This book provides laboratory managers with business tools that apply the best science to the best evidence in a manner that increases the efficiency and effectiveness of their management decision making...
The ISO 9001 standard specifies requirements for quality management systems. All requirements of ANSI/ISO/ASQ Q9001-2008, the American National Standard (ANS) version of ISO 9001, are generic and are intended to be applicable to all organizations.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.