You are on page 1of 367

GMA-GT-2014-01-MRQ

(Volume 1)

Metrology in

Mass and Related Quantities

March 10-21, 2014

 Lecture and Practice 


Metrology in General (MiG)

Global Metrology Academy


GMA-GT-2014-01-MRQ

(Volume 1) 

LECTURES

Metrology in General [MiG]

March 10 (Mon) – 21 (Fri), 2014

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

National Standards System in Korea


Prof. Dr. Gun‐Woong Bahng 

File: G-1-0-GT-2014-01-NSS in Korea (ms word)

File: G-1-1-GT-2014-01-NSS in Korea (ppt)

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

National Standard System of Korea (MiG‐01‐NSS)


Prof. Dr. Gun-Woong BAHNG
Chair Professor, SUNY Korea
The State University of New York, Korea
Phone : +82 32 626 1222
Fax : +82 32 626 1539
E-mail: gwbahng@sunykorea.ac.kr

This lecture presents a general overview of the Korea's national standards


system including standardization, metrology, and accreditation. These are the
three essential backbones of national standard system to provide reliable
measurement results and certification for commercial products. This leads
eventually to improving quality in measurement and testing done by industry
over wide sectors such as manufacturing, foods, health, safety, environment,
etc.

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.

Regarding the measurement standards, KRISS, the Korea Research Institute of


Standards and Science is responsible. As the National Metrology Institute
designated by the Framework Act on National Standard, KRISS has been
actively participating in international activities especially key comparisons
since it signed the CIPM MRA, Mutual Recognition Arrangement, in 1999.
Nowadays, KRISS is expanding the scope of its services of R&D and supply of
national measurement standards, not only for physical measurement but also
for other new emerging areas such as chemical analysis, environmental
measurement, and materials metrology.

The third part of national quality system infrastructure is accreditation and


certification. KOLAS, the Korea Laboratory Accreditation Scheme, which is the
accreditation body based on ISO 17011 and 17025, was organized in 1992 and
has been operated by KATS. There are more than 200 accredited calibration
laboratories as of 2011. Besides, there are two more accreditation bodies. They

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.

Harmonized operation of these three essential elements composing the national


standard system is requisite for realizing a safer and reliable society. Korea is
still trying to move ahead in this direction for improved quality of life and
better competitiveness of the Korean industries.

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)

2008-present Chairman, TC 5, Hardness, IMEKO (International Measurement Confederation)


2003-2008 Chairman, ad-hoc WGMM (Working Group on Materials Metrology), APMP (Asia Pacific Metrology Program)
2002-2006 Chairman, ANMET (APEC Network for Materials Evaluation Technology)
2003, 2007, 2010 Peer reviewer in Hardness for NMIJ, NIM, HKSCL

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

Global Metrology Academy


-2-
Prologue 1
Korean War (1950-1953)
Independence ; 1945
Government Election ; 1948
Korean War ; 1950. 6 – 1953. 7.

KwangWhaMoon Ave., Seoul

Global Metrology Academy


-4-
Growing up as it is from nearly no resources but…

The Korean War destroyed almost everything in the Korean Peninsula. (1950’s)

Global Metrology Academy


-5-
Korean War
 Casualties
- South Korea, 1 million dead (85 % of them are civilians),
0.2 million of widow, 0.1 million of orphan, 10 million of departed
family, 45 % of industrial facilities were destroyed.
- North Korea, 1.13 million dead, 80 % of industrial facilities were
destroyed.
Soldiers Dead Wound Lost
S. Korea 149,006 710,783 132,256
N. Korea 294,000 226,000 120,000
 16 countries sent UN army
- 57,933 dead, 481,155 wound, 1,047 lost.

Population in 1950 ; S. Korea, 21 million N. Korea, 9 million


About 7 % of people died.

Global Metrology Academy


-6-
Series of 5-year Plans for Economic Development
1st: 1962 ~ 1966, ……. 7th: 1992 ~ 1996

Construction of Seoul – Busan highway,


Ulsan Industrial complex (population 50,000)
1968 - 1970

Hyundai Heavy Industry Oil refinery


Global Metrology Academy
-7-
Economic Growth of Korea (1)
Grown up to be
World’s 8th Largest
Exporter today

Wireless Telecom
Construction Equipment
Burj Khalifa (Dubai) Computers,
Semiconductors
Petrochemicals
Automobile
Steel making Ship building

Global Metrology Academy


-8-
Economic Growth of Korea (2)
25,000 GNI per capita 20,759
(US$)
20,000

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

That’s why it might be called


“the Miracle on HAN river!”

Global Metrology Academy


- 10 -
Schools during the Korean War
(1950’s)
11
Better Standards, Better Life !
Prologue 2

How Korea has grown up so quickly?


What was the Role of NMI?
 Quality System and Metrology!

12
Better Standards, Better Life !
National Standards System

1 Standardization

2 Measurement Standard

3 Conformity Assessment
- Accreditation
- Certification

Global Metrology Academy


- 13 -
Standard System

 Essential infrastructure of modern society

 Three elements of Standard System

- Standardization (Documentary standard)


- Metrology (Measurement Standard)
- Conformity Assessment (Accreditation/Certification)

Global Metrology Academy


- 14 -
Global Metrology Academy
- 15 -
The Quality Infrastructure

ISO & UNIDO ; Building Trust, The Conformity Assessment

Global Metrology Academy


- 16 -
Hamburger Cookbook

Ingredients
Procedure
- Grill temperature
- Heating time, etc.

STANDARDIZATION of
Process

Same taste, Same quality


Can be guaranteed

Global Metrology Academy


- 17 -
Standard

 Standardization (Cooking recipe) is enough to


provide the same quality of hamburger to
customers?

 Do they measure temperature exactly using


calibrated thermometer?
- Measurement standard
 How can we make sure that they are cooking in
right way as written in the recipe?
- Accreditation/Certification

Global Metrology Academy


- 18 -
Standard System

Word contnents concept


Standard Documentary standard General meaning
Measurement standard,
Standard Standards
Documentary standard,
system infrastructure
Accreditation system
Measurement
NMI, calibration lab., Equivalency
standard
Documentary Standard developer, Defacto
Harmonization
standard standard
Accreditation Traceability,
ISO 17011/ISO 17025
system comparability

Final Goal : Establishment of Traceability Chain 


Securing Equivalency, comparability, reliability of data !!!  FTA

FTA ; Free Trade Agreement

Global Metrology Academy


- 19 -
Dissemination of Standards

CGPM, CIPM ISO/IEC


APMP Codex
Measurement Documentary
Standards Standards

ILAC/APLAC
Hardware Laboratory Software
Accreditation

Dissemination of standards to industry

- 20 -
Global Metrology Academy
12
Standard System
Laboratory
Measurement Accreditation Documentary
standard system standard
CIPM / MRA 인정체계
ILAC / MRA ISO/IEC, ITU

Key Evaluation for Traceability Documentation


Comparison Test/Calibration ISO 17025
Verification ISO 17020
Equivalency Ref. materials Conformity
ISO guide 34/35
assessment
Lab. Medicine ISO 15189
Food ISO 22000

Reliability
Proficiency test
Education lab. lab.

Global Metrology Academy


- 21 -
International Standard System
 Measurement standard
- CGPM/CIPM/BIPM
- Meter treaty in 1875, SI unit system in 1960 CGPM.
- CIPM MRA in 1999
 Standardization
- ISO/IEC, ITU, Codex, ifcc, IAEA, etc.
- ISO established in 1947, 19000 standards, 164 countries
- FAO and WHO  Codex 1962
 Accreditation system
- ILAC 1996 (Testing and calibration laboratory)
- IAF 1993 (Quality System accreditation)
Only recently int’l standard system has been established!
Global Metrology Academy
- 22 -
National Standard System of Korea
 Standardization
- Korean Agency of Technology and Standards (KATS), Ministry of Trade,
Industry and Energy (MOTIE) ; ISO/IEC
- Korea Communications Commission (KCC), Ministry of Science, ICT and
Future Planning (MSIP) ; ITU
- Ministry of Food and Drug Safety (MFDS) Ministry of Health and Welfare ;
Codex
- Korea Food Research Institute (KFRI), Ministry of Agriculture, Food and
Rural affairs ; Codex
 Measurement Standard
- Korea Research Institute of Standards and Science (KRISS) ; CGPM,
CIPM, APMP
 Accreditation
- Korea Laboratory Accreditation Scheme (KOLAS) ; ILAC, APLAC
- Korea Accreditation Board (KAB) ; IAF, PAC
- Korea Accreditation System (KAS)
Global Metrology Academy
- 23 -
National Standards Council
 Legal basis ; Framework Act on National Standards
 Chairman; Minister of Trade, Industry and Energy
 Board members ; Vice ministers of other ministries
 Major role ;
- Harmonization of standard activities
- Establishment of “National Standard Framework Plan”
every 5 years.
- The 3rd plan starts from 2011.

1. Framework Act on National Standards


2. Measures Act; Legal metrology
3. Industrial Standardization Act; Standardization ㉿

Global Metrology Academy


- 24 -
National Standards System

1 Standardization

2 Measurement Standard

3 Conformity Assessment
- Accreditation
- Certification

Global Metrology Academy


- 25 -
Standardization system of Korea
Measurement Standard NMI KRISS

Standards Voluntary Standard


KATS MOTIE
Industrial Std. (KS)
Inf. Comm. Std. (KICS)
KCSC MSIP
Technology Code
12 Ministries
Type Approval
81 Laws about
Safety Inspection
Testing and Inspection Type approval,
Verification Inspection,
Verification,
Defense Quality Assu. Certification, etc.
Certification

As of 2011. March

KCSC; Korea Communications Standards Commission

Global Metrology Academy


- 26 -
Ministries of Korean Government Work coordination
Permission for gas appliance Between central government
manufacturing business
As of 2012
Credibility accreditation
Ministry of Trade, Industry and Board of National
Standards Review
Energy
Type approval of
fire-fighting equipment
Korea Electric
System certification of standard Ministry of Security and Public Appliance Safety
electronic document Administration Certification Korean Agency for
Quality certification of Technology and Standards
KS Certification
educational contents
Developing and Disseminating
Quality certification of Ministry of Education of Industrial Standards
traditional foods
CODEX
KS H delegation
Quality certification of
alcoholic beverages
Quality certification Ministry for Agriculture, Food Korea Food
of marine products and Rural Affairs Research Institute
Quality certification of
agricultural products
Safety checks on Ministry of
WHO JTC1 WTO/TBT
medical supplies and instruments Health and Welfare
certification of
ISO APEC
new health technology IEC PASC
SCSC
Acceptance criteria on Ministry of
vehicle exhaust gas Environment
Environmental declaration
of products
UN/ECE
Inspection dangerous Ministry of
apparatus and protected Areas Employment and Labor
KOSHA
ITU
Vehicle type Ministry of Land,
approval
Transport and Maritime Affairs
Construction new technology
Voluntary
Radio Research regulations
Telecommunication Korea Communications Agency
equipments
Standards Commission Compulsory
regulations
Quality certification
of S/W Telecommunications
Defense Acquisition Technology Association Government
Quality certification
of military aircraft Program Administration Ministries

Developing and Disseminating Private Institutes


Excellent products of small Small and Medium of Information and
and medium enterprises
Business Administration communications standards
District

Compulsory/voluntary Documentary Standard/


Voluntary Standard International
Accreditation Accreditation
Standard Developer
 KATS
- Korea Agency for Technology and Standards, under the Ministry of Trade,
Industry and Energy
- Korean Industrial Standards (KS, ㉿)
- Government focuses on standard policy, while the responsibility on standard
development and management moves to the private sector.

 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.

Global Metrology Academy


- 28 -
Background
Sharp increase in quantity thanks to the effort of harmonization with
International Standards (ISO)

49,000 Number of National Standards

29, 583
30,000
25,793
22,760 22,068
20,000 IEC
5,613

10,000 ISO
16,455

ISO/IEC

Ways to correspond to changes in the standard environment and market demand

Increase in National Standards of 2007 in comparison with 2000


IT(3.3times), Food(3.3times), Electricity(2.6times), Machine(2.3times), Aerospace(2.1times)

Global Metrology Academy


- 29 -
Policy change in standard development
Move from government-led to private-led standardization

KATS COSD

1step 2step 3step


Policy planning
Standard
Development
Std. Development

Std. Management Full


Standard
Application
Management
Trial Adjustment
Review & Notify
’08 ’09 ’10-12

100 %, 2008

Global Metrology Academy


- 30 -
Role of COSD
1. Demand Survey and Planning
- Survey of standards in need
- Planning for the development of standards
- Establishing of roadmap

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

proposal standard development previous notice Final review Notify

International

NWIP WD/DC CD DIS/CDV FDIS publish

vote circulate circulate vote vote

KS

NWIP COSD FDIS publish

KATS KATS

KATS, official member of ISO, in charge of administrative work.

Global Metrology Academy


- 32 -
Member list of COSD
Acronym Organization name Keywords
KSA Korean Standards Association Standardization, Quality Management,
http://www.ksa.or.kr Intelligent transport systems,
Geographic information / Geomatics

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 Korea Electric Association Electric installation, wiring, equipment, electric


shock ,SPD, Lightning protection, Electro Technical
http://www.electricity.or.kr Regulations, Conformity Criteria, Boilers, Pressure
Vessels, piping, welding, NDE (non-destructive
examination), KEPIC, Nuclear

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

Global Metrology Academy


- 33 -
Acronym Organization name Keywords
KIEC Korea Institute for Electronic eBusiness, e-Business, Electronic Commerce, IT,
http://www.kiec.or.kr Commerce Information Technology, Electronic Document,

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

KICM Korea instiature of Construction Construction, concrete, wood, glass, cement,


http://www.kicm.or.kr Materital Construction safety,

FITI FITI Testing & Research Institute technical textile, clothing, protective clothing & equipment,
www.fiti.re.kr geosynthetic, floor coverings, automotive interiors,
hygiene testing, filters,

KERI Korea Electrotechnology Research on Electrotechnology, Testing of power


http://www.keri.re.kr Research Institute apparatus, Power transformers, Switchgear and
controlgear,

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,

Global Metrology Academy


- 34 -
Acronym Organization name Keywords
MPI Korea Machinery-Meter and Legal metrological service(type approval, verification,
http://www.mpi.or.kr Petrochemical Testing & calibration and measuring instrument ), Fan(Ventilator)-
Research Institute related testing and evaluation, Machinery and
Lubrication

KAMICO Korea Agricultural Machinery agriculture machinery, agriculture industry


www.kamico.or.kr Industry Cooperative

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

KSCIA Korea Specialty Chemical Specialty Chemical, CFC(Chloro Fluoro Carbon),


http://www.kscia.or.kr Industry Association CWC(Chemical Weapons Convention)

ERI EMC Research Insstitute EMC,EMI,EMS


http://www.eri.re.kr Electromagnetic Susceptibility
Electric,Electric safety

Global Metrology Academy


- 35 -
Acronym Organization name Keywords
KTL Korea Testing Laboratory Certification, IECEE-CB, IECQ, ANF, safety certification mark,
http://www.ktl.re.kr electric appliance test, electric appliance safety certification,
K mark, machinery, CBTL, wire communication terminal test,
energy efficiency test, EMC test,

KCA Korea Crane Safety Association Crane, Construction, Machinery, Tower,


Manufacturing, Safety, Technology, Wire rope,

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

KASTO Korea Association of Standards Vocabulary, Terms,


http://www.kasto.or.kr & Testing Organizations Metrology, Legal metrology, Statistics, Random, Sampling,
Plans, Management, Measurement, Procedure,
Calibration, Testing, Inspection, Quantities, SI, units,
Symbols,

Global Metrology Academy


- 36 -
Acronym Organization name Keywords
KRI Korea Railroad Research Railway Structure, Vehicle & Trackor, Electronic Power
http://www.krri.re.kr Institute Supply, Railway Environments, Railway Transport &
Logistics, Rail Industry Promotion

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

Global Metrology Academy


- 37 -
Activities
 Korea's Membership within ISO/IEC TC/SC

Organization No. of P- member O-member (%)


TC/SCs P-member
ISO 743 619 103 83.3 %

IEC 175 144 27 82.3 %

Total 918 763 130 82.8 %

(As of Feb 2014)


http://www.standard.go.kr/main/index.asp?OlapCode=STAU00
New work items proposed (cumulative total)
Year 2002 2004 2006 2008 2010 2011 2012 2013

Offer 24 53 80 249 390 450 508 561

Global Metrology Academy


- 38 -
Dissemination of Standards
Korea Standard Association (KSA)

Establishment ; March 12, 1962


Legal basis ; Article 29, Industrial Standard Act

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.

Global Metrology Academy


- 39 -
Field of Activities
1. Certification :
- KS, JIS
- Management system ; ISO 9001, 14001, QS 9000, TL 9000,
K-OH SMS 18001/OHSAS 18001 HACCP, etc.
2. Standardization : Member of COSD
3. Quality Award :
- National Quality Award, National Quality Award Circles Competition
- Service quality excellent company recognition system
- KS-SQI (Korean Standard Service Quality Index)
- Korea Service Grand Prix

4. Training and Education


5. Promotion and dissemination
- Korean Standards Service network ; www.kssn.net/
- Quality Korea Network ; www.q-korea.net
- Quality Management (Monthly), Quality and Creativity (Monthly), Books

Global Metrology Academy


- 40 -
National Standards System

1 Standardization

2 Measurement Standard

3 Conformity Assessment
- Accreditation
- Certification

Global Metrology Academy


- 41 -
Principia
Isac Newton

Principia defines three “Fundamental quantities”


Length, Time, Mass

Meter Second Kilogram


as measurable and objective.

SI unit started with these three units.

Global Metrology Academy


- 42 -
BIPM: Bureau International des Poids et Measures
International Bureau of Weights and Measures

BIPM
www.bipm.org

Global Metrology Academy


- 43 -
Intnational Organization Metre Convention
Diplomatic
for Measurement Standards 1875
Treaty

General Conference on Weights and Measures


Associate States Governments
and Economies ( CGPM ) of
51 Member States, Member States
of the CGPM meets every four years and consists
25 Associate States of delegates from Member States

18 individuals each from a International Committee for Weights and Measures


different Member States ( CIPM )
consists of eighteen individuals elected International
by the CGPM organizations

It is charged with supervision of the BIPM


and affairs of the Metre Convention
The CIPM meets annually at the BIPM

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.

Bureau International des Poids et Mesures


( BIPM )
International centre for metrology
Laboratories and offices at Sèvres
with an international staff of about seventy

44
Global Metrology Academy
- 44 - Located at Sèvres, France
List of Consultative Committees

CIPM CCL (Length)


CCM (Mass and Related Quantities)
CCTF (Time and Frequency)
CCT (Thermometry)
CCPR (Photometry and Radiometry)
CCEM (Electricity and Magnetism)
CCQM (Amount of Substance)
CCRI (Ionizing Radiation)
CCAUV (Acoustics, Ultrasound & Vibration)
CCU (Units)

Global Metrology Academy


- 45 -
Measurement Standard

 Quantity
- Number + Reference,
 Reference ; unit, reference procedure, reference materials

 Meter convention ; Meter treaty


- SI unit

 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

Global Metrology Academy


- 46 -
Measurement Standard and Traceability
 Key element in Metrology
- Measurement standard and Traceability
- calibration hierarchy and uncertainty evaluation

 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

 Traceability; Became an issue in late 1990s.


Property of the result of a measurement or the value of a standard
whereby it can be related to stated references, usually national or
international standards, through an unbroken chain of comparisons all
having stated uncertainties
- VIM: International vocabulary of Basic and General Terms in Metrology

Global Metrology Academy


- 47 -
Why ‘TRACEABILITY’ in quality system?
 Production of data
- For the comparison with the specification, requirement, regulation,
etc.
- Quality of data ; Comparability

 How can we guarantee the comparability of data?


- Equivalency among NMIs  key comparison
- Traceability of data to measurement standard maintained by NMI

 ISO 17025/ISO 15189(medical laboratory)


- Quality system + technical requirements
- Key point of technical requirement ; Traceability
- Certification can be accepted world widely.

Global Metrology Academy


- 48 -
Traceability and Comparability
Why Data in number? Equivalency among NMIs.

Meter Convention (1875)


Country A CIPM-MRA1999 → Effective since 2005 Country B

KC (Equivalency)  1999 ~

NMI NMI
Country C
Accredited Accredited
Lab. Lab.

Industrial work Dissemination of Industrial work


site measurement NMI site
standards
Traceability
Calibration

Accredited
Lab Providing comparability of
data by securing traceability

Industrial work site

Same scale, same standard. Quality of data

Global Metrology Academy


- 49 -
Key Comparisons
CIPM organized KCs according to the MRA signed in 1999

Global Metrology Academy


- 50 -
Key Comparison Result
BIPM.EM-K11.b [DC voltage (10 V) , Zener diode]

Participant : BIPM, SPRING(Singapore), NIST(USA), METAS(Switzerland), CMI(Czech Republic),


BEV(Austria), SMU(Slovakia), GUM(Poland), NMISA(South Africa), NMIA(Australia),
NML(Ireland), INMETRO(Brasil), NCM(Bulgaria),VNIIM(Rusia), KRISS(Korea)

Global Metrology Academy


- 51 -
BIPM Homepage www.bipm.org

Global Metrology Academy


- 52 -
KCDB
Key
Comparison
Data Base

Global Metrology Academy


- 53 -
CIPM CMC Table
(Calibration and Measurement Capability)

Global Metrology Academy


- 54 -
Traceability

NMI Domain of the Industry


(KRISS)

Accredited
Calibration and
Testing Industrial
Laboratories Reference
(KOLAS)
Working Standards

Measuring Equipment
Metrological Infrastructure
in a Country
Products

KOLAS ; Korea Laboratory Accreditation Scheme

Global Metrology Academy


- 55 -
Metrology in short, 2nd ed
Traceability Chain
BIPM

National Metrology
Institutes or designated
National laboratories

Calibration
Laboratories,
often accredited

Enterprises

End users

The national metrological


Uncertainty Increases down the traceability chain.
infrastructure

Global Metrology Academy


- 56 -
Traceability and TBT
Figure2 Traceability and technical barriers to trade

National accreditation body(A)

Firm-level measurement(A) Calibration laboratory(A) NMI: National standard(A)

Technical Barrier to Trade

Firm-level measurement(B) Calibration laboratory(B) NMI: National standard(B)

National accreditation body(B)

No metrological relations between country A and B.


Firm in country A should get the certification from country B also.
Global Metrology Academy
- 57 -
Traceability and TBT
Figure3 Traceability, TBT, and mutual recognition : How TBT might be reduced

National accreditation body(A)

Firm-level measurement(A) Calibration laboratory(A) NMI: National standard(A)

Technical Barrier to Trade MOU


ILAC MRA CIPM MRA

Firm-level measurement(B) Calibration laboratory(B) NMI: National standard(B)

Potential TBT
Reducing link
Trade regulations National accreditation body(B)

No need to duplicate the work of certification.

Global Metrology Academy


- 58 -
Mutual Recognition Arrangement

REGULATORY MRAs (ILAC)

Conformity Conformity
A assessment assessment B
Country Country
ISO 17025 ISO 17025

VOLUNTARY
ISO 9001/14000 ISO 9001/14000
MRAs

Test/Calibration Test/Calibration

NSS system NSS system

CIPM MRAs (KC, CMC)

Tested once, accepted everywhere.


ILAC ; International Laboratory Accreditation Cooperation

Global Metrology Academy


- 59 -
CIPM MRA Success Story in Korea (1-1)
DSME, Korea – BP, USA
[2002]

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

• DSME Offshore Plant

Global Metrology Academy


- 60 - 60
CIPM MRA Success Story in Korea (1-2)
DSME, Korea – BP, USA
[2002]

Technical Barrier

to Trade

Likely
quite a big
Loss of
Time!
Loss of
Money!

•US$ 1 million, two months • US$10 million


for recalibrating 130 items for penalty of two month delay
at NIST of project

Global Metrology Academy


- 61 - 61
CIPM MRA Success Story in Korea (1-3)
DSME, Korea – BP, USA
[2002]
KRISS Calibration
Certificate for DSME
BP (USA)
accepting
“Traceable to KRISS,
Traceable to NIST”

ILAC CIPM MRA


MRA NIST-KRISS
KOLAS
Accreditation of DSME

Accreditation by Calibration
KOLAS by KRISS

DSME
(Korea)
Traceable to KRISS

Global Metrology Academy


- 62 - 62
CIPM MRA Success Story in Korea (1-4)
DSME, Korea – BP, USA
[2002]
• Offshore plant order by BP,USA.
Claim
• Calibration traceable to NIST required.
• DSME, accredited by KOLAS, a member of ILAC MRA.
• DSME keeps traceability of its standards traceable to
KRISS.
• KRISS and NIST are all signatory to the CIPM MRA.
Solution
• NIST confirmed that “traceability to KRISS is equivalent
to traceability to NIST” via the CIPM MRA.
• BP accepted accreditation by KOLAS and calibration
certificates issued by KRISS.
< DSME offshore plant >
Benefit • US$ 11 million saved • recalibration at NIST; US$ 1 million
• US$ 30,000 Invested for calibration • penalty of 2 month delay; US$ 10 million

ROI Coming over Economic benefits


CIPM MRA, to
360 times technical barrier
ILAC MRA to trade global enterprise

Global Metrology Academy


- 63 - 63
Measurement Standards in Korea
 KRISS
- Representing Korea as a National Metrology Institute by the
Standard Framework Act on National Standards.
- Signed on CIPM MRA in 1999.

 Numbers of Measurement Standards: 241


- Established: 196 (as of Feb 2014)
Length 15/18 Mass & Related Quantities 18/21
Time & Frequency 11/11 Electricity & Magnetism 37/46
Acoustics, Ultrasound &
Thermometry 14/17 6/10
Vibration
Photometry & Radiometry 25/30 Ionizing Radiation 14/35

Amount of Substance 11/37 Materials Properties 4/16

Global Metrology Academy


- 64 -
Some Results of Key Comparison
CCQM-K3
Automotive emission gases
(Carbon monoxide)

CCAUV.A-K1

Pressure sensitivity level of


Microphone LS1P f=250 Hz

Global Metrology Academy


- 65 -
KRISS ACTIVITIES FOR CIPM MRA-KC, CMC
Participation in KC, Key Comparisons
CMC Registration, Calibrations and Measurement Capabilities
AUV EM L MRQ PR QM RI T TF
Field 음향 광도 전리 시간 Total
진동 전자기 길이 질량 복사도 물질량 방사선 온도 주파수
KC 20 56 23 67 19 104 58 25 1 373
CMC 41 141 41 49 41 519 214 69 24 1139

BIPM KCDB (http://kcdb.bipm.org/ Feb 2014)

Country USA Russia Germany China UK Korea Japan


CMC 2180 1598 1541 1248 1194 1139 1095

Country Germany USA UK Japan France KRISS


KC 644 473 460 438 430 373
KC-PL 164 110 100 84 49 62

* PL: Pilot Laboratory

Global Metrology Academy


- 66 - 66
KRISS ACTIVITIES FOR CIPM MRA-KC, CMC
KC participation reported at the BIPM KCDB
Serving as Pilot lab
for 62 KC’s

644
473 460 438 430 373

Germany USA UK Japan France KRISS

CMC registration at the BIPM KCDB

2180
1598 1541
1248 1194 1139 1095

USA Russia Germany China UK Korea Japan

Global Metrology Academy


- 67 - 67
Expansion of Standards

Industry

Trade Science

Standards

Defense Medicine/Health

Environment

Global Metrology Academy


- 68 -
  Increased role of international organizations such as WHO, WMO
qStronger regulations enforced in areas such as
qenvironment/ health care/ medical service/ food safety

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

National Calibration Service CIPM-MRA


(National traceability) (International traceability)

ISO/17025 : Competence of testing and calibration laboratories

ISO guide34 :Competence of the production of reference materials

ISO 15189 : Confidence in medical laboratories

ISO 22000 : Food safety management system

Global Metrology Academy


- 69 -
Measurement Standards in New Areas

NMI

CRM Calibration laboratories

Laws/Regulations

Food Medical test Environmental Testing/Analysis


safety test analysis laboratories

Industry Academia Research Institutes

Global Metrology Academy


- 70 -
National Calibration System

International Standards

Korea Research Institute of Standards and Science

Accredited Calibration Laboratories


(No. of Cal. Lab. : 206 as of Feb 2014)

Industries, Research Institutes, Testing/Inspection Labs,


Educational Institutes, Health/Medical Agencies, etc

• Legal Basis
- Framework Act on National Standards in 1999

Global Metrology Academy


- 71 -
Calibration services provided
Services to calibration laboratories is over 50 %.
Year 2005 2006 2007

Calibration Lab. 9,780 9,723 10,477

Total number of
20,644 19,652 19,456
Services

Ratio 47% 50% 54%

Number of CMC registration is increasing

Year 2005 2006 2007 … 2013

CMC 778 871 1033 … 1139


Number of
- 93 180 …
increase

Global Metrology Academy


- 72 -
Traceability for Innovation towards Competitiveness
“”
High quality services stimulating innovation of Industry
based on internationally recognized traceability
- Calibration, testing and technical consulting
- Development of CRMs for industry
- Training and education on precision measurement

Services provided by KRISS (’10-’13)


Year Calibration Testing CRMs Training
2013 12,054 2,307 3,404 374
2012 16,826 2,957 3,134 515
2011 17,306 3,231 2,735 353
2010 17,742 3,288 2,255 579
2009 17,441 2,952 2,147 526
Covering some 3 000 customer organizations

Global Metrology Academy


- 73 - 73
KRISS Contribution to National Economy
  Direct Value created : US$ 860 mil (for 10 years of 1994-2003), BCR of 1.5
(Data : Revenue from calibration/testing and CRM services for 10 years: 1994-2003)
  Economic Impact : US$ 812 mil, BCR of 12.76 (FY 2003 budget of $ 63.7 mil)
  Data prepared/analyzed : Bearing Point, Inc. (Jul. 2004)
120
1,200
총편익 비용 (Unit: million US$)
100
1,000
Total benefit
80
800
Cost
600
60

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

- Usually 1 % to 6 % of the economic indicators (GNP, market growth


…) are mentioned as the contribution of measurement.

Modelling based on Numbers of


- calibration certificates (both in NMI and
calibration/testing laboratory)
- accreditations which request traceability of
metrology (e.g. ISO 9001)
- patents related to metrology
- document standards related to metrology

Source: The assessment of the economic role of measurements and testing


in modern society, G Williams, 2002

Global Metrology Academy


- 75 -
Responding to Customers and Circumstances
Effectively responding to customer’s needs for measurement standards under ever‐evolving circumstances

1980’s 1990’s 2000’s


Expanded Traditional core industry IT Nano/Materials Environment Food/Health/Medicine
Horizon of
NEEDs for
Measurement
Standards
Open
Markets Traceability in local Global Equivalency
markets (1979) Required (1999)
Widespread
End-users ISO 17025 ISO Guide34 ISO 15189 ISO 22000
Test/Calibration lab RM Producers Lab Medicine QMS Food Safety

Evolving Needs of National Measurement Standards

S&T, Commerce, Industry, Energy, Education,


Governmental Science & Technology
Health, Environment, Agriculture, Forestry, Fishery,
Customers Commerce, Industry, Energy
Security, Climate, Food, Drug, …

Global Metrology Academy


- 76 - 76
Measurement Solutions for Automobile Industry
 Torque control in Automobile assembling
 - Essential for quality control of engine performance

Fastening of bolts occupies


90 % of Engine Assembly
 Accurate Torque Measurement - Producing world best vehicles

Torque standards in KRISS Torque calibration machine Torque wrench


(0.005 %) (0.1 %) (1 %)
World class car
• Improving Torque Measuring Capability of KRISS: 0.1 % (’99)  0.005 % (‘06)
• Reducing Failure Rate due to Torque Measurement at HYUNDAI: 35.1 % (’99)  0.5 % (’06)

For HYUNDAI Motors


Global Metrology Academy
- 77 -
Metrology for Quality of Life
“KRISS, working towards better standards for better quality of life”

Measurement standards for the environment and food


- International equivalence of the environmental measurement
- Top quality standards for greenhouse gas measurement
760 items of
- Developed 304 items of environmental and food CRMs KRISS CRMs

Measurement standards for health


- National standards for clinical diagnosis and biomolecule
- Developed 27 items of clinical CRMs

Global Metrology Academy


- 78 -
Measurement Solutions for Environment
 Standard Gas for Gas Analysis in Semiconductor & Display industry
Organic Light Emitting Display
Desk top computer display

Process Control Gas Scrubber

 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)

Standards gas for GHG Analyzing vehicle gas emission


Global Metrology Academy
- 79 -
Measurement Solutions for IT Industry
• Thin film thickness: Key metrological challenge in Semiconductor Industry
KRISS provided solutions by developing CRMs
capable of measuring thickness of ultra-thin film SiO2/Si (< 1 nm)

Using KRISS High-Accuracy Developed CRM for measuring Used for Calibration of Measuring
Ellipsometer thickness of thin film thickness of thin film

• Vacuum processing in Display industry


 Key role in quality control, process innovation, productivity improvement

Vacuum Process in Fab. : 80 %


Korea Vacuum Market Value: > $ 60B/year (ave. 8 % of world wide)

For SAMSUNG
- 80 -
Electronics
Global Metrology Academy
Industrial Metrology
“KRISS, exploring cutting‐edge industrial technology”
“KRISS, exploring cutting-edge industrial technology”

Cutting-edge measurement technology to enhance the global


competitiveness of industries, such as:
- space optics, vacuum, advanced instrumentation, etc.
Total measurement solutions for safety and security in energy sectors
Measurement technologies for public safety
Measurement capabilities in the fields of nano-materials

Global Metrology Academy


- 81 -
National Standards System

1 Standardization

2 Measurement Standard

3 Conformity Assessment
- Accreditation
- Certification

Global Metrology Academy


- 82 -
Conformity Assessment

 Definition (ISO/IEC Guide 2 )


 any activity concerned with determining directly or
indirectly that relevant requirements are fulfilled.

 Examples
 sampling, testing, inspection, evaluation, verification,
assurance of conformity (supplier’s declaration,
certification), registration, accreditation, approval,
and their combinations

Global Metrology Academy


- 83 -
Certification & Accreditation
 Certification
 the most common type of third-party conformity
assessment
 third-party attestation related to
• products, processes, systems, persons

 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

Global Metrology Academy


- 84 -
Accreditation / Certification System

Accreditation Body
Accreditation

Certification Certification Certification


Body Body Body

Certification

Customer : Product, Service

Global Metrology Academy


- 85 -
Relations between Consumer and
Certification / Accreditation

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

Global Metrology Academy


- 86 -
National Standards System

1 Standardization

2 Measurement Standard

3 Conformity Assessment
- Accreditation
- Certification

Global Metrology Academy


- 87 -
International Organizations
 International Laboratory Accreditation Cooperation (ILAC)
established in 1996 by signing of 44 countries
various laboratory accreditation schemes for testing,
calibration and inspection
develops international cooperation for facilitating trade by
promotion of the acceptance of accredited test and calibration
results

 International Accreditation Forum (IAF)


coordinates and establishes international uniformity for
accreditation of certification bodies (est. 1993)
primary focus has been on the accreditation of bodies
certifying quality systems to ISO 9000/14000

Global Metrology Academy


- 88 -
Traceability – ILAC policy

Global Metrology Academy


- 89 -
The International Picture
ILAC

EA APLAC
IAAC

SADCA

EA European co-operation for Accreditation


APLAC Asia Pacific Laboratory Accreditation Cooperation
ILAC International Laboratory Accreditation Cooperation
IAAC Inter-American Accreditation Cooperation
SADCA Southern African Development Cooperation for Accreditation
CAC-MAS-Q Central Asia Cooperation
Unaffiliated Bodies – Peer evaluated ABs who are not geographically located in one
of the established regions
Global Metrology Academy
- 90 -
Requirements for
Accreditation Body & Accredited Lab.
 Accreditation body
 ISO 17011
• Conformity assessment General requirements for accreditation
bodies accrediting conformity assessment bodies
 Accredited lab.
 ISO 17025 ; Testing and calibration lab.
 ISO 15189 ; Medical lab.
 ISO 22000 ; food safety.
 Traceability is the key factor in technical requirements.

Global Metrology Academy


- 91 -
ISO/IEC 17011:2004
 ISO/IEC 17011:2004, Conformity assessment - General
requirements for accreditation bodies accrediting conformity
assessment bodies

 Merged and combined in 2004

 ISO/IEC Guide 58:1993, Calibration and testing laboratory


accreditation systems -- General requirements for operation
and recognition

 ISO/IEC Guide 61:1996, General requirements for assessment


and accreditation of certification/registration bodies

 ISO/IEC TR 17010:1998, General requirements for bodies


providing accreditation of inspection bodies

Global Metrology Academy


- 92 -
Types of Accreditation System

Type Centralized Decentralized Mixed


Germany
United
Economy France U.S.A. Japan (in transit to
Kingdom
coordinated)

Accredi-  NACLA  IA Japan


 17 Acc. Bodies in
tation  UKAS  COFRAC  NELAC  JAB
total
Body  Etc  JCLA

 coordinating by govt.  non-governmental  operates coordinating


 economical activities committee
 convenient to the  specialized support in  overall coordinating
Features customer each area  needs cooperations
 operates technical  less-economical among accreditation
committees in each  lack of overall bodies
area coordinating

Global Metrology Academy


- 93 -
United Kingdom (centralized)

ILAC
BIPM

EA

 non profit organization


NPL, NEL UKAS
 MoU with government
LGC

Int’l Traceability
Scheme
Calibration Testing Inspection Certification
Lab Lab Lab Body

Research
Industries Universities
Institutes

Control Cooperation/Supporting

Global Metrology Academy


- 94 -
Germany (mixed) until Dec 2009

ILAC
BIPM
EA

BMWi DAR BMU BMELV

PTB Govt. + non Govt.


BAM UBA BLV

DAP,GAZ,
DKD DACH DAU AKS Hanover
TGA, DASMIN,
(physics) (chem/mat’l) DATech (environment) (food)

Calibration Testing / Inspection Lab


Lab

Research
Industries Universities Institutes

CA Scheme Designated
Cooperation/Supporting Int’l Traceability

Global Metrology Academy


- 95 -
Germany (coordinated) since Jan 2010

Sole provider
of accreditation
In Germany

Global Metrology Academy


- 96 -
Accreditation System in Korea
- 10 ministers and
National Standards Council nongovernmental delegates

KCSC Ministry
MOTIE MND MOE MFDS
MSIP

KOLAS Accreditation
DAPA NIER RRL (KFDA)
(KATS) Body

Cal./Test/ Local Local Certification


Testing Inspection
Inspec. Testing Testing Body
Labs Labs
Labs Labs Labs

Research
Industries Universities Customer
Institutes

Control Service
Legal Cooperation/Supporting
Only KOLAS satisfies requirements of ISO 17011 as an accreditation body.

RRL ; Radio Research Laboratory DAPA ; Defense Acquisition Program Administration

Global Metrology Academy


- 97 -
NIER ; National Institute of Environmental Research
Accreditation/Certification System of Korea
(Documentary (Laboratory (Measurement
(Legal Metrology)
Standards) Accreditation) Standards)

International
OIML ISO, IEC ILAC, IAF CGPM, BIPM
Level

ISO/IEC 17025 International


RI’s and DI’s ISO 9000, 14000 Measurement
Series Standards

National
KATS (MOTIE) KRISS
Level

KOLAS,
COSD
KAB, KAS

Industry
Level Laboratory Accreditation, RM Certification, Management Certification System, Mark, etc.

Global Metrology Academy


- 98 -
Accreditation Body of Korea - KOLAS
KOLAS KAS KAB

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

※ KOLAS, KAS ⇒ Governmental accreditation body (KATS)


※ KAB ⇒ Semi Private accreditation body
KAS ; Korea Accreditation System
Global Metrology Academy
- 99 -
KOLAS
 Korea Laboratory Accreditation Scheme
 Founded in 1992, Operated by KATS of MOTIE
- Framework Act on National Standards (1999)

 Mission
 Accreditation of Testing/Calibration Labs

 Accreditation of Inspection Bodies


 Proficiency Testing

 Training of Testing Personnel, etc.

 Accreditation Requirements
— Testing/Calibration Labs: ISO/IES 17025

— Inspection Bodies: ISO/IEC 17020

Global Metrology Academy


- 100 -
History of KOLAS
 Dec. 1992: Launched KOLAS
 Apr. 1995: Joined the APLAC as a full member
 Sep. 1996: Joined the ILAC as a inaugural member
 Sep. 1998: Integrated the accreditation program of calibration laboratories
 into KOLAS
 Oct. 1998: Signed the APLAC MRA for testing field
 Jun. 2000: Re-assessment of accredited calibration laboratories.
Signed ILAC MRA for Testing
 May 2001: Extended the APLAC MRA to include calibration laboratories.
Signed ILAC MRA for calibration.
 2004, 2008 ; Reassessment

Global Metrology Academy


- 101 -
Organization of KOLAS
Head of KOLAS

Executive Director

Training Quality Steering Committee Provider of


Assessor Technical Committee Proficiency Testing
Institute Manager

Metrology and Conformity Assessment


Measurement Division Policy Division

RM Producer Calibration Testing Inspection Proficiency Education


Laboratory Laboratory Body
Accreditation Accreditation Testing & Training
Accreditation Accreditation

Global Metrology Academy


- 102 -
Accreditation Fields (Testing)
 Mechanical testing
 Chemical testing
 Electrical testing
 Heat and Temperature measurement
 Non-destructive testing
 Acoustics and vibration testing
 Optics and photometry testing
 Medical testing
 Biological testing
 Forensic science testing
 Good laboratory practice for chemicals based on the OECD
guidelines

Global Metrology Academy


- 103 -
Accreditation Fields (Calibration)
 Length and related quantities
 Mass and related quantities
 Time and Frequency
 Electricity and Magnetism
 Temperature and Humidity
 Acoustics and Noise
 Photometry and Radiometry
 Ionizing Radiation
 Amount of substance
Calibration laboratories 189
Testing laboratories 418
Inspection laboratories 49
CRM manufacturers 11
As of Dec 2012

Global Metrology Academy


- 104 -
Accreditation Body of Korea - KAB
KOLAS KAS KAB

ISO/IEC ISO/IEC ISO/IEC ISO/IEC


17025, 17020 Guide 34 17065 17021

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

※ KOLAS, KAS ⇒ Governmental accreditation body (KATS)


※ KAB ⇒ Semi Private accreditation body
KAS ; Korea Accreditation System
Global Metrology Academy
- 105 -
KAB
 Korea Accreditation Board
 Authorized by MKE
 Founded in September 1995
 Objectives
 Accreditation of certification / training bodies for
Management System (ISO 9001, ISO 14001)
 Establishment of multilateral recognition arrangements
in the field of management system
 Mutual cooperation with domestic or overseas bodies
in relation to accreditation/certification system

Global Metrology Academy


- 106 -
History of KAB
1995. Established under the supervision of Korea Industrial Advancement
Administration (KIAA)

1996 Joined IAF and PAC, Recognized as EMS accreditation body by MKE

1997 Recognized as QMS accreditation body by MKE

1999 Joined IAF MLA for QMS

2002 Recognized as TL 9000 accreditation body by the QuEST Forum,


Launched OHSAS accreditation scheme

2004 Joined IAF MLA for EMS

2006 Launched program for FSMS accreditation scheme, Recognized as


supervision agency for national status of certification by MKE

2007 Launched program for ISMS accreditation scheme

2008 Peer Evaluation for PAC QMS & EMS MLA


Global Metrology Academy
- 107 -
II. The status of accreditation and certification
Accreditation Program

Quality Management System (QMS) : ISO 9001, TL 9000

Environmental Management System (EMS): ISO 14001

Occupational Health and Safety Management Systems : OHSAS 18001

Food Safety Management System (FSMS) : ISO 22000

Personnel Certification: ISO/IEC 17024


Certification of Management System
Government
(MOTIE, KATS)

Korea Accreditation Board


Accreditation Accreditation
· Accreditation and surveillance of ISO 9000/14000
certification and training body
Surveillance Surveillance
· Accreditation and surveillance of QS-9000
certification body
· Evaluation of assessor and registration

Registration
Certification body Training body
(34) Assessment (6)

Registration Training

Enterprise Assessor
(22,000) (3,900)

Global Metrology Academy


- 109 -
Accredited Certification Body

Quality system Standard Number of


Accredited
certification
bodies
Quality ISO 9001 33
Management
Std Issue Cancel Current
Environment ISO 30
Management 14001 ISO 9001 44,197 27,798 16,399
Information/ TL 9000 8 ISO 14001 14,275 7,641 6,634
Communication
TL 9000 435 225 210
Safety/Health K-OHSMS 6
18001 K-OHSMS 264 59 205
18001
Food safety ISO 7
22000 ISO 22000 139 12 127

(As of 2011)

Global Metrology Academy


- 110 -
Number of Certificates Issued
Total number of certificate issued in Korea : 41,378 (KAB + FAB)

28,000 ISO 9001 (as of June 2009) 26,373


25,529
26,000

24,000
KAB accredited Cert.(KAB)

22,000 Foreign AB accredited Cert. (FAB)


20,490
20,000

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

ISO/IEC ISO/IEC ISO/IEC ISO/IEC


17025, 17020 Guide 34 17065 17021

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

※ KOLAS, KAS ⇒ Governmental accreditation body (KATS)


※ KAB ⇒ Semi Private accreditation body
KAS ; Korea Accreditation System
Global Metrology Academy
- 113 -
KAS (Korea Accreditation System)
KAS Accredited Product Certification Bodies ; 13 Total number of issued certification ; 1,038
Number of
Accreditation
Name of Organization Website certification
No.
issued
Korea Institute of Ceramic Engineering
KAS-P-15 http://www.kicet.re.kr 1
and Technology
Meter and Petrochemical Testing and
KAS-P-14 http://www.mpi.or.kr -
Research Institute
KAS-P-13 Korea Testing Laboratory http://www.ktl.re.kr -
Korea Minting & Security Printing
KAS-P-12 http://www.komsco.com -
Corporation
KAS-P-11 FITI Testing & Research Institute http://www.fiti.re.kr 19
Korea Apparel Testing & Research
KAS-P-10 http://www.katri.re.kr 8
Institute
KAS-P-09 New and Renewable Energy Center http://www.energy.or.kr 697
KAS-P-08 Korea Electrical Safety Corporation http://stc.kesco.or.kr 89
Korea Electrotechnology Research
KAS-P-06 http://www.keri.re.kr 111
Institute
KAS-P-05 Korea Testing & Research Institute http://www.ktr.or.kr 67
KAS-P-04 Korea Gas Safety Corporation http://www.kgs.or.kr -
Korea Testing & Research Institute
KAS-P-03 http://www.eri.re.kr 4
(Yongin)
KAS-P-02 Korea Electric Testing Institute http://www.keeti.re.kr 12

Global Metrology Academy


- 114 -
National Standards System

1 Standardization

2 Measurement Standard

3 Accreditation/Certification
- Accreditation
- Certification

Global Metrology Academy


- 115 -
Global Metrology Academy
- 116 -
Global Metrology Academy
- 117 -
Current status of National Certification System
 Conformity Assessment in Products and Services
 57 Acts and Regulations from 14 Ministries
- 80 Legal Certification (compulsory / arbitrary)
- certification, accreditation, inspection, type approval,
permission, designation, registration, etc

 Voluntary System for Safety and Quality etc.


 Civil Certification System
- 60 Civil Certification from Association, Union, Testing Labs

Global Metrology Academy


- 118 -
National Certification System Innovation plan

1. Unification of legal certification


- Introducing National Mark (KC mark)
2. Harmonization of certification criteria
- Technical requirements based on National Standards
3. Build-up infrastructure of certification
- Promoting facility and manpower

 Developing systematic basis


- National Standard Council
- Executive Committee, Working Group

Global Metrology Academy


- 119 -
Introducing a new KC Mark

KOREA
KS Mark: KS CERTIFICATION (KC)
Mark (Voluntary)

KC Mark: National Integrated Mark (Regulatory)


• Introduces one single Korea Certification mark (“KC mark”
in its abbreviated form), which integrates and unifies all 13
existing legally compulsory certification marks.

Global Metrology Academy


- 120 -
From July 2011
Existing Certification Mark
Integrated KC Mark

Electrical Goods Industrial Safety & Reserves

Industrial Voluntary Child Elevator


Products Safety
Protection

Gas Environment(E), Quality(Q)


Energy Gas
Meters Safety(S), Health(H)
Efficiency Canisters Products

※ Existing marks and the KC mark are allowed to be


Fire Fighting concurrently used until Jun. 30, ‘11.
Water Communication
Purifiers Devices Supplies
Global Metrology Academy
- 121 -
Reducing Standard Certification Audit

When stipulated in the law, Standard Certification


제품에 대한 인증ㆍ검정 등을 반드시 받도록 법령에 규정하는 경
Audit System should be used.

20 Types of Certification Audit

Reduces form 20 to 9 based on international standards (ISO/IEC Guide 67).

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

Duplicative Acceptance of test result


certification

A package application for multiple certification

Simultaneous implementation of certification and factory audit for a


periodical inspection.
Global Metrology Academy
- 123 -
International Standards System

Measurement Management
Documentary Legal Laboratory
Standards System
Standards Metrology Accreditation
Accreditation

Inter- CGPM, CIPM,


national BIPM ISO, IEC OIML ILAC IAF

Regional
(APEC) APMP PASC APLMF APLAC PAC

National KATS/ KATS/ KATS/ KATS/


KRISS COSD KTC KOLAS KAB

KTC; Korea Testing Certification


Global Metrology Academy
- 124 -
Legal Metrology

 KATS (Became a member of OIML in 1978)


- Net weight indication ; 26 products
- Started from 2008.

 Korea Testing Certification


- 18 items listed in “Measures Act”
- Legal Measuring instruments
- Type approval, Verification, Periodic inspection,
Manufacturer registration

Global Metrology Academy


- 125 -
OIML D1 Elements for a Law on Metrology

Global Metrology Academy


- 126 -
Summary
CGPM, CIPM ISO/IEC
APMP Codex
Measurement Documentary
Standards Standards
KRISS COSD

ILAC/APLAC
Hardware Accreditation Software
/Certification
KOLAS/KAB/
KAS

Dissemination of standards to industry


Guaranteed Reliability, Safety, Quality
- 127 -
Global Metrology Academy
12
Concept of Quality Infrastructure for Products
IAF, ILAC - MRA
Farm to Fork System
APLAC, PAC

Regulatory Body Services Accreditation Body


Accreditation Body

Sanitary Surveillance e.g. residue


monitoring ISO/IEC ISO/IEC ISO/IEC ISO/IEC ISO/IEC
Guide 65 17020 17025 17043 Guide 34
Packaging

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

Global Metrology Academy


- 128 -
National Food Safety System

National coordination Technical support:


SPS inquiry point,
information, etc

National
Standards
Institute

Access to Additional international National


specific clients in voluntary requirements Metrology
international GlobalGAP, BRC, IFS, etc Institute
markets
Testing/
Calibration
International legal Laboratories
General access
to international requirements
EU directives, US-FDA, etc Certification/
markets
Inspection Bodies

National legal
General access to requirements National
domestic market Accreditation
technical regulations, etc. Body
for Food Safety

Industries, SME’s, Exporters, etc.

Global Metrology Academy


- 129 -
Technical Quality Infrastructure

Standardization = Definition of properties, dimensions, tolerances, etc.


Metrology = Guarantee of exact and reliable measurements
Testing = Analysis of properties, ingredients, characteristics, etc.

Quality Management = Reliable application of quality standards


Certification = Conformity with requirements defined in standards
Accreditation = Recognition of technical competence
Global Metrology Academy
- 130 -
Taking advantage of latecomers

One Standard,
We are One World.

 Only about 10 years.

Do we measure in right way (Standardization) ? 1962 (KS)


using right tools (Measurement Standard)? 1975 (KRISS)
How can we make sure it (Accreditation)? 1992 (KOLAS)

Harmonious operation of three main elements is essential.


Thank you for
your attention !
Abbreviation Full Name
APEC Asia-Pacific Economic Cooperation
APLAC Asia-Pacific Laboratory Accreditation Cooperation
APLMF The Asia-Pasific Legal Metrology Forum
APMP Asia-Pacific Metrology Program
ASEAN Association of South-East Asian Nations
BAM Federal Institute for Materials Research and Testing, Germany
BIPM International Bureau of Weights and Measures
BLV The Federal Office of Consumer Protection and Food Safety, Germany
BMELVB The Federal Ministy of Food, Agriculture and Consumer Protection, Germany
BMU Bundesministeriums fur Umwelt, Naturschutz und Reaktorsicherheit
BMW Federal Ministry of Economics and Technology, Germany
CGPM General Conference on Weights and Measures
CIPM International Committee of Weights and Measures
COFRAC Comite Francais d'Accreditation, France
CRM Certified Reference Material
DACH Deutsche Akkreditierrungsstelle Chemie GmbH, Germany
DAP Deutsches Akkreditierrungsstelle Prufwesen GmbH, Germany
DAPA Defense Acquisition Program Administration
DAR German Accreditation Council
DASMIN Deutsche Akkreditierrungsstelle Mineralol GmbH, Germany
DATech Deutsche Akkreditierrungsstelle Technik e.V.
133
DKD German Calibratio Service(Deutscher Kalibrierdienst)
EA European Cooperation for Accreditation
EC European Commission
EURAMET European Association of National Metrology Institutes
FAO Food and Agricultural Organization
IAF International Accreditation Forum
IEC International Electrotechnical Commission
ISO International Organization for Standardization
ITU International Telecommunication Union
ITU International Telecommunication Union
JAB Japan Accreditation Board for Conformity Assessment
KAB Korea Accreditation Board
KASTO Korea Association of Standards and Testing Organizations
KATS Korean Agent for Technology and Standards
KC Key Comparison
KCC Korea Communications Commission
KFDA Korea Food and Drug Administration
KOLAS Korea Laboratory Accreditation Scheme
KSA Korean Standards Association
LGC National Measurement Institute for Chemical and Biochemical analysis
MIHWAF Ministry for Health, Welfare and Family Affairs
MKE Ministry of Knowledge Economy
MND Ministry of National Defense
134
MOE Ministry of Environment
NACLA National Cooperation for Laboratory Accreditation, USA
NEL National Engineering Laboratory, UK
NELAC Environmental Laboratory Accreditation Conference, USA
NIER National Institute of Environmental Research
NMI National Metrology Institute
NORMET North American Metrology Network
NPL National Physical Laboratory
OECD Organization for Economic Cooperation and Development
PAC Pacific Accreditation Cooperation
PASC Pacific Area Standards Congress
PTB Physikalisch-Technische Bundesanstalt
RM Reference Material
RMO Regional Metrology Organizations
RRL Radio Research Laboratory
SADCMET Southern African Development Community Cooperation in Measurement Traceability
SIM The Inter-America Metrology System
TBT Technical Barrier of Trade
TGA The Therapeutic Goods Administration
UBA Umwelt Bundes Amt, Germany
UKAS United Kingdom Accreditation Service
WADA World Anti-Doping Agency
WMO World Meteological Organization
WTO World Trade Organization
135
GLOBAL METROLOGY ACADEMY

Metrology in General

2. G-2

QMS: Why and for what


– Management Requirements with ISO/IEC 17025
Dr. Jongseon Park 

File: G-2-0-GT-2014-01-QMS-management (ms word)

File: G-2-1-GT-2014-01-QMS-management (ppt)

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.

The lecture also compares some important terms used in conformity


assessment and quality management which may be confused. Recent
changes in the latest version of ISO/IEC 17025 are provided as well.

ISO/IEC 17025 consists of two main sections, management requirements


and technical requirements. There are twenty-five requirements in total
below.
 4. Management Requirements

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

Understanding of relationship among the requirements of ISO/IEC 17025


on next page is a key issue in this lecture.
Figure 1 Relationship among the requirements of ISO/IEC 17025

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.

 Key points of ISO/IEC 17025


 Management Requirements
- Control of Customer Feedbacks
- Internal Audits
- Management Reviews
 Technical Requirements
- Personnel with Competence
- Method and Method Validations
- Equipments with Traceability
Metrology in 
Mass and Related 
Quantities
(GMA-GT-2004-02)

QMS: Why and for What


- Management requirements of ISO/IEC 17025

Metrology in General
(G-2)

March 10, 2014
Dr. Jongseon PARK
jspark@kriss.re.kr
Summary of the main contents and goal of class

Understanding the managerial aspect of Quality Management


System in general

Establishment and Maintaining QMS are essential to assure the results of


measurement worldwide. Why and for what we need to know QMS are
introduced. Some details in metrology and conformity assessment
activities are introduced as well.

After taking this lecture, trainee will have comprehensive knowledge on


QMS in general and management requirements of ISO/IEC 17025.
Profile of Dr. Jongseon Park
Dr. Jongseon Park
Center for Measurement and Calibration Services
Division of Technology Services, KRISS
W: 042-868-5409/ Cell:010-5454-1968
Fax:042-868-5419
jspark@kriss.re.kr

Academic and Research Career


2012.12 ~ Present TCQS, APMP / Chair
2012.12 ~ Present Center for Calibration and Measurement Services / Head
2001 ~ Present KOLAS Assessor
2001 ~ 2012 Center for Quality Management, KRISS / Principal Quality Officer
1993 ~ 2000 Technical Information Center, KRISS / Librarian

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

• Are the results of test/calibration domestic use


only?
• Are the results used for exporting commodities?

Once Tested, Accepted Everywhere

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)

Purpose To operate QMS To operate QMS

Output Accreditation Certification

Testing and Calibration


Applicable to Any business
Laboratories only
Major changes Process approach
Principle of 9001:2000
in latest edition (2000)

Key document Procedure Process

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

Procedure by which a third party (a certification b


ody or lab) gives a written assurance that a prod
uct , process or service (of an organization) con
forms to specified requirements.

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

Customer Customer ISO 9001 etc.

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

Start Task 1 Task 2 Task 3 End

Process Management

Input Process Output

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)

However, it does not mean that a laboratory be


accredited to ISO/IEC 17025 automatically meet the
requirements of ISO 9001 because of lack of eight
QMS principles, especially process approach

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

5.8 5.4 5.10


Reporting
Handling Methods/Validation
the Results
5.7 5.3 5.5 5.9
Sampling Environments Equipments Assuring
5.2 5.6 Results
Personnel Traceability

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

• shall ~ : must (Clauses)


• should ~ : strong recomm.(Notes)
• may : optional
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 requests, and/or calibration work
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
20
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
21
Organization (4.1)
• The laboratory shall be entity that can be held
legally responsible. (4.1.1)
• It is the responsibility of the laboratory to carry
out its testing and calibration activities in
such a way as to meet the requirements of
this International Standard and to satisfy
the needs of the customer, the regulatory
authorities or organizations providing
recognition. (4.1.2)
• The management system shall cover work
carried out in the laboratory’s permanent
facilities, at sites away from its permanent
facilities, or in associated temporary or mobile
facilities. (4.1.3) 22
Organization (4.1)
• If the laboratory is part of an organization
performing activities other than testing
and/or calibration, the responsibilities of
key personnel in the organization that have an
involvement or influence on the testing and/or
calibration activities of the laboratory shall be
defined in order to identify potential conflicts of
interest. (4.1.4)

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 shall ensure that


appropriate communication processes are
established within the laboratory and that
communication takes place regarding the
effectiveness of the management system.
(4.1.6)
28
Organization (4.1)
• Typical structure

Top
management

Technical Technical
Quality
Manager in Manager in
manager
area A area B

Personnel for Personnel for


specific test specific test

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
30
Management system (4.2)

• The laboratory shall establish,


implement and maintain a quality
management system appropriate to the
scope of its activities. (4.2.1)
• The laboratory’s management system
policies related to quality, including a
quality policy statement, shall be defined
in a quality manual (however named).
(4.2.2)
31
Management system (4.2)
• Quality policy statement shall include at least the
following:
a. the laboratory management’s commitment to good
professional practice and to the quality of its testing
and calibration in servicing its customers
b. the management’s statement of the laboratory’s
standard of service
c. the purpose of the quality system
d. a requirement that all personnel concerned with testing
and calibration activities within the laboratory
familiarize themselves with the quality documentation
and implement the policies and procedures in their
work
e. the laboratory management’s commitment to
compliance with this International Standard and to
continually improve the effectiveness of the
management system
32
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
33
Document control (4.3)

• The laboratory shall establish and


maintain procedures to control all
documents that form part of its quality
system (internally generated or from
external sources), such as regulations,
standards, other normative documents,
test and/or calibration methods, as well as
drawings, software, specifications,
instructions and manuals. (4.3.1)
34
Document control (4.3)
• Typical structure of documents

Quality
manual

Procedures

• Guides
• Service Procedures

35
Document control (4.3)

• Types of document(4.3.1 note)


– policy statements
– procedures, specifications, calibration tables,
charts, text books, posters, notices,
memoranda, software, drawings, plans, etc.

– these may be on various media, whether hard


copy or electronic, and they may be digital,
analog, photographic or written

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)

• The laboratory shall establish and


maintain procedures for the review
of requests, tenders and
contracts.(4.4.1)
• Any differences between the request or
tender and the contract shall be resolved
before any work commences. Each
contract shall be acceptable both to the
laboratory and the customers. (4.4.1)
38
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 requests, and/or calibration work
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and 4.12 Preventive actions
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
39
Subcontracting of tests and calibrations (4.5)

• When a laboratory subcontracts work


whether because of unforeseen
reasons(e.g. workload, need for further
expertise or temporary incapacity) or on a
continuing basis(e.g. through permanent
subcontracting, agency or franchising
arrangements), this work shall be placed
with a competent subcontractor.
(4.5.1)
40
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 requests, and/or calibration work
tenders and contracts 4.10 Improvement
4.5 Subcontracting of 4.11 Corrective actions
tests and calibrations 4.12 Preventive actions
4.6 Purchasing 4.13 Control of records
services and 4.14 Internal audits
supplies 4.15 Management reviews
4.7 Service to the
customer
41
Purchasing services and supplies (4.6)

• The laboratory shall have a policy and


procedure(s) for the selection and
purchasing of services and supplies it uses
that affect the quality of the tests and/or
calibrations. (4.6.1)
• The laboratory shall evaluate suppliers
of critical consumables, supplies and
services which affect the quality of testing
and calibration, and shall maintain
records of these evaluations and list
those approved. (4.6.4) 42
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
43
Service to the customer (4.7)
• The laboratory shall be willing to
cooperate with customers or their
representatives in clarifying the customer’s
request and in monitoring the laboratory’s
performance… (4.7.1)
• The laboratory shall seek feedback, both
positive and negative, from its
customers. The feedback shall be used
and analysed to improve the
management system, testing and
calibration activities and customer
services. (4.7.2) 44
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
45
Complaints (4.8)

• The laboratory shall have a policy and


procedure for the resolution of
complaints received from customers
or other parties. Records shall be
maintained of all complaints and of the
investigations and corrective actions taken
by the laboratory.(4.8)

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)

• The laboratory shall have a policy and


procedures that shall be implemented
when any aspect of its testing and/or
calibration work, or the results of this
work, do not conform to its own
procedures or the agreed
requirements of the customer. (4.9.1)

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
50
Improvement (4.10)

• The laboratory shall continually


improve the effectiveness of its
management system through the use
of the quality policy, quality
objectives, preventive actions and
management reviews. (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
52
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

53
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
54
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)

55
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
56
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.
58
Control of records (4.13)

 When mistakes occur in records, each


mistake shall be crossed out, not
erased, made illegible or deleted, and
the correct value entered alongside.
All such alterations to records shall be
signed or initialled by the person
making the correction. (4.13.2.1)

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
60
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)
61
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
62
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)

63
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.
64
Conclusion
• Essential Points of Management
Requirements
– Control of Customer Feedbacks
– Internal Audits
– Management Reviews

• Future of ISO/IEC 17025


– Next version of 17025 is being reviewed to allow
synchronization with the ISO 9001 revisions

65
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.

Quality Management - accountability for the


successful implementation of the quality system.

Quality Plan - the documented result of quality


planning that is disseminated to all relevant levels
of the organization.
[Appendix]
Terminology in ISO/IEC 17025
Quality Control - the steps taken during the generation
of a product or service to ensure that it meets
requirements and that the product or service is
reproducible.
Quality Assurance - proactive and retrospective
activities that provide confidence that requirements
are fulfilled.
Customer – organisation or person that receives a prod
uct (for laboratories, the product is the calibration or
test results) . Examples - consumer, client, end-user,
retailer, beneficiary and purchaser.
Conformity – fulfilment of a requirement. [Appendix]
Terminology in ISO/IEC 17025
Management system – means the quality, a
dministrative and technical systems that g
overn the operations of a laboratory

Top management – person or group of peop


le who directs and controls an organisatio
n at the highest level, e.g. CEO, BoD, MD,
ED, head of the laboratory, etc. Have the
authority to make policies and decisions
[Appendix]
Abbreviations

• KOLAS : Korea Laboratory Accreditation Scheme

• ISO : International Organization for Standardization

• IEC : International Electrotechnical Commission

• QMS : Quality Management System

• CEO : Chief Executive Officer

• BoD : Board of Directors

• 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

QMS: Why and for what


– Technical Requirements with ISO/IEC 17025
Dr. Hum‐Young So   

File: G-3-GT-2014-01-QMS-technical (ppt)

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

Global Metrology Academy


외부강사 2. Hun-Young So, Ph.D. 소헌영 박사

Advisor, Dongil Shimadzu 동일시마즈 고문


Office: +82 – (0)42 – 864 – 1161
Cellular: +82 – (0)10 – 9123 – 7453
Email: hyso@shimadzu.co.kr

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.

4
Global Metrology Academy
History of ISO/IEC 17025:2005
ISO Guide 25:1978 – “General Requirements for the Competence of Testing and Calibration Laboratories” (1st Edition)

ISO/IEC Guide 25:1982 – 2nd Edition

European Standard EN 45001:1989 - “General Criteria for the Operation of Testing Laboratories”

ISO/IEC Guide 25:1990 – 3rd Edition

European Union, Nov 1993 and 1995 (AUT, FIN, SWE)

WTO, 1995 – TBT, SPS

CIPM MRA, 14 Oct 1999

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”
5
Global Metrology Academy
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.

• ISO 17025 provides specific guidance on the application of the


ISO 9001 principles to laboratories
– As a result of agreements with laboratory AB, many ISO 9001
certification bodies will not allow their certification to be cited by
commercial testing or calibration laboratories in support of their
services.

6
Global Metrology Academy
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.

7
Global Metrology Academy
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:

‒ Insistence on a demonstrated commitment to continually improve the


quality management system and identified mechanisms for achieving this

‒ Greater emphasis of the need to communicate with customers and,


especially, to actively solicit feedback on service quality and ensure the
resulting information is used as the basis of action to improve the
management system.

‒ Greater emphasis of the need to use information from quality control


data to evaluate the performance of the quality system and to identify
opportunities for improvement.

8
Global Metrology Academy
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.

9
Global Metrology Academy
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

10
Global Metrology Academy
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.

The acceptance of testing and calibration results between countries should be


facilitated if laboratories comply with this International Standard and if they
obtain accreditation from bodies which have entered into mutual recognition
agreements with equivalent bodies in other countries using this International
Standard.

The use of this International Standard will facilitate cooperation between


laboratories and other bodies, and assist in the exchange of information and
experience, and in the harmonization of standards and procedures.
Introduction 3/3 11
Global Metrology Academy
Single market
• Free movements of four things
– Capital
– Labour
– Goods
– Services

• Removal of three barriers


– Physical (borders)
– Technical (standards)
– Fiscal (taxes)

12
Global Metrology Academy
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

• The first multilateral agreement – WELAC (Western Europe


Laboratory Accreditation Co-operation) in 1992
– UK, Netherlands, France, Sweden, Denmark

13
Global Metrology Academy
IS for Accreditation
• Accreditation bodies operate according to ISO/IEC 17011

• Accredited entities in specific sectors must provide evidence to the


accreditation body that they conform to other standards in the same series:

– ISO/IEC 17011:2004 Conformity assessment - General requirements for accreditation bodies


accrediting conformity assessment bodies
– ISO/IEC 17020:2012 Conformity assessment - Requirements for the operation of various
types of bodies performing inspection
– ISO/IEC 17021: 2006 Conformity assessment - Requirements for bodies providing audit and
certification of management systems
– ISO/IEC 17024:2012 Conformity assessment - General requirements for bodies operating
certification of persons
– ISO/IEC 17025:2005 General requirements for the competence of testing and calibration
laboratories

14
Global Metrology Academy
CIPM MRA
2 Scope of the arrangement

2.1 Participating national metrology institutes, listed in Appendix A, recognize


the degree of equivalence of national measurement standards, derived
from the results of key comparisons, for the quantities and values specified
in Appendix B. This constitutes part one of the arrangement.

2.2 Participating institutes recognize the validity of calibration and


measurement certificates issued by other participating institutes for the
quantities and ranges specified in Appendix C. This constitutes part two of
the arrangement.

15
Global Metrology Academy
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.

Demonstration of competence and capability may require visits and examination of


procedures by an NMI and/or by peers selected by the local RMO.
16
Global Metrology Academy
ISO/IEC 17025
4.1 Organization Management
Requirements
4.15 Management Reviews
4.2 Management
System 4.14 Internal
audits
4.3 Document
4.13 Control Control 4.10 mprovement 4.11 Corrective 4.7 Service
of Records action to the customer
4.12 Preventive
action

4.4 Review of request, 4.5 Subcontracting of 4.6 Purchaseing of 4.9 Control of


4.8 Complaints
tenders and contracts testing/calibrations services/supplies nonconforming work

5.7 Sampling 5.2 Personnel

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

5.6 Measurement Technical


traceability Requirements17

Global Metrology Academy


1 SCOPE
• Specifies requirements applicable to Testing / Calibration laboratories
• Notes given in the standard provide clarification of the text, examples and
guidance. They do not contain requirements
• Standard is meant for use by laboratories, customers, accreditation bodies
etc.
• Compliance with the regulatory and safety requirements are not covered
by this standard
• Compliance with this standard ensures compliance with ISO 9001

18
Global Metrology Academy
2 Normative references
• ISO/IEC 17000, Conformity assessment — Vocabulary and general
principles

• VIM, International vocabulary of basic and general terms in metrology,


issued by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML

19
Global Metrology Academy
3 Terms and definitions
• ISO/IEC 17000:2004
Conformity assessment - Vocabulary and general principles

• ISO/IEC Guide 99:2007


International vocabulary of metrology -- Basic and general concepts and
associated terms (VIM)

20
Global Metrology Academy
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
21
Global Metrology Academy
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

22
Global Metrology Academy
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)

5.1.2 These factors contribute to the uncertainty of measurement.

These factors should be taken into account in;


- developing test and calibration methods and procedures
- training and qualification of personnel
- the selection and calibration of the equipment it uses.

23
Global Metrology Academy
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.

24
Global Metrology Academy
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.

5.2.5 The management shall authorize specific personnel to perform


particular types of sampling, test and/or calibration, to issue test
reports and calibration certificates, to give opinions and
interpretations and to operate particular types of equipment. The
laboratory shall maintain records of the relevant authorization(s),
competence, educational and professional qualifications, training, skills
and experience of all technical personnel, including contracted
personnel. This information shall be readily available and shall include
the date on which authorization and/or competence is confirmed.

25
Global Metrology Academy
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.

The laboratory shall ensure that the environment conditions do not


invalidate the results or adversely affect the required quality of any
measurement. Particular care shall be taken when sampling, tests
and/or calibrations are undertaken at sites other than a permanent
laboratory facility. The technical requirements for accommodation
and environmental conditions that can affect the results of tests
and calibrations shall be documented.

26
Global Metrology Academy
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.

27
Global Metrology Academy
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.

5.3.5 Measures shall be taken to ensure good housekeeping in the


laboratory. Special procedures shall be prepared where
necessary.

28
Global Metrology Academy
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.

29
Global Metrology Academy
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
customer is considered to be inappropriate or out of date. 30
Global Metrology Academy
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.

5.4.4 Non-standard methods


When it is necessary to use methods not covered by standard methods, these
shall be subject to agreement with the customer and shall include a clear
specification of the customer's requirements and the purpose of the test
and/or calibration. The method developed shall have been validated
appropriately before use.

31
Global Metrology Academy
5.4.5 Validation of methods

5.4.5.1 Validation is the confirmation by examination and the provision


of effective evidence that the particular requirements for a specific
intended use are fulfilled.

5.4.5.2 The laboratory shall validate non-standard methods, laboratory-


designed/developed methods, standard methods used outside
their intended scope, and amplifications and modifications of
standard methods to confirm that the methods are fit for the
intended use. The validation shall be as extensive as is necessary to
meet the needs of the given application or field of application. The
laboratory shall record the results obtained, the procedure used
for the validation, and a statement as to whether the method is
fit for the intended use.

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.
32
Global Metrology Academy
5.4.6 Estimation of uncertainty of measurement

5.4.6.1 A calibration laboratory, or a testing laboratory performing its own


calibrations, shall have and shall apply a procedure to estimate the
uncertainty of measurement for all calibrations and types of
calibrations.

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
validation data. 33
Global Metrology Academy
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.

34
Global Metrology Academy
5.4.7 Control of data

5.4.7.1 Calculations and data transfers shall be subject to appropriate


checks in a systematic manner.

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.
35
Global Metrology Academy
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
use (see 5.6). 36
Global Metrology Academy
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.

37
Global Metrology Academy
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:

a) the identity of the item of equipment and its software;


b) the manufacturer's name, type identification, and serial number or
other unique identification;
c) checks that equipment complies with the specification;
d) the current location, where appropriate;
e) the manufacturer's instructions, if available, or reference to their
location;
f) dates, results and copies of reports and certificates of all calibrations,
adjustments, acceptance criteria, and the due date of next
calibration;
g) the maintenance plan, where appropriate, and maintenance carried
out to date;
h) any damage, malfunction, modification or repair to the equipment.

38
Global Metrology Academy
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.

5.5.7 Equipment that has been subjected to overloading or mishandling, or


gives suspect results, or has been shown to be defective or outside
specified limits, shall be taken out of service. It shall be isolated to
prevent its use or clearly labelled or marked as being out of
service until it has been repaired and shown by calibration or test to
perform correctly. The laboratory shall examine the effect of the defect
or departure from specified limits on previous tests and/or calibrations
and shall institute the "Control of nonconforming work" procedure (see
4.9).

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

39
Global Metrology Academy
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.

5.5.10 When intermediate checks are needed to maintain confidence in


the calibration status of the equipment, these checks shall be
carried out according to a defined procedure.

5.5.11 Where calibrations give rise to a set of correction factors, the


laboratory shall have procedures to ensure that copies (e.g. in
computer software) are correctly updated.

5.5.12 Test and calibration equipment, including both hardware and


software, shall be safeguarded from adjustments which would
invalidate the test and/or calibration results.

40
Global Metrology Academy
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.

5.6.2 Specific requirements


5.6.2.1 Calibration
5.6.2.1.1 For calibration laboratories, the programme for calibration of
equipment shall be designed and operated so as to ensure that
calibrations and measurements made by the laboratory are
traceable to the International System of Units (SI) (Système
International d’unites).

41
Global Metrology Academy
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.

42
Global Metrology Academy
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.

5.6.2.2.2 Where traceability of measurement to SI units is not possible


and/or not relevant, the same requirements for traceability to, for
example, certified reference materials, agreed methods and/or
consensus standards, are required as for calibration laboratories
(see 5.6.2.1.2).

43
Global Metrology Academy
5.6.3 Reference standards and reference materials

5.6.3.1 Reference standards

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.

5.6.3.2 Reference materials

Reference materials shall, where possible, be traceable to SI units of


measurement, or to certified reference materials. Internal reference
materials shall be checked as far as is technically and economically practicable.

44
Global Metrology Academy
5.6.3.3 Intermediate checks

Checks needed to maintain confidence in the calibration status of reference,


primary, transfer or working standards and reference materials shall be
carried out according to defined procedures and schedules.

5.6.3.4 Transport and storage

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.

45
Global Metrology Academy
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.

5.7.2 Where the customer requires deviations, additions or exclusions from


the documented sampling procedure, these shall be recorded in detail
with the appropriate sampling data and shall be included in all documents
containing test and/or calibration results, and shall be communicated to
the appropriate personnel.

46
Global Metrology Academy
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.

47
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.

48
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.

49
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.

50
Global Metrology Academy
5.10 Reporting the results
5.10.1 General

The results of each test, calibration, or series of tests or calibrations


carried out by the laboratory shall be reported accurately, clearly,
unambiguously and objectively, and in accordance with any
specific instructions in the test or calibration methods.

The results shall be reported, usually in a test report or a calibration


certificate (see note 1), and shall include all the information requested
by the customer and necessary for the interpretation of the test or
calibration results and all information required by the method used. This
information is normally that required by 5.10.2 and 5.10.3 or 5.10.4.

In the case of tests or calibrations performed for internal customers, or


in the case of a written agreement with the customer, the results may
be reported in a simplified way. Any information listed in 5.10.2 to
5.10.4 which is not reported to the customer shall be readily available in
the laboratory which carried out the tests and/or calibrations.
51
Global Metrology Academy
5.10.2 Test reports and
calibration certificates
Each test report or calibration certificate shall include at least the
following information, unless the laboratory has valid reasons for not
doing so:
a) a title
b) the name and address of the laboratory
c) unique identification of the test report or calibration certificate
d) the name and address of the customer;
e) identification of the method used;
f) the condition of, and identification of the item(s) tested or calibrated;
g) the date of receipt of the test or calibration
h) reference to the sampling plan
i) the test or calibration results
j) the name(s), function(s) and signature(s) of person(s) authorizing the
test report or calibration certificate;
k) where relevant, a statement to the effect that the results relate only to
the items tested or calibrated.
52
Global Metrology Academy
5.10.3 Test reports
5.10.3.1 In addition to the requirements listed in 5.10.2, test reports
shall, where necessary for the interpretation of the test results, include
the following:
a) deviation from, additions to, or exclusions from the test method, and
information on specific test conditions, such as environmental conditions;
b) where relevant, a statement of compliance/non-compliance with
requirements and/or specifications;
c) where applicable, a statement on the estimated uncertainty of
measurement; information on uncertainty is needed in test reports when
it is relevant to the validity or application of the test results, when a
customer’s instruction so requires, or when the uncertainty affects
compliance to a specification limit;
d) where appropriate and needed, opinions and interpretations
e) additional information which may be required by specific methods,
customers or groups of customers.
53
Global Metrology Academy
5.10.3.2 In addition to the requirements listed in 5.10.2 and 5.10.3.1,
test reports containing the results of sampling shall include
the following, where necessary for the interpretation of test
results:
a) the date of sampling;
b) unambiguous identification of the substance, material or product
sampled (including the name of manufacturer, the model or type
of designation and serial numbers as appropriate);
c) the location of sampling, including any diagrams, sketches or
photographs;
d) a reference to the sampling plan used;
e) details of any environmental conditions during sampling that may
affect the interpretations of the test results;
f) any standard or other specification for the sampling method or
procedure, and deviations, additions to or exclusions from the
specification concerned.

54
Global Metrology Academy
5.10.4 Calibration certificates

5.10.4.1 In addition to the requirements listed in 5.10.2, calibration certificates


shall include the following, where necessary for the interpretation of calibration
results:

a) the conditions (e.g. environmental) under which the calibrations were


made that have an influence on the measurement results;
b) the uncertainty of measurement and/or a statement of compliance with
an identified metrological specification or clauses thereof;
c) evidence that the measurements are traceable (see note 2 in
5.6.2.1.1).

55
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.

When a statement of compliance with a specification is made


omitting the measurement results and associated uncertainties, the
laboratory shall record those results and maintain them for possible
future reference.

When statements of compliance are made, the uncertainty of


measurement shall be taken into account.

56
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.

5.10.5 Opinions and interpretations

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.

57
Global Metrology Academy
5.10.6 Testing and calibration results obtained from subcontractors

When the test report contains results of tests performed by subcontractors,


these results shall be clearly identified. The subcontractor shall report the
results in writing or electronically.
When a calibration has been subcontracted, the laboratory performing the work
shall issue the calibration certificate to the contracting laboratory.

5.10.7 Electronic transmission of results


In the case of transmission of test or calibration results by telephone, telex,
facsimile or other electronic or electromagnetic means, the requirements of this
International Standard shall be met (see also 5.4.7).

58
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.

5.10.9 Amendments to test reports and calibration certificates


Material amendments to a test report or calibration certificate after issue shall
be made only in the form of a further document, or data transfer, which includes
the statement:

"Supplement to Test Report [or Calibration Certificate], serial number...[or as


otherwise identified]", or an equivalent form of wording.

Such amendments shall meet all the requirements of this International


Standard. When it is necessary to issue a complete new test report or
calibration certificate, this shall be uniquely identified and shall contain a
reference to the original that it replaces.

59
Global Metrology Academy
THE END

Thanks for Your Attention!

60
Global Metrology Academy
GLOBAL METROLOGY ACADEMY

Metrology in General

4. G-4

Measurement and Traceability


5. G-5, G-6

Uncertainty in Measurement
(Lecture and practice)
Dr. Chu‐Shik KANG 

File: G-4-6-GT-2014-01-Mearuement-Traceability-Uncertainty (ppt)

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

Academic and Research Career


1993 – 1994: Post doctoral fellow, KRISS
1994 – 2001: Senior Research Scientist, KRISS
2001 – present: Principal Research Scientist, KRISS
1995. 4. – 1995. 6.: Guest Researcher, Physikalisch-Technische Bundesanstalt (Germany)
1998. 4. – 1998. 9.: Guest Researcher, Physikalisch-Technische Bundesanstalt (Germany)
1999. 10.. – 1999. 12.: Guest Researcher, Physikalisch-Technische Bundesanstalt (Germany)
2000 – present: Technical Assessor, Korea Laboratory Accreditation Scheme (KOLAS, Korea)
2005 – present: Professor, University of Science and Technology (UST, Korea)
2010. 12 – 2011. 11.: Guest Researcher, National Institute of Standards and Technology (USA)
2013. 11. – present: Vice Chair of APMP Technical Committee for Length (Chair Elect)

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

 Metrology = “meter” + “ology”


(to measure) + (science)
= Science of measurements
and its application

 includes all theoretical and practical aspects of


measurement

 World metrology day


 20th of May
 Meter convention
 May 20, 1874
4
Categories of metrology
1. Scientific metrology
Scientific deals with the organization and development of
metrology measurement standards and with their maintenance
(highest level).

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

Measurement Documentary Legal Laboratory


Standards Standards Metrology Accreditation

CGPM, CIPM, ILAC


International-level ISO/IEC/CIE OIML
BIPM IAF, UILI

APMP, AFRIMETS, PASC, ARSO, APLMF, EMLMF, APLAC, EA,


Regional-level COOMET, SIM, SCSC, WELMEC, IAMS, SADCA, IAAC,
EURAMET EACNMI, … EOTC, …

National-level

IEC: International Electrotechnical Commission


ITU International Telecommunication Union)
PASC: PACIFIC AREA STANDARDS CONGRESS
ILAC - International Laboratory Accreditation Cooperation
ISO 국제표준화기구 International Organization for Standardization
IAF International Accreditation Forum
KOLAS 한국인정기구 Korea Laboratory Acceditation Scheme 6
Meter Convention Organization

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

 CIPM Mutual Recognition Arrangement


 Agreement between NMIs (1999, revised 2003)
 Only one NMI per country can sign the MRA
 DI can also be designated and participate in MRA
through the signatory NMI
 Part 1:
 relates to the establishment of the degree of
equivalence of national measurement standards
 Part 2:
 concerns the mutual recognition of calibration and
measurement certificates issued by participating
institutes
12
CIPM MRA (2)

 Objectives of CIPM MRA:


1. to establish the degree of equivalence of
national measurement standards maintained by
NMIs;
2. to provide for the mutual recognition of
calibration and measurement certificates issued
by NMIs;
3. thereby to provide governments and other
parties with a secure technical foundation for
wider agreements related to international trade,
commerce and regulatory

13
CIPM MRA (3)

 Required processes to meet the objectives:

1. peer review of the declared Calibration and


Measurement Capabilities (CMCs) of the
participating NMIs and DIs
2. credible participation by NMIs and DIs in
international comparisons of measurement
standards (key comparisons or supplementary
comparisons)
3. peer review of the quality systems and
demonstration of competence by the
participating NMIs and DIs

14
Calibration

 Set of operations that establish, under specified


conditions, the relationship between the quantity
values with measurement uncertainties provided
by measurement standards or certified reference
materials and corresponding indications with the
associated measurement uncertainties of the
measurement instrument, measuring system or
reference material under test.

 Value(Correction) = Value(Ref) – Val(Indication)

15
Main Reasons to Calibrate an Instrument

1. To establish and demonstrate traceability.

2. To ensure readings from the instrument are


consistent with other measurements.

3. To determine the accuracy of the instrument


readings.

4. To establish the reliability of the instrument i.e.


that it can be trusted.

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

 Analysis of results: Pilot laboratory, KCRV


 BIPM KC Database (KCDB)

18
BIPM KCDB

 BIPM Key Comparison Database (KCDB)


 considered as appendices of CIPM MRA

 Appendix A: List of participating NMIs and DIs


 Appendix B: Results of KCs and SCs
 Appendix C: CMCs of the NMIs and DI
 Appendix D: List of KCs

19
Calibration and Measurement Capability (CMC)

 A “CMC” is:
a Calibration and Measurement Capability
available to customers under normal conditions:

(a) as published in the BIPM key comparison


database (KCDB) of the CIPM MRA; or

(b) as described in the laboratory’s scope of


accreditation granted by a signatory to the ILAC
Arrangement.

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

 SI (The International System of Units)


 8th edition (2006)
 Published by BIPM

 7 Base units and quantities


 meter (m): length
 kilogram (kg): mass
 second (s): time
 Ampere (A): electric current
 kelvin (K): thermodynamic temperature
 candela (cd): luminous intensity
 mole (mol): amount of substance

24
SI base unit: metre

 Metre (Meter)

 Base unit for length


 Name: metre (meter)
 Symbol: m

 Definition:

 The metre is the length


of the path travelled by
light in vacuum during a
time interval of 1/299 792
458 of a second.
 17th CGPM (1983)

25
SI base unit: kilogram

 kilogram

 Base unit of mass


 Name of unit: kilogram
 Symbol of unit: kg

 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

 Mass change of 50 μg in 100 yr

 New definition: based on physical


constants

 Avogadro project
 Determination of Avogadro
constant
 Counting number of atoms in a
silicon sphere

 Watt balance experiment


 Determination of Plank constant
 KRISS started in 2012

27
SI base unit: second

 second

 Base unit of time


 Name of unit: second
 Symbol of unit: s

 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

 Base unit of thermodynamic


temperature
 Name of unit: kelvin
 Symbol of unit: K

 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)]

 t/C = T/K – 273.15

29
SI base unit: ampere

 ampere

 Base unit of electric current


 Name of unit: ampere
 Symbol of unit: A

 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

 Base unit of luminous


intensity
 Name of unit: candela
 Symbol of unit: cd

 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

 Place a space between number and unit


 Examples: 100 km, 50 g, 220 V, 50 %
 Exception: angle (degree, minute, second)
 Example: 384527
 Symbols for units should be typed in an upright
(roman) typeface
 Unit symbols are printed in lower-case letters
 Examples: m, kg, s, cd, mol
 Exception: when the name of the unit is derived
from the name of a person
 Examples: N, W, K, A, V, , Hz, B, Pa

36
GUM

 Evaluation of measurement data — Guide to


the expression of Uncertainty in Measurement
 Published in 1995
 By BIPM, IEC, IFCC, ISO, IUPAC, IUPAP,
OIML

 ISO/IEC Guide 98-3


 JCGM 100: 2008 (free, GUM with minor revision)
BIPM: Bureau International des Poids et Mesures
IEC: International Electrotechnical Commission
IFCC: International Federation of Clinical Chemistry
ILAC: International Laboratory Accreditation Cooperation (2005)
ISO: International Organization for Standardization
IUPAC: International Union of Pure and Applied Chemistry
IUPAP: International Union of Pure and Applied Physics
OlML: International Organization of Legal Metrology

37
VIM

 Vocabulary in Metrology (VIM)


 by BIPM, IEC, IFCC, ILAC, IUPAC, IUPAP, ISO, OIML
 VIM1 (1st Edition): 1984
 VIM2 (2nd Edition): 1993/1995
 VIM3 (3rd Edition): 2007/2012

 ISO/IEC Guide 99 (2007)


 JCGM 200 (2012)
 Downloadable free online (www.bipm.org)

BIPM: Bureau International des Poids et Mesures


IEC: International Electrotechnical Commission
IFCC: International Federation of Clinical Chemistry
ILAC: International Laboratory Accreditation Cooperation (2005)
ISO: International Organization for Standardization
IUPAC: International Union of Pure and Applied Chemistry
IUPAP: International Union of Pure and Applied Physics
OlML: International Organization of Legal Metrology

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

 Measurement: process of experimentally


obtaining one or more quantity values that can
reasonably be attributed to a quantity
 Measurement implies comparison of quantities
or counting of entities.

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

 measured (quantity) value


 quantity value representing a measurement result
 For a measurement involving replicate indications, each
indication can be used to provide a corresponding measured
quantity value. This set of individual measured quantity values
can be used to calculate a resulting measured quantity value,
such as an average or median, usually with a decreased
associated measurement uncertainty.

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)

• A parameter associated with the result of a measurement,


that characterizes the dispersion of the values that could
reasonably be attributed to the measurand (VIM, 2nd Edition, 1993)

• Uncertainty itself does not contain plus-minus sign!


• Uncertainty is positive or zero.

Y  y U
Measurement Error

 Error: measured quantity value minus a reference


quantity value

 Error = Measured quantity value – reference quantity value


 Error can be known

 Error = Measured quantity value – true quantity value


 Error cannot be known

 Measurement error should not be confused with production


error or mistake.
Measurement Error (2)

 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)

 Error = Random error + Systematic error


= Result(Finite) – True value(Ref. value)
Error vs. Uncertainty

Error of uncorrected measurement value

Systematic error
Random error
Unrecognized Recognized systematic error
systematic
error
Correction

Systematic error Random error


Error of corrected
measurement
value

Uncertainty resulting Uncertainty


from random effect resulting from
Uncertainty resulting random effect
from systematic effect
Corrected Uncorrected
True measurement
measurement
value value
value
Error vs. Uncertainty (2)

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)

This time, It must be


I swear! between 17
There are and 19.
18. (X=18±1)

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

Mean 5.00 Mean 5.00 Mean 5.00

SD 0.00 SD 0.62 SD 3.18

• Standard deviation 1 n
s(q k )   k
n  1 k 1
( q  q ) 2

• Standard uncertainty: uncertainty expressed as a


standard deviation
52
Measurement Model and Measurement Function
Measurement model:
mathematical relation among all quantities known to be involved in a
measurement

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)

• measurement uncertainty expressed as a


standard deviation:

Combined standard uncertainty: uc ( y )

• Standard measurement uncertainty that is


obtained using the individual standard
measurement uncertainties associated with the
input quantities in a measurement model
• Usually the standard uncertainty of an output
quantity is a combined standard uncertainty
• A subscript “c” is used to denote it
Expanded uncertainty

 product of a combined standard measurement


uncertainty and a factor larger than the number
one
 The factor is called “coverage factor”, k

U = k  uc

 Combined standard uncertainty covers only part


of the uncertain probability distribution
 Expanded uncertainty covers almost all (95 %) of
the uncertain probability distribution

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

 number larger than one by which a combined


standard measurement uncertainty is multiplied to
obtain an expanded measurement uncertainty

 The factor depends upon the type of probability


distribution of the output quantity in a measurement
model and on the selected coverage probability.
 Normal distribution: k = 2
 Rectangular distribution: k = 1.65
 t-distribution: k depends on the degrees of freedom

57
Flow chart of uncertainty evaluation

Modeling the measurement


Law of propagation of

uncertainty
Derive combined standard uncertainty equation

Evaluate standard uncertainties of each input quantity


Sensitivity coefficients 칙
Draw an uncertainty Calculation of combined standard uncertainty
budget to figure out
the probability 칙
distribution of the
output quantity Determine coverage factor

Calculate expanded uncertainty

58
Modeling the measurement

 Mathematical model of the measurement process


 The measurand Y may be determined from N other quantities
X1, X2, …, XN through the measurement function f :

Y  f ( X 1 , X 2 , ..., X N )

Output quantity intput quantities

• Best estimate of the measurand, y, is obtained by inputting the


input estimates x1, x2, …, xN into the measurement function f :

y  f ( x1 , x2 , ... , xN )

Best estimate input estimates

59
Examples of measurement function

y  f ( x1 , x2 , ... , xN )

 Direct reading of indication: y  xb

 Comparison with a reference standard: y  xd b

 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(x2) uc ( y )  g ( u ( x1 ), u ( x2 ), ...) u(y)


a a

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 )

• For uncorrelated input quantities: uc ( y )  


 i i
c  u ( x ) 2

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)=c1u(x)
<small sensitivity
y1+u(y) <big sensitivity coeff.
coeff. (low slope)>
(high slope)>
y1
u(y)=c1u(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)

 Measurement of the area of a square: y  ab


f f
ca  b cb  a
a b

u(b) a  u (b)

b ab 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

u 2 c ( y)  a 2u( x1 ) 2  b2u( x2 ) 2  2a b u( x1 )u( x2 )r12

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 )

Combined Standard Uncertainty


N N 1 N
uc ( y )   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

Sensitivity Coefficient Correlation Coefficient


f u ( xi , x j )
ci  ri j  , - 1  ri j  1
xi u ( xi )u ( x j )
Uncertainty Contribution Uncorrelated case
N
u i  ci u ( xi ) uc ( y )   c  u ( x )
2
i i
i 1

Coverage Factor Expanded Uncertainty

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

– Data provided in calibration certificates


– Previous measurement data
– Experience with or general knowledge of the behaviour and
properties of relevant materials and instruments
– Manufacturer’s specifications
– Uncertainties assigned to reference data taken from
handbooks

68
Type A evaluation of uncertainty

* n : number of readings

• Method 1 : Calculate standard • Method 2 : Utilize the pooled


deviation (SD) of the mean experimental standard deviation :
• Arithmetic 1 n
q   qk M
mean n k 1  v i s i2
• Pooled SD s p  i 1
M
1 n
• SD s(q k )  
n  1 k 1
(q k  q ) 2  i1
vi

• 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

1. Determine the probability distribution


2. Determine the half width of the distribution (except for normal distribution)
3. Calculate standard deviation
for a  a  a
a a a
• Rectangular distribution u ( xi )    u ( xi ) 
a a 12 3

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

 Minimum display (resolution): 1 m


 Indication: 10.123 mm

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

Standard Sensitivity Uncertainty Degrees of


Uncertainty coefficient Probability contribution
Uncertainty Freedom
component Distribution
u ( xi ) ci | ci | u ( xi ) vi
u ( x1 )
u ( x2 )
u ( x3 )
u ( x4 )
u ( x5 )
uc ( y )

72
Uncertainty budget (2)

Standard Sensitivity Uncertainty Degrees of


Uncertainty coefficient Probability contribution
Uncertainty Freedom
component Distribution
u ( xi ) ci | ci | u ( xi ) vi
u ( x1 )
u ( x2 )
u ( x2,1 )
u ( x2 , 2 )
u ( x3 )
uc ( y )

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)

* For level of confidence ~95 % : k ( p )  p 3  0.95  3  1.65

75
2 major rectangular distributions

• Convolution of 2 rectangular distribution yields a trapezoidal distribution

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

• variance a2 β=0 : triangular distr.


u ( y )  (1   2 )
2
β=1 : rectangular distr.
•(square of SD) 6

 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

• Effective degree of freedom:


– Welch-Satterthwaite equation uc4 ( y ) uc4 ( y )
veff  N  N 4
ciu ( xi ) 4
ui ( y )
– Required to get the coverage
factor when the measurand has  v
i 1 vi
i 1 i
a t-distribution

79
Coverage factor

For level of confidence of 95 % :

• Rectangular distribution k  1.65

1  0.475(1   )   0.905
k 
• Trapezoidal distribution 1  2
1  0 . 05(1   2
)   0.905
6

• Normal distribution k 2

• Calculate effective degree of freedom


• t-distribution • Find k from the Student’s t-table
• k  t (veff , p )
• For veff  10 , k  2 can be used

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)

• Significant digits : at most 2 digits. (1 or 2)

• 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)

• The numerical value of the measurement value should in the final


statement normally be rounded to the least significant figure in the
value of the expanded uncertainty assigned to the measurement result.

Example 1)
– measurand’s best estimate : 12.1234 mm
– expanded uncertainty calculated to be : 0.234 mm

(1) U= (12.12  0.23) mm (k=2, level of confidence: approx. 95 %)


(2) U= (12.1  0.3) mm (k=2, level of confidence: approx. 95 %)

Example 2)
– measurand’s best estimate : 34.51 mm
– expanded uncertainty calculated to be : 0.058 mm

(1) U= (34.510  0.058) mm (k=2, level of confidence: approx. 95 %)


(2) U= (34.51  0.06) mm (k=2, level of confidence: approx. 95 %)

83
Alternative method to calculate sensitivity coefficients

 Calculate sensitivity coefficients numerically

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  ab
 a: rectangular distribution, center = 10, half-width = 2: {8 ≤ a ≤ 12}

 b: rectangular distribution, center = 5, half-width = 2: {3 ≤ b ≤7}

 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 0.975N-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

You might also like