Taiwan Accreditation Foundation - NCSL International · specification (ILAC-G8:03/2009) ... (Taiwan...

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Taiwan Accreditation Foundation http://www.taftw.org.tw/

Transcript of Taiwan Accreditation Foundation - NCSL International · specification (ILAC-G8:03/2009) ... (Taiwan...

Page 1: Taiwan Accreditation Foundation - NCSL International · specification (ILAC-G8:03/2009) ... (Taiwan Accreditation Foundation), as the only body in Taiwan recognized by the government…

Taiwan Accreditation Foundation

http://www.taftw.org.tw/

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Content

Introduction

The significance of calibration

Learning and Development

Summary

Taiwan Accreditation Foundation Taiwan Accreditation Foundation

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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

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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

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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

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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

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“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.

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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

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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

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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

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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

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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.

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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.

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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

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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

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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

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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

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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).

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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

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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

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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

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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

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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

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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

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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

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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

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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/