研讨会演示PPT2

Report
Taking CE Marking
a step further
从CE认证…拓展
Graham McKay
June 2013
Copyright © 2012 BSI. All rights reserved.
Objectives 目的
• To gain an understanding of the “CE Marking” process
理解“CE认证”的过程
• To gain a more detailed understanding of current CE
Marking requirements for gas appliances. 详细了解现行
的燃气用具CE认证要求
• Some idea of what the future might hold for supply of
gas appliances in Europe. 未来欧盟燃气用具的一些看法
• How we can expand this for other markets? 如何向其它
目标市场拓展?
Copyright © 2012 BSI. All rights reserved.
2
CE Marking affixed to a product… 产品上的CE标志
• Confusion Everywhere ?
随处困惑?
• Caveat Emptor ?
出门恕不退换,买者自负?
Vast majority of people do not
know what CE Mark means
绝大多数人不知晓CE标志的含义
Copyright © 2012 BSI. All rights reserved.
3
CE Marking CE认证
Quality Mark?
质量标志
Meets EN standard?
符合欧盟EN标准
Independently tested?
第三方测试
Copyright © 2012 BSI. All rights reserved.
4
CE Marking CE认证
Simply a declaration from the
manufacturer that the product
complies with ALL RELEVANT
European Directives
简而言之,制造者声明,产品符
合所有相关的欧盟指令
But what are the “Relevant European Directives”?
然而,何谓“相关的欧盟指令”?
Copyright © 2012 BSI. All rights reserved.
5
“New Approach” Directives “新方法”指令
Example of a gas water heater:
以热水器为例
• Gas Appliances Directive? 燃气用具指令?
• Covers safety of gas appliances
涵盖燃气用具安全性
• Independent testing always required
总是要求第三方测试
Copyright © 2012 BSI. All rights reserved.
6
“New Approach” Directives “新方法”指令
Example of a gas water heater:
以热水器为例
• Gas Appliances Directive? 燃气用具指令?
• Low Voltage Directive? 低电压指令?
• Covers safety of electrical equipment
涵盖电气设备安全性
• Independent testing never required
不要求第三方测试
Copyright © 2012 BSI. All rights reserved.
7
“New Approach” Directives “新方法”指令
Example of a gas water heater:
以热水器为例
• Gas Appliances Directive? 燃气用具指令?
• Low Voltage Directive? 低电压指令?
• Electromagnetic Compatibility Directive?
电磁兼容性指令?
• Covers EMC emissions & immunity
涵盖电磁辐射与抗扰性
• Independent testing not normally required
通常不要求第三方测试
Copyright © 2012 BSI. All rights reserved.
8
“New Approach” Directives “新方法”指令
Example of a gas water heater:
以热水器为例
• Gas Appliances Directive? 燃气用具指令?
• Low Voltage Directive? 低电压指令?
• Electromagnetic Compatibility Directive?
电磁兼容性指令?
• Pressure Equipment Directive?
承压设备指令?
• Covers safety of pressurised equipment
涵盖承压设备
• Independent testing might be required
或许要求第三方测试
Copyright © 2012 BSI. All rights reserved.
9
“New Approach” Directives “新方法”指令
Example of a gas water heater:
以热水器为例
• Gas Appliances Directive? GAD?
• Low Voltage Directive? LVD?
• Electromagnetic Compatibility Directive? EMC?
• Pressure Equipment Directive? PED?
Even for relatively simple products, it is not easy to
know for sure which EU Directives apply to it: 即使对于
相对简单的产品,也难于确定适用的欧盟指令
- Scopes of Directives are often complex 范围繁复
- Directives may have many exclusions 指令可能有豁免
- New Directives appear from time to time 新指令不时出
现
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10
CE Marking – Where does it apply? 适用区域
Applicable in the countries of the “European Economic Area”
适用于“欧洲经济区(EEA)”
Which includes: 包括
• 27 Member States of the EU
27个欧盟成员国
• Members of EFTA
3个欧洲自由贸易区成员
• Member States joining the EU
申请加入欧盟的国家
Copyright © 2012 BSI. All rights reserved.
11
CE Marking – Principles 原则
• Products legally supplied in one country should be able to
move freely through the Community 合法产品区内流通自由
• Barriers to trade resulting from “local” variations are permitted,
but only if: 允许“当地”差异性导致的贸易壁垒,但是仅当
• They are necessary to satisfy health, safety, consumer protection and
environmental protection 对于健康、安全、消费者保护和环保是必需的
• They serve a legitimate purpose and can be justified 用于某个法定目的,
并可证明是合理的
• They are applied equally to everybody 对每个人都同等适用
• Examples include 例子有
• UK Plugs & Sockets Regulations 英国的插头插座法规
• Different gas types and pressures used in different countries
不同国家不同燃气种类和压力
Copyright © 2012 BSI. All rights reserved.
12
CE Marking – Principles 原则
• Regulations are limited to “essential requirements”
法规仅限于“必要要求”
• European Standards will detail how the essential
requirements are interpreted for specific products.
对于特定产品,欧盟标准解释了必要要求
• Use of EN standards remains voluntary – only the
essential requirements have force of law.
欧标的采用是自愿的 – 只有必要要求是法定强制的
• Products manufactured in compliance with EN standards
will benefit from a “presumption of conformity” with the
corresponding essential requirements
按照欧标生产的产品可以从标准“符合性推定”得益
Copyright © 2012 BSI. All rights reserved.
13
“New Approach” Directives “新方法”指令
•
•
•
•
•
•
•
•
•
•
Gas Appliances Directive 燃气用具指令
Low Voltage Directive 低电压指令
Electromagnetic Compatibility Directive 电磁兼容性指令
Pressure Equipment Directive 承压设备指令
Boiler Efficiency Directive 锅炉能效指令
Construction Products Directive 建筑产品指令
Marine Equipment Directive 船用设备指令
Lifts Directive 升降机(电梯)指令
Machinery Directive 机械安全指令
etc…等等
Copyright © 2012 BSI. All rights reserved.
14
Enforcement & Penalties 执法与惩罚
Each Member State can decide how to monitor and
enforce each Directive within their territory 每个成员
国可以决定在其管辖范围内如何监管每个指令的实施
• Penalties for non-conformity are
generally left at the discretion of
each Member State 不符合性的惩
罚一般由各成员国自行确定
 Fines 罚款
 Imprisonment for serious offences 严
重后果,可课以刑罚
Bear in mind that CE Marking is a LEGAL process
牢记,CE认证是一个符合法规的过程
Copyright © 2012 BSI. All rights reserved.
15
Defence 申辩
Observing “Due Diligence” is the only acceptable
defence, but this will NOT stop non-compliant
products being removed from the market. “勤勉
尽职”是唯一可接受的申辩,但是这不能阻止不
符合性产品撤离市场
“Such diligence as a reasonable person under the same
circumstances would use: use of reasonable but not
necessarily exhaustive efforts..”
“这种勤勉是一个普通的人在同等境况下做到的:合理的用
法而不必是全部的精力..”
Copyright © 2012 BSI. All rights reserved.
16
CE Marking – How to do it… 如何实施CE认证
7 steps to compliance
for any product
任何产品CE
符合性的7个步骤
Copyright © 2012 BSI. All rights reserved.
17
CE Marking – How to comply 如何符合
1) Determine which EU Directives apply to your product
确定产品适用的欧盟指令
• Consider scope of all Directives that may be relevant 关注相关
的所有指令的适用范围
• Consider exclusions given in most Directives 关注指令规定的豁
免内容
• Take advice and consider what others have done 咨询并关注
别人做了些什么
• Don’t be unnecessarily harsh on yourselves but be reasonable
不必过分苛求自身但要合理
DOCUMENT all decisions made at this stage, along with the
reasons why they were made
在此阶段所作的全部决定连同其理由要形成文件
Copyright © 2012 BSI. All rights reserved.
18
CE Marking – How to comply 如何符合
2) Evaluate and/or test your product to cover the essential
requirements of each Directive that applies 评估和/或测试产
品,涵盖每个适用指令的必要要求
•
Easier to “design-in” compliance than to modify for it later 符合性整合
设计比符合性改型更容易
•
Balance risk against cost of testing 风险与测试成本的平衡
•
Make use of harmonised standards where possible 采用协调标准
•
•
Helps avoid excessive testing 有助于避免过度测试
•
Gives presumption of conformity 获得符合性推定
•
Should ensure a consistent approach with competitors 确保与竞争
者一致的方法
Consider using an independent test laboratory 使用第三方实验室
•
May be mandatory for certain product types or Directives 指令强制
•
Specialised test equipment may be required 要求定制的设备
Copyright © 2012 BSI. All rights reserved.
19
CE Marking – How to comply 如何符合
3) Modify your design as necessary following evaluation
and retest if appropriate 根据评估结果,如果必要,修
改设计,并进行再测试
•
Failure to rectify a known problem with a product is not likely
to be considered as “due diligence” 不能修正某一已知问题,
是不可能被认为“勤勉尽职”的
•
Evidence of problems that were identified and solved adds
credibility to your technical file 发现并解决问题的证据增加技
术文档的可信度
Copyright © 2012 BSI. All rights reserved.
20
CE Marking – How to comply 如何符合
4) Decide how conformity will be maintained and ensured for
volume production 确定量产的符合性维持方法
•
Specified in some Directives 有些指令有规定
•
Formal Quality System may be beneficial 规整的质量体系可能有益
•
Quality Plan to show tests and inspections to be applied: 质量计划
列明适用的测试和检验
•
Goods inwards checks on suppliers 供应商的供货查验
•
Routine production line tests (sub-assembly & final assembly)
日常生产线测试(分组件和最终集成体)
•
More detailed audit tests on % of products made 按产品%更深
入的跟踪测试
Remember that the Directives apply to EACH
INDIVIDUAL PRODUCT that you place on the market!
牢记,那些适用指令适用于每一件投放市场的产品!
Copyright © 2012 BSI. All rights reserved.
21
CE Marking – How to comply
5) Write your “EC Declaration of Conformity” for the product.
This should include: 编撰产品的“符合性声明”,包括
•
The name and address of the manufacturer 制造者名称和地址
•
Full identification of the product(s) covered 所含产品完整识别信息
•
A list of all Directives that have been applied 已用指令列表
•
References of all harmonised standards applied 已用所有协调标准
信息
•
Notified Body certificate references (where relevant) 公告指定认证
机构信息(如果相关的)
•
Identification of the individual responsible 责任人信息
The DoC is the document that explains what the CE
Mark means on your product!
该符合性声明是对其所含产品上CE标志的解释!
Copyright © 2012 BSI. All rights reserved.
22
CE Marking – How to comply 如何符合
6) Complete your technical file for the product: 编制产品的技术文档
•
Complete description of the product 完整的产品描述
•
Details of procedures (standards) used to ensure conformity with each
applicable Directive 用于每一个指令符合性的程序(标准)细节
•
Test reports giving details of tests & examinations made 包含检测细节的测
试报告
•
A complete set of product drawings and/or photographs 全套产品图纸和/或
照片
•
All instruction manuals that are supplied with the product 伴随产品的所有使
用手册
•
Details of quality control procedures in place 现场质量控制程序细节
•
A copy of the Declaration of Conformity 一份符合性声明(DoC)
The technical file must be made available to enforcement
bodies if they request it.
在执法机构要求时,技术文档必须提供
Copyright © 2012 BSI. All rights reserved.
23
CE Marking – How to do it… 如何符合…
Step 7 is the one that
the vast majority of
companies forget
about…
第7步是绝大多数公司都
不放在心上的…
Copyright © 2012 BSI. All rights reserved.
24
CE Marking – How to comply 如何符合
7) At regular intervals, REVIEW the decision to affix the
CE Mark to your products: 定期检视在产品上加用CE标
志的决定
•
The product may have changed 产品可能已经改变
•
The environment for the product may have changed 产品所处的
环境可能已经改变
•
Standards used to assess the product may have changed 评价
产品的标准可能已经改变
•
New “CE Marking” Directives may have come into force 新的CE
指令可能实施
Remember that the Directives apply to EACH INDIVIDUAL
PRODUCT that you place on the market – at the time they are
supplied!
牢记,那些适用指令适用于每一件投放市场的产品 – 在供货时!
Copyright © 2012 BSI. All rights reserved.
25
CE Marking – How to do it…
“CE Marking” should be considered
as a continual process over the
whole life of a product and not as a
“one-off” exercise.
“CE认证”应视为产品全生命周期
中持续的过程,而不是“一次性”
的作业
Copyright © 2012 BSI. All rights reserved.
26
Summary 概要
• “CE Marking” is a legal procedure “CE认证”是一个合法的过程
• Responsibility of manufacturer or responsible person 制造者
或责任人的责任
• To identify all applicable directives 识别所有适用指令
• To follow procedures detailed in each directive 遵循每项指令规定的程序
• To comply with the requirements of each directive 符合每项指令的必要
要求
• Due diligence is only legal defence 勤勉尽职仅是合法的申辩
• Compile “technical file” as evidence of your diligence 编撰“技术文档”是
勤勉的证据
• Review your decision on a regular basis 定期检视您的决定
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27
Questions? 提问?
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28
The Future? 未来?
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29
The Future – Gas Appliances? 未来 – 燃气用具?
Gas Appliances Directive is currently under review by the
European Commission. Subjects under consideration include:
目前,欧盟正在检讨燃气用具指令,主题包括:
• Revision of the scope of the Directive 指令范围修改
• To cover a wider range of gas appliances? 覆盖更宽范围的燃气用具?
• To clarify the position of new technologies? 澄清新技术的处境?
• To cover installation components? 覆盖安装元器件?
• Revision of the essential requirements of the Directive 指令
的必要要求修改
• To adequately address new technologies? 充分涵盖新技术?
• To remove “rational use of energy” requirement? 删除“能源合理运用”的
要求
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30
The Future – new requirements? 新要求?
• European Commission are actively working on a new
“Energy Related Products” (ERP) Directive on efficiency. 欧
盟正在积极推行关于能效的“涉能产品”(ERP)指令
• Likely to include efficiency requirements for many products
by 2013 – 2015? 可能到2013至2015年,对许多产品会有能
效要求?
• This will require some sort of consumer label? 这将要求某
种消费识别标签?
• Least efficient products will gradually be banned from the
market over time (filament light bulbs) 最低能效等级的产
品将逐步从市场淘汰(白炽灯泡)
• The ROHS Directive will apply to gas appliances (July 2019)
RoHS指令将在2019年7月适用于燃气用具
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31
The Future - Standards? 标准?
• Revisions to European Standards: 欧盟标准修改
• EN standards are revised frequently 欧标频繁地修改
• Standards are NOT mandatory, but they are generally considered to
represent “state of the art”. 标准不是强制性的,但通常视其为代表“先进
性”
• New standards may consider risks or “foreseeable abnormal use” that the
manufacturer had not considered. 新的标准会考虑风险或“可预见的不正
常使用”,而这是制造者未曾考虑的
• If certification was based on complying with an out of date EN standard,
“presumption of conformity” may be lost. 如果认证是基于过时的标准,
“符合性推定”将失效
Copyright © 2012 BSI. All rights reserved.
32
Copyright © 2012 BSI. All rights reserved.
33
Other markets 其他市场
• CE Marking and compliance with EN standards can also
help provide access to other markets for gas appliances:
燃气用具的CE认证有助于进入其他市场
•
•
•
Some territories accept CE Marking
某些国家/地区接受CE认证
Some countries have adopted EN standards
某些国家采用欧标
The detail varies from product to product, but here is an overview,
along with a few examples 具体的视产品而定,然而,可以有个概括,
并举出一些例子
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34
Other markets 澳大利亚
• Australia requires compliance with its own AS standards for gas
appliances and approval by AGA (mainly) 澳大利亚要求符合燃气用具
的澳标,并经AGA(主要的认证机构)认证
• Safety and control devices tested by BSI to EN standards will usually
be accepted 经BSI按照欧标测试的安全和控制装置通常是可接受的
• BSI can also test appliances and controls to AS standards if required
and this will be accepted in Australia. BSI也可以按照澳标测试燃气用具
和控制器,这是澳大利亚接受的
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35
Other markets 新西兰
• New Zealand requires compliance with its own NZS 5262 standard for
gas appliances 新西兰要求符合燃气用具的新标NZS 5262
• EU approval by BSI is accepted for most products within their standard
plus some minor additional testing and marking requirements for the
local conditions 对于大多数产品,经BSI的欧标认证,是可以接受的,
仅须加做一些次要测试,并按照当地条件,满足标识要求
• Special case for mobile space heaters… 移动空间取暖器是特例
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36
Other markets 南非
• South Africa requires compliance with its own SANS 1539 standard for
gas appliances 南非要求符合燃气用具的SANS 1539
• BSI is an accredited test lab and certification body for the South
African standard… BSI是该南非标准的认可实验室和认证机构
Copyright © 2012 BSI. All rights reserved.
37
Other markets 俄罗斯
• Russia has its own GOST-R requirements for gas appliances 俄罗斯对
燃气用具有其GOST-R的要求
• Technically, the Russian requirements are based on compliance with
the EN standards with some variations of gas pressure and language
used 就技术而言,俄罗斯的要求是基于欧标的符合性,只是气压差异和
所用语言不同
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38
Other markets 以色列
• Israel has its own SI standards for gas appliances 以色列有燃气用具的
SI标准
• Technically, the Israeli requirements are based on the EN standards
with some minor variations to suit local custom and use 就技术而言,
以色列的要求基于欧标,只有些许差异,以满足当地习惯和用途
• Compliance has to be checked by SII in Israel 符合性必须在以色列由
SII查核
• BSI will become the first body outside Israel to offer this approval BSI
将成为以色列境外第一个提供该认证的机构
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39
Discussion & Questions 问答
BSI can help with many other markets for gas and
electrical products… this was just a sample
BSI可以助您进入许多别的(燃气和电气用具)市场…
上述只是一些例子
Copyright © 2012 BSI. All rights reserved.
40
4
1
Making excellence a habit
英国
Graham Mckay
Global Head of Electrical &
Gas Products
电话:
+44 (0)1509 33 11 01
上海
广州
钱树霖
曾翠伦
地址:
上海市南京西路338号
仙乐斯广场10楼1006-1011
地址:
广州市天河路208号
粤海天河城大厦12楼1209室
邮编:200003
邮编:510620
电话:
+86 (0) 21 2316 0312
电话:
+86 (0)20 8516 8180
手机:
+86 (0) 1360 196 7459
电邮:
[email protected]
Copyright © 2012 BSI. All rights reserved.
传真:
+86 (0) 21 2316 0208
传真:
+86 (0)20 8516 8169
电邮:
[email protected]
电邮:
[email protected]
41

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