FOREWORD: This Manual identifies each section of the applicable ISO Standard and FDA Regulations and provides either a description of how the Quality Management System complies with the requirement, or references the related Level 2, Standard Operating Procedures (SOP’s).Command Medical Products hold FDA Registration Number: 1526611 for the 15 Signal Ave. Ormond Beach Florida facility and Registration Number: 3005382983,
Owner Operator Number: 1526611, for the COMMAND MEDICAL NICARAGUA SA Km 12.5 Carretera Norte Parque Industrial Las Mercedes, Edificio 16 and 17 Managua NICARAGUA.Each section is structured with the ISO section #, its title, and to the right of it, the comparable section of the CFR regulation and title, if applicable.
INTRODUCTION: Command Medical Products is a Contract Manufacturer of Medical devices for various customersThe Quality Management System described in this manual is structured to comply with; ISO 13485:2016 and 21 CFR Part 820, Quality System Regulation.The Quality Manual applies both to Command Medical Product facilities located in Ormond Beach, Florida and Managua, Nicaragua.
