Implementing Quality Management Systems in Small Companies

Instructor: William G Mclain
Product ID: 700210
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

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Read Frequently Asked Questions

Many small or virtual companies make one of two common mistakes: their Quality Management System (QMS) is either too cumbersome for their operation or they don’t have a quality management system at all


Quality management issues facing small, startup or "virtual" companies and identifying all required quality management system elements.

This presentation will address the issues facing the small, startup or "virtual" company. Participats will learn how to ensure all required quality management system elements are identified, scaled appropriately to meet their compliance requirements, and effectively implemented. We will also discuss what to to if the inspector or auditor comes for an unexpected visit.

Areas Covered in the Seminar:

  • Quality Management System Basics
  • Identifying which QMS elements are required.
  • Deciding between ISO 13485:2003 and 21 CFR Part 820.
  • How to ensure compliance if you’re not responsible for design or manufacturing.
  • Using supplier agreements for compliance needs.
  • When do I implement my QMS.

Who Will Benefit:

  • Entrepreneurs
  • Small Company CEO’s
  • Research & Development and Engineering
  • Investors

Instructor Profile:

William G. Mclain, RAC, B.S.E. is the President and Principal Consultant for Keystone Regulatory Services, LLC. He has over 15 years experience in product development, domestic and international regulatory affairs and risk management, and quality management system design in the medical device industry. He has contributed to the timely development and market introduction of cardiovascular, anesthesiology, gastroenteral, diagnostic and general surgical devices by providing regulatory, quality system and risk management strategy, oversight, and support. An active member of RAPS and ASQ Biomedical Division, Mr. McLain is RAC Certified and holds a BS in Mechanical Engineering from Grove City College.

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