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
Lean ISO Management Consultant Mark Kaganov

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
Lean Approaches to Management Systems
Consulting for Development and Implementation of ISO

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
Lean ISO Management Consulting Services

Learn how easy it is to eliminate waste in management system documents. Check this complimentary service today.

Quality Assurance Director

Quality Assurance Manager, 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

Sr. Quality Engineer, 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 Manager
Quality Assurance Engineer

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.