALITY WORKS, Lakewood, CO, 1990 to present
Director of Operations
Established and
manages Web-based E-commence consulting business with focus on
development of QMS and general Business Management. Managed staff of up
to 4 associates and coordinated workflow to ensure timely delivery of
services. Responsible for meeting company's financial goals and
objectives.
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Developed
and implemented QMS and EMS for clients to achieve ISO 9001, ISO
13485 and ISO 14001 certification.
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In
cooperation with Moscow-based software development company,
developed and implemented custom distributor management software for
a medical device manufacturer.
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Provided
Business Management consulting to start-up companies. Developed
business and marketing strategies and business plans. Developed,
validated and maintains customers' Web sites to support their
business presence on the Internet.
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Wrote and
published numerous books and papers in the areas of ISO 9001, ISO
14001, ISO 13485, EN 46001 standards, Medical Device Directive
93/42/EEC and the US FDA Quality System Regulation to assist readers
in understanding complex requirements and regulations.
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Made
numerous public presentations to promote company's services and
establish its competitive position on the market.
MK Internet, LLC,
Lakewood, CO, 2004 to 2009
President
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Managed a WSI Internet Business
Consulting franchise with full P&L responsibility.
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Developed and implemented a Business Management
System for the company to ensure its effective operation.
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Conducted business development activities to
acquire and maintain client base.
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Developed and delivered Internet business
solutions to establish and improve client’s Internet business with
measurable ROI.
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Coordinated and implemented
short and long-term business objectives with responsibility for
achieving the organization’s financial goals.
INTERTEK SYSTEMS CERTIFICATION,
Boxborough, MA January 2003 – March 2004
Lead Auditor
Provided domestic and international customers with timely ISO 9001, ISO
13485, CMDCAS, MDD 93/42/EEC CE-mark and ISO 14001 registration
services. Conducted pre-, certification, surveillance and special
assessments to assist clients in obtaining and maintaining their
registrations and improving their quality and environmental management
systems.
TUV AMERICA,
Boulder, CO January 2002 - March 2003
Project Manager / Medical Device Auditor
Provided domestic and international customers with timely ISO 9000, ISO
13485, EN 46000, ISO 14000, CMDCAS and CE Mark registration services.
Conducted pre-, initial, continuous and special assessments to assist
clients in obtaining and maintaining their registrations and improving
their quality and environmental management systems. Developed and taught
ISO 13485:2003 public course.
BSI (BRITISH STANDARDS
INSTITUTION), Inc., Reston, VA, April 1996 to August 2001
Client Manager
Provided domestic and international customers with timely ISO 9000, ISO
13485, EN 46000, ISO 14000, AS 9001 and CE Mark registration services,
generating annual revenue in excess of $250,000. Conducted pre-,
initial, continuous and special assessments to assist clients in
obtaining and maintaining their registrations and improving their
quality and environmental management systems.
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Achieved
qualifications of lead assessor for Quality Management Systems (QMS)
for ISO 9001, EN 46001, ISO 13485 and Medical Device Directive (MDD)
93/42/EEC for CE marking. Led an assessment for the first
registration in North America to ISO 13485:1996 standard. Achieved
qualification of assessor for Environmental Management Systems (EMS)
for ISO 14001 standard.
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Designed a
Microsoft Access-based Assessment Management software system to
computerize assessment reporting to improve accuracy and quality of
documentation and to increase assessment efficiency.
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Conducted
market research in Russia to assess business opportunities and to
identify BSI's competitors' positions. Submitted business
development plan to BSI QA and BSI Testing management groups.
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In addition
to assessment responsibilities, conducted marketing and sales
activities to promote BSI's services. Generated additional revenue
in excess of $100,000. Developed and taught EN 46001 course to BSI,
Inc. staff.
EMCO (ENGINEERING MEASUREMENT COMPANY),
Longmont, CO, May 1995 to April 1996
Quality Assurance Manager
Directed activities of the Quality Assurance organization for an ISO
9001 certified flow meter manufacturing facility. Managed QA and
Documentation Management groups to support business in timely production
of high quality products meeting budgetary requirements and customers'
expectations.
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Directed
implementation of company-wide Quality Management System and
manufacturing documentation to reduce operating costs and to enhance
compliance with ISO 9001 Standard.
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Developed
and introduced Balanced Scorecard and trend analysis software to
define and monitor key business performance indicators and
objectives.
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Implemented
effective corrective and preventive action, MRB, internal auditing
and calibration programs.
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Performed
training in ISO 9000 standards, internal auditing, SPC and TQM.
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Developed
and implemented effective design management, servicing and
documentation change programs to improve compliance with ISO 9001
Standard and to increase effectiveness of QA organization.
MEDTRONIC HEMOTEC, INC., Englewood, CO, March 1991 to
November 1994
Quality Assurance Engineer
Coordinated activities of incoming, in-process and final QA
organizations to meet regulatory requirements and product delivery
schedules for medical equipment manufacturer.
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Led QA
function for introduction of new products by designing and
implementing product validation protocols. Developed and implemented
supplier certification program.
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Reduced
incoming inspection cost 50% by revising part drawings to identify
critical functional attributes for instruments and disposable
product operations. Cut in-process failure rate 50% by leading
multi-functional corrective action team to identify and eliminate
root causes of non-conformities. Designed and implemented MS
Access-based failure analysis software system to support this task
and to comply with FDA QSRs and ISO 9001 Standard.
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Established
conformance with FDA QSRs and ISO 9001 Standard by implementing and
coordinating supplier certification program to improve quality of
incoming materials. Conducted numerous supplier and internal audits
per QSRs and ISO 9001 Standard.
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Designed and
implemented SPC program at supplier's facility which reduced failure
rate of incoming parts from major supplier 40%. Saved more than
$25,000 annually by eliminating in-process inspection and
transferring assembly and product verification functions to
production personnel. Developed complete structure of manufacturing
procedures for instrument product line.
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Designed and
implemented Environmental program for recycling of packaging
material including location of subcontractors accepting card board
and packaging foam. Established recyclable material collection
centers and trained personnel in handling recyclable materials.
COBE LABORATORIES, INC., Lakewood, CO, June 1987 - October 1990
Quality Assurance Engineer III, Group Leader
Led QA activities for CentrySystem3 product line (nephrology
equipment) meeting required quality standards and FDA QSR regulatory
requirements. Managed staff of up to seven employees with
responsibilities for project management, hiring, employee
development and performance evaluation.
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Realized 7X improvement in MTBF of major product line by analyzing
and improving customer satisfaction and product performance through
design and implementation of field failure tracking system with
audit centers.
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Established compliance with GMPs by designing and implementing
failure analysis system for manufacturing facility identifying and
solving production floor problems.
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Played an active role in implementation of Just-In-Time (J-I-T)
program for Nephrology division to increase throughput 300% and
reduce Work-In-Process (WIP) by 90%
COBE LABORATORIES, INC., Lakewood, CO, June 1986 to June 1987
Quality Assurance Engineer III, Project Leader
Designed and validated conceptually new pH combination electrode for
Nephrology equipment. Led development, validation and implementation
of differential pH circuit which resulted in tenfold improvement of
electrode's lifetime. Project led to estimated increase in sales of
$ 1,000,000, significant savings in warranty cost, two technical
publications and five US and international patents.
COBE LABORATORIES, INC., Lakewood, CO, June 1985 to June 1986
Quality Assurance Engineer III
Conducted reliability studies of disposable sets for blood component
technology (BCT) equipment. Designed and validated various
prototypes of sets to select and qualify final design to meet
equipment specifications and FDA QSR requirements.
COBE LABORATORIES, INC., Lakewood, CO, June 1984 to June 1985
Quality Assurance Engineer II
Performed root cause analysis of field failures and customer
complaints for Nephrology equipment to provide R&D group with
suggestions for improvement of reliability and performance of
equipment. Analyzed failures of printed circuit boards, hydraulic
and electro-mechanical components to resolve customer complaints
RCA CORPORATION, "SelectaVision", Indianapolis, IN,
November 1982 to December 1983,
Quality & Reliability Engineer
Developed and implemented test methods for assessment of in-process
and final quality of PVC video disks to improve process efficiency
and quality of final product. Developed a mathematical model of
material flow for automated PVC compounding facility to establish
correlation between quality of the final compound and lots of raw
materials. Developed and implemented operating procedures for PVC
compounding facility
CAPITOL RECORDS, INC., Jacksonville, IL, November 1981 to November
1982
Engineer
Coordinated activities of Incoming Quality laboratory. Developed and
implemented test methods for assessment of incoming, in-process and
final quality of PVC audio records.
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Developed clear and concise specifications for raw materials to
improve communication with suppliers.
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Conducted design of experiments on production equipment to
optimize process settings and improve process efficiency and quality
of final product. Defined relationship between record audio quality
and such processing parameters as blending cycle, extruder
temperature profile and pressing cycle to reduce scrap and product
cost.
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Led product cost reduction program by optimization of PVC compound
that resulted in reduction of cost of raw materials by $8,000 per
year
INSTITUTE OF PLASTICS, Moscow, USSR, December 1975 to April 1981
Senior Engineer
Led design and development of non-standard testing
equipment and methods for various plastic materials and finished
products to evaluate new and existing materials and technological
processes.
Characterized thermoplastic and thermoset materials by such
properties as tensile and compression strength & strain, shear,
stiffness, impact strength, tear, hardness, and others.
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Implemented and conducted environmental and accelerated aging
studies for materials and finished products used in various
industries.
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Designed plastic materials, and developed test equipment and
processing methods for automotive, aerospace, agricultural, consumer
and other applications
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Participated in activities of the group representing the USSR on
the ISO Technical Committee (TC) 61 that developed test methods for
plastics for ISO standards.
INSTITUTE OF PLASTICS, Moscow, USSR, October 1968 to December 1975
Technician
Maintained Instron and Zwick test equipment to assist research
personnel in timely completion of projects. Designed and constructed
specialized high and low temperature test equipment for
characterization of materials for application in aerospace and
automotive industries. Maintained high speed (up to 1,000 m per
second) impact test equipment to assist research personnel in
qualifying materials for defense applications
INSTITUTE OF CHEMICAL MACHINERY, Moscow, USSR, October 1966 to
October 1968
Associate Technician
Assembled, installed and tested pressure, temperature and humidity
control circuits to assist engineering staff in evaluating
prototypes' performance for optimization of industrial chemical
processing methods.
Education
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Moscow University of Radio Electronics and Automation, Moscow, USSR
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M.S. Design and Technology of Electromechanical
Equipment, 1975
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B.S. Design and Technology of Electromechanical
Equipment, 1971
Professional
certifications
and affiliations
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IQA International Register of
Certificated Auditors (IRCA), UK
QMS Lead Auditor, Certification No. A008436
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Registrar Accreditation Board
(RAB), USA
EMS Lead Auditor, Certificate No. E052617
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Health Canada
CMDCAS Auditor, Certificate No. M-1233
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American Society for Quality (ASQ)
Member 1994 - 2006
Patents
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"Safe Failure Ion-Selective Combination Electrode,"
Mark Kaganov
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Patent No. 40 21
853, March 9, 1995, Germany
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Patent No. 2,019,728, January 17, 1995, Canada
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Patent No. 1,240,484, December 17, 1993, Italy
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Patent No. 2,233,768, January 5, 1993, Great Britain
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Patent No. 5,096,565, March 17, 1992,
USA
Publications
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ISO 9001
Quality Management - Corporate Manual
Mark Kaganov, EzineArticles.com, February 2009. (16)
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ISO
Certification - Hidden Revene Streams for ISO Registrars
Mark Kaganov, EzineArticles.com, November, 2008. (15)
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ISO 9001:2000 - A Process Interaction Matrix - A
Case Study
Mark Kaganov, Quality Progress, October 2004, p 194. You can
download a .pdf version of this publication from our
Download page. (14)
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Transition Checkup for ISO 13485:2003
Mark Kaganov, Quality System Update (QSU), June 2004, pp 12-14. You
can download a .pdf version of this publication from our
Download page.
(13)
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ISO 9001:2000 - A Quality Manual For the
Transition and Beyond
Mark Kaganov, Quality Progress, March 2003, pp 27-31. You can
download a .pdf version of this publication from our
Download page. (12)
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Keep Your Web Site Under Control - This case
study shows how effective Web site management can help you establish
compliance with ISO 14001 and ISO 9001:2000
Mark Kaganov, Quality Progress, November 2001, pp 51-56. You can
download a .pdf version of this publication from our
Download page. (11)
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Checklists - A Perfect Tool to Tune-up Your
Quality Manual
Mark Kaganov, Quality Progress, October 2000, pp.37-41. You can
download an updated version of this publication from our
Download page.
(10)
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EN 46001 / ISO 13485 - A Practical Approach to
the Development and Implementation of a Quality Manual
Mark Kaganov, Quality Works, 1999, Quality Works Store (9)
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ISO 9000 - A Practical Approach to the
Development and Implementation of a Quality Manual
Mark Kaganov, Standards & Quality, Moscow, 1999 (Russian) (8)
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ISO 9000 - A Practical Approach to the
Development and Implementation of a Quality Manual
Mark Kaganov, Quality Works, 1998, Quality Works Store, 1998 (7)
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Monte Carlo Approach to Assessment of the
Accuracy of Ion-Selective Circuits
Mark Kaganov, American Laboratory, September 1996, pp. 46-51 (6)
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Ground Loop Current: The Achilles' Heel of Ion
Measurement
Mark Kaganov, American Laboratory, March 1992, pp. 59-62, Part I;
October 1992, pp. 17-23, Part II (5)
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A Practical Approach to Measurement of pH Glass
Resistance
Mark Kaganov and Ken Maydew, American Laboratory, June 1988, pp.
68-78 (4)
Processing Economics: Here's a Simple Way to Make Comparisons
Mark Kaganov, Plastics Technology, June 1984, pp. 71-73 (3)
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The Properties of New Low Temperature Resistant
Polymers
Yakutsk, USSR, 1977, pp. 233-235 (Russian) (2)
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Evaluation of Viscoelastic Tensile Properties for
Several Polymer Films
Rostov-Don, USSR, 1976, pp. 34-36 (Russian) (1)
Public presentations and courses
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Need Leads? Check the Internet
Business Excellence Forum, Denver Metro Chamber of Commerce, January
24, 2006
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Does your Website Bring you Money?
Denver Metro Chamber of Commerce, September 11, 2006
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ISO 13485:2003 - Overview and Transition Strategy
for Medical Device Personnel
A two-day public course for The Center for Professional Innovation &
Education, Southeastern, PA, April 25-26, 2005
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ISO 13485:2003 - Overview and Transition Strategy
Half day 10 public courses, TUV America, Boulder, CO, San Diego, CA,
January 2003 - March 2003
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Checklists - A Perfect Tool to Tune-up Your
Quality Manual
ASQ Rochester Section, 57th Annual Quality Conference, Rochester,
NY, March 28, 2001
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Checklists - A Perfect Tool to Tune-up Your
Quality Manual
ASQ Salt Lake City Section, Salt lake City, UT, January 18, 2001
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Assessors' Secrets
ASQ Salt Lake City Section, Salt lake City, UT, January 18, 2001
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Trend Analysis System for ISO 9001
ASQ Denver Section, Denver, CO, January 1994
Professional development
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Internet Business Consulting
WSI, Toronto, Canada, October 2005 - January 2006
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Project Management Certificate Program
Colorado State University, Denver, CO, September 2004 - February
2005, (6.0 CEUs / 60 PDUs)
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The Rosetta Stone Language Library, Spanish 1
Self-study CD course, February 2002 to present
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Canadian Medical Devices Regulations
Academia Qualitas, Montreal, Canada, June 2001
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Aerospace Auditor Training Course AS 9001
Bureau Veritas, BSI, July 2000
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Advanced EMS (ISO 14000) Lead Auditor Course
CEEM, Reston, VA, July 1999
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Effective Negotiating
Karrass, Denver, CO, October 1997
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Think & Talk Spanish
Berlitz self-study course, August 1996 to present
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ISO 9000 Lead Assessor of Quality Systems
Perry Johnson, Inc., Southfield, MI, September 1994
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Statistical Process Control
QINAS, Inc., Englewood, CO, June 1989
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Design of Experiments Utilizing Taguchi Concepts
QINAS, Inc., Englewood, CO, February 1989
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How to Work with People
Fred Pryor Seminars, Denver, CO, August 1988
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Interact - Interpersonal Problem Solving
COBE Laboratories, Inc., Continuous Education Program, Lakewood, CO,
June 1988
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Supervisory Skills
Mountain States Employee Council, Inc., Denver, CO, March 1988
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Just-In-Time Manufacturing
J-I-T Institute of Technology, Inc., Parker, CO, December 1987
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Managing Conflict
AT&T Organization Effectiveness Group, Aurora, CO, December 1986
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Design of Experiments
RCA Engineering Education Course, Indianapolis, IN, Spring 1983
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Programming in BASIC
MacMurray College, Jacksonville, IL, Fall 1982
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Manufacturing Economics
Institute of Plastics, Moscow, Russian Federation, 1976 - 1977
Languages
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Russian, native, fluent spoken and written
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English. fluent spoken and written
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Spanish, beginner, self-study
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