CLSI QMS19 : 2017

Abstract
Committee Membership
Foreword
Chapter 1 - Introduction
Chapter 2 - The Customer Focus Process
Chapter 3 - Quality System Essentials
Chapter 4 - Conclusion
Chapter 5 - Supplemental Information
References
Appendix A - Customer Needs Assessment Process
Appendix B - Sample Gap Analysis Tool
Appendix C - Customer Satisfaction Survey Process
Appendix D - Sample Online Satisfaction Survey for
             Blood Collective Service
Appendix E - Patient Feedback Survey
Appendix F - Sample Customer Feedback Form
Appendix G - Sample Patient Satisfaction Survey for Blood
             Collective service
Appendix H - Sample Nursing Satisfaction Survey
Appendix I - Sample Clinical Satisfaction With Laboratory
             Service Survey
Appendix J - Sample Acute Care and Community Physician
             Survey
Appendix K - Sample Sales and Marketing Survey
Appendix L - Example of an Internal Form for Leadership
             Rounds
Appendix M - Sample Laboratory Quality Management Service
             Survey
Appendix N - Staff Satisfaction Survey
Appendix O - Exit Interview Questions
Appendix P - Customer Query Call Log Information
Appendix Q - Sample Communication Tool: Situation, Background,
             Assessment, Recommendation Briefing Format
The Quality Management System Approach
Related CLSI References Materials

Gives useful information for how laboratories can develop and maintain a customer focus and meet the regulatory and accreditation requirements for managing external and internal customers.

This guideline is intended to assist laboratories in meeting customer-based requirements for their QMS as represented by quality system essential (QSE) Customer Focus. This guideline does not review the theory of good customer relations or service but instead discusses areas in which the laboratory should focus in order to provide appropriate outputs (such as examination results and reports), products (such as blood and tissue), and customer services (such as courier retrieval of collected specimens from physicians’ offices). This guideline is applicable to medical laboratories of any size, complexity, or specialty, including point-of-care testing. However, because the concepts of customer service and satisfaction are generic, this guideline can be,used by other types of laboratories, such as public health, research, food, environmental, and veterinary laboratories. It can be used by all levels of personnel to develop and support a customer-focused laboratory. This guideline does not apply to patients who use test devices and kits at home, because they are customers of the test kit manufacturer and not the laboratory.