2014 EU-TWN High Voltage Electrical Equipment Management Seminar
2014 台歐高壓用電設備管理制度論壇   (中文請詳見本網頁下半部)

Taipei, 28 March The European Chamber of Commerce Taiwan (ECCT)

ECCT today called upon the Taiwan government to bring Taiwan’s regulations governing electrical engineering and equipment in line with the best international standards and practices. The call comes following an intensive two-day “EU-Taiwan high voltage electrical equipment management forum” held from 25-26 March in Taipei. The forum was jointly organized by the ECCT together with the European Economic and Trade Office (EETO), the Ministry of Economic Affairs’ (MoEA) Bureau of Foreign Trade (BoFT) and Bureau of Energy (BoE). It was co-organised by the Taiwan Research Institute and the European Business and Regulatory Cooperation programme (EBRC, a service project funded and supervised by the European Commission and implemented by the ECCT).

The forum provided a rare opportunity for open communication between EU and Taiwan regulatory authorities and industry experts. The forum brought together three industry experts from the International Electrotechnical Commission (IEC) and senior government officials from the European Commission, The Netherlands and Germany to discuss regulations governing electrical equipment. By bringing in foremost technical experts from the IEC to Taiwan, the organizers’ main objective was to give a comprehensive briefing and share the best international standards and practices with the Taiwan government and industry players in order to assist them to put in place a system in Taiwan that is line with the best international standards and practices. It also established communication channels for further exchanges in the future.

The forum focused on aspects of Taiwan’s regulations which are not fully in line with international standards and practices, particularly guidelines for Directive 401 on the Indoor Wiring Standard. The BoE first officially announced these guidelines on 1 January 2012 and amendments to the guidelines on 25 December 2012. The guidelines set out provisions for the inspection and accreditation of high voltage electrical facilities (of over 600 volts). The regulation requires BoE certification of laboratories, factories of origin and type test reports, with the aim of verifying the quality and safety of products. The amended version of the guidelines provides a two-year grace period to allow companies to obtain BoE certifications for their products. The amended guidelines, while an improvement on the original guidelines are nevertheless not in line with European practices in two ways: Firstly, Taiwan requires factories to obtain IEC/ISO 17025 certification for production facilities, although internationally, this is the standard for test and lab facilities and not for production facilities. The international standard for production facilities is ISO 9001. Secondly, Taiwan regulations require that factories with ISO 9001 certification are also required to be inspected by the BoE upon renewal of their certification within three years.

Through the forum, the effectiveness and efficiency of the European regulatory system was comprehensively demonstrated. Experts and government officials clearly showed how the European authorities and industry players cooperate to ensure the highest possible level of safety of electrical equipment.

At the conclusion of the forum, delegates urged the Taiwan authorities to follow the European practice related to electrical equipment and thereby harmonise Taiwan’s regulations with the best international standards and practices.

A major difference between the EU and Taiwan system is the recognition in the EU that IEC 17025 is the standard to ensure the competency of laboratories. It does not guarantee, as such, the safety of the products, but just the accuracy of the test. Manufacturers need to do type tests to ensure that their products are safe. The best place to do type tests is in 17025-certified labs. Once the type test is done, production is done in a factory, after which routine tests on products are done to ensure compliance with the type test. Laboratories/testing facilities have 17025 certification but factories have ISO 9001 certification and this quality standard ensures they are producing according to standard (as tested in the laboratories). Factories are inspected
every 3 years by an accreditation body to ensure compliance.

The EU obliges manufacturers to ensure that products are totally safe and must at all times be able to prove to authorities that the products are safe by maintaining and being able to provide the relevant technical documentation. While the EU encourages the use of international standards, ISO/IEC 17025 only sets general requirements for the competence of testing and calibration laboratories, while ISO/IEC 9001 refers to quality management. They do not directly cover the safety of products. The EU does not require testing or third party certification in government-recognised laboratories. The government's role is to police the market and the EU achieves a very high safety record.

The forum highlighted the fact that there are no new players in the high voltage industry. They are all established players with long and reputable track records in terms of technical know-how and dealing with safety. Moreover, their customers have similar track records and reputation. All stakeholders are acutely aware of the need for safety and the costs and dangers of failure. The main customers will only buy from reputable players and the manufacturers know that the consequences of supplying unsafe products are severe. Providing unsafe products would result in them having to pay significant damages, and much more importantly for them, would damage their reputation. This is a crucial factor. None of the major players would risk damaging their reputation and therefore future business prospects by supplying unsafe products. IEC 17025 accreditation only ensures the competence of the laboratory to conduct type tests. The obligation for accreditation based on ISO/IEC 17025 is only useful for test laboratories but not for factories. ISO/IEC 17025 accreditation does not prevent manufacturers from producing non-compliant products, factories should be accredited with ISO 9001, which means they ensure the quality of their products (identical to the type test) through adequate routine testing.

In the EU the market surveillance system is very effective. Manufacturers can be liable to pay large damages for faulty products so they do not dare to introduce unsafe products in the market. Technological innovation happens very quickly and much faster than the government can keep up with. If regulations are too specific, they can become outdated as better technologies are developed, therefore the obligation to guarantee the safety of products is placed on the producer.

Delegates also discussed the benefits of the post market surveillance system adopted in the EU. They noted that post market surveillance is a much more efficient use of government resources than pre-market approval as long as enough inspectors are employed. They also emphasized that high voltage products are usually custom-made and complex. Not every inspector will understand all the technical requirements for every new product. It is therefore important to trust established players. The job of inspectors in the EU is to check to make sure all the tests have been done properly and that the products passed the tests. The practice in the EU is not to get involved in the operations of producers because this actually hampers innovation. Panelists from the EU therefore recommended that Taiwan uses some kind of post market surveillance.

In the final panel discussion of the forum, panelists concluded that the European system is very effective to guarantee the safety of electrical equipment. In addition, a robust market surveillance system ensures that producers comply with their quality and safety commitments. The best way to guarantee safety is the combination of ISO/IEC 17025 for testing facilities and ISO 9001 for factories..

Currently Taiwan has two permitting options, one through ISO/IEC 17025 and one through ISO 9001. The EU side argues that in fact the two routes are complementary rather than alternative since ISO/IEC 17025 is the relevant standard for testing facilities and ISO 9001 for factories. For this reason panelists recommended that Taiwan authorities include this combination of the two current paths for certification.  The current option 1 is not according to international practice because it imposes ISO/IEC 17025 in Directive 401 to manufacturers instead of testing facilities and without a relevant standard for factories (ISO 9001) is insufficient to prevent incidents and accidents. The current option 2 should be supplemented with the requirement to carry out type tests in ISO/IEC 17025 accredited testing facilities (anywhere in the world) but it should not require additional factory visits, since inspections of accreditation bodies are already previewed in ISO 9001.

Delegates also welcomed further exchanges to resolve any remaining technical obstacles caused by a lack of understanding of product design. In order to avoid doubling testing and the misunderstanding of type test reports, Directive 401 reviewing committee members and Taiwanese testing lab experts were invited to communicate with IEC experts and manufactures to achieve a comprehensive understanding of product designs. In addition, members of the ECCT’s Electrical Engineering and Equipment committee offered to set up video conferences to enable direct communication between Taiwan regulators and IEC experts or manufacturers to discuss technical issues at any time in the future.




328台北訊】 歐洲商務在台協會(ECCT)

歐洲商會
(ECCT)28日表示,願意持續協助台灣的電機工程及設備法規體系,與國際最佳的標準及慣例接軌。歐洲商會與歐洲經貿辦事處(EETO)、經濟部國貿局(BoFT)及能源局(BoE)32526天共同主辦「臺歐高壓用電設備管理制度論壇」,本論壇並由台灣綜合研究院(TRI)與歐洲商務與法規合作計畫(EBRC,由歐盟執委會出資並監督、歐洲商會負責執行的服務計畫)協辦。

這項論壇提供一次難得的機會,讓歐盟與台灣法規主管機關及業界專家進行開放式的溝通。此次論壇邀請三位國際電工委員會
(IEC)的專家、歐盟執委會、荷蘭及德國的高級官方代表齊聚一堂,討論電機設備的相關法規。此次,極具專業技術背景的IEC專家受邀來台,針對國際最佳的標準及實務慣例提出整體性的說明,與台灣政府及業界人士交流分享,以協助台灣與國際接軌;同時建立起雙方未來進一步交換意見的溝通管道。 

此次論壇聚焦於台灣政府法規中與國際性標準及慣例不符的層面,尤其是在屋內線路裝置規則第
401條的部分。能源局最早在2012年元月1日公布相關規範,並於20121225進行第一次修正。這項規範訂定高壓用電設備(電壓超過600伏特以上者)的檢驗與鑑定標準。根據規定,業者須具備能源局所認可之實驗室、原製造廠家及型式試驗報告,與出廠試驗報告,以確保其品質及安全性。修正後的條款提供兩年的寬限期,讓業者能取得能源局所要求的各類產品證書,但修改後的版本仍然與歐洲的實務慣例不一致。第一,台灣要求產品須由具IEC/ISO17025的工廠所生產,IEC/ISO17025雖是國際性的證書,但卻是為實驗室及其檢驗設備所設的檢視標準,而非與生產端設備有關。針對負責生產端的工廠,國際性的標準一般是ISO 9001。其次,修正後的401條款規定,具ISO 9001認證工廠所出具的產品,其證書僅獲得三年有效期限;若在三年後要更新認證,須接受能源局到工廠進行檢查。

透過這次論壇,歐洲的專家及政府官員清楚而整體性的說明其法規制度運作的效果與效率,主管當局與業者間如何密切合作,以確保電機設備盡可能達到最高的安全標準。

在結論報告中,與會代表們建議台灣當局參照歐洲管理電機設備的慣例,進一步調和台灣的法規,與國際間最佳標準及實務運作接軌。

歐洲與台灣在制度上的最大差異,在於歐洲承認
IEC 17025是確保各實驗室驗證能力的標準,其並不保證產品的安全性而是檢驗的正確性。製造廠商必須進行產品型式試驗,以證明產品安全無虞。做型式試驗的最佳場所,是獲得IEC 17025認證的各實驗室。一旦完成產品型式試驗,工廠便開始生產,之後再對產品進行出廠試驗,以確保產品能夠符合型式試驗。實驗室/測試設備擁有IEC 17025認證,而工廠擁有ISO 9001認證,如此的品質標準及運作,可確保工廠是進行標準化生產。工廠每3年接受認證機構的例行檢查,以確保符合標準。

歐盟要求製造廠商須保證產品充分安全,且必須隨時能向歐盟主管當局證明產品在維修上的安全性,並能提供相關的技術文件。儘管歐盟鼓勵業者使用各項國際標準,但
ISO/IEC 17025是規範實驗室測試及校正能力的一般性標準,而ISO/IEC 9001則是對工廠一般品質管理的要求。這些標準並未直接與產品安全性畫上等號。歐盟對於經政府認證的實驗室,並未要求須具備檢驗或第三方的證書。政府的角色是監督市場,而歐盟也達成高度的安全記錄。

這次論壇也突顯出目前高壓用電產業中尚無新進的業者的事實,均是在專業技術及安全維護方面基礎深厚且記錄良好的業者,而他們的客戶也都擁有類似的記錄及聲譽。所有產業相關成員都深切解安全的必要性,以及一旦安全性不足所造成的代價及危險。主要的用戶只向聲譽卓著的廠商採購設備,而製造廠商也了解,如果提供不安全產品可能造成嚴重後果,將須付擔鉅額的損害賠償;更重要的是商譽受損,這是最為關鍵的因素。沒有一家大廠商願意冒著商譽砸鍋及未來業務受損的重大風險,而提供不安全的產品。
IEC 17025僅保證實驗室執行產品型式試驗的能力。具ISO 9001的工廠所出具的出廠試驗報告,則足以確保出廠產品安全且符合標準。ISO/IEC 17025規範的義務內容僅適用於測試實驗室而非工廠;擁有ISO/IEC 17025,並不能防止製造商生產不符標準的產品,工廠應具有ISO 9001認證以示該廠通過適當的常規檢測來確保產品品質(與型式試驗相符)

在歐盟市場監督體制也非常有力。製造商如果供應瑕疵品,可能面臨鉅額的損害賠償,因此廠商不敢在市場上推出不安全的產品。科技創新非常迅速,遠非政府所能追上。如果法規太過僵硬,則當廠商開發出更先進的技術時,法規便會落伍,因此確保產品安全的義務便落到生產廠商上。

出席論壇的代表們也討論到歐盟後市場查核制度的優點。他們強調,只要僱用足夠的檢查人員,則後市場監督制度遠比上市前核准制度更能有效運用政府的資源。他們也強調,高壓用電產品經常是依客戶需要訂製,且非常複雜。並非每一位檢查人員都能了解各種新產品的技術,因此信任那些信譽著卓著的廠商是非常重要的。歐盟後市場督察人員的工作,是檢查確認所有的檢驗都適當完成,且產品已通過檢驗。歐盟的慣例是不介入生產廠商的營運,因為如此勢必會阻礙創新,有鑑於此歐盟代表建議台灣採取後市場監督措施。

在論壇最後進行互動式討論,結論中提及,歐洲規範系統能夠有效保證電機設備安全無虞。此外,有力的市場監督體制能確保生產廠商遵守他們對品質及安全性的承諾。同時,兼具
ISO/IEC 17025認證的試驗設備與ISO9001的工廠認證將會是保障安全最佳途徑。

目前,台灣有兩個許可方案:透過
ISO/IEC 17025或者透過ISO 9001。歐盟代表爭論ISO/IEC17025ISO 9001分別為試驗設備與工廠的相關標準,兩種途徑事實上應為互補而非兩者取其一。有鑑於此,歐方代表建議台灣有關當局採納兩者兼併的方式來做認證。目前第一個方案並未依循國際作法,因為根據「屋內線路裝置規則第401條」規定,須對原製造商家而非試驗設備施行ISO/IEC 17025認證,且此方案內並未規定工廠應符合相關檢測標準(ISO 9001),因此不足以預防意外與事故。現行第二個方案應搭配下列要求:在(世界任何一地)ISO/IEC 17025認證的(實驗室)測試設備通過型式試驗,但不應要求額外的工廠訪視,因為認證機構的查驗已在ISO 9001中檢視過。

代表們並歡迎與政府進一步溝通,以解決因政府對產品設計缺乏了解,而存在的各種技術性障礙。此次論壇最大的成果,在於台歐雙方針對技術面深入的討論,彼此的差距也因面對面溝通而減少。為了避免重複檢驗,及對型式試驗報告產生誤解,歐洲商會電機工程與設備委員會提議,未來可舉辦視訊會議,隨時能讓台灣主管機關與
IEC專家或廠商針對技術性問題進行直接溝通;並邀請法規檢討委員會的成員、台灣測試實驗室的專家們與IEC的專家及製造廠商們持續進行溝通,以對產品設計有更全面的了解。