Professional Documents
Culture Documents
(Volume 1)
Metrology in
(Volume 1)
LECTURES
March 10 Admin. Bldg
Metrology in General (MiG)
(Mon) (Conference room, 2nd floor)
G‐1: National standards system of Korea ‐ Prof. Dr. Gun‐Woong
10:30‐12:30 BAHNG
quality infrastructure
G‐2: QMS: why and for what ‐ management Dr. Jongseon PARK
13:30‐15:00
requirements with ISO/IEC 17025
G‐3: QMS: why and for what ‐ technical Dr. Hun‐Young SO
15:00‐17:00
requirements with ISO/IEC 17025, ISO
March 11 Conference room (Admin.
Metrology in General (MiG)
(Tue) Bldg. 2nd floor)
G‐4: Measurement and traceability Dr. Chu‐Shik KANG
09:30‐10:30
G‐5: Uncertainty in measurement Dr. Chu‐Shik KANG
11:00‐12:00
G‐5: Uncertainty in measurement Dr. Chu‐Shik KANG
13:30‐15:00
(continued)
G‐6: Uncertainty evaluation (Practice) Dr. Chu‐Shik KANG
15:30‐17:00
GLOBAL METROLOGY ACADEMY
Metrology in General
1. G-1
Metrology in Mass and Related Quantities (MRQ)
(GMA‐GT‐2014‐01‐MRQ)
Metrology in Mass and Related Quantities
(GMA‐GT‐2014‐01) MAR 10‐21, 2014, Daejeon, Korea
For the standardization, almost all of the ministries of the Korean government
have their own areas of regulations, which are in operation as part of the
standard documents of Korea. Especially for the industrial standards, which
are closely related with the ISO/IEC standards, the Korean Agency for
Technology and Standards(KATS) is responsible for it as an official member of
ISO representing Korea. Recently, KATS organized COSD, cooperating
organizations for standard developers. This organization is composed of 38
societies or institutes as of 2011 and they are responsible for developing new
standards as well as taking care of and refining those already in effect.
1
GLOBAL METROLOGY ACADEMY
Metrology in Mass and Related Quantities
(GMA‐GT‐2014‐01) MAR 10‐21, 2014, Daejeon, Korea
are KAS, the Korea Accreditation System, and KAB, the Korea Accreditation
Board. KAS is mainly working on the accreditation of the certification bodies of
final products. KAB is for the accreditation of organizations working on quality
management system certification.
2
GLOBAL METROLOGY ACADEMY
Metrology in
Mass and Related
Quantities
(GMA-GT-2014-01)
10 March 2014
Prof. Dr. Gun-Woong Bhang
(gwbahng@sunykorea.ac.kr)
Metrology in General
(G-1)
Prof. Dr. Gunwoong Bahng
한국뉴욕주립대학교 석좌교수
Prof. Dr. Gunwoong Bahng
Chair Professor, SUNY Korea
The State University of New York, Korea
W: 032-626-1222/ Cell:010-8628-3208
Fax:032-626-1539
gwbahng@sunykorea.ac.kr
Academic and Research Career
2014.1.– present Chair Professor, SUNY Korea (The State University of New York, Korea)
2012-2013. 12. Div. of Industrial Measurement Standard, Center for Energy Materials Metrology
2009 -2011 Director, National Center for Standard Reference Data, KRISS
2006-2008 Director, Office of Global Partnership, KRISS
1989-2013. 12. Principal research scientist
Served as Head, Microstructure analysis lab., Group Leader, Microstructure characterization lab. etc.
1984-1988 Senior research scientist
Education
1978- 1982 MS and Ph. D in Mat. Sci. and Eng.
Northwestern University
1972- 1976 BSc in Engineering
Dept. of Metallurgical Eng., Seoul National University
The Korean War destroyed almost everything in the Korean Peninsula. (1950’s)
Wireless Telecom
Construction Equipment
Burj Khalifa (Dubai) Computers,
Semiconductors
Petrochemicals
Automobile
Steel making Ship building
15,000
10,000
5,000
255
0
1970 1975 1980 1985 1990 1995 2000 2005 2010
Year ’70 ’75 ’80 ’85 ’90 ’95 ’00 ’05 ’10
GNI per capita
255 607 1,660 2,355 6,303 11,735 11,292 17,531 20,759
(U$)
US$79 (1960): second to the lowest in the world (* increased more than 250 times for 50 years:1960-2010)
http://kosis.kr/
Global Metrology Academy
-9-
Growth of Korea: Miracle
12
Better Standards, Better Life !
National Standards System
1 Standardization
2 Measurement Standard
3 Conformity Assessment
- Accreditation
- Certification
Ingredients
Procedure
- Grill temperature
- Heating time, etc.
STANDARDIZATION of
Process
ILAC/APLAC
Hardware Laboratory Software
Accreditation
- 20 -
Global Metrology Academy
12
Standard System
Laboratory
Measurement Accreditation Documentary
standard system standard
CIPM / MRA 인정체계
ILAC / MRA ISO/IEC, ITU
Reliability
Proficiency test
Education lab. lab.
1 Standardization
2 Measurement Standard
3 Conformity Assessment
- Accreditation
- Certification
As of 2011. March
COSD
- Co-operating Organization for Standard Development
- Established in 2006
As of June 2011
- Member organization ; 44
- Responsible for 23.5 % of KS standards (5420 stds)
- Till 2012, will take care 80 % of KS.
29, 583
30,000
25,793
22,760 22,068
20,000 IEC
5,613
10,000 ISO
16,455
ISO/IEC
KATS COSD
100 %, 2008
2. Operation of committee
- Operation of mirror committee and working groups
3. Development of standards
- Development of Korean Industrial Standards ㉿
- Review of KS every 5 years
4. Feedback
- Feedback of stakeholder opinion
Global Metrology Academy
- 31 -
Standard Development Process
1st step 2nd step 3rd step 4th step 5th step 6th step
International
KS
KATS KATS
TTA Telecommunications Technology TTA, TTAS, TTAK, KICS, IT standard, Wibro, DMB,
http://www.tta.or.kr Association IMT-2000, IMT-Advanced
KDA Korean Dental Association Tooth, dentistry, dentist, dental materials, dental
www.kda.or.kr instrument, dental equipment, oral care products,
KEA Korean Electronics Association Policy suggestion and system improvement related to
http://www.gokea.org electronic industry, Export activation support,
KEAA Korea Energy Appliances Industry Energy appliances, boilers, heating system, gas
http://www.eaa.or.kr Association industry, gas testing
KERIS Korea Education & Research Educational Information, Research Information, ICT in
http://english.keris.or.kr/e Information Service education, e-Learning
s_main/index.jsp
KT&G CRI Korea Tomorrow &Global Central Tobacco, cigarette, ginseng, red ginseng
http://www.ktng.com Research Institute Smoke, filter, cigarette paper, ginsenoside
KESI Korea Elevator Safety Institute Elevator Escalator and, movingwaik Elevator safety, lifts,
http://www.kesi.or.kr Inspection for lifts,
KOMERI Korea Marine Equipment Marine Equipment, Marine technology, ships, Testing,
www.komeri.re.kr Research Institute Certification, KOLAS, BWM, MIC
FITI FITI Testing & Research Institute technical textile, clothing, protective clothing & equipment,
www.fiti.re.kr geosynthetic, floor coverings, automotive interiors,
hygiene testing, filters,
KETI Korea Electric Testing Institute Electrical appliances, electronic appliances, electronic
http://www.keti.or.kr equipments, Medical Equipments. Safety test, Testing
and certification, EMC, Quality assurance, Performance
test,
KATRI Korea Apparel Testing & textile, apparel, geotextile, geosynthetics, test, analysis,
www.ktri,re,kr Research Institute research, reliability, standard, KOLAS, KAS, KPS, KC
KOFIC Korean Film Council Korean film, korean film industry, Korean film promotion
http://www.koreanfilm.or.kr
FILK Fire Insurers Laboratories of Fire safety, fire equipment, reaction to fire testing, fire
http://www.filk.re.kr Korea electricity, fire resistance, construction materials,
construction environment
KOCEMA Korean Construction Equipment Establishing policy and conducting research for the/
http://www.kocema.org Manufacturers Association development of the construction equipment industry
KOMMA Korea Machine Tool Machine tool, Metal forming, Metal cutting, Press, Industrial
http://www.komma.org Manufacturers’ Association robot, Lathe, Turning machine, Turning machine, Machining
center,
KOEMA Korea Electrical Manueacturers Qualification Exemption System for heavy electrical machine,
www.koema.or.kr Association Collective Standards(KOEMA Standards)
Power IT Standardization Forum
KILT Korea Institute of Lighting Lighting, Electrical appliances, Safety test, Testing and
http://www.kilt.re.kr Technology Certification, Quality assurance, Performance test
Korean Standards, Efficiency Energy, Underwriters
Laboratories, KOLAS
KTR Korea Testing & Research Testing &Evaluation, Product Certification and
http://www.ktr.or.kr Institute Assessment, Hazardous Substances Evaluation
KSAE The Korean Society of Advancing and developing automotive science &
www.ksae.org Automotive Engineers Technology, Automotive research and studies,
KSAE Baja, Automotive Standardization
KEMCO Korea Energy Management Creation of new energy, Low carbon & green energy,
www.energy.or.kr Corportion New& renewable energy
KOSA Korea Iron & Steel Steel, Steels for structural purposes, Heat treatable and
http://www.kosa.or.kr Association alloy steels, Continuous mill flat rolled products, Steel
tubes
KICET Korea Institute of Ceramic Fine Ceramics, Tiles & porcelain, white ware
http://www.kicet.re.kr Engineering & Technology
History
1970 ; Designated as the Secretariat of Central Headquarters for QC promotion
Presented the First National Quality Award
1980 ; Designated as KS certification body
2000 ; Recognized as JIS certification body by METI, Japan
Started LOHAS certification service
Organization
Standards and QM Div. KS certification Div. Int’l certification Div.
Quality Innovation Div. Knowledge Service Div. HRD Div.
1 Standardization
2 Measurement Standard
3 Conformity Assessment
- Accreditation
- Certification
BIPM
www.bipm.org
CIPM
Consultative Committees MRA
10 Consultative ( CCs )
Committees National
Ten CCs each chaired by a member of CIPM; metrology
to advise the CIPM; act on technical matters and institutes
take important role in CIPM MRA; comprise ( NMIs )
representatives of NMIs and other experts.
44
Global Metrology Academy
- 44 - Located at Sèvres, France
List of Consultative Committees
Quantity
- Number + Reference,
Reference ; unit, reference procedure, reference materials
Purpose of measurement
- To obtain data in number with unit for comparison
- Need to use the same scale and procedure
- Necessary to align with Int’l Measurement standard
Measurement standard
Material measure, measuring instrument, reference material or
measuring system intended to define, realize, conserve or reproduce a
unit or one or more values of a quantity to serve as a reference - VIM
KC (Equivalency) 1999 ~
NMI NMI
Country C
Accredited Accredited
Lab. Lab.
Accredited
Lab Providing comparability of
data by securing traceability
Accredited
Calibration and
Testing Industrial
Laboratories Reference
(KOLAS)
Working Standards
Measuring Equipment
Metrological Infrastructure
in a Country
Products
National Metrology
Institutes or designated
National laboratories
Calibration
Laboratories,
often accredited
Enterprises
End users
Potential TBT
Reducing link
Trade regulations National accreditation body(B)
Conformity Conformity
A assessment assessment B
Country Country
ISO 17025 ISO 17025
VOLUNTARY
ISO 9001/14000 ISO 9001/14000
MRAs
Test/Calibration Test/Calibration
DSME BP
Daewoo Shipbuilding and British Petroleum
Marine Engineering (Korea) (USA)
REQUIRING An Order of
calibration of all
equipment to be used
in construction
Constructing
Traceable to
NIST Offshore Plant
Technical Barrier
to Trade
Likely
quite a big
Loss of
Time!
Loss of
Money!
Accreditation by Calibration
KOLAS by KRISS
DSME
(Korea)
Traceable to KRISS
CCAUV.A-K1
644
473 460 438 430 373
2180
1598 1541
1248 1194 1139 1095
Industry
Trade Science
Standards
Defense Medicine/Health
Environment
Extended scope of
measurement standards
2002 Joint Committee for Traceability
in Laboratory Medicine (JCTLM)
Amount of substance
1995 CCQM
Physical standards 1988 CCM/CCT/CCPR
Over regional 1999
1979
boundaries
NMI
Laws/Regulations
International Standards
• Legal Basis
- Framework Act on National Standards in 1999
Total number of
20,644 19,652 19,456
Services
400 Balance
40
200
20
-
1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999 2001 2003
• BCR: benefit to cost ratio
Global Metrology Academy
- 74 -
Economic Contribution of Measurement
Contribution of measurement to the economy; 3.5 % of the GNP
- Source: Estimates of the Cost of Measurement in Twenty Major Sectors of the U.S. Economy, NBS, 1984
Gas Analysis : Quality control of products, development of new product & problem
solving in process
CRMs for Analysis of Natural Gas, Green House Gas, Air Pollution, etc.
Prices of natural
gases depend on
concentrations of
components
(hydrocarbon)
Using KRISS High-Accuracy Developed CRM for measuring Used for Calibration of Measuring
Ellipsometer thickness of thin film thickness of thin film
For SAMSUNG
- 80 -
Electronics
Global Metrology Academy
Industrial Metrology
“KRISS, exploring cutting‐edge industrial technology”
“KRISS, exploring cutting-edge industrial technology”
1 Standardization
2 Measurement Standard
3 Conformity Assessment
- Accreditation
- Certification
Examples
sampling, testing, inspection, evaluation, verification,
assurance of conformity (supplier’s declaration,
certification), registration, accreditation, approval,
and their combinations
Accreditation
means ‘to give confidence’
provides recognition that a conformity assessment body
is capable to provide its service in a professional,
reliable and efficient manner
Accreditation Body
Accreditation
Certification
Accreditation
Demands for
Certification body accreditation
Inspection body
Testing laboratory
Market
Consumer
Product/Service WTO +
Regions +
National Gov.
Producer
Requirement
Conformity assessment
CIPM MRA provides Equivalency among NMIs ; Guarantees Comparability
1 Standardization
2 Measurement Standard
3 Conformity Assessment
- Accreditation
- Certification
EA APLAC
IAAC
SADCA
ILAC
BIPM
EA
Int’l Traceability
Scheme
Calibration Testing Inspection Certification
Lab Lab Lab Body
Research
Industries Universities
Institutes
Control Cooperation/Supporting
ILAC
BIPM
EA
DAP,GAZ,
DKD DACH DAU AKS Hanover
TGA, DASMIN,
(physics) (chem/mat’l) DATech (environment) (food)
Research
Industries Universities Institutes
CA Scheme Designated
Cooperation/Supporting Int’l Traceability
Sole provider
of accreditation
In Germany
KCSC Ministry
MOTIE MND MOE MFDS
MSIP
KOLAS Accreditation
DAPA NIER RRL (KFDA)
(KATS) Body
Research
Industries Universities Customer
Institutes
Control Service
Legal Cooperation/Supporting
Only KOLAS satisfies requirements of ISO 17011 as an accreditation body.
International
OIML ISO, IEC ILAC, IAF CGPM, BIPM
Level
National
KATS (MOTIE) KRISS
Level
KOLAS,
COSD
KAB, KAS
Industry
Level Laboratory Accreditation, RM Certification, Management Certification System, Mark, etc.
ISO/IEC ISO/IEC
17025, 17020 Guide 34
Testing Lab.
Testing Lab. Reference
Reference Product Q.M.S
Calibration Lab. Material
Calibration Lab. Material Certification E.M.S.
Inspection Body Producer
Inspection Body Producer
Testing,
Calibration, ISO Guide Certification ISO 9000,
Inspection, 31, 35 Criteria ISO 14000 etc.
Method
Customer
Mission
Accreditation of Testing/Calibration Labs
Accreditation Requirements
— Testing/Calibration Labs: ISO/IES 17025
Executive Director
Testing Lab.
Testing Lab. Reference
Reference Product Q.M.S
Calibration Lab. Material
Calibration Lab. Material Certification E.M.S.
Inspection Body Producer
Inspection Body Producer
Testing,
Calibration, ISO Guide Certification ISO 9000,
Inspection, 31, 35 Criteria ISO 14000 etc.
Method
Customer
1996 Joined IAF and PAC, Recognized as EMS accreditation body by MKE
Registration
Certification body Training body
(34) Assessment (6)
Registration Training
Enterprise Assessor
(22,000) (3,900)
(As of 2011)
24,000
KAB accredited Cert.(KAB)
18,000
15,739 15,273
16,000 14,791 15,110 15,005
14,000 13,169
12,000
10,000
8,000
6,000
4,000
2,000
0
'04 '05 '06 '07 '08 '09.6
Number of KAB accredited certificates
300
TL
250 243
OHSAS
222 218
FSMS 213
200
187
150
129 ` 127
113
100
79 85 87
71 65
50 57
45 49
33
15
0
2003 2004 2005 2006 2007 2008 2009.7
※ As of 2009.7
Global Metrology Academy
- 112 -
Accreditation Body of Korea - KAS
KOLAS KAS KAB
Testing Lab.
Testing Lab. Reference
Reference Product Q.M.S
Calibration Lab. Material
Calibration Lab. Material Certification E.M.S.
Inspection Body Producer
Inspection Body Producer
Testing,
Calibration, ISO Guide Certification ISO 9000,
Inspection, 31, 35 Criteria ISO 14000 etc.
Method
Customer
1 Standardization
2 Measurement Standard
3 Accreditation/Certification
- Accreditation
- Certification
KOREA
KS Mark: KS CERTIFICATION (KC)
Mark (Voluntary)
122
Global Metrology Academy
- 122 -
Avoid duplicative work
Mutual recognition of test results
before after
Certification B
Duplic
ation Certification A
Certification A Certification B
Measurement Management
Documentary Legal Laboratory
Standards System
Standards Metrology Accreditation
Accreditation
Regional
(APEC) APMP PASC APLMF APLAC PAC
ILAC/APLAC
Hardware Accreditation Software
/Certification
KOLAS/KAB/
KAS
Certification Calibration
Processing
Transport
Body Lab PT
Farming
Testing
Provider RM
Lab Provider
Inspection
traceability
Body
• Technical
NQI Support National Metrology Institute - NMI
Regulations
• Directives
• Standards
• Laws APMP
CIPM - MRA
National
Standards
Institute
National legal
General access to requirements National
domestic market Accreditation
technical regulations, etc. Body
for Food Safety
One Standard,
We are One World.
Metrology in General
2. G-2
Metrology in Mass and Related Quantities (MRQ)
(GMA‐GT‐2014‐01‐MRQ)
QMS: Why & for What
- Management requirement of ISO/IEC 17025
By Jongseon Park, Ph D.
ISO/IEC 17025
General requirements for the competence of testing and
calibration laboratories
- overview and management and technical requirements
ISO/IEC 17025 provides a defined and ordered process for operating all
facets of a laboratory and is basis for laboratory accreditation programs. It
also specifies the general requirements that testing and calibration
laboratories have to meet if they wish to demonstrate that
they operate a management system and
are technically competent and
are able to generate technically valid test results and calibrations
The lecture starts from why the ISO/IEC 17025 is needed in the
laboratories including NMIs and comparing functions and histories between
ISO/IEC 17025 and ISO 9001.
4.1 Organization
4.2 Management systems
4.3 Document control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective actions
4.12 Preventive actions
4.13 Control of records
4.14 Internal audits
4.15 Management reviews
5. Technical Requirements
5.1 General
5.2 Personnel
5.3 Accommodation and environment conditions
5.4 Test and calibration methods and method validation
5.5 Equipment
5.6 Measurement traceability
5.7 Sampling
5.8 Handling of test and calibration items
5.9 Assuring the results
5.10 Reporting the result
Key of this lecture is six essential points of ISO/IEC 17025. Focusing on the
six key points below and relationship among the requirements, twenty-five
total requirements are explained.
Metrology in General
(G-2)
March 10, 2014
Dr. Jongseon PARK
jspark@kriss.re.kr
Summary of the main contents and goal of class
Education
Feb. 2011 Ph. D. in Management Science, Chungnam National University, Daejeon, Rep. of Korea
Apr. 1993 Master in Library and Information Science
School of Library and Information Science, University of Pittsburgh, USA
Contents
1 Why ISO/IEC 17025?
2 Overview
2-1 Comparisons of the terms
2-2 Comparisons with the other QMS
2-3 Overview of 17025
3 Management Requirements
4 Conclusion
Why ISO/IEC 17025?
General requirements for the competence
of testing and calibration laboratories
5
Why ISO/IEC 17025?
ISO/IEC 17025
• is basis for laboratory accreditation
programs
• provides a defined and ordered process for
operating all facets of a laboratory
• specifies the general requirements that
testing and calibration laboratories have to
meet if they wish to demonstrate that
– they operate a management system and
– are technically competent and
– are able to generate technically valid test
results and calibrations
6
ISO/IEC 17025 vs. ISO 9001
ISO/IEC 17025 ISO 9001
(2005) (2008)
7
ISO/IEC 17025 vs. ISO 9001
ISO 9001
Management Technical
Requirements Requirements
of ISO/IEC of ISO/IEC
17025 17025
8
Terms that may be confused
Accreditation
Procedure by which an authoritative body (the Nati
onal Accreditation Body) gives formal recogniti
on that a body (the laboratory) and its personne
l are competent to carry out specific tasks (Accre
ditation scope).
Certification
9
Terms that may be confused
Accreditation Body ISO/IEC 17011
Accreditation
Conformity Assessment
Bodies • ISO/IEC 17021
• ISO/IEC 17020
• ISO/IEC 17025 Labs Certification Bodies • ISO/IEC 17024
• ISO/IEC 17065
Results Certification
10
Terms that may be confused
Procedure
specified way to carry out an activity or a process
NOTE 1 Procedures can be documented or not.
NOTE 2 When a procedure is documented, the term “written procedure” or
“documented procedure” is frequently used. The document that contains a
procedure can be called a “procedure document”.
Process
set of interrelated or interacting activities which transfor
ms inputs into outputs
NOTE 1 Inputs to a process are generally outputs of other processes.
NOTE 2 Processes in an organization are generally planned and carried out under cont
rolled conditions to add value.
NOTE 3 A process where the conformity of the resulting product cannot be readily or e
conomically verified is frequently referred to as a “special process”
11
Terms that may be confused
Procedure
Process Management
Resources
12
Terms that may be confused
Procedure Process
Processes behave - they are
Procedures exits - they are static
dynamic
Procedures focus on satisfying the Processes focus on satisfying the
rules stakeholders
Procedures are driven by completion Processes are driven by achievement
of the task of a desired output
Procedures define the sequence of Processes transform inputs into
steps to execute a task outputs through use of resources
Processes are operated and
Procedures are implemented
managed
Procedures are discontinuous Processes flow to conclusion
Processes are driven by physical
Procedures are driven by humans
forces some of which may be human
13
Historical Summary of the amendment to
ISO/IEC 17025 and ISO 9001
ISO Guide 25
ISO 9000 TC/176
- 1978 (1st)
Established (1979)
ISO/IEC Guide 25
- 1982 (2nd) ISO 9000 Series
- 1987 (1st)
ISO/IEC Guide 25
- 1990 (3rd) ISO 9000 Series
- 1994 (2nd)
ISO/IEC 17025
- Dec 1999 (1st) ISO 9001
- 2000 (3rd)
ISO/IEC 17025
- May 2005 (2nd) ISO 9001
- 2008 ((4th)
14
ISO/IEC 17025:2005
“If testing and calibration laboratories comply with the
requirements of this International Standard, they will o
perate a quality management system for their testing
and calibration activities that also meets the principles
of ISO 9001.” (1.6)
15
Impacts from ISO 9001 to ISO/IEC 17025:2005
• Management Requirements
– Terms changed
• Client Customer
• Quality System Quality Management System or
Management System
– More responsibilities for top management
– Emphasis on continual improvement and
personnel awareness of quality efforts and
changes
– Customer feedback use and analysis required
– Evaluation of effectiveness of training required
• Technical Requirements
– Analysis of quality control data required
16
Relationship among the Requirements of ISO/IEC 17025
4.1
Organization
4.2 4.15 4.14
Mngt. System Mngt. Review Internal Audits
4.13 4.3 4.10 4.11 4.8
Records Document Improvement Corrective Actions Complaints
4.12
4.4 Preventive Actions 4.9 4.7
Review of 4.5 4.6 Nonconforming Service to
Contract Subcontracting Purchasing Work Customer
17
Essentials of ISO/IEC 17025:2005
• Management Requirements
– Control of Customer Feedbacks
– Internal Audits
– Management Reviews
• Technical Requirements
– Personnel
– Method and Method Validations
– Equipments including Traceability
18
ISO/IEC 17025
General requirements for the competence
of testing and calibration laboratories
- management requirements
23
Organization (4.1)
• The laboratory shall
a. have managerial and technical personnel who,
irrespective of other responsibility, have the
authority and resources needed to carry out their
duties , including the implementation, system, and
to identify the occurrence of departures from the
management system or from the procedures for
performing tests and/or calibrations, and to initiate
actions to prevent or minimize such departures(see
also 5.2).
b. have arrangements to ensure that its management
and personnel are free from any undue
internal and external commercial, financial
and other pressures and influences that may
adversely affect the quality of their work.
24
Organization (4.1)
c. have policies and procedures to ensure the
protection of its customers' confidential
information and proprietary rights, including
procedures for protecting the electronic storage and
transmission of results.
d. have policies and procedures to avoid
involvement in any activities that would
diminish confidence in its competence,
impartiality, judgement or operational integrity.
e. define the organization and management
structure of the laboratory, its place in any
parent organization, and the relationships
between quality management, technical operations
and support services.
25
Organization (4.1)
f. specify the responsibility, authority and
interrelationships of all personnel who manage,
perform or verify work affecting the quality of the
tests and/or calibrations.
g. provide adequate supervision of testing and
calibration staff, including trainees, by persons
familiar with methods and procedures,
purpose of each test and/or calibration, and
with the assessment of the test or calibration
results.
h. have technical management which has overall
responsibility for the technical operations and the
provision of the resources needed to ensure the
required quality of laboratory operations.
26
Organization (4.1)
i. appoint a member of staff as quality manager
(however named) who, irrespective of other duties
and responsibilities, shall have defined responsibility
and authority for ensuring that management system
related to quality is implemented and followed at all
times; the quality manager shall have direct access
to the highest level of management at which
decisions are made on laboratory policy or
resources.
j. appoint deputies for key managerial personnel.
27
Organization (4.1)
k. ensure that its personnel are aware of the
relevance and importance of their activities and
how they contribute to the achievement of the
objectives of the management system.
• NOTE Individuals may have more than one function and it
may be impractical to appoint deputies for every function.
Top
management
Technical Technical
Quality
Manager in Manager in
manager
area A area B
29
4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management 4.9 Control of
System nonconforming testing
4.3 Document control and/or calibration work
4.4 Review of requests, 4.10 Improvement
tenders and contracts 4.11 Corrective actions
4.5 Subcontracting of 4.12 Preventive actions
tests and calibrations 4.13 Control of records
4.6 Purchasing services 4.14 Internal audits
and supplies 4.15 Management reviews
4.7 Service to the
customer
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Management system (4.2)
Quality
manual
Procedures
• Guides
• Service Procedures
35
Document control (4.3)
36
4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming testing
4.4 Review of and/or calibration work
requests, tenders 4.10 Improvement
and contracts 4.11 Corrective actions
4.5 Subcontracting of 4.12 Preventive actions
tests and calibrations 4.13 Control of records
4.6 Purchasing services 4.14 Internal audits
and supplies 4.15 Management reviews
4.7 Service to the
customer
37
Review of requests, tenders and contracts (4.4)
46
4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming
testing and/or
4.4 Review of requests,
calibration work
tenders and contracts
4.10 Improvement
4.5 Subcontracting of
tests and calibrations 4.11 Corrective actions
4.6 Purchasing services 4.12 Preventive actions
and supplies 4.13 Control of records
4.7 Service to the 4.14 Internal audits
customer 4.15 Management reviews
47
Control of nonconforming testing and/or calibration work
(4.9)
48
Control of nonconforming testing and/or calibration work
(4.9)
• Key non-conformities in the
requirements of ISO/IEC 17025 found
during KOLAS assessment
– No or insufficient training
– No technical procedures (standard
operating procedures or guide to services)
or No amendment
– No or inadequate validation of methods
– Insufficient integrity of electronic records
49
4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming testing
and/or calibration work
4.4 Review of requests,
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and calibrations 4.12 Preventive actions
4.6 Purchasing services 4.13 Control of records
and supplies 4.14 Internal audits
4.7 Service to the 4.15 Management reviews
customer
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Improvement (4.10)
51
4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming testing
and/or calibration work
4.4 Review of requests,
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and calibrations 4.12 Preventive actions
4.6 Purchasing services 4.13 Control of records
and supplies 4.14 Internal audits
4.7 Service to the 4.15 Management reviews
customer
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Corrective actions (4.11)
• The laboratory shall establish a policy and
procedure and shall designate appropriate
authorities for implementing corrective action
when nonconforming work or departures from the
policies and procedures in the quality system or
technical operations have been identified. (4.11.1)
• Steps to implement corrective action (4.11.2,4.11.3)
– Analysis of root cause(s) of the problem
– Implement the action
– Prevent recurrence
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4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming testing
and/or calibration work
4.4 Review of requests,
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and calibrations 4.12 Preventive
4.6 Purchasing services actions
and supplies 4.13 Control of records
4.7 Service to the 4.14 Internal audits
customer 4.15 Management reviews
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Preventive actions (4.12)
• Needed improvements and potential sources
of nonconformities, either technical or concerning
the quality system, shall be identified. When
improvement opportunities are identified or if
preventive action is required, action plans shall
be developed, implemented and monitored to
reduce the likelihood of the occurrence of such
nonconformities and to take advantage of the
opportunities for improvement. (4.12.1)
• Preventive action is a pro-active process to
identify opportunities for improvement rather than a
reaction to the identification of problems or
complaints. (4.12.2 note)
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4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming testing
and/or calibration work
4.4 Review of requests,
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and calibrations 4.12 Preventive actions
4.6 Purchasing services 4.13 Control of records
and supplies 4.14 Internal audits
4.7 Service to the 4.15 Management reviews
customer
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Control of records (4.13)
The laboratory shall establish and
maintain procedures for
identification, collection, indexing,
access, storage, maintenance and
disposal of quality and technical
records. Quality records shall include
reports from internal audits and
management reviews as well as records of
corrective and preventive
actions.(4.13.1.1)
Back-ups are need for the electronic
records (4.13.1.4) 57
Control of records (4.13)
Including technical records.(4.13.2.1)
accumulations of data and information which
result from carrying out tests and/or
calibrations and which indicate whether
specified quality or process parameters are
achieved.
may include forms, contracts, work sheets,
work books, check sheets, work notes, control
graphs, external and internal test reports and
calibration certificates, customers' notes,
papers and feedback.
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Control of records (4.13)
59
4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming testing
and/or calibration work
4.4 Review of requests,
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and calibrations 4.12 Preventive actions
4.6 Purchasing services 4.13 Control of records
and supplies 4.14 Internal audits
4.7 Service to the 4.15 Management reviews
customer
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Internal audits (4.14)
• Objective : to ensure the services be carried out in
accordance with the regulations of quality manuals
• The laboratory shall periodically, and in accordance
with a predetermined schedule and procedure,
conduct internal audits of its activities to verify
that its operations continue to comply with
the requirements of the management system
and this International Standard. (4.14.1)
– It is the responsibility of the quality manager to plan
and organize audits.
– Audits shall be carried out by trained and qualified
personnel who are independent of the activity to be
audited.
– The cycle for internal auditing should normally be
completed in one year (4.14.1 note)
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4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 Management System 4.9 Control of
4.3 Document control nonconforming testing
and/or calibration work
4.4 Review of requests,
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and calibrations 4.12 Preventive actions
4.6 Purchasing services 4.13 Control of records
and supplies 4.14 Internal audits
4.7 Service to the 4.15 Management
customer reviews
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Management reviews (4.15)
• Objectives : to ensure suitability and effectiveness
of management system and to draw out measures
for further improvements
• In accordance with a predetermined schedule and
procedure, the laboratory’s executive management
shall periodically conduct a review of the
laboratory’s management system and testing and/or
calibration activities to ensure their continuing
suitability and effectiveness, and to introduce
necessary changes or improvements. (4.15.1)
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Management reviews (4.15)
• Points of Reviews
– the suitability of policies and procedures.
– reports from managerial and supervisory personnel.
– the outcome of recent internal audits.
– corrective and preventive action.
– assessments by external bodies.
– the results of interlaboratory comparisons or proficiency
tests
– changes in the volume and type of the work.
– customer feedback.
– complaints.
– other relevant factors, such as quality control activities,
resources and staff training.
– recommendations for improvement.
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Conclusion
• Essential Points of Management
Requirements
– Control of Customer Feedbacks
– Internal Audits
– Management Reviews
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Questions ?
감사합니다!
(Gam-sa-ham-ni-da)
Thank You !
Jongseon Park
jspark@kriss.re.kr
66
Terminology in ISO/IEC 17025
Quality System - formalized business practices that
define management responsibilities for
organizational structure, processes, procedures
and resources needed to fulfill product/service
requirements, customer satisfaction, and continual
improvement.
• MD : Managing Director
• ED : Executive Director
Bibliographies
ISO 9000:2005
Quality management systems – Fundamentals and vocabulary (3rd)
ISO 9001:2008
Quality management systems – Requirements (4th)
ISO 17000:2004
Conformity assessment – Vocabulary and general pronciples (1st)
ISO/IEC 17025:2005
General requirements for the competence of the testing and calibration laboratories (2nd)
GLOBAL METROLOGY ACADEMY
Metrology in General
3. G-3
Metrology in Mass and Related Quantities (MRQ)
(GMA‐GT‐2014‐01‐MRQ)
Metrology in
Mass and Related
Quantities
(GMA-GT-2014-01)
10 March 2014
Hun-Young SO, Ph.D.
(hyso@shimadzu.co.kr)
Metrology in General
(G-3)
ISO/IEC 17025:2005
General requirements for the competence of
testing and calibration laboratories
Exigences générales concernant la compétence des
laboratoires d'étalonnages et d'essais
Career
2014. 1. - present Advisor, Dongil Shimadzu co.
1988 – 2013.12. Research Scientist, KRISS
1988 - 2012 Served the TCQM of the APMP as a Chair and as a participant
1994 - 2012 Founded CCQM and delegated to the CC
2009 - 2012 Director, Division of Metrology for Quality of Life
1993 - 1998 Director, Division of Metrology in Chemistry and Materials
Visits NMI Australia, NMI Japan, NIM China, A*STAR, HSA (Singapore), PTB, LGC, NPL,
LNE, VSL, NIMT, VIM, MASM, NMI Ethiopia, VNIIM, NIST, NRC Canada, CENAM,
INM (Colombia)
Education
1987 Ph. D. in Physical Chemistry, Case Western Reserve University
1983 M.S. in Analytical Chemistry, University of Kansas
1980 M.S. in Organic Chemistry, Seoul National University
1974 B.S. in Chemical Education, Seoul National University
Introduction (1/3)
ISO/IEC 17025:2005
The first edition (1999) of this International Standard was produced as the
result of extensive experience in the implementation of ISO/IEC Guide 25 and
EN 45001, both of which it replaced. It contained all of the requirements that
testing and calibration laboratories have to meet if they wish to demonstrate
that they operate a management system, are technically competent, and are
able to generate technically valid results.
The first edition referred to ISO 9001:1994 and ISO 9002:1994. These
standards have been superseded by ISO 9001:2000, which made an
alignment of ISO/IEC 17025 necessary. In this second edition, clauses have
been amended or added only when considered necessary in the light of ISO
9001:2000.
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History of ISO/IEC 17025:2005
ISO Guide 25:1978 – “General Requirements for the Competence of Testing and Calibration Laboratories” (1st Edition)
European Standard EN 45001:1989 - “General Criteria for the Operation of Testing Laboratories”
ISO/IEC 17025:1999 - “General Requirements for the Competence of Testing and Calibration Laboratories”
ISO 9001:2000 replaces ISO 9001, 9002, 9003 – customer focus, people involvement, continuous improvement
ISO/IEC 17025:2005 - “General Requirements for the Competence of Testing and Calibration Laboratories”
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ISO 17025 vs. ISO 9001
• ISO 9001: the general standard specifying the requirements for a
quality management system.
– an organisation which holds ISO 9001 certification may use a laboratory
accredited against ISO 17025 as a supplier of test data without the
need to carry out its own audit of the laboratory’s quality system.
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ISO 17025 vs. ISO 9001
• The additional requirements in ISO 17025 include;
– participation in proficiency testing,
– adherence to documented, validated methodology,
– specification of technical competence.
• ISO 17025 assessment bodies will always use technical assessors who
are specialists and who carry out a peer review of the methods being used
and the way in which those methods are applied.
• Laboratories meeting the requirements of ISO 17025 fulfil all the relevant
requirements of ISO 9001 when acting as subcontractors. The practical
effect of this is that if an organisation which is certified to ISO 9001 is using
an ISO 17025 accredited laboratory as a sub-contractor, it can treat it as
an ISO 9001 certified sub-contractor for any work within the laboratory’s
scope of ISO 17025 accreditation.
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ISO/IEC 17025, 1999 vs. 2005
• No fundamental differences between the two
• No essential difference in the technical requirements
• The main differences can be summed up as follows:
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Introduction (2/3)
Accreditation bodies that recognize the competence of testing and calibration
laboratories should use this International Standard as the basis for their
accreditation. Clause 4 specifies the requirements for sound management.
Clause 5 specifies the requirements for technical competence for the type of
tests and/or calibrations the laboratory undertakes.
Growth in the use of management systems generally has increased the need to
ensure that laboratories which form part of larger organizations or offer other
services can operate to a quality management system that is seen as compliant
with ISO 9001 as well as with this International Standard. Care has been taken,
therefore, to incorporate all those requirements of ISO 9001 that are relevant to
the scope of testing and calibration services that are covered by the
laboratory's management system.
Testing and calibration laboratories that comply with this International Standard
will therefore also operate in accordance with ISO 9001.
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Accreditation
• Accreditation is generally performed by national accreditation bodies (AB).
• A laboratory might use an AB other than its domestic organisation when,
– the latter has either no international recognition or
– where it lacks recognition in parts of the world relevant to the laboratory’s operations.
• International recognition of accreditations awarded by national bodies is
based on the Mutual Recognition Agreements (MRAs) between national AB.
• AB audit each other’s operations against ISO 17011.
• Regional laboratory accreditation conferences linked through ILAC.
– APLAC, EAL, SADCA
Scope of Acccreditation
• ‘accredited laboratory’ is not accurate
• a laboratory accredited for a specific list of methods
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Introduction (3/3)
Conformity of the quality management system within which the laboratory
operates to the requirements of ISO 9001 does not of itself demonstrate the
competence of the laboratory to produce technically valid data and results. Nor
does demonstrated conformity to this International Standard imply conformity of
the quality management system within which the laboratory operates to all the
requirements of ISO 9001.
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History of international mutual
recognition
• Bilateral agreements of corporations
– U.K. NPL – U.S. NBS, 1983
– U.K. – Australia, New Zealand, 1985
– U. K. – France, 1986
– U. K. – The Netherlands, Hong Kong, 1990
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IS for Accreditation
• Accreditation bodies operate according to ISO/IEC 17011
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CIPM MRA
2 Scope of the arrangement
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CIPM MRA
7.3 In addition to participation in the key and supplementary comparisons, identified in
paragraph 6, recognition of calibration and measurement certificates requires one of the
following procedures in order to establish the necessary mutual confidence:
a. an NMI that chooses for its calibration and measurement services a quality system
that meets the requirements of ISO Guide 25 or equivalent for an NMI, assessed by
an accreditation body fulfilling the requirements of ISO Guide 58, declares its
calibration measurement capabilities (see paragraph T.7) and submits them to the
local RMO for review and transmission to the Joint Committee for analysis and
inclusion in Appendix C;
b. an NMI that chooses to use a different way of assuring quality or chooses a different
quality system, or ISO Guide 25 without third-party assessment, for its calibration and
measurement services declares its calibration measurement capabilities (see
paragraph T.7) and submits them to the local RMO for review and transmission to the
Joint Committee for analysis and inclusion in Appendix C.
5.8 Handling items 5.4 Method & validation Data handling 5.10 Reporting results
Testing/Calibration
5.3 Acconmmodation 5.5 Equipment 5.9 Quality of Results
and environment
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2 Normative references
• ISO/IEC 17000, Conformity assessment — Vocabulary and general
principles
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3 Terms and definitions
• ISO/IEC 17000:2004
Conformity assessment - Vocabulary and general principles
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4 Management requirements
4.1 Organization
4.2 Management system
4.3 Document control
4.4 Review of requests, tenders and contracts
4.5 Subcontracting of tests and calibrations
4.6 Purchasing services and supplies
4.7 Service to the customer
4.8 Complaints
4.9 Control of nonconforming testing and/or calibration work
4.10 Improvement
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management reviews
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5 Technical requirements
5.1 General
5.2 Personnel
5.3 Accommodation and environmental conditions
5.4 Test and calibration methods and method 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 and calibration results
5.10 Reporting the results
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5.1 General
5.1.1 Factors affecting calibration/test results :
- human factors (5.2)
- accommodation and environmental conditions (5.3)
- test and calibration methods and method validation (5.4)
- equipment (5.5)
- measurement traceability (5.6)
- sampling (5.7)
- the handling of test and calibration items (5.8)
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5.2 Personnel
5.2.1 The laboratory management shall ensure the competence of all who
operate specific equipment, perform tests and/or calibrations, evaluate
results, and sign test reports and calibration certificates. When using
staff who are undergoing training, appropriate supervision shall be
provided. Personnel performing specific tasks shall be qualified on
the basis of appropriate education, training, experience and/or
demonstrated skills, as required.
5.2.2 The management of the laboratory shall formulate the goals with
respect to the education, training and skills of the laboratory personnel.
The laboratory shall have a policy and procedures for identifying
training needs and providing training of personnel. The training
programme shall be relevant to the present and anticipated tasks of the
laboratory. The effectiveness of the training actions taken shall be
evaluated.
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5.2.3 The laboratory shall use personnel who are employed by, or under
contract to, the laboratory. Where contracted and additional technical
and key support personnel are used, the laboratory shall ensure that
such personnel are supervised and competent and that they work in
accordance with the laboratory's quality system.
5.2.4 The laboratory shall maintain current job descriptions for managerial,
technical and key support personnel involved in tests and/or calibrations.
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5.3 Accommodation and
environmental conditions
5.3.1 Laboratory facilities for testing and/or calibration, including but not
limited to energy sources, lighting and environmental conditions, shall
be such as to facilitate correct performance of tests and/or calibrations.
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5.3.2 The laboratory shall monitor, control and record environmental
conditions as required by the relevant specifications, methods and
procedures or where they may influence the quality of the results. Due
attention shall be paid, for example, to biological sterility, dust,
electromagnetic disturbances, radiation, humidity, electrical supply,
temperature, and sound and vibration levels, as appropriate to the
technical activities concerned. Tests and calibrations shall be
stopped when the environmental conditions jeopardize the results
of the tests and/or calibrations.
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5.3.3 There shall be effective separation between neighbouring
areas in which there are incompatible activities. Measures shall
be taken to prevent cross-contamination.
5.3.4 Access to and use of areas affecting the quality of the tests
and/or calibrations shall be controlled. The laboratory shall
determine the extent of control based on its particular
circumstances.
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5.4 Test and calibration methods
and method validation
5.4.1 General
The laboratory shall use appropriate methods and procedures for all tests
and/or calibrations within its scope. These include sampling, handling,
transport, storage and preparation of items to be tested and/or calibrated,
and, where appropriate, an estimation of the measurement uncertainty as well
as statistical techniques for analysis of test and/or calibration data.
The laboratory shall have instructions on the use and operation of all relevant
equipment, and on the handling and preparation of items for testing and/or
calibration, or both, where the absence of such instructions could jeopardize the
results of tests and/or calibrations. All instructions, standards, manuals and
reference data relevant to the work of the laboratory shall be kept up to
date and shall be made readily available to personnel (see 4.3). Deviation
from test and calibration methods shall occur only if the deviation has been
documented, technically justified, authorized and accepted by the customer.
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5.4.2 Selection of methods
The laboratory shall use test and/or calibration methods, including methods for sampling,
which meet the needs of the customer and which are appropriate for the tests and/or
calibrations it undertakes. Methods published in international, regional or national
standards shall preferably be used. The laboratory shall ensure that it uses the latest
valid edition of a standard unless it is not appropriate or possible to do so. When
necessary, the standard shall be supplemented with additional details to ensure
consistent application.
When the customer does not specify the method to be used, the laboratory shall select
appropriate methods that have been published either in international, regional or national
standards, or by reputable technical organizations, or in relevant scientific texts or
journals, or as specified by the manufacturer of the equipment. Laboratory developed
methods or methods adopted by the laboratory may also be used if they are
appropriate for the intended use and if they are validated. The customer shall be
informed as to the method chosen. The laboratory shall confirm that it can properly
operate standard methods before introducing the tests or calibrations. If the standard
method changes, the confirmation shall be repeated.
The laboratory shall inform the customer when the method proposed by the
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5.4.3 Laboratory-developed methods
The introduction of test and calibration methods developed by the laboratory for
its own use shall be a planned activity and shall be assigned to qualified
personnel equipped with adequate resources.
Plans shall be updated as development proceeds and effective communication
amongst all personnel involved shall be ensured.
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5.4.5 Validation of methods
5.4.5.3 The range and accuracy of the values obtainable from validated
methods (e.g. the uncertainty of the results, detection limit, selectivity
of the method, linearity, limit of repeatability and/or reproducibility,
robustness against external influences and/or cross-sensitivity
against interference from the matrix of the sample/test object) as
assessed for the intended use, shall be relevant to the
customers' needs.
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5.4.6 Estimation of uncertainty of measurement
5.4.6.2 Testing laboratories shall have and shall apply procedures for
estimating uncertainty of measurement. In certain cases the nature of
the test method may preclude rigorous, metrologically and statistically
valid, calculation of uncertainty of measurement. In these cases the
laboratory shall at least attempt to identify all the components of
uncertainty and make a reasonable estimation, and shall ensure that
the form of reporting of the result does not give a wrong impression of
the uncertainty. Reasonable estimation shall be based on knowledge
of the performance of the method and on the measurement scope
and shall make use of, for example, previous experience and
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5.4.6.3 When estimating the uncertainty of measurement, all
uncertainty components which are of importance in the
given situation shall be taken into account using appropriate
methods of analysis.
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5.4.7 Control of data
5.4.7.2 When computers or automated equipment are used for the acquisition,
processing, recording, reporting, storage or retrieval of test or
calibration data, the laboratory shall ensure that:
a) computer software developed by the user is documented in sufficient
detail and is suitably validated as being adequate for use;
b) procedures are established and implemented for protecting the data;
such procedures shall include, but not be limited to, integrity and
confidentiality of data entry or collection, data storage, data
transmission and data processing;
c) computers and automated equipment are maintained to ensure proper
functioning and are provided with the environmental and operating
conditions necessary to maintain the integrity of test and calibration
data.
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5.5 Equipment
5.5.1 The laboratory shall be furnished with all items of sampling,
measurement and test equipment required for the correct performance of
the tests and/or calibrations (including sampling, preparation of test
and/or calibration items, processing and analysis of test and/or
calibration data). In those cases where the laboratory needs to use
equipment outside its permanent control, it shall ensure that the
requirements of this International Standard are met.
5.5.2 Equipment and its software used for testing, calibration and sampling
shall be capable of achieving the accuracy required and shall comply
with specifications relevant to the tests and/or calibrations concerned.
Calibration programmes shall be established for key quantities or values
of the instruments where these properties have a significant effect on the
results. Before being placed into service, equipment including that used
for sampling) shall be calibrated or checked to establish that it meets
the laboratory's specification requirements and complies with the relevant
standard specifications. It shall be checked and/or calibrated before
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5.5.3 Equipment shall be operated by authorized personnel. Up-to-date
instructions on the use and maintenance of equipment (including any
relevant manuals provided by the manufacturer of the equipment) shall
be readily available for use by the appropriate laboratory personnel.
5.5.4 Each item of equipment and its software used for testing and calibration
and significant to the result shall, when practicable, be uniquely
identified.
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5.5.5 Records shall be maintained of each item of equipment and its software
significant to the tests and/or calibrations performed. The records shall
include at least the following:
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5.5.6 The laboratory shall have procedures for safe handling, transport,
storage, use and planned maintenance of measuring equipment to
ensure proper functioning and in order to prevent contamination or
deterioration.
5.5.8 Whenever practicable, all equipment under the control of the laboratory
and requiring calibration shall be labelled, coded or otherwise
identified to indicate the status of calibration, including the date
when last calibrated and the date or expiration criteria when
recalibration is due
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5.5.9 When, for whatever reason, equipment goes outside the direct
control of the laboratory, the laboratory shall ensure that the
function and calibration status of the equipment are checked
and shown to be satisfactory before the equipment is returned to
service.
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5.6 Measurement traceability
5.6.1 General
All equipment used for tests and/or calibrations, including equipment for
subsidiary measurements (e.g. for environmental conditions) having a
significant effect on the accuracy or validity of the result of the test, calibration
or sampling shall be calibrated before being put into service. The laboratory
shall have an established programme and procedure for the calibration of
its equipment.
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5.6.2.1.2 There are certain calibrations that currently cannot be
strictly made in SI units. In these cases calibration shall provide
confidence in measurements by establishing traceability to appropriate
measurement standards such as:
– the use of certified reference materials provided by a
competent supplier to give a reliable physical or chemical
characterization of a material;
– the use of specified methods and/or consensus standards
that are clearly described and agreed by all parties concerned.
Participation in a suitable programme of interlaboratory comparisons is
required where possible.
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5.6.2.2 Testing
5.6.2.2.1 For testing laboratories, the requirements given in 5.6.2.1 apply for
measuring and test equipment with measuring functions used,
unless it has been established that the associated contribution from
the calibration contributes little to the total uncertainty of the test
result. When this situation arises, the laboratory shall ensure that
the equipment used can provide the uncertainty of measurement
needed.
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5.6.3 Reference standards and reference materials
The laboratory shall have a programme and procedure for the calibration
of its reference standards. Reference standards shall be calibrated by a body
that can provide traceability as described in 5.6.2.1. Such reference standards
of measurement held by the laboratory shall be used for calibration only and
for no other purpose, unless it can be shown that their performance as
reference standards would not be invalidated. Reference standards shall be
calibrated before and after any adjustment.
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5.6.3.3 Intermediate checks
The laboratory shall have procedures for safe handling, transport, storage
and use of reference standards and reference materials in order to prevent
contamination or deterioration and in order to protect their integrity.
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5.7 Sampling
5.7.1 The laboratory shall have a sampling plan and procedures for
sampling when it carries out sampling of substances, materials or
products for subsequent testing or calibration. The sampling plan as well
as the sampling procedure shall be available at the location where
sampling is undertaken. Sampling plans shall, whenever reasonable, be
based on appropriate statistical methods. The sampling process shall
address the factors to be controlled to ensure the validity of the test and
calibration results.
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5.7.3 The laboratory shall have procedures for recording relevant data and
operations relating to sampling that forms part of the testing or
calibration that is undertaken. These records shall include the sampling
procedure used, the identification of the sampler, environmental
conditions (if relevant) and diagrams or other equivalent means to
identify the sampling location as necessary and, if appropriate, the
statistics the sampling procedures are based upon.
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Global Metrology Academy
5.8 Handling of test and
calibration items
5.8.1 The laboratory shall have procedures for the transportation, receipt,
handling, protection, storage, retention and/or disposal of test and/or
calibration items, including all provisions necessary to protect the
integrity of the test or calibration item, and to protect the interests of the
laboratory and the customer.
5.8.2 The laboratory shall have a system for identifying test and/or
calibration items. The identification shall be retained throughout the life
of the item in the laboratory. The system shall be designed and operated
so as to ensure that items cannot be confused physically or when
referred to in records or other documents. The system shall, if
appropriate, accommodate a sub-division of groups of items and the
transfer of items within and from the laboratory.
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Global Metrology Academy
5.8.3 Upon receipt of the test or calibration item, abnormalities or departures
from normal or specified conditions, as described in the test or
calibration method, shall be recorded. When there is doubt as to the
suitability of an item for test or calibration, or when an item does not
conform to the description provided, or the test or calibration required is
not specified in sufficient detail, the laboratory shall consult the
customer for further instructions before proceeding and shall record
the discussion.
5.8.4 The laboratory shall have procedures and appropriate facilities for
avoiding deterioration, loss or damage to the test or calibration item
during storage, handling and preparation. Handling instructions provided
with the item shall be followed. When items have to be stored or
conditioned under specified environmental conditions, these conditions
shall be maintained, monitored and recorded. Where a test or calibration
item or a portion of an item is to be held secure, the laboratory shall have
arrangements for storage and security that protect the condition and
integrity of the secured items or portions concerned.
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Global Metrology Academy
5.9 Assuring the quality of test
and calibration results
5.9.1 The laboratory shall have quality control procedures for monitoring
the validity of tests and calibrations undertaken. The resulting data
shall be recorded in such a way that trends are detectable and, where
practicable, statistical techniques shall be applied to the reviewing of the
results. This monitoring shall be planned and reviewed and may
include, but not be limited to, the following:
a) regular use of certified reference materials and/or internal quality
control using secondary reference materials;
b) participation in interlaboratory comparison or proficiency-testing
programmes;
c) replicate tests or calibrations using the same or different methods;
d) retesting or recalibration of retained items;
e) correlation of results for different characteristics of an item.
5.9.2 Quality control data shall be analysed and, where they are found to be
outside pre-defined criteria, planned action shall be taken to correct the
problem and incorrect results from being reported.
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Global Metrology Academy
5.10 Reporting the results
5.10.1 General
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5.10.4 Calibration certificates
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Global Metrology Academy
5.10.4.2 The calibration certificate shall relate only to quantities and the results
of functional tests. If a statement of compliance with a specification
is made, this shall identify which clauses of the specification are met
or not met.
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Global Metrology Academy
5.10.4.3 When an instrument for calibration has been adjusted or repaired, the
calibration results before and after adjustment or repair, if available,
shall be reported.
5.10.4.4 A calibration certificate (or calibration label) shall not contain any
recommendation on the calibration interval except where this has
been agreed with the customer. This requirement may be superseded
by legal regulations.
When opinions and interpretations are included, the laboratory shall document
the basis upon which the opinions and interpretations have been made.
Opinions and interpretations shall be clearly marked as such in a test report.
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Global Metrology Academy
5.10.6 Testing and calibration results obtained from subcontractors
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Global Metrology Academy
5.10.8 Format of reports and certificates
The format shall be designed to accommodate each type of test or calibration
carried out and to minimize the possibility of misunderstanding or misuse.
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Global Metrology Academy
THE END
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Global Metrology Academy
GLOBAL METROLOGY ACADEMY
Metrology in General
4. G-4
Uncertainty in Measurement
(Lecture and practice)
Dr. Chu‐Shik KANG
Metrology in Mass and Related Quantities (MRQ)
(GMA‐GT‐2014‐01‐MRQ)
Global Metrology Academy
Measurement, Traceability,
and Measurement Uncertainty
March 11 2014
Chu-Shik Kang
cskang@kriss.re.kr
KRISS
About the lecturer
Dr. Chu-Shik Kang
Phone: +82-42-868-5103 / Cell: +82-10-9405-3384
Fax: +82-42-868-5012
Email: cskang@kriss.re.kr
Education
1983 – 1987: BS in Physics education, Seoul National University
1987 – 1989: MS in Physics, KAIST
1989 – 1993: Ph.D. in Physics, KAIST
2
Will deal with…
Metrology
Categories of metrology
International organizations of metrology
CIPM MRA, RMO, NMI, DI, KC, SC, KCDB
Metrological traceability, Calibration, CMC
SI units
Some vocabularies related to measurement
Measurement uncertainty
Definition of measurement uncertainty
Measurement function, standard uncertainty
law of propagation of uncertainty
Evaluation methods
Approximation of combined standard uncertainty
Coverage factor, expanded uncertainty, reporting
Concept of Monte Carlo method
Example
3
Metrology
2. Industrial metrology
has to ensure the adequate functioning of
Industrial measurement instruments used in industry, in
metrology production and testing processes, for ensuring quality of
life for citizens and for academic research.
3. Legal metrology
Legal is concerned with measurements where these influence
the transparency of economic transactions, particularly
metrology where there is a requirement for legal verification of the
measuring instrument.
5
Metrology related Organizations
National-level
CGPM
General Conference on
Weights and Measures
CIPM
International committee
for Weights and
Measures
BIPM CC
Consultative
International Bureau of Committee
Weights and Measures
7
BIPM
8
Consultative Committees (CCs) of CIPM
CCAUV: Consultative Committee for Acoustics, Ultrasound and
Vibration
CCEM: Consultative Committee for Electricity and Magnetism
CCL: Consultative Committee for Length
CCM: Consultative Committee for Mass and Related Quantities
CCPR: Consultative Committee for Photometry and Radiometry
CCQM: Consultative Committee for Amount of Substance - Metrology
in Chemistry
CCRI: Consultative Committee for Ionizing Radiation
CCT: Consultative Committee for Thermometry
CCTF: Consultative Committee for Time and Frequency
CCU: Consultative Committee for Units
Several Working Groups under each CC
9
Regional Metrology Organization (RMO)
10
NMI and DI
NMI: National Metrology Institute
DI: Designated Institute
Republic of Korea: KRISS
Bangladesh: NML-BSTI, DRICM
Hong Kong: SCL
Indonesia: Puslit KIM-LIPI, PTKMR-BATAN, RCChem-LIPI
Kenya: KEBS
Mongolia: MASM
Philippines: NML/ITDI
Vietnam: VMI, INST (, historically QUATEST3 was an NMI)
Zambia: ZABS
Zimbabwe: NMI-SIRDC
Ethiopia: NMIE
11
CIPM MRA
13
CIPM MRA (3)
14
Calibration
15
Main Reasons to Calibrate an Instrument
16
Metrological Traceability
Property of a measurement
whereby the result can be
related to a reference through
an unbroken chain of
calibrations, each contributing
to the measurement
uncertainty.
A traceability chain is an
unbroken chain of comparisons,
all having stated uncertainties.
This ensures that a
measurement result or the
value of a standard is related to
references at the higher levels,
ending at the primary standard.
17
International Comparisons
Key Comparison (KC): CIPM KC, RMO KC
Supplementary Comparison (SC): CIPM SC, RMO SC
Pilot Study
18
BIPM KCDB
19
Calibration and Measurement Capability (CMC)
A “CMC” is:
a Calibration and Measurement Capability
available to customers under normal conditions:
20
CMC (2)
CMC is described in the KCDB by:
measured quantity
range
expanded uncertainty (level of confidence: 95 %)
method or instrument used
values of the influence parameters if any
any other relevant information
21
Example of Appendix C
22
3 Important Documents regarding Metrology
1. SI
2. GUM (JCGM 100)
3. VIM (JCGM 200)
23
SI: International System of Units
24
SI base unit: metre
Metre (Meter)
Definition:
25
SI base unit: kilogram
kilogram
Definition:
The kilogram is the unit of
mass; it is equal to the mass
of the international prototype
of the kilogram.
3rd CGPM (1901)
The only unit based on
prototype
26
Efforts on re-definition of the kilogram
Avogadro project
Determination of Avogadro
constant
Counting number of atoms in a
silicon sphere
27
SI base unit: second
second
Definition:
The second is the duration
of 9 192 631 770 periods of
the radiation corresponding
to the transition between
the two hyperfine levels of
the ground state of the
caesium 133 atom.
13th CGPM (1967)
28
SI base unit: kelvin
kelvin
Definition:
The kelvin, unit of thermodynamic
temperature, is the fraction 1/273.16
of the thermodynamic temperature
of the triple point of water.
13th CGPM (1967)]
29
SI base unit: ampere
ampere
Definition:
The ampere is that constant current
which, if maintained in two straight
parallel conductors of infinite length,
of negligible circular cross-section,
and placed 1 m apart in vacuum,
would produce between these
conductors a force equal to 2x10–7
newton per metre of length.
9th CGPM (1948)
30
SI base unit: mole
mole
Base unit of amount of substance
Name of unit: mole
Symbol of unit: mol
Definition:
The mole is the amount of substance
of a system which contains as many
elementary entities as there are
atoms in 0.012 kilogram of carbon 12.
When the mole is used, the
elementary entities must be specified
and may be atoms, molecules, ions,
electrons, other particles, or specified
groups of such particles.
14th CGPM (1971)
31
SI base unit: candela
Candela
Definition:
The candela is the luminous
intensity, in a given direction,
of a source that emits
monochromatic radiation of
frequency 540 x 1012 hertz
and that has a radiant
intensity in that direction of
1/683 watt per steradian.
16th CGPM (1979)
32
SI derived units
Derived units are products of powers of base units.
33
SI derived units with special names and symbols
34
SI prefixes
Upper case
Lower case
35
Rules and style convention to use units
36
GUM
37
VIM
38
Quantity
Quantity:
Property of a phenomenon, body, or substance,
where the property has a magnitude that can be
expressed as a number and a reference
Example:
• length of a given rod
Quantity value:
number and reference together expressing
magnitude
Examples:
• length of a given rod: 5.3 m
• Rockwell C hardness of a given sample: 53.4 RHC
C: 150 kg 39
Measurement
40
Measurand
Measurand:
Measurand:
quantity intended to be length of the
bar in 20 °C.
measured
The measurement, including the
measuring system and the
conditions under which the
measurement is carried out,
might change the phenomenon,
body, or substance such that the
quantity being measured may
Correction is
differ from the measurand as necessary if
defined. In this case, adequate measured in
25 °C.
correction is necessary.
41
Measured value
indication1
average correction
indication2 Average Measured
indication value
indicationN
42
Measurement result
measurement result
set of quantity values being attributed to a
measurand together with any other available
relevant information
generally expressed as a single measured
quantity value and a measurement uncertainty.
X x U
If the measurement uncertainty is considered to
be negligible for some purpose, the
measurement result may be expressed as a
single measured quantity value.
43
Measurement Uncertainty
• Measurement Uncertainty :
• Non-negative parameter characterizing the dispersion of the
quantity values being attributed to a measurand, based on the
information used (VIM, 3rd Edition, 2008)
Y y U
Measurement Error
Random error :
component of measurement error that in replicate measurements
varies in an unpredictable manner
Random error = Value(Finite) – Value(Infinite)
Systematic error :
component of measurement error that in replicate measurements
remains constant or varies in a predictable manner
Systematic error = Result(Infinite) - True value(Ref. value)
Systematic error
Random error
Unrecognized Recognized systematic error
systematic
error
Correction
Could you
Yeah! measure
It’s 11. how many
turtles are
there?
Mr. Careless
Error vs. Uncertainty (3)
Oh! I’am
Sorry! So, you are Mr.
There are Careless!
13 turtles.
He always
counts one
more or
Mr. Careless
one less!
Error vs. Uncertainty (4)
Mr. Careless
Error vs. Uncertainty (5)
Unless I see
myself, I can
Now there only think that
are 12. X=12±1
Wow!
This time,
the error is
zero!
Mr. Careless
How to express uncertainty?
• How can we characterize the dispersion of the
measurement quantity values?
12 12 12
10 10 10
8
8 8
measured value
measured value
measured value
6
6 6
4
4 4
2
2 2
0
0 0
0 5 10 15 20 25 0 5 10 15 20 25 0 5 10 15 20 25
data number data number data number
• Standard deviation 1 n
s(q k ) k
n 1 k 1
( q q ) 2
Measurement function:
function of quantities, the value of which, when calculated using
known quantity values for the input quantities in a measurement
model, is a measured quantity value of the output quantity in the
measurement model
x1
x2 y = f (x1,x2, `x3, …) y
x3 (measurement function) (output quantity)
(input quantities)
Combined standard uncertainty
Standard uncertainty: u( y)
U = k uc
55
Expanded uncertainty (2)
CP = 57.7 %
* CP: coverage probability
SD
Uncertain range
CP = 100 %
SD
CP = 68.3 % Uncertain
range =
CP = 95.5 %
CP = 99.7 %
56
Coverage Factor
57
Flow chart of uncertainty evaluation
58
Modeling the measurement
Y f ( X 1 , X 2 , ..., X N )
y f ( x1 , x2 , ... , xN )
59
Examples of measurement function
y f ( x1 , x2 , ... , xN )
Density measurement: y m
V
60
Law of Propagation of Uncertainty
x1
x2 y = f (x1,x2, x3, …) y
x3
(measurement function) (output quantity)
(input quantities)
u(x1)
-U U
u(x3)
a a (Law of propagation of uncertainty)
-U U
61
Law of Propagation of Uncertainty (2)
• General expression:
N N 1 N
uc ( y ) c u ( x ) 2 c c
2
i i i j u ( xi , x j )
i 1 i 1 j i 1
N N 1 N
c u ( x ) 2 c c
2
i i i j u ( xi ) u ( x j ) r ( xi , x j )
i 1 i 1 j i 1
f u ( xi , x j )
ci : sensitivity coefficient r ( xi , x j ) : correlation coefficient
xi u ( xi )u ( x j )
i 1
62
Sensitivity coefficient and Uncertainty contribution
f
sensitivity coefficient: ci
xi
Partial derivative of the measurement function with respect to a
given input quantity
Slope of the approximated measurement function
y y u(y)=c1u(x)
<small sensitivity
y1+u(y) <big sensitivity coeff.
coeff. (low slope)>
(high slope)>
y1
u(y)=c1u(x)
y1+u(y)
y1
x1 x1+u(x) x1 x1+u(x)
uncertainty contribution: u i c i u ( x i )
63
Sensitivity coefficient and Uncertainty contribution(2)
u(b) a u (b)
b ab b u (a )
a
u(a)
u (a ) u (b) ub u a (cb ca )
64
Law of propagation of uncertainty (3)
y ax1 bx2
y a x1 x2
2 2 2
uc ( y) u(x1) u(x2 ) u(x1) u(x2 )
2 r12
y x1 x2 x1 x2
65
Law of propagation of uncertainty (4)
General form y a x1 x2
b c
2 2 2
uc ( y ) bu ( x1 ) cu ( x2 ) bu ( x1 ) cu ( x2 )
2 r12
y x1 x2 x1 x2
Examples:
y a x1 / x2 y a x1 x2
2
1
a x1 x2
1
a x1 x2
1 2
2 2 2
uc ( y) u(x1) u(x2 ) u(x1) u(x2 )
2 2 2
uc ( y) u(x1) 2u(x2 ) u(x1) 2u(x2 )
2 r12 2 r12
y 1 x 2 1 2
x x x y x1 x2 x1 x2
a x1
y a x1 x2 y 2
x2
ax1 x2
1 1/ 2
2
ax1 x2
1
2 2 2
uc ( y) u(x1) u(x2 ) u(x1) u(x2 )
2 r12 2 2 2
uc ( y) u(x1) 2u(x2 ) u(x1) 2u(x2 )
y x1 2x2 x1 2x2 2 r12
y x1 x2 x1 x2
66
Summary of notation
Measurement Function Standard Uncertainty
y f ( x1 , x 2 , x 3 , ...) u ( xi )
k U k uc
67
Evaluation of standard uncertainty
• Type A evaluation:
: Method of evaluation of uncertainty by the statistical analysis
of series of observations
• Type B evaluation:
: Method of evaluation of uncertainty by means other than the
statistical analysis of series of observations
68
Type A evaluation of uncertainty
* n : number of readings
• SD of the s(q )
s(q k )
mean • Standard sp
n u ( xi )
uncertainty n
• Standard
uncertainty
u ( xi ) s(q)
M
• Degrees
• Degrees
v p vi
vi n 1 of freedom i 1
of freedom
69
Type B evaluation of uncertainty
a a a
• Triangular distribution u ( xi ) u( xi )
a a 24 6
• U shped distribution a
u ( xi )
-a a 2
• Normal distribution U
u( xi )
-U U k
70
Example of Type B evaluation: limited resolution
10.1225 L 10.1235 1 0 . 1 2 3
probability
10.1225, 10.1226, 10.1227,
10.1228, 10.1229, 10.1230,
10.1231, 10.1232, 10.1233,
10.1225 10.1230 10.1235
10.1234, 10.12344, ..
No priority! Rectangular distribution
1
Half width = resolution /2 u ( Lb ) m
2 3
71 71
Uncertainty budget
72
Uncertainty budget (2)
73
Approximation of combined standard uncertainty
1 major
uc ( y) u 12 ( y ) u 22 ( y ) u 32 ( y ) u 42 ( y ) ... 2 major
component components
u 2
( y) u ( y)
2 2
u Major ( y ) u12 ( y ) u 22 ( y )
Major 1
2
u Rest ( y ) u 22 ( y ) u 32 ( y ) .... 2
u Rest ( y ) u 32 ( y ) u 42 ( y ) ....
uc ( y) 2
u Major ( y ) u Rest
2
( y) uc ( y ) 2
u Major ( y ) u Rest
2
( y)
u Rest ( y )
0 .3
u Major ( y )
uc ( y ) u Major ( y )
74
1 major rectangular distribution
1/(2a)
y U
U
p (U ) ( y' )dy'
y U
p
a
-a -U U a
a
U ( p) p a U k u( y) k
3
U ( p)
k ( p) p 3
u( y)
75
2 major rectangular distributions
1/(2a2)
1/(2a1)
-a1 a1 -a2 a2
convolution a a1 a2
b a1 a2
b a1 a2
-a -b b a a a1 a2
76
Combined probability distribution
1 1
#
#
0 0
0 2 4 6 8 10 12 14 16 18 20 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28
A B
A B
10 10
8 8
6 6
5
#
#
4 4
2 2
0 0
18 20 22 24 26 28 30 32 34 36 38 40 42 0 2 4 6 8 10 12 14 16 18 20
A+B B-A
A+B A-B
77
2 major rectangular distribution (2)
• probability 1 y a
y
densay function 1 1 1
( y) a y a
of trapezoidal a (1 ) 1 a
distribution 0 a y
p (1 ) p
• coverage factor
1 2 2 p
of a trapezoidal k ( p)
1 2 1 (1 p )(1 2 ) p
distribution
6 2 p
1 0.475(1 ) 0.905
k
• p=0.95 1 2
1 0 . 05(1 2
) 0.905
6
78
Degrees of freedom
• Type A evaluation:
• SD of the mean : v n 1 M
• Utilize the pooled experimental SD : v vp ( v p vi ) ☜ Refer to
i 1 page 69
• Type B evaluation:
– Estimate relative uncertainty of
standard uncertainty 2
1 u ( xi )
2
1 100
– R : probability in percent, of vi
uncertainty value to exceed the 2 u ( xi ) 2 R
estimated uncertainty interval
79
Coverage factor
1 0.475(1 ) 0.905
k
• Trapezoidal distribution 1 2
1 0 . 05(1 2
) 0.905
6
• Normal distribution k 2
80
Coverage factor (2)
Student’s t-table
DOF Level of confidence p (%)
81
Reporting Uncertainty
Reporting items:
Expanded uncertainty
coverage factor
level of confidence
(probability distribution)
(effective degrees of freedom)
• Rounding:
– When uncertainty is to be reported with 2 significant digits, just do the
normal rounding.
– When uncertainty is to be reported with 1 significant digits, do normal
rounding first. Only when the uncertainty value is decreased more
than 5 % of its original value as a result of the rounding, use round-up
to prevent underestimation of the uncertainty.
82
Reporting Uncertainty (2)
Example 1)
– measurand’s best estimate : 12.1234 mm
– expanded uncertainty calculated to be : 0.234 mm
Example 2)
– measurand’s best estimate : 34.51 mm
– expanded uncertainty calculated to be : 0.058 mm
83
Alternative method to calculate sensitivity coefficients
y f ( x1 , x2 ,...., x N )
y
f ( x1 u ( x1 ), x2 ,...., x N ) f ( x1 u ( x1 ), x2 ,...., x N )
c1
2u ( x1 ) y1
f ( x1 , x2 u ( x2 ),...., x N ) f ( x1 , x2 u ( x2 ),...., x N )
c2
2u ( x2 ) 2u(x)
x1 - u(x) x1 x1+u(x)
…
f ( x1 , x2 ,...., x N u ( xN )) f ( x1 , x2 ,...., x N u ( x N ))
cN
2u ( xN )
84
Monte Carlo Simulation Method
Concept
• Obtain numerical results by repeated random sampling
• Generate random data for input quantities
• Calculate output quantity using generated input quantity values
• From the distribution of the output quantity, find the value
corresponding to expanded uncertainty
Simple example
y ab
a: rectangular distribution, center = 10, half-width = 2: {8 ≤ a ≤ 12}
Generate a and b randomly about 200000 times and calculate a+b (N=200000)
Sort y(=a+b) values and subtract average value of y from the 0.975N-th value
of y. The result will be the expanded uncertainty (level of confidence: 95 %).
85
Example of MCS
200
frequency
150
a b y 100
11.45787 4.021302972 15.47917 50
0
8.0005…
8.2558…
8.5110…
8.7663…
9.0216…
9.2769…
9.5322…
9.7874…
10.042…
10.298…
10.553…
10.808…
11.063…
11.319…
11.574…
11.829…
11.3378 3.162164089 14.49996
9.831771 6.110708549 15.94248
10.44291 6.062337079 16.50524 A
11.61252 4.28559372 15.89811
200
10.02053 6.975986872 16.99652
frequency
150
8.360193 5.502741481 13.86293 100
50
10.75604 3.227403384 13.98345 0
3.000…
3.227…
3.454…
3.681…
3.908…
4.134…
4.361…
4.588…
4.815…
5.042…
5.269…
5.496…
5.723…
5.950…
6.177…
6.404…
6.631…
6.857…
8.00629 5.671955056 13.67824
10.97286 5.261168596 16.23402
B
8.643781 3.340718842 11.9845
9.769978 3.321147597 13.09113 400
frequency
300
11.4846 4.986723427 16.47133 200
10.07888 3.178403362 13.25728 100
10.48521 5.750870235 16.23608 0
11.0851…
11.5334…
11.9817…
12.4300…
12.8782…
13.3265…
13.7748…
14.2231…
14.6714…
15.1197…
15.5680…
16.0163…
16.4646…
16.9129…
17.3612…
17.8095…
18.2578…
18.7061…
9.216756 4.268885095 13.48564
11.98271 3.996381149 15.97909
y=a+b
8.277883 4.744584042 13.02247
10.28087 3.694399129 13.97527
9.573665 5.071488824 14.64515 y 15.0 3.1
86
Example of a complex measurement function
Example: density measurement
Measurement function
Combined standard
uncertainty
1st sensitivity
coefficient
87
Uncertainty evaluated by MCS method
88
Exercise
Height measurement of a flag pole
distance: 5 m, angle: 30
Repeated 20 times. SD: 0.05 m and 0.5, respectively
Uncertainty of distance meter: 0.02 m (k=2, 95 %)
Uncertainty of angle meter: 1 (k=2, 95 %)
Resolution: 0.01 m and 0.5, respectively
89
Thank you for your attention!
90