24

Creating significant results

締造ANNUAL REPORT2010年報 認證業務

斐然成果Performance & Achievement in Accreditation

25

認證業務

認證現況

TAF為非以營利為目的之全國性認證專責機構，主要業務包含驗證機構認證、實驗室認證、檢驗

機構認證及能力試驗執行機構認證，提供經濟與

社會發展之公正、客觀、獨立及符合國際規範之

第三者認證服務，其認證現況如下：

在驗證機構認證方面，涵括管理系統驗證 (品質、環境、職業安全衛生、資訊安全、食品安全、

綠色產品 )、產品驗證 (工業產品、農業產品 )、人員驗證、溫室氣體確證與查證等認證業務，

至 2010年底維持認證現況之驗證機構共計 89家。產品驗證機構的發展經過多年努力已逐漸受

主管機關重視，如農產品產銷履歷及有機農產品

驗證，認證家數亦逐年加速成長中。稽核員的能

力攸關驗證的品質，人員驗證可以確保驗證的品

質及公正性，而氣候變遷、溫室效應等目前為國

際上所重視的議題，溫室氣體確證與查證及後續

相關綠色議題，未來都將是新起之秀。因應經濟

部及 NCC對國內電信事業赴大陸投資要求具備ISO 27011驗證證明之要求，本會於資訊安全管理系統，增加 NCC「電信事業資訊通訊安全管理作業要點」之認證服務，同時於 2010年 6月開始該項服務。

在實驗室認證方面，涵括校正、測試、土木工程

及醫學四大領域，至 2010年底維持認證現況之實驗室達 1,362家；維持認證之外國勞工健檢醫院則有 59家。目前校正領域服務量已能滿足市場需求，測試實驗室呈穩定成長，至於土木工

程測試實驗室則以加強實驗室自主管理為重點，

而醫學領域實驗室的認證家數在這兩年中加速

成長，顯現檢驗室的水準與國民健康安全已受到

關切與重視。檢驗機構則包括工廠檢查、計量儀

器、非破壞檢驗、安全檢驗四個部分，認可家數

為 23家。能力試驗執行機構認可家數為 8家，OECD GLP登錄試驗單位家數為 9家。本會認證服務的對象已擴及各類產業，並提供實質之認

證服務。

Performance & Achievement in Accreditation

Performance & Achievement in Accreditation

Current Status of AccreditationTAF is a not-for-profit national accreditation body, specialised in accreditation services for certification bodies, laboratories, inspection bodies and proficiency testing providers. It provides impartial, objective and independent third-party accreditation services in conformance with international standards to promote the economic and social developments. The current accreditation operations are as follows:

The accreditation services for certification bodies include management system (quality, environmental, occupational health and safety, information security, food safety, green product), product (industrial products, agricultural products), personnel and greenhouse gas (GHG) validation and verification. A total of 89 certification bodies have received their accreditation at the end of 2010. The development of product certification bodies has gradually been highly regarded by the governmental authorities. For instance, the number of accredited certification bodies for the traceability of agricultural products and the certification of organic agricultural products was growing rapidly in each year. As the competence of an auditor is closely related to the quality of certification, personnel certification is a way to ensure the quality and impartiality of certification. While climate change and greenhouse effect are presently the subjects being emphasized internationally, the validation and verification of greenhouse gas and consequently related green issues will become an emerging market in the future. To accommodate the new requirements of the Guidelines for Information and Communication Security of the Telecommunications Industry for information security, publicized by the NCC, TAF began to provide such accreditation service in June 2010.

The laboratory accreditation includes four major fields: calibration, testing, civil engineering and medical. There were 1,362 labs and 59 hospitals carrying health examination for foreign labourers holding accreditation status. Currently, service capacity of calibration laboratories is able to satisfy the market demand, and a steady growth remains in the testing field. As for the civil engineering testing field, laboratory self-management is strongly emphasized and executed. The growth of accredited labs in medical testing field has accelerated in the past two years, which shows the quality of medical laboratories as well as people's health and safety are receiving more attention from the public. The inspection bodies include 4 sub-fields: factory inspection, measurement instrument, non-destructive testing and safety inspection. There were a total number of 23 accredited inspection bodies. 8 proficiency testing providers were accredited and 9 test facilities were registered for OECD GLP Compliance. TAF accreditation services have been expanded to provide substantial services for a wide range of industries.

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26

領域 Fields 次領域 Sub-Fields 家數mber

管理系統

驗證機構

Management System Certification Bodies

品質管理系統 (QMS)、環境管理系統 (EMS)、資訊安全管理系統 (ISMS)、食品安全管理系統 (FSMS)、職業衛生安全管理系統 (OHSAS)、綠色產品管理系統 (GPMS)Quality Management System (QMS), Environmental Management System (EMS), Information Security Management System (ISMS), Food Safety Management System (FSMS),Occupational Health and Safety Management System (OHSAS), Green Product Management System (GPMS)

35

產品驗證機構

Product Certification Bodies

電機類、電氣類、電信終端設備、紡織品、化工類、機械類、預拌混凝土

廠驗證、綠色產品零組件、農漁牧產品

Electrical, Electric, Telecommunication Terminal Equipment, Textile Product, Chemical, Mechanical, Good Ready-Mixed Concrete Plant Certification, Component of Green Product, Agricultural, Fishery and Husbandry Products

45

人員驗證機構

Personnel Certification Body

稽核人員驗證

Auditor2

溫室氣體確證與查證

機構

Greenhouse Gases Validation and Verification Bodies

組織層級溫室氣體排放與移除量化及報告、計畫層級溫室氣體排放減量或

移除增量量化、監督及報告

Quantification and reporting of the organization level greenhouse gases emission and mitigation, the quantification, monitoring and reporting of the project level greenhouse gases emission reduction or mitigation increase

7

校正實驗室

(11個次領域 )Calibration Laboratory (11 sub- fields)

長度、振動量 /聲量、質量 /力量、壓力量 /真空量、溫度 /溼度、電量、電磁量、流量、化學量、時頻、游離輻射

Length, Vibration & Acoustics, Mass/Force, Pressure/Vacuum, Temperature/Humidity, Electricity, Electromagnetics, Flow, Chemical, Time and Frequency, Ionizing Radiation

180

測試實驗室

(10個次領域 )Testing Laboratory(10 sub-fields)

音響與振動、生物、化學、電性、游離輻射、機械、非破壞檢測、溫度與

熱、光學、鑑識科學試驗

Acoustics and Vibration, Biological, Chemical, Electrical, Ionizing Radiation, Mechanical, Non-Destructive Testing, Temperature and Heat, Optics, Forensic Science Testing

844

截至 2010年 12月 31日止，TAF認證情況統計如下列圖表：The statistics of TAF accreditation status up to 31 Dec 2010 is summarized in the following table:

TAF認證現況 Current Status of TAF Accreditation

締造斐然成果

Creating significant results

27

締造斐然成果

Creating significant results

土木工程測試實驗室

(2個次領域 )Civil Engineering Testing Laboratory(2 sub-fields)

化學、營建

Chemical, Construction191

醫學實驗室

(10個次領域 )Medical Testing Laboratory(10 sub-fields)

解剖病理學、臨床生化學、輸血醫學、血液學、臨床免疫血清學、臨床微

生物、臨床毒物學、臨床鏡檢學、細胞遺傳學、遺傳學與分子病理學

Anatomical pathology, Clinical biochemistry, Transfusion medicine, Hematology, Clinical immunoserology, Clinical microbiology, Clinical toxicology, Clinical microscopy, Cytogenetics, Genetics and molecular pathology

147

受聘僱外國人入國後健

康檢查醫院

Designated hospitals for health examination of employed aliens after entry

指定項目：

梅毒試驗 -RPR/VDRL、梅毒螺旋體血液 /膠體凝集試驗、B型肝炎病毒表面抗原 後天免疫不全症候群抗體—篩檢、蟲卵檢查、形態鑑別、阿米巴抹片 /染色檢查、胸部 X光檢查 (檢查、判讀與保存 )、健康檢查流程與動線

Designated items:RPR/VDRL test, TPHA/TPPA test, Hepatitis B Virus surface antigen, HBs Ag, HIV antibody-Screening, Ova examination, Identification of morphology, Amoebic smear/stain examination, Chest X ray examination (imaging, diagnosis and preservation). The process and moving path for health examination

59

檢驗機構

Inspection Body工廠檢查、計量儀器、非破壞檢驗、安全檢驗

Factory Inspection, Metrical Instrument, Non-Destructive Testing, Safety Inspection

23

能力試驗執行機構

Proficiency Testing Provider

校正、測試、醫學

Calibration, Testing, Medical8

OECD GLP

物理―化學測試、毒性試驗、致變異性試驗、水域與陸域生物之環境毒性

試驗、水、土壤、空氣內行為試驗、生物累積作用、殘留試驗、模擬生態

池及自然生態系統效應、分析性及臨床化學測試

Physical-chemical Testing, Toxicity Studies, Mutagenicity Studies, Environmental toxicity Studies on aquatic and terrestrial organisms, Studies on behavior in water, soil and air, Bioaccumulation, Residues studies, Studies on effects on mesocosms and natural ecosystems, Analytical and clinical chemistry testing

9

合 計 Total 1,550

28

驗證機構認證家數歷年成長圖

Accredited certification bodies annual growth diagram

2006年 : 45家2007年 : 65家2008年 : 82家2009年 : 87家2010年 : 89家

驗證機構認證四大領域 2006-2010年家數成長圖Four fields of certification body accreditation Number of growth in 2006-2010

驗證機構認可數

Number of accredited certification bodies

管理系統 Management System

產品 Product

人員 Personnel

溫室氣體 Green House Gases

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29

實驗室認證四大領域 2006-2010年家數成長圖Four fields of laboratory accreditation Number of growth in 2006-2010

校正 Calibration

測試 Testing

土木工程 Civil engineering

醫學 Medical

實驗室認可數（含終止實驗室）

Number of accredited laboratories (including terminated labs)

實驗室認證家數歷年成長圖

Accredited laboratories annual growth diagram

2006年 : 1,481家

2007年 : 1,649家

2008年 : 1,774家

2009年 : 1,903家

2010年 : 2,020家

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30

統計年度：2010年總計認證家數：1,550家

Statistic Year: 2010Total Number of Accredited bodies: 1,550

TAF認證家數區域分佈圖Distribution of TAF accredited bodies

南部 Southerrn Taiwan 336實驗室 Laboratories 322受聘僱外國人健檢醫院 14Health Examination Hospitals for Foreign Labourers 1產品驗證機構Product Certification Bodies 7檢驗機構 Inspection Bodies 3

金門 Kinmen 3實驗室 Laboratories 3馬祖 Matzu 1實驗室 Laboratory 1澎湖 Penghu 2實驗室 Laboratories 2

中部 Central Taiwan 275實驗室 Laboratories 255受聘僱外國人健檢醫院 HealthExamination Hospitals for Foreign Employees 13OECD GLP 2管理系統驗證機構 Management Systems Certification Bodies 1產品驗證機構 Product Certification Body 8檢驗機構 Inspection Bodies 3

北部 Northern Taiwan 783實驗室 Laboratories 689受聘僱外國人健檢醫院 Health Examination Hospitals for Foreign Labourers 26OECD GLP 7能力試驗執行機構 Proficiency Testing Provider (PTP) 6管理系統驗證機構 Management Systems Certification Bodies 34產品驗證機構 Product Certification Bodies 30人員驗證機構 Personnel Certification Body 2溫室氣體確證與查證 Greenhouse Gases Validation and Verification 7檢驗機構 Inspection Bodies 16

東部 Eastern Taiwan 65實驗室 Laboratories 59受聘僱外國人健檢醫院Health Examination Hospitalsfor Foreign Labourers 6

海外 Overseas 32實驗室 Laboratories 31能力試驗執行機構 Proficiency Testing Provider (PTP) 1

Up to the end of 2010, the number of organizations receiving accreditations from TAF totalled 1,550, as shown in afore-mentioned diagram. TAF's service capacity has satisfied the present demand from domestic market and will move towards even better service quality and management standard.

截至 2010年底， TAF提供的各項認證服務，認

證家數現況總計有 1,550家，如上圖各類認證數

據顯示，TAF服務量已可滿足目前國內市場的需

求，未來將朝更優質的服務及管理水準邁進。

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TAF 2010年之認證業務，包括新申請及當年度認證家數統計如下：

Total number of TAF accreditation, including new applications and accreditations granted in 2010:

領域

Field新申請家數

New Applications年度認證家數

Annual Accreditations

管理系統驗證機構

Management System Certification Bodies 0 1

產品驗證機構

Product Certification Bodies 2 1

人員驗證機構

Personnel Certification Bodies 0 1

溫室氣體確證與查證機構

Greenhouse Gases Validation and Verification Bodies 3 3

測試實驗室

Testing Laboratories 111 79

校正實驗室

Calibration Laboratories 14 8

土木工程測試實驗室

Civil Engineering Testing Laboratories 22 14

醫學測試實驗室

Medical Testing Laboratories 28 16

受聘僱外國人入國後健康檢查醫院

Designated Hospitals for Health Examination of Employed Aliens after Entry

3 2

檢驗機構

Inspection Bodies 4 4

能力試驗執行機構

Proficiency Testing Providers 2 3

國家 GLP符合性監控系統 3 5

合 計 Total 192 137

在 TAF同仁的齊心努力及各界支持下，業務日

漸成長，未來將持續精進，提供更優質的認證服

務，期能擴大服務能量並使其效益極大化，以滿

足國內市場需求，不負顧客期望。

面對國內市場的各類認證需求，TAF將竭盡所

能，透過與學術界、產業界及權責機關的充分協

調與通力合作，共同推動建構我國產業品質及民

生安全的認證大環境，提昇產業之國際競爭力，

掌控經貿命脈。

On basis of TAF teamwork and with external support, the operations have been growing steadily. TAF will continuously improve itself to provide better accreditation services, and keep up with customers' expectations by providing greater service capacities to satisfy domestic market demands efficiently.

In order to satisfying the demand for various accreditations in domestic market, TAF will do its best to coordinate and cooperate with academic institutes, industries and authorities to promote and establish national industrial quality and public safety through effective accreditation to raise industrial international competitiveness and in control of economy and trade mainstream.

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認證作業相關文件

為有效管理本會認證事務，2010年度有關認證

作業相關文件之制修訂情況簡述如后：

1. 驗證機構認證規範 32份 (新制定 1份、修訂

2份 )、內部作業程序 21份 (新制定 1份、

修訂 12份 )及表單 81份 (修訂 11份 )、通

報 16份 (新制定 2份 )。

2. 實驗室認證業務認證規範 89份 (新制定 9份、

修訂 9份 )、內部作業程序 23份 (修訂 1份 )及表單 88份 (新制定 6份、修訂 7份 )。

3. 檢驗機構認證業務規範 9份 (修訂 2份 )、表

單 23份 (新制定 2份、修訂 2份 )。

4. 能力試驗執行機構認證業務認證規範 5份、

內部作業程序 4份及表單 17份。

5. OECD GLP國家符合性監控系統規範 8份、

內部作業程序 4份及表單 12份 (修訂 1份 )。

能力試驗現況

為符合 ILAC及 APLAC相互承認要求，認證實

驗室需適度參與國際能力試驗活動，而各認證

組織於舉辦相關活動時，應邀請其他認證組織參

與，以作彼此實驗室之能力比對。因此，2010年 TAF除了與 APLAC合作之能力試驗外，亦積

極協助認可實驗室參與其他的 APLAC能力試驗

活動。而且 TAF為提升實驗室之技術能力，並

符合能力試驗要求，2010年除了持續完成 2009年的能力試驗活動外，增加辦理 2項土木測試領

域和規劃 LED 測試 (含光強度 ,配光曲線 )的能

力試驗活動，藉以確認 TAF認證實驗室之後續

Accreditation documentation

The status of accreditation documentations and the establishments/revisions are as follows:

1. For certification body accreditation:-- 32 accreditation criteria: established 1 new and

revised 2 existing documents;-- 21 SOPs: established 1 new and revised 12

existing documents;-- 81 forms: revised 11 existing documents, and-- 16 notifications: established 2 new documents.

2. For laboratory accreditation:-- 89 accreditation criteria: established 9 new and

revised 9 existing documents;-- 23 SOPs: revised 1 existing document, and-- 88 forms: established 6 new and revised 7 existing

documents.3. For inspection body accreditation;

-- 9 accreditation criteria: established 2 new documents, and

-- 23 forms: established 2 new and revised 2 existing documents.

4. For PTP accreditation:-- 5 accreditation criteria;-- 4 SOPs, and-- 17 forms

5. OECD GLP Compliance Monitoring Registration:-- 8 criteria;-- 4 SOPs, and-- 12 forms: revised 1 existing document.

Current status of Proficiency testingTo comply with the requirements of ILAC MRA and APLAC MRA, accredited laboratories are requested to participate in international proficiency testing activities where applicable. When one accreditation body conducts relevant PT activities, other accreditation bodies shall be invited for participation for interlaboratory comparisons. Therefore in 2010, in addition to cooperation with APLAC in proficiency testing, TAF also actively assisted accredited laboratories in participating in other APLAC proficiency testing activities. Besides, in order to upgrade the technical competence of laboratories to comply with the proficiency testing requirements, in 2010, TAF not only completed the 2009 proficiency testing program but also run 2 civil engineering testing fields and planned 1 LED PT program (luminous intensity and distribution

締造斐然成果

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33

curve) so as to assure the condition of accredited laboratories in maintaining their technical competences after being accredited by TAF. TAF held a panel discussion on the development of PT program in civil engineering testing field on 3 December. The activity aimed to understand the willingness of PTPs to run PT programs and the problems encountered, and such information will be a reference of the actions to meet requirements of ILAC P13 policy.

技術能力的維持狀況。於 12月 3日辦理土木工

程測試領域能力試驗發展座談會，瞭解專業機構

/團體對辦理能力試驗的意願與相關問題，作為

本會因應 ILAC P13政策的準備。

1. TAF主辦之 APLAC能力試驗活動：

TAF hosted APLAC proficiency testing activities:

APLAC能力試驗活動APLAC Proficiency Testing Activities

期間

Period參加家數

No. of Participants

APLAC T070 PBDE in ABS 2010/03~ 2010/12 31

編號

No.主辦機構

Host BodyAPLAC能力試驗活動APLAC Proficiency Testing Activities

TAF參與家數No. of Participants

from TAF

M011 新加坡 SACSAC, Singapore Thermocouple 2

M022 泰國 NSC-ONACNSC-ONAC ,Thailand Gauge Block 2

M023 馬來西亞 SMSM, Malaysia Relative Humidity Measurement 2

M024 韓國 KOLASKOLAS, Korea Plain Plug Gages 3

T061 日本 VLACVLAC, Japan Electromagnetic Interference 4

MEP IMEP-26 Intercomparison for brominated flame retardants in plastic 2

IMEP IMEP-31 Trace elements in mineral feed 1

2. 參與其他認證組織舉辦之 APLAC能力試驗活動：

Participating in APLAC proficiency testing activities held by other accreditation bodies:

備註：

(1) M011已發出總結報告；M023已發出個別報告；M024, T06及 IMEP均已報名，M022報名中。

M011 final report completed, M023 interim report completed, M024, T06及 IMEP registration completed, M022 registration underway.

(2) 對已完成個別報告及總結報告之能力試驗項目進行認可實驗室數據之檢討。

Review of data for the accredited laboratories regarding the proficiency testing items contained in the completed interim report and summary report.

締造斐然成果

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34

編號No.

期間

Period

參與家數No. of

Participants

2009年能力試驗計畫The 2009 Proficiency Testing Program

TAF-CNLA-CL12 細粒料中水溶性氯離子含量

Content of Soluble Chlorides in Fine Aggregates2009/3~2009/12 49

TAF-CNLA-CL13 混凝土圓柱體抗壓強度

Compressive Strength Concrete Cylinders2009/3~2009/12 153

TAF-CNLA-CL14 土壤夯實

Soil Compaction2009/3~2009/8 70

TAF-CNLA-CN05 非破壞檢測 -MT & PTNon-Destructive- MT & PT

2009/3~2009/12 27

2010年能力試驗計畫The 2010 Proficiency Testing Program

APLAC T079 Phthalates in Plastic materials 2010/3~2010/12 31

TAF-CNLA-CL15 土木 -粒料篩分析試驗 &細粒料比重吸水率試驗Test of sieve analysis for aggregates & Test for specific gravity and absorption of fine aggregates

2010/3~2010/12 90

TAF-CNLA-CL16 土木 -土壤阿太堡限度及指數試驗

Test for Liquid Limit, Plastic Limit, and Plasticity Index of Soils

2010/3~2010/8 30

3. TAF辦理之國內能力試驗活動

Domestic proficiency testing activities organized by TAF

締造斐然成果

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The purpose of proficiency testing activities is to confirm the technical competences of laboratories. TAF launched accreditation service for proficiency testing providers to provide diversified PT programs, which helps maintain stable technical levels of accredited laboratories. TAF adopts the proficiency testing results from domestic proficiency testing providers to effectively meet the requirements of international accreditation cooperations. In the case where no domestic proficiency testing provider is available for conducting particular professional proficiency testing items, TAF will organise such proficiency testing activities to meet the laboratory's needs.

The major benefits of participating in APLAC proficiency testing activities is understand the competences of other international laboratories in the relevant technical field. It also links the proficiency testing results with domestic ones indirectly, which helps understand the overall competences of domestic proficiency testing providers and laboratories. TAF has been actively involved in conducting APLAC proficiency testing activities for years and won numerous recognitions and praises from APLAC and accreditation bodies in other countries. TAF has not only made its technical competences compatible with international standards, but also has made itself into the international leading position.

執行能力試驗活動係為確認實驗室技術能力的展

現， TAF開放能力試驗執行機構之認證業務，

提供多元化的服務，使認證實驗室維持穩定的技

術水準。TAF運用國內能力試驗執行單位所辦

理之能力試驗結果，以有效滿足國際認證組織對

於能力試驗的要求。基於特殊領域有其專業性考

量，目前國內尚無單位可承辦的能力試驗項目，

則由 TAF繼續提供符合實驗室需求的能力試驗

活動。

參與 APLAC能力試驗活動之主要效益，係藉由

國際能力試驗活動的參與，瞭解國際上相關產業

技術領域實驗室的能力狀態，間接可將能力試驗

結果與國內能力試驗結果相聯結，通盤瞭解國內

能力試驗執行機構與實驗室的相關能力。而 TAF多年來積極主辦 APLAC能力試驗活動，已深

受 APLAC區域組織及各國認證組織的肯定與讚

揚，除技術實力與國際接軌，並已躋身國際領導

地位。

締造斐然成果

Creating significant results