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Table of contents

• Short biography

• Professional Experience

• Education

• Professional certifications and affiliations

• Patents

• Publications

• Public presentation and courses

• Professional development

• Languages

Short biography     > back to the top

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 30 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.

Professional experience     > back to the top

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.

• Developed and implemented QMS and EMS for clients to achieve ISO 9001, ISO 13485 and ISO 14001 certification.

• In cooperation with Moscow-based software development company, developed and implemented custom distributor management software for a medical device manufacturer.

• 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.

• 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.

• Made numerous public presentations to promote company's services and establish its competitive position on the market.

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.

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.

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.

• 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.

• 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.

• 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.

• 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.

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.

• Directed implementation of company-wide Quality Management System and manufacturing documentation to reduce operating costs and to enhance compliance with ISO 9001 Standard.

• Developed and introduced Balanced Scorecard and trend analysis software to define and monitor key business performance indicators and objectives.

• Implemented effective corrective and preventive action, MRB, internal auditing and calibration programs.

• Performed training in ISO 9000 standards, internal auditing, SPC and TQM.

• 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.

Coordinated activities of incoming, in-process and final QA organizations to meet regulatory requirements and product delivery schedules for medical equipment manufacturer.

• Led QA function for introduction of new products by designing and implementing product validation protocols. Developed and implemented supplier certification program.

• 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.

• 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.

• 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.

• 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.

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.

• 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.

• Established compliance with GMPs by designing and implementing failure analysis system for manufacturing facility identifying and solving production floor problems.

• 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%

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.

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.

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

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

Coordinated activities of Incoming Quality laboratory. Developed and implemented test methods for assessment of incoming, in-process and final quality of PVC audio records.

• Developed clear and concise specifications for raw materials to improve communication with suppliers.

• 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.

• 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.

• Implemented and conducted environmental and accelerated aging studies for materials and finished products used in various industries.

• Designed plastic materials, and developed test equipment and processing methods for automotive, aerospace, agricultural, consumer and other applications

• 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.

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

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.

• M.S. Design and Technology of Electromechanical Equipment, 1975

• B.S. Design and Technology of Electromechanical Equipment, 1971

• IQA International Register of Certificated Auditors (IRCA), UK
  QMS Lead Auditor, Certification No. A008436

• Registrar Accreditation Board (RAB), USA
  EMS Lead Auditor, Certificate No. E052617

• Health Canada CMDCAS Auditor, Certificate No. M-1233

• American Society for Quality (ASQ)Member 1994 - 2006

"Safe Failure Ion-Selective Combination Electrode," Mark Kaganov

• Patent No. 40 21 853, March 9, 1995, Germany

• Patent No. 2,019,728, January 17, 1995, Canada

• Patent No. 1,240,484, December 17, 1993, Italy

• Patent No. 2,233,768, January 5, 1993, Great Britain

• Patent No. 5,096,565, March 17, 1992, USA

Publications     > back to the top

• Quality objectives and Quality Dreams
  Quality Works, Lakewood, CO October 6, 2010 (18) Read more...
  
• cGMP and ISO 13485 Integrated Quality Management System
  Quality Works, Lakewood, CO October 14, 2009 (17) Read more...
• ISO 9001 Quality Management - Corporate Manual
  Mark Kaganov, EzineArticles.com, February 2009. (16)
• ISO Certification - Hidden Revene Streams for ISO Registrars
  Mark Kaganov, EzineArticles.com, November, 2008. (15)

• 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)

• 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)

• 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)

• Keep Your Web Site Under Control
  Mark Kaganov, Quality Progress, November 2001, pp 51-56. You can download a .pdf version of this publication from our Download page. (11)

• 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)

• 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)

• ISO 9000 - A Practical Approach to the Development and Implementation of a Quality Manual
  Mark Kaganov, Standards & Quality, Moscow, 1999 (Russian) (8)

• ISO 9000 - A Practical Approach to the Development and Implementation of a Quality Manual
  Mark Kaganov, Quality Works, 1998, Quality Works Store, 1998 (7)

• Monte Carlo Approach to Assessment of the Accuracy of Ion-Selective Circuits
  Mark Kaganov, American Laboratory, September 1996, pp. 46-51 (6)

• 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)

• 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)

• The Properties of New Low Temperature Resistant Polymers
  Yakutsk, USSR, 1977, pp. 233-235 (Russian) (2)

• Evaluation of Viscoelastic Tensile Properties for Several Polymer Films
  Rostov-Don, USSR, 1976, pp. 34-36 (Russian) (1)

• Need Leads? Check the Internet
  Business Excellence Forum, Denver Metro Chamber of Commerce, January 24, 2006

• Does your Website Bring you Money?
  Denver Metro Chamber of Commerce, September 11, 2006

• 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

• ISO 13485:2003 - Overview and Transition Strategy
  Half day 10 public courses, TUV America, Boulder, CO, San Diego, CA, January 2003 - March 2003

• Checklists - A Perfect Tool to Tune-up Your Quality Manual
  ASQ Rochester Section, 57th Annual Quality Conference, Rochester, NY, March 28, 2001

• Checklists - A Perfect Tool to Tune-up Your Quality Manual
  ASQ Salt Lake City Section, Salt lake City, UT, January 18, 2001

• Assessors' Secrets
  ASQ Salt Lake City Section, Salt lake City, UT, January 18, 2001

• Trend Analysis System for ISO 9001
  ASQ Denver Section, Denver, CO, January 1994

Professional development     > back to the top

• Internet Business Consulting
  WSI, Toronto, Canada, October 2005 - January 2006

• Project Management Certificate Program
  Colorado State University, Denver, CO, September 2004 - February 2005, (6.0 CEUs / 60 PDUs)

• The Rosetta Stone Language Library, Spanish 1
  Self-study CD course, February 2002 to present

• Canadian Medical Devices Regulations
  Accademia Qualitas, Montreal, Canada, June 2001

• Aerospace Auditor Training Course AS 9001
  Bureau Veritas, BSI, July 2000

• Advanced EMS (ISO 14000) Lead Auditor Course
  CEEM, Reston, VA, July 1999

• Effective Negotiating
  Karrass, Denver, CO, October 1997

• Think & Talk Spanish
  Berlitz self-study course, August 1996 to present

• ISO 9000 Lead Assessor of Quality Systems
  Perry Johnson, Inc., Southfield, MI, September 1994

• Statistical Process Control
  QINAS, Inc., Englewood, CO, June 1989

• Design of Experiments Utilizing Taguchi Concepts
  QINAS, Inc., Englewood, CO, February 1989

• How to Work with People
  Fred Pryor Seminars, Denver, CO, August 1988

• Interact - Interpersonal Problem Solving
  COBE Laboratories, Inc., Continuous Education Program, Lakewood, CO, June 1988

• Supervisory Skills
  Mountain States Employee Council, Inc., Denver, CO, March 1988

• Just-In-Time Manufacturing
  J-I-T Institute of Technology, Inc., Parker, CO, December 1987

• Managing Conflict
  AT&T Organization Effectiveness Group, Aurora, CO, December 1986

• Design of Experiments
  RCA Engineering Education Course, Indianapolis, IN, Spring 1983

• Programming in BASIC
  MacMurray College, Jacksonville, IL, Fall 1982

• Manufacturing Economics
  Institute of Plastics, Moscow, Russian Federation, 1976 - 1977