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1990ISO/IEC Guide 25
1999ISO/IEC 17025
2005ISO/IEC 17025
24 Requirements 25 Requirements13 Requirements
1994ISO 9001
2000ISO 9001
(QI)Quality Improvement
(QA)Quality Assurance
(QC)Quality Control
ISO 17025:1999 ISO Guide 25:1990 ISO 9000:1994()
ISO 17025:2005 ISO 17025:1999 ISO 9001:2000() () ()
ISO 17025
2005 Proactive Prevent errors Everybody Customer
satisfaction Management for
effectiveness Continual
improvement
2005 Proactive Prevent errors Everybody Customer
satisfaction Management for
effectiveness Continual
improvement
1999 Reactive Detect faults Key persons Laboratory
focus Management for
quality Maintain
conformity
1999 Reactive Detect faults Key persons Laboratory
focus Management for
quality Maintain
conformity
ISO/IEC 17025
/
4.5
5.8
5.4
5.5
4.4
5.3
4.6
5.9
4.13
5.10
5 5 4 4 5.2 4.1 4.2
4.7
4.8
4.9
4.3
4.14
4.15
4.10
4.11
4.12
5.7
5.4 5.6
4.9
PDCAISO 17025
()
()
***
---
*/*//**///*/
*/****/* *
()
(5.7)(5.8)
Magic Box Results
(5.2) (5.3)
(5. 9 )(5.10)
Sample
(5.5)(5.6)
(5.4)
ISO 17025
Quality Management System
MaterialMaterial
QualityQualityManagementManagement
SystemSystem
MachineMachine ManMan
MethodMethod
Specification of incoming materialSuppliers evaluationTraceability of reference standard
Well-accepted methodologiesValidation and VerificationMeasurement of uncertainties
Technical competenceTraining plan Optimized Evaluation
Maintenance planTraceability and Calibration Performance check
Current strategies for Lab QMS
(4.1, 4
.2)
(4.3
, 4.13)
(4.4, 4.7,
4.8)
(4.5, 4.6)
(4.9, 4.10, 4.11,4.12)
(4.14, 4.15)
The success lies in the combination
4.1 ISO 17025
ISO17025:2005
SUPPLIER INPUT PROCESS OUTPUT CUSTOMER
4.4 5.4.5 5.7 5.8
5.2 5.5 5.4 5.3 /4.9 5.9
4.10 4.13 5.10 5.4.6 5.10.5
4.7 4.8
4.1 4.2 4.3
4.14 4.9 4.11 4.12
4.15 4.10
LAB
4.15, 4.104.1, 4.2
4.5 4.6 5.6
4.2
()
KISS
4.2.2, 4.2.3, 4.2.4, 4.2.7, 4.1.6, 4.15.1
4.2.2, 4.2.3, 4.2.4, 4.10
:4.1.6, 4.2.4:4.7.2
4.1.5(k)
OperationalPoliciesProceduresRecords
CustomerExpectations
GovernmentRegulations
CompanyPositioning
RelationalCustomersEmployeesSuppliers
TechnicalFacilitiesEquipmentMaterial
GMPGLPGTP
4.3
4.2
4.3
4.13
4.4 /The lab shall not accept and commerce new
work without a prior feasibility study.
4M Review Man, Method, Machine, Material
4.7
4.8
Call out
Call in
3FFact, Fast, Friendly
4.5
ISO 17025/()ISO 17025
4.6
4.6.1
4.6.4
4.6.3
4.6.2/
()
4.9
4.9.1
a. b. c. (Correction;Remedial action)
d. (vs 5.10.9)
e. Resumption4.9.2
4.10 :
4.11
additional audit
4.12
Design error-free process
PlanPlan
CheckCheck DoDo
ActActWhat to do?How to do it?
Do what was planned.Did things happen according to plan?
How to improve next time?
P D C A
(4.9.1c) (4.11) (4.10) (4.12)
() Reactive It is reacting to change It is taken to prevent recurrence()
() Proactive(on-going improvement) It is preparing for change It is taken to prevent occurrence()
4.14
ISO 17025 ()
Auditing is fact finding, not fault finding. Ask system questions, not yes/no questions. Criticize the condition, not people. Look for major problems, not minor concerns. EE or LL: Eyes (Look) and Ears (Listen) of
management FF: Be Friendly and Frankly
:
+ >
4.15
()
4.14
4.15
(4.14) (4.15) (4.2)
(4.14) (4.15) (4.2)
TheManagement
System
CustomerSatisfaction
ContinualImprovement
Non conformanceInvestigation
Corrective Action& Preventive Action
Managem
ent Review
Validation Studies
& Quality Control
Audit Finding
New Te
st proc
edure
Confidence
Staff TrainingTest Resu
lts
Fit for pu
rpose
Support for Challenged results
8 Principles of GMP/GLP/GTP You shall define good policies. You shall write and follow your procedures. You shall document (record) your work. You shall validate your manufacturing and testing
processes. You shall design, build and maintain proper
facilities and equipment. You shall be competent (as a result of education,
experience, and training). You shall build quality into our products by
systematically controlling your processes. You shall audit for compliance.
ISO 17025:1999 Quality Management SystemCurrent strategies for Lab QMS4.1 ISO17025:20054.2 4.3 4.13 4.4 /4.7 4.5 4.6 4.9 4.10 4.11 4.12 4.14 4.15 8 Principles of GMP/GLP/GTP