Steve Mundwiller, author of “Statistical Process Control, A Pragmatic Approach”, which focuses on SPC from a manufacturing viewpoint, has provided comprehensive ISO consulting services, training and mentoring services, and systems development to manufacturing and service sectors, both public and private. Key engagements include; ISO 9001 auditing and ISO consulting  for quality systems development, transition and audit preparation, Lean Manufacturing, Supply Chain Management and Improvement, Good Manufacturing Practices (GMP’s) systems development and improvement meeting the requirements of the U.S. Food and Drug Administration (FDA), leadership coaching and development, team development, mentoring and improvement, Statistical Process Control (SPC) training, Continuous Improvement, Kaizen, Benchmarking and general problem resolution.

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Steve’s prior experience includes many years training, improving, developing, implementing, and auditing in the pharmaceutical, medical device industries.  Steve has trained hundreds of individuals at dozens of organizations in Good Manufacturing Practices, FDA regulations, ISO 13485, CE Marking, ISO 9001 and related systems, Statistical Process Control, Supply Chain Improvements, and general Quality Assurance. His work experience includes global Pharma and medical device (Guerbet), Medical Device (Allied Health), Pharmaceuticals (Sherwood Medical, Mallinckrodt), Manufacturing (Reckitt Colman, Watlow Electric) and Chemical (Sigma Chemical).