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