1.4 Hierarchy (QMS only)

Question 1

Quality Management System

• can be defined as “coordinated activities to ______ and ______an organization with regard to quality”.
  This definition is used by
  the ______________________________ and by the ___________________________

Answer 1

direct; control; International Organization for Standardization (ISO); Clinical and Laboratory Standards Institute (CLSI)

Question 2

Quality Management System

• all aspects of the laboratory operation, including the ________________, processes and ____________, need to be addressed to assure quality.

Answer 2

organizational structure; procedures

Question 3

Quality Management System

• model used presented in the module organizes all of the laboratory activities into _____ quality system essentials. These
  quality system essentials are a set of coordinated activities that serve as _______________ for quality management.
• model was developed by ______, and is fully compatible with ______ standards.

Answer 3

12; building blocks; CLSI; ISO