Beruflich Dokumente
Kultur Dokumente
Quality Management
System
Learning Objectives
Personnel
Purchasing
&
Inventory
Process
Control
Documents
&
Records
Occurrence
Management
Process
Improvement
Customer
Service
Equipment
Information
Management
Assessment
Facilities
&
Safety
What is Quality?
Result:
1% failure
accurate,
reliable, and
timely
8
personnel
effort
patient
outcomes
Patient/Client Prep
Sample Collection
Personnel Competency
Test Evaluations
Data
& Laboratory
Management
Safety
Customer Service
Record Keeping
Quality Control
Testing
Sample Transport
10
Path of Workflow
THE PATIENT
Test selection
Sample Collection
Preexamination Phase
Sample Transport
Laboratory Analysis
Examination Phase
Report Transport
Result Interpretation
Report Creation
Postexamination Phase
11
laboratory environment
knowledgeable staff
competent staff
reagents and equipment
quality control
process management
occurrence management
record keeping
12
set of
coordinated
activities that
function as
building blocks
for
quality
management
Organization
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Management
Assessment
Process
Improvement
Customer
Service
Facilities
&
Safety
14
Organization
Responsibilities, Authorities
Quality
Policy
Provision
of
resources
Communication
15
Personnel
human resources
job qualifications
job descriptions
training
competency assessment
professional development
16
Equipment
acquisition
installation
maintenance
calibration
troubleshooting
service and repair
17
vendor qualifications
supplies and reagents
critical services
inventory management
18
Process Control
sample management
method validation and
method verification
19
Information Management
confidentiality
logs and records
reports
computerized laboratory
20
Documents
creation
revisions and review
control and distribution
Records
collection
review
storage
retention
21
22
23
Occurrence Management
complaints
mistakes and problems
documentation
root cause analysis
immediate actions
corrective actions
24
Laboratory Assessment
Internal
External
Internal
Proficiency
testing (EQA)
Accreditations
Inspections
25
Process Improvement
26
Customer Service
customer group identification
customer needs
customer feedback
27
28
Implementing
Quality Management
does not
guarantee
an
ERROR-FREE
Laboratory
But it detects
errors that may
occur and
prevents them
from recurring
29
Organizatio
n
Personnel
Equipment
Purchasing
&
Inventory
Process
Control
Information
Management
Documents
&
Records
Occurrence
Manageme
nt
Assessmen
t
Process
Improvement
Customer
Service
Facilities
&
Safety
Laboratories not
implementing a
quality management
system guarantees
UNDETECTED
ERRORS
30
Innovators of Quality
Walter
Shewhart
1891-1967
W. Edwards
Deming
1900-1993
Joseph Juran
1904-2008 (103 years)
31
Innovator
Date
Cycle
Walter A.Shewhart
1920s
Statistical Process
Control
W. Edwards Deming
1940s
Continual Improvement
Joseph M. Juran
1950s
Quality Toolbox
(matrices and
flowcharts, data
collection, analysis
techniques, )
32
Standards Organizations
ISO
International Organization
for Standardization
Guidance for quality in
manufacturing and service
industries
Broad applicability; used
by many kinds of
organizations
Uses consensus process in
developing standards
CLSI
ISO 15189:2007
The
foundation of international
medical laboratory quality
management
Medical laboratoriesParticular
requirements for quality
and competence
35
36
In summary
37
Key Messages
38