SMILE

Johns Hopkins University

Baltimore, MD USA

Organizational Structure Policy Number Doc10-14AppB

Effective Date 30-Jul-08
Approval Signature: Laboratory Director Supersedes New
Review by Heidi Hanes Review date: 10-Feb-20
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your lab’s
specific processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local laws and
study protocol policies when considering the application of this document. If you have any questions contact SMILE.
QSE 2: Organizational Structure - Policy

Policy The laboratory complies with all external requirements and has an organizational
structure that ensures quality and meets customer needs.

Purpose This policy provides the effective demonstration of the laboratory’s structure
and quality management system as it is coordinated with other facility
quality management programs.

Responsibility The Laboratory Medical Director is responsible for the allocation of

resources so that strategic plans can be executed.

The Laboratory Supervisor is responsible for maintaining the organizational

chart.

The Quality Manager is responsible for developing the laboratory quality

management system and coordinating it with other facility quality
management programs.

Quality Management The laboratory quality management system will be developed and linked
System with other facility quality management systems.

Chart of Laboratory A chart of the organizational structure of the administration and staff of the
Organization laboratory will be maintained.

Referral Laboratories A chart identifying all Referral Laboratories is maintained.

Supporting The following processes support this policy:

Documents
 Implementing a Laboratory Quality Management System

 Organizational Chart Development and Maintenance

 Identification of Referral Laboratories

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 SMILE
Johns Hopkins University
Baltimore, MD USA

Implementing a Laboratory Quality Management System – Process

Process for Implementing a Laboratory Quality Management System
What Happens Who’s Responsible Procedures
A Quality Manager is  Laboratory Director  Personnel
designated Processes/Procedures
 Human Resources
Internal and external  Quality Manager  Quality Management
customers’ needs are
identified  Laboratory Management

The resources needed to meet  Quality Manager  Resource Allocation

those needs are identified and
obtained  Laboratory Management  Quality Management

Policies for each QSE are  Quality Manager  Quality Management

developed and integrated into
a Quality Manual
The processes and  Quality Manager  Quality Management
procedures needed to
implement each policy are
developed
The principles in the Quality  Quality Manager  Quality Management
Manual are communicated to
all personnel  Laboratory Supervisor  Personnel Training
Procedures
Laboratory leadership reviews  Quality Manager  Quality Management
the Laboratory Quality
Management System at least  Laboratory Management
annually  Laboratory Director
Laboratory leadership works  Laboratory Management  Quality Management
with other departments to
coordinate the laboratory  Laboratory Director  Other Departments’
quality system with other Quality Management
 Facility Executive
facility quality management Procedures
Management
systems

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 SMILE
Johns Hopkins University
Baltimore, MD USA

Organizational Chart Development and Maintenance - Process

Process for Organizational Chart Development and Maintenance

What Happens Who’s Responsible Procedures

The laboratory administration  Executive  Developing and
is identified Management Maintaining the
Organizational Chart
 Laboratory Director
The levels of authority and  Executive  Developing and
responsibility for all personnel Management Maintaining the
are defined Organizational Chart
 Laboratory Director
The chain of command  Executive  Developing and
(reporting relationships among Management Maintaining the
personnel) is identified Organizational Chart
 Laboratory Director
An organizational chart  Executive  Developing and
(organogram) is published Management Maintaining the
Organizational Chart
 Laboratory Director

Identification of Referral Laboratories - Process

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 SMILE
Johns Hopkins University
Baltimore, MD USA

Process for Identification of Referral Laboratories

What Happens Who’s Responsible Procedures

The need for referral
laboratories is assessed
Referral laboratory’s capabilities
are assessed
A list of Referral Laboratories
and the tests that they conduct
is maintained
 Laboratory Supervisor  Use of Referral
Laboratories
 Laboratory Testing
Menu
 Review of Physician
Order History
 Laboratory Supervisor  Use of Referral
Laboratories
 Referral Laboratory
Testing Menus
 Laboratory Supervisor  Chart of Referral
Laboratories

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