Organization
Learning Objectives
At the end of this session, you will be able to


Describe organizational elements needed for
a quality management system.
Discuss management roles and
responsibilities in a quality system.

Explain the process for designing,
implementing, maintaining, and improving
the laboratory quality management system.

Explain the purpose of a quality manual.
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The Quality Management System
Organization-Module 18
Organization
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
3
Essential
1. Management committed to a
quality management system.
2. An organizational structure
designed to assure quality goals.
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Leadership, Managerial Roles
Organizational
Structure
Planning
Process
Implementation
Monitoring:
Maintenance
and Improvement
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Leadership

exercising responsible
authority, while
providing motivation
and vision

influencing and
encouraging staff
to good performance
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Management Responsibilities

implement and continuously improve the
quality management system

document and
communicate
to all personnel

provide a
quality manual
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Management Commitment
Ministry of Health
Finance Manager
Staff
Meeting
s
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Organizational Structure
establish a working structure that
ensures sufficiency at all parts in the
laboratory work flow
designate responsibilities and roles;
develop an organization chart
designate a Quality Manager
allocate sufficient resources
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Path of Workflow
THE PATIENT
Test selection
Sample Collection
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport
Result Interpretation
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Report Creation
Postexamination Phase
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HOSPITAL DIRECTOR
LABORATORY
DIRECTOR
CHARGE
TECHNOLOGIST
QUALITY
MANAGER
ASSISTANT CHARGE
TECHNOLOGIST
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NURSING
DIRECTOR
NURSING
TECHNOLOGIST
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Quality Manager
ISO 15189 requirement
 has responsibility and authority to
oversee compliance
 reports directly to the decisionmaking level of laboratory
management

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Quality Manager Responsibilities
 monitor quality management system
 assure compliance
 review all records
 conduct, coordinate audits
 investigate deficiencies
 inform decision makers
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Planning for Quality Management
System
 approaches vary
with local situation
 many factors influence
starting point
 include all quality
elements in plan
 may implement in stepwise process
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Keep in mind
communicate, be transparent
 set feasible timelines


develop realistic,
measurable objectives

set priorities,
proceed stepwise
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Conduct Gap Analysis
 determine the gaps, using quality
management systems checklist
— GAP ANALYSIS —
 develop a task list
 prioritize by:

quick fixes first

determine what
would have the
greatest positive impact
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Gap Analysis
Common problems identified
 test ordering
 sample management
 training level (competence)
of technical staff
 quality control
 analytical process
 recording and reporting results
 reagent and equipment management
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Written Quality Management
System Plan should include





what should be done
who will be responsible
when (timeline)
how many resources are needed
benchmarks
Must be available to all staff
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Implementation
 commit to completion
 prepare for implementation in stages
 assure resources are available
 use a Gantt chart
 be sure everyone knows their
responsibility
then
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BEGIN
19
Gantt Chart
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Provide Resources



financial requirements/budget
personnel needs
 additional staff
 skills, training needed
facilities, equipment,
supplies, computers
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Monitoring Compliance

assign responsibility

develop indicators

establish monitoring
system

conduct audits

management review
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Internal Audit
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What is a Quality Manual?
A document describing the quality
management system of an
organization.

essential organizational step

management responsibility
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Quality Manual

communicates information

serves as a framework for meeting
quality system requirements

demonstrates management’s
commitment to quality
QUALITY
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Maintaining the Quality Manual
 communicates quality policy
 needs management approval
 requires updating
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Successful implementation requires
 having management commitment
 understanding the benefits of a quality
management system
 engaging staff at all levels
 striving to
continually improve
 having realistic
expectations
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Intent to Action
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Intent to Action

assign responsibility for implementation

allocate resources

develop and distribute a quality manual

implement quality system

monitor compliance with quality
management system requirements
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Remember
Quality is not a science,
it’s a way of thinking.
 Spend time today to
gain rewards tomorrow:
quality results
efficiency
professional, personal satisfaction
peer recognition

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Who is Responsible for Quality?
EVERYONE!
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Organization
Purchasing
&
Inventory
Personnel
Equipment
Process
Control
Information
Management
Questions?
Comments?
Documents
&
Records
Occurrence
Management
Process
Improvement
Customer
Service
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Assessment
Facilities
&
Safety
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