North America Office
8757 West Cornell Avenue Suite 4
Lakewood, CO 80227 USA
+1 (720) 635-5563

Mexico Office:
Calle Arthur Ashe No. 40
Raquet Club
San Juan Cosala
Jalisco C.P. 45820 Mexico
+1 (720) 635-5563

ISO 13485 2003 QMS

ISO 13485 quality management

Development of documentation systems

Executive and staff ISO 13485 training

Internal and supplier ISO audits

Quality process improvement

ISO 13485 Consulting

ISO 13485

Quality Management System

  • Manufacturing or selling medical devices?

  • Plan to sell your products in the Europe or Canada?

  • Need to comply with the US FDA QSR?

  • Need to improve field action and customer complaint processes?

  • Wish you could do things right the first time?

We can help! Quality Works assisted dozens of companies around the World in establishing and implementing effective ISO 13485 2003 Quality Management Systems. ISO 13485 is a quality management system standard designed specifically for medical device manufacturers. A Quality Management System compliant with the standard is mandatory for a number of classes of medical devices in Europe and Canada. The ISO 13485 2003 is based on ISO 9001 2000 standard, and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, traceability, compliance with regulatory requirements and others.

Check our Products page to discover how our documentation sets can help you in developing your Quality Management System or call us for a complimentary, no obligation consultation. We will be glad to assist you!

Call us today to discuss your specific ISO 13485 quality management system needs!

Discover techniques to build Lean ISO 13485 Management Systems.

Download a complimentary copy of our

The Perfect Manual - A Guide to Lean Management Systems book

© Copyright 1996 - 2016 Quality Works