scope:

QMS14 assists laboratories in meeting leadership requirements for their QMS. A conceptual framework comprising three organizational dimensions (ie, cultural, structural, and functional) is introduced, and content relevant to managing laboratory quality is provided for each dimension. QMS14's content was developed with the aim of enhancing the effectiveness of leadership at shaping (ie, designing, implementing, and maintaining) the quality-related aspects of each dimension, thereby supporting leaders in the fulfillment of their QMS roles and responsibilities. QMS14 is intended for use by all organizations and individuals involved in the management or operation of preexamination, examination, and postexamination phases of the medical laboratory. QMS14 may be applicable to other types of laboratories, as well as nonlaboratory settings.

QMS14 addresses the leadership requirements as described by QSE Organization, and aspects to be considered to enable the successful development, implementation, and/or maintenance of:

• A quality policy

• An appropriate scope of services

• An organizational structure to ensure quality Roles and responsibilities to carry out the work processes and activities of the QMS

• An appropriately designed and integrated QMS

• A quality manual

• A process for resource management in support of the QMS and provision of laboratory services

• A process for quality planning

• A process for review of performance to assess the effectiveness of the QMS

• A program or plan for ongoing communication of quality-related information