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.

Organization-Module 18 2
 The Quality Management System
Organization Personnel Equipment

Purchasing Process Information

& Control Management
Inventory

Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Organization-Module 18 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

Organization-Module 18 6
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
Finance Manager
Ministry of Health

Staff
Meeting
s
Organization-Module 18 8
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 Report Creation

Result Interpretation Postexamination Phase

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 HOSPITAL DIRECTOR

LABORATORY
DIRECTOR NURSING
DIRECTOR

CHARGE QUALITY
TECHNOLOGIST MANAGER

ASSISTANT CHARGE
NURSING

TECHNOLOGIST TECHNOLOGIST

Organization-Module 18 11
Quality Manager
 ISO 15189 requirement
 has responsibility and authority to
oversee compliance
 reports directly to the decision-
making level of laboratory
management

Organization-Module 18 12
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
Organization-Module 18 14
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
 develop a task list
— GAP ANALYSIS —
 prioritize by:
 quick fixes first
 determine what
would have the
greatest positive impact

Organization-Module 18 16
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

Organization-Module 18 17
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

Organization-Module 18 18
Implementation
 commit to completion
 prepare for implementation in stages
 assure resources are available
 use a Gantt chart
 be sure everyone knows their responsibility

then

BEGIN

Organization-Module 18 19
Gantt Chart

Organization-Module 18 20
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

Organization-Module 18 22
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

Organization-Module 18 25
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

Organization-Module 18 27
Intent to Action
Q
M ual
an ity
ua
l

Organization-Module 18 28
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

Organization-Module 18 29
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

Organization-Module 18 30
 Who is Responsible for Quality?

EVERYONE!

Organization-Module 18 31
 Organization Personnel Equipment

Purchasing Process Information

Questions?
& Control Management
Inventory

Comments?
Documents Occurrence
& Assessment
Management
Records

Process Customer Facilities

Improvement Service &
Safety

Organization-Module 18 32