Transcript ISO/IEC 17025:1999- General Requirements for Competence of

From Good Laboratory Practice
to Total Quality Management in
Medical Laboratories :
The Perspective
October, 2002
S Cheng
1
What is Quality
 Quality
is the entity of a product ( service )
which fulfils the defined and expected
requirement
 The customer checks if the product meet the
requirements
2
Quality in Medical Laboratory Testing
 The
right test result, at the
 Right time, on the
 Right specimen, from the right patient, with
result interpretation based on
 Correct reference data, and at the
 Right price
3
Evolution of Quality
Management Philosophy
1930 – 60, Q.C. ( Cure )

1970 – 80, Q.A. ( Preventive )

To-day, TQM ( Holistic involvement )
4
Evolution of Quality Systems
>2000
Beyond TQM
1975-90 West
1962-75 Japan
Total Quality Managment
1950-62 TQC
Deming, Juran,
Ishikawa
Quality Management
System
1942-45 TPC
1930 SPC
Shewart
1920-1945 QC Depts
1915 Gilbreth
1890's Taylor
Quality Assurance
Good
Manufacturing
Practice
Quality
Control
ISO9001:2000
ISO9004:1994
ISO9001:1994
1980's ISO9000
1988 EEC
1972 EPIC
1969 WHO
1968 UK
1962 USA
5
Overview on the Functions of
The Medical Laboratory
Reference Standards
and/or Statutory Requirements
Subcontracting
Laboratories
(Te s ts & C alibrati on)
Hospital,
Clinicians &
Clients
Medical
Laboratory
GLP/ISO/TQM
6
Clinical Specimen Adulteration
Material
Suppliers
X
r
M
Equipment
Tissue
Process or
Techniques
Y
s
M
Result:
 Accuracy
 Precision
 Reliability
 Efficiency
 Confidentiality
Microbial
Contamination
Physical Damage
or Contamination
Environment
Personnel
Information
Patient or Client
(sample sources)
7
Quality Management System


Achieving customer satisfaction by
meeting customer’s expectation and
preventing non-conformity at all stage of
process from design to service.
Enhance the performance of the
organization through internal and external
audit
8
QM, QA and QC interrelationships
Quality Management
Quality System
External QA
Quality Assurance
Quality
Control
Policy, Objective,
Committent & Direction
Organization Structure,
Responsibility, Accoutability
Internal QA
Operational & Technical
Activities on Fulfilling Quality
Require ments
9
Why Quality Management is
everybody’s darling
Quality
costs, but poor Quality
costs more
 Regulator
: reduces workload, ( manpower )
 Blood Industry Officials: makes the
environment transparent
 Hospitals : reduces responsibility to patients
10
Cost of Quality
Appraisal
gain
Appraisal
Failure
Prevention
Before
Failure
Prevention
After
11
Demings chain
Improvement of quality
Improvement of productivity
Market-share
Price-reduction
Secure position
Secure jobs
Cost-reduction
12
Demings chain in Laboratory Service
Improvement of quality
Improvement of productivity
Market-share
Price-reduction
Secure position
Secure jobs
Cost-reduction
13
My problems with the definitions
of quality
 Does
the customer have all the information
he needs to qualify the products? Service?
 Is it his responsibility to check the quality
or standards?
 Is’nt there a discrepancy between
customer’s expectations and requirements ?
14
It is our ethical responsibility to
define the level of quality
 A patient
is not able to figure all transfusion
risks. He might be unconscious on intensive
care.
 We know all about transfusion risk and
must be responsible for the safety.
 A perfect balance is the major support for a
good quality management.
15
Flawless quality management:
( Error Management )
 Quality
management has to be flawless.
Discovery of errors in documents, or
problems must lead to the consideration to
end, or change the process.
16
Quality Layers
1.
2.
3.
4.
Minimal requirements “ Bad Quality”
Functional Requirement “Quality”
Non-functional requirements “Good
Quality”
Far ahead of customer expectations
“Excellence”
17
Should’nt we achieve excellence ?
Quality = Excellence
Excellence begins in your mind
18
Quality Planning
 Part
of Quality management focused on
setting quality objectives and specifying
necessary processes and related resources to
fulfil the quality objective
19
3 E in quality
Effectiveness ( doing the right things)
- extent to which planed activities are realized
and planed results achieved
 Efficiency ( doing things right )
- relationship between the result achieved and
the resources used
 Excellence
- Doing the right things right !!

20
The 8 columns of excellence
Responsibility for
the community
Building partnerships
Continuous learning
Involvement of
employees
Orientation on results
Orientation of customers
Leadership &
consequences of goals
Management of
processes & facts
21
Achieved By Good Practices
GLP – Good Laboratory Practice
 GCL – Good Clinical Practice
 GMP – Good Manufacturing Practice
 GTP – Good Transportation Practice
 GDP – Good Distribution Practice
 GAMP – Good Automated Manufacturing
Practice
 GRP- Good Regulatory Practice

22
Medical laboratory quality
system
 A quality
system is essential in the
laboratory to ensure the correct results
for the correct patient / donor
 By Good Laboratory Practice
( GLP )
23
Good Laboratory Practice( GLP )
 Main
areas of GLP
- Organization and personnel
- Facilities
- Equipment
- Reagent / test kits
- Documentation
- Inter-laboratory comparison
24
Organization and Personnel
 Quality
management system
On Accountability
-Responsibilities
-Authorities
 Training
- Competency based
25
Facilities
 Appropriate
infrastructure
 Safety measures
 Hygiene measures
26
Equipment
 Validated
- Does it do what you want it to do ?
 Maintained
 Calibrated
27
Reagents / Test Kits
 Evaluated
 Methodology
validated
 Test run validated
- Kit / reagent controls
- Internal control
28
Documentation (1)
Testing strategies / protocols
- Specimen identification
- Confidentiality
 SOPs
- Sample processing
- Test performance and result interpretation
- Inspection of incoming goods
- Validation
- Equipment maintenance and calibration
- Safety

29
Documentation (2)
 Records
- Test results
- Equipment maintenance
- Equipment calibration
- Control charts
- Validation
- Training
30
Inter-laboratory comparison
 External
Quality Assurance Scheme
( Proficiency Test , P.T. )
31
By Other Quality Management
System
International Standards
e.g. ISO 9000 series,
ISO/IEC 17025:1999
( General Requirements for the Competence of
Testing and Calibration Laboratories )
32
ISO1/IEC 17025, ISO15189
Development History
>2000
ISO9000-2000
ISO9000-1994
ISO9000-1987
Beyond TQM
ISO/DIS 15189 (2002)
Medical Laboratories
Particular Requirements for Quality
& Competance
ISO/IEC 17025:1999
(Standard)
ISO/IEC
Guide 25 2nd Ed.
1990
ISO/IEC
Guide 25 1st Ed.
1982
NATA ILAC
(1947) (1945)
ISO
Guide 25
1978
Standards
Requirements for
Competence of
Testing & Calibration
Requirement
(Testing/Calibration)
Requirement
(Testing)
Guideline
(Testing)
33
In 1985 JCAHO published its 10-step
QA monitoring process.
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Assign responsibility for QA plan.
Define scope of patient care.
Identify important aspects of care.
Construct indicators.
Define thresholds for evaluation.
Collect and organize data.
Evaluate data.
Develop corrective action plan.
Assess action; document improvement.
Communicate relevant information.
34
JCAHO has also established nine
dimensions of performance that
must be included and measured in
the design of the organization’s
quality assessment and performance
improvement plan:
35
Nine Dimension
 Efficacy
 Appropriateness
 Availability
 Timeliness
 Effectiveness
 Continuity
 Safety
 Efficiency
 Care
and Respect
36
National Accreditation Scheme
 CAP Laboratory Accreditation
Programm
( LAP ), USA
 CPA ,
Clinical Pathology Accreditation
( UK) Ltd., Standards for the Medical
Laboratory
37
ISO/IEC 17025:1999- General Requirements
for the Competence of Testing & Calibration
Laboratories ( Based on ISO9001:1994 )
 An
international standard for
recognising competence in testing &
calibration laboratories
38
ISO/IEC 17025:1999- General Requirements
for the Competence of Testing & Calibration
Laboratories
con’t
 Sets
out basic quality system requirements
in accordance with ISO9001 or 9002
 Laboratories carrying out calibration and
testing activities and meeting the
requirements will therefore also operate
accordance with the ISO 9000 series quality
system
39
ISO9001:1994 – The Role and
Function of 20 Elements
4.1
4.2
Policy & Organisation
Structure
4.5 4.16 4.18
4.14
4.17
4.8
4.13
Control Management &
Training
4.20
Measuring, Identification
& Traceability
4.12
4.10
4.11
Essential Processes
4.3
4.4
4.6/7
4.9
4.15
4.19
Q
40
Management and Technical
criteria for Accreditation
Compliance with criteria in Section 4,
Management Requirements;
 Compliance with the criteria in Section 5,
Technical Requirements of Technical Criteria for
Laboratory Accreditation HKLAS 003
 Compliance with HKLAS 002 – regulations
governing the administration of HOKLAS and
the obligations of accredited laboratories.

41
UNCERTAINTY OF
MEASUREMENT
Calibration Laboratories
 Accredited for calibrations under the
“Calibration Service” Test category
 Refer to ISO “Guide to Expression of
Uncertainty in Measurement” (GUM)
 Refer to EA-4/02, for application of GUM
website:www.european-accreditation.org
42
Testing Laboratories
 Required
to estimate the uncertainty of
measurement in accordance with 5.4.6.2 of
the HKLAS 003
43
Asia Pacific Laboratory Accreditation
Cooperation (APLAC)



1.
2.
3.
4.
5.
6.
7.
Established in 1992, Secretary Office in Australia
MRA, Mutual Recognition Agreement
Members consisted of 7 countries, 13 Laboratory
accredition bodies (December, 1999 figure)
China, China Taipei, China Hong Kong
Australia
New Zealand
Korea
Singapore
United State
Japan
44
The Hong Kong Laboratory
Accreditation Scheme (HOKLAS)
 Found
in 1985
 Function : identifying and recognising
competent testing & calibration laboratories
in Hong Kong
 Expanded in 1998, forming Hong Kong
Accreditation Service (HKAS)
45
HKLAS – Scope of
Accreditation









Electrical and Electronic Products
Textiles and Garments
Toys and children product
Food
Calibration service
Construction materials
Environmental testing
Chemical testing
Miscellaneous
Other Test Categories may be added when
significant needs are identified.
46
Pathology Laboratory
Accreditation in Hong Kong
 In
year 2003
 Mandatory or
Voluntary ??
Based on which standard (S ) ??
47
Technical Criteria – ISO/IEC17025:1999
4. Management Requirements
4.1 Organizaton
4.2 Quality system
4.3 Document control
4.4 Review of request,
tenders or contract
4.5 Subcontracting of tests
and calibrations
4.6 Purchasing services and
supplies
4.7 Service to the client
4.8 Complaints
4.9 Control of NC Testing
and/or calibration work
4.10 Corrective action
4.11 Preventive action
4.12 Control of records
4.13 Internal audits
4.14 Management Reviews
48
5. Technical Requiremnts
5.1 General
5.2 Personnel
5.3 Accommodation &
environment conditions
5.4 Tests & calibration
methods and methods
validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and
calibration items
5.9 Assuring the quality of
test
5.10 Reporting the results
49
Quality Policy – determined and
issued by the Top Management
Policy Statement, Vision, Mission &
Quality Planning:
Commitment to
 Quality of Professional Standards
 Quality Standard Requirements
e.g. ISO9000; ISO/IEC17025 etc
Objectives
Service Standards
and / or Statutory
Requirements
Communication
Understanding,
Implementation &
Review
50
Documentation Structure : hierarchy
QM
QP
WI
Quality Manual
(Policy, Vision, Mission, Objectives
and Commitment to Quality)
Structure, Responsibility &
Authority
SOP
Records
Quality Procedure
(Guidelines to perform quality
related activities)
Forms, Results, Reference
Standards &
Equipment Manuals
51
Documentation System
Quality
Policy
Service Standards
OS&H Ordinance
International Standa rds (ISO
9000)
(ISO 17025)
Specifications
Codes of
Profession
Quality Policy
Manual
Quality
Records
Organization Background,
Vision, Mission, Obje ctives, Plans
Organization Review s
Responsibilty, Authority
Directions
Materia ls
Chemicals (MSDS)
Computer
Reagents / Kits
Maintenance
Critical Materials
Labels
Process
Calibra tion
Distribution
Training
Quality Control
Production
Equipm ent
Patient / Client
Calibra tion De vice
QC/QA Testing
Registers / Log
Other Records
Management QMs
Management QPs
Collection
Proces s ing
Tes ting/
W orkplace W Is
Exam
Stor age
Labe lling
Per sonal Data and Te sting
Audit
Incide nt and Com plaint
Sur veillance QA
Dis posal
Syste m Review s
52
Document Control
Easy Accessible to All
Distribution
Retrieval
Prepare
Documents as Authority
Required in
Standard Format
Use Only
Valid &
Controlled
Documents
Authority
Regular
Review,
Revise
Return &
Destroy
Obsolete Document
53
Benefits of Quality Systems
 Consistently
achieve ‘customers’
requirements
 Minimize errors, “waste” and complaints
 Improve efficiency
 Reduces
- negative impact on customers
- likelihood of litigation
- communication breakdown
54
Con’t
 Improve
safety and morale
 Standardization
 Ensure adequacy of resources
 Build-in improvement tools
 Facilitates changes & easier problem
solving
55
ISO 15189 Medical Laboratories –
Particular requirements for quality and
competence ( Based on ISO9001:2000)
4 Management requirement
4.1 Organisation and management
4.2 Quality management system
4.3 Document control
4.4 Review of requests and contracts
4.5 Examination by referral laboratories
4.6 External services and supplies
4.7 Advisory services
56
Medical Laboratories – Particular
requirements for quality and
competence (con’t)
4.8 Resolution of complaints
4.9 Identification and control of nonconformities
4.10 Continual improvement
4.11 Corrective action
4.12 Preventive action
4.13 Quality and technical records
4.14 Internal audits
4.15 Management review
57
Medical Laboratories – Particular
requirements for quality and competence
(con’t)
5 Technical requirements
5.1 Personnel
5.2 Accommodation and environmental conditions
5.3 Laboratory equipment
5.4 Pre-examination procedures
5.5 Examination procedures
5.6 Assuring the quality of examination procedures
5.7 Post-examination process
5.8 Reporting of results
5.9 Alterations and amendments of reports
58
Continual Improvement
Improvement
In
m
for
on
i
t
a
Benchmarking
or Beyond TQM
Act
Check
Plan
Do
Objective of Changes
Quality Management System
Time
59
Deming Cycle
(Plan, Do, Check & Act)
Act
(Head & Manager)
Check
(Monitor & Auditor)
P-D-C-A
Do
(Operator)
Plan
(Manager & Supervisor)
60
Seven Determinants in TQM
Machine
Materials
÷
¾
Information
Methods
Man
Monitoring &
Measuring
5M
1E
1I
Environment
61
ISO17025 (ISO15189) GENERAL LAYOUT
Medical
History
Medical Questioning
Patient/Client Seeking
Health Service
Appropriate Choice of
Tests
ISO15189 (Based
on ISO9001:2000)
Laboratory
File
Quality
Planning
Requirements &
Specifications
DOCUMENTATION,
RECORD, DATA
CONTROL
Collection
Logistics
Testing Sample Transport
ISO17025 (Based
on ISO9001:1994)
Resources
Test/Calibration
Results Assurance
Q.C., Q.A.
EQAS
Proficiency Test
(ISO/IEC Guide 43)
Measurement
Traceability
Purchasing
& Supplies
Personnel
Corrective Preventive Action
Logistics
Management Review
Testing
QUALITY SYSTEM
Contracted
Laboratories
for tests and
calibrations
Dispensing / Archive
Analysis & Testing
Analytical Test Result
Confirmatory Test
Material Control
Acceptance,
Quarantine &
Storage
Inventory
Management
STAFF
TRAINING &
COMPETENCE
SYSTEM
VALIDATION
Hygiene
Sterility
Control
OS&H
Result Verification
Re-test
INFORMATION SYSTEM
Handling of Test
and Calibration
Items
Storage Security
Disposal
Management
Feedback
Communication
Monitoring,
Measuring & Testing
Laboratory-clinic
Interface
Request, Tenders & Contract Review
Registration (Reconciliation)
EQUIPMENT
MAINTENANCE &
CALIBRATION
Policies
Objective
Structure
Responsibilities
Complaint
Audit
NON-COMFORMITY CONTROLS
Clinical
Diagnosis
Accommodation & Environmental Conditions
Security Control
Patient & Laboratory Data
Up-Date, & Storage
Authorization To Release
Reporting
Use of
Laboratory Data
Result
Distribution
Logistics
ISO15189
(Continual
Improvement)
Laboratory-clinic
Interface
Patient during at after
Health Service
ISO15189
Ethics in Laboratory Medicine
Feedback
62
Model for Medical Laboratories with
Patient / Client as “Customer”
Medical
Laboratory
FUNDING AGENCY
SUPPLIERS
PERSONNEL
hardware software consumables
Patient/
Client
sampling
Seeking
Clinical
Pathology
Service
Education and Competency
END-USERS
reporting
MANAGE
testing
SUPPORT
result analysis
PATIENT
during &after
Health Service
SUBCONTRACTORS
(tests & calibration)
LEGISLATURE
REGULATORY AGENCY
63
New Rules of the Game…..
Diminishing Resources
 Lowering of staff level
 Increasing Accountability
 Increasing Regulation
 Complex Relationships
 Rate of changes
 New value Systems
The Age of Innocence is over

64
The Drive for Public Sector
Efficiencies
 The
quest for balanced Budgets
 Monopolies and monopsonies
 Privatisation
 Regionlization
 Price signals
65
Some Common Goals
 Standardize
Business System
 Standardize System Performance
 Strengthen the Skills of our People
66
Customers Focus and
Expectation continue for
Good Price for Best Quality
67
Overview of ISO 9001:2000
Model of process-based quality management system
Continual Improvement of
the Quality Management System
Management
responsibility
Customers
(and other
interested
parties)
Resource
management
Requirements
Input
Customers
(and other
interested
parties)
Measurement,
analysis & improvement
Product
Realization
Product
Output
Satisfaction
Quality Standard Compliance Triangle &
Quality System Accreditation/Certification
Documentation
QMS
Certification
Accreditation
Training
Audit
69
“The system approach begins
when first you see the world
through the eyes of another”
C.W. Churchman
1968
70