About Us

The Consultant: Mark Kaganov

  • MS degree in Design and Technology of Electro-Mechanical Equipment
  • Quality Assurance and Design functions in Electro-Tech and Medical Device industries
  • Certified ISO 9001 and 14001 Lead Auditor since 1996
  • Audited hundreds of management systems against 9001, 13485 and 14001 standards internationally
  • Successfully consulted dozens of businesses
  • Five international patents
  • Dozens of publications in quality and environmental management systems fields
  • Numerous onsite and public training courses on Lean management systems, writing procedures and corrective action system
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Lean ISO Management Systems, 2019 - present

  • Consulting to promote Lean approaches to the management systems for ISO 9001, ISO 13485, ISO 14001, and other standards
  • Training courses on Lean procedure writing and Lean documentation
  • Coaching on implementation of Lean techniques for quality, environmental, and other management systems

Quality Works, 1996 to 2019

  • Consulting for development and implementation of ISO 9001, ISO 14001, and ISO 13485 management systems
  • Training courses on writing procedures and effective NC-CAPA system
  • Numerous articles and studies in the improvement of ISO 9001, ISO 14001, and ISO 13485 management systems
  • Developed and published a model for Process Interaction Matrix
  • Partial customer list

Lead Auditor / Project Manager 1996 - present

  • Domestic and international auditing against ISO 9001, ISO 13485, and ISO 14001 generated annual revenue over $250,000
  • Designed software to computerize assessment reporting to improve the accuracy and quality of audit reports (BSI)
  • Marketing to promote BSI's services generating additional revenue above $100,000
  • Internal and public training courses on ISO 13485 for TUV Product Service

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Director, Quality Assurance, 1994 - 1996

  • Implemented a company-wide ISO 9001 Quality Management System
  • Developed the Balanced Scorecard and trend analysis software for the company to monitor and manage business KPIs
  • Training on ISO 9001 standard and internal and supplier auditing
  • Implemented effective design, servicing and documentation management programs to comply with the ISO 9001 Standard
  • Led continual improvement program to address business deficiencies

Manager, Quality Assurance, 1991 – 1994

  • Led QA function for the introduction of new products by designing and executing product validation policies
  • Reduced incoming inspection cost by 50% through identifying critical attributes for verification
  • Designed and implemented NC-CAPA software to act upon identified trends — the project resulted in a reduction of in-process and external failures by 35%
  • Designed and implemented an SPC program to reduce incoming inspection of parts from a major supplier by 40%
  • Saved more than $50,000 annually by streamlining inspection steps throughout the manufacturing process

Quality Assurance Engineer, Group Leader, 1984 - 1991

  • Led QA function for a medical device product line to meet FDA QSR requirements
  • Managed staff of seven with responsibilities for hiring, employee development, and performance evaluation
  • Facilitated implementation of Just-In-Time (J-I-T) program to increase production throughput by 300% and reduce Work-In-Process by 90%
  • Led development of differential pH circuit that resulted in tenfold improvement of electrode's lifetime — the project resulted in two technical publications and US and international patents.