scope:

• Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline

This guideline presents concepts and information intended to assist a laboratory in meeting leadership requirements for its quality management system. Guidance is provided for leaders to effectively design, implement, and maintain the cultural, structural, and functional aspects of their laboratory's organization that are critical to managing and sustaining quality.

• Executive Summary

This companion product provides an executive summary of GP38-A-Quality Management System: Leadership and Management Roles and Responsibilities; Approved Guideline.