Clinical and Laboratory Standards Institute document QMS16—Laboratory Personnel Management provides guidance for processes involved in managing personnel resources such as personnel qualifications, preparation and maintenance of effective job descriptions, introduction of new personnel to the laboratory organization, continuing education, professional development, and contents of personnel records. This guideline focuses on how to meet regulatory and accreditation requirements for personnel. Useful tools and templates related to these topics are also provided.

This guideline is intended to assist laboratories in meeting the personnel management requirements for their QMS, as represented by Quality System Essential (QSE) Personnel. Laboratory personnel can benefit from reading this guideline because it explains management’s expectations and personnel responsibilities. 

QSE Personnel involves recruiting, hiring, and retaining an adequate number of qualified, well-trained, and competent laboratory personnel to perform and manage the activities of the laboratory. The processes and procedures needed to achieve these goals are described in QSE Personnel. This guideline is intended for use by laboratory directors, managers, supervisors, quality managers, and others responsible for implementing, maintaining, and evaluating the laboratory’s QMS as it relates to the requirements contained in QSE Personnel. The processes described and examples provided can be used in any size, type, or scope of laboratory, anywhere in the world, to meet published regulatory and accreditation requirements. 

This guideline does not address, in detail, the following topics and content, and the information covered in other CLSI documents: 

-Communication between the laboratory and other health care providers or regulatory agencies as related to patient-centered care activities 

-Communication theory and practices 

-Behavioral management theory and practices 

-Personnel interaction management theory and practices 

-Training and competence assessment (refer to CLSI document QMS035) 

-Leadership and management development (refer to CLSI document QMS146) 

In addition, this guideline is not meant to be prescriptive, but rather suggestive, in approach. It is not a comprehensive instructional manual for application of the concepts discussed.