Taiwan Accreditation Foundation
http://www.taftw.org.tw/
Content
Introduction
The significance of calibration
Learning and Development
Summary
Taiwan Accreditation Foundation Taiwan Accreditation Foundation
Not-for-profit & self-funded organization
3rd-party assessment
services
TAF accreditation symbol
- recognized & supported
by government and industries
International accreditation
co-operations
Significant connection to : other ABs, regional bodies and accreditation related
organizations.
Introduction
TAF
TAF is - the only body in Taiwan recognized by Government for the accreditation
of conformity assessment against international standards.
We …
Impartial, Independent, Transparent
Assessment Services Mutual Recognition
Play an important role
Tested once, Accepted everywhere
TAF’s Mutual Recognition Arrangement
− PAC MLA:QMS, EMS, Product
− IAF MLA:QMS, EMS, Product
− APLAC MRA:Calibration, Testing, Inspection, ISO 15189
− ILAC MRA:Calibration, Testing, Inspection
ILAC Combined MRA Mark All ILAC Full Members (MRA signatories) are able to enter into a licensing agreement with ILAC
to use the ILAC-MRA Mark in combination with their own accreditation body Symbol.
Taiwan Accreditation Foundation
TAF Accredited Laboratories
Testing Medical Calibration
Number of Laboratories 1251 251 198
KA KB KC KD KE KF KG KH KI KJ KK
Length Vibration Mass/ Force
Pressure/ Vacuum
Temperature/ Humidity
Electrical Electromagnetic Flow Chemical Time/ Frequency
Ionizing radiation
101 17 69 28 67 97 21 24 21 31 7
Laboratory Accreditation Status of Calibration Field (July, 2013)
Taiwan Accreditation Foundation
Total : 1700 (July, 2013)
TAF Accredited Laboratories
“Drift” → Calibration
When a sensor or instrument experiences temperature variation
or physical stress over time, its performance will invariably begin to decline, which is known as “drift”. →This means that measurement data from the sensor becomes unreliable and could even affect the quality of a company’s production.
Promote calibration laboratories
Introduce the importance of calibration
Provide the latest knowledge of calibration
Clarify ambiguous concept
Raise the quality & reliability of testing reports
Taiwan Accreditation Foundation
A train program to help our accredited laboratories to learn more about calibration
Learning & Experience Sharing Process
• Invitation
• Introduction
• Volunteers
Laboratory Meeting
Experience Sharing
Brain Storming
Solution
How to educate testing and medical laboratories together with calibration laboratories?
• Experience
• Obstacles
• Suggestion
• Why
• What
• Where
• How
• Experience
• Obstacles
• Suggestion
Taiwan Accreditation Foundation
The Usage, Calibration, and Acceptability Criterion for Measurement Instrument in Testing and Medical Laboratories
Topics of the series of seminar (Taipei, Taichung, and Kaohsiung):
Why instruments need to be calibrated? How to choose calibration laboratories wisely which meets users needs? The usage, calibration of instruments, and how to use the information of calibration reports. − Thermocouple thermometer − Balance − Micropipette
Taiwan Accreditation Foundation
Why calibrate?
1. Instruments maintenance 2. Regulatory compliance 3. The reliability of data results
Laboratory
Industry
Technology
NMI
Energy Manufacture
Medical
Environment
Trade
National Defense
For laboratories, companies, end users
For government, regulators, manufacturers , customers
1. Health care 2. Safety or comfort 3. Defense 4. Economic / Fair trade 5. Technology improvement
End users
Company
Taiwan Accreditation Foundation
12 Standard transfer
Products
Reassurance
Quality Control
Production test
[Pass / Failure]
Periodically calibration
Avoid false passes or false failure
Calibration is about confidence in the measurement results you’re getting.
Ref. Why Calibrate? 1966 US Navy Training Film
Calibration assures that measurement are accurate within the specification limits.
Traceability of Measurement
NML
Secondary Calibration Laboratory
Testing & Calibration Laboratory
Measurements in industry, commerce, and community
1st level standards National level
2nd level standards Calibration Lab level
3rd level standards User level
Primary standards
Reference standards
Working standards
BIPM
NMi GIM BNM SFOM PTB NPL NIST CSIR
VNIM
CSIRO KRISS NRLM
Measurement traceability refers to an unbroken chain of comparisons relating an instrument’s measurements to a known standard.
How to choose calibration laboratories?
A laboratory with the cheapest
calibration fee?
A laboratory with the most
expensive calibration
fee?
The nearest laboratory?
The most famous
laboratory?
International laboratory?
The calibration laboratory which meets your needs
Taiwan Accreditation Foundation
A laboratory’s fulfillment of the requirements of
ISO/IEC 17025 : 2005 means the laboratory meets
both the technical competence requirements and
management system requirements that are
necessary for it to consistently deliver technically
valid test results and calibrations.
What would you consider when choosing a calibration laboratory? When selecting a laboratory to fulfill your testing, calibration, or instrument needs, you need make sure that they can supply you with accurate and reliable results.
ISO/IEC 17025:2005
What do calibration laboratories do?
• Follow the calibration procedures
• Qualified laboratory environment
• Calibration reports/calibration labels
• The traceability to reference national/international standards (an unbroken chain of comparison)
• Periodical check of calibration system
• Inter-laboratory comparison, proficiency test
• 3rd part accreditation - sustain quality system and technical competence
16 Taiwan Accreditation Foundation
The compliance with specification
Test specification
Code of practice or
related criteria
Accuracy of the
method applied
The compliance requirement of laboratory
Taiwan Accreditation Foundation
ISO/IEC 17025
• 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).
Taiwan Accreditation Foundation
References
Guidelines on the reporting of compliance with specification (ILAC-G8:03/2009)
Method of Stating Test and Calibration Results and Compliance with Specification (APLAC TC 004)
− Chinese Version: TAF-CNLA-G04(2)
Taiwan Accreditation Foundation
1.1.6 When a specification describes an interval with an upper and lower limit, the ratio of the uncertainty of measurement to the specified interval should be reasonably small. → If U:T=1:3 → 2T-2U=0.667*2T
2T - 2U
If the measured value falls within this range, a compliance conclusion can be made
2T
U
upper limit - U
U
lower limit + U
lower limit
upper limit
Ability to Distinguish Compliance from Non-compliance
APLAC TC 004
Taiwan Accreditation Foundation
Calibration Report
• ISO/IEC 17025:
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 statements of compliance are made, the uncertainty of measurement shall be taken into account.
Taiwan Accreditation Foundation
APPENDIX A
Case 1 Case 2 Case 3 Case 4 Case 5
◆
Case 6 Case 7 Case 8 Case 9 Case 10
APLAC TC 004
The ability to distinguish compliance from non-compliance Case 1 & 6: The measurement is within (below) the specification limit when the measurement uncertainty is taken into account. Case 2 & 7: It is not possible to state compliance using a 95 % coverage probability for the expanded uncertainty although the measurement results is below the limit.
Compliance (Pass)
Non-Compliance (Fail)
Not possible to state compliance/non-compliance
UL
LL
Outcome I – Satisfaction Survey
Number of Attendance
• Taipei
• Taichung
• Kaohsiung
Overall Satisfaction
27 %
62 %
11 %
0 %
0 %
332 people
92 people
139 people
Taiwan Accreditation Foundation
Outcome II
Why Calibrate
Choosing A Calibration Lab
Balance
Micropipette
Thermocouple
50 45
4 1
52 47
1
55 34
10 1
51 30
18 1
53 21
25 1
Taiwan Accreditation Foundation
Summary I
It is essential that users set up acceptability criteria based on the requirement of accuracy, precision, measurement scope, testing method, and/or manufacture.
It is recommended that instruments should be calibrated periodically by accredited calibration laboratories with certain calibration scope and measurement uncertainty which meets the requirement of related standards.
The data results and measurement uncertainties of calibration reports can be used as important reference for instruments compliances and quality control.
Taiwan Accreditation Foundation
Summary II
One of our missions to increase the value of accreditation
Our goal is to offer
(1) comprehensive and effective accreditation services
(2) various ways of knowledge acquisition
By holding the series of seminars, we aim to:
(1) provide the idea of the importance of calibration
(2) bring new concept and practical information to audience
(3) increase their basic understanding about metrology,
calibration, and calibration reports
TAF (Taiwan Accreditation Foundation), as the only body in Taiwan recognized by the government…
Taiwan Accreditation Foundation
Taiwan Accreditation Foundation (TAF)
Department of Laboratory Accreditation
Speaker: I-Jhen, Lin
E-mail: [email protected]
Co-authors :
Accreditation Manager, Calibration section: Joshua Yang
E-mail: [email protected]
Director: Sylvia, Lin
E-mail: [email protected]
Taiwan Accreditation Foundation
http://www.taftw.org.tw/
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