علامت CE نشانگر انطباق محصول با استانداردها ، قوانین و مشخصات تعریف شده در اروپای متحد است و محصولی که موفق به اخذ این آرم شود مجوز ورود به بازارهای اروپایی را اخذ کرده و می تواند در تمامی کشورهای عضو اتحادیه اروپا عرضه شود .
با توجه به این الزامات و ضرورت آگاهی از قوانین و استانداردهای هماهنگ اتحادیه اروپا، گروه مهندسی شایگان Shaygan Groupبا در بر داشتن کارشناسان مجرب و کارآزموده و با شناخت کافی از مقررات و استانداردهای هماهنگ شده اروپایی به اخذ نمایندگی از چندین مؤسسه Notification Body ثبت شده و قابل ردیابی در سایت اتحادیه اروپا ( دارای کد 4 رقمی ) اقدام نموده که با دارا بودن امکانات تست و بازرسی از مراجع و آزمایشگاه های تأیید شده و پس از طی مراحل ممیزی و اخذ تأییدیه فنی از مؤسسات مذکور ، بطور رسمی و انحصاری و در حداقل زمان و کمترین هزینه های ممکن به ارائه خدمات مشاوره و اخذ گواهینامه CE می پردازد.
مراحل اخذ گواهینامه و نشان CE ؛
1) مطالعه کامل محصول و تهیه گزارش شناخت ، مشخصات فنی و ویژگیهای محصول Specifications
2) تهیه و یا تدوین راهنمای کاربرد محصول و موارد رعایت نکات ایمنی
3) مطالعه و شناسایی مقررات و استانداردهای هماهنگ شده اتحادیه اروپا Harmonized Standards
4) شناسایی دایرکتیو ها و راهنماهای مورد کاربرد European Directives
- عمدتاً آنچه در این دایرکتیو ها بیان می شود، رعایت الزامات اساسی در مورد ایمنی و سلامت مصرف کننده و حفاظت از محیط زیست است.
5) گردآوری و یا تهیه دستورالعملها و طرح های کیفی تست و بازرسی
6) جمع آوری گزارشات و یا انجام تست و آزمون های لازم بر اساس روش های تست مندرج در استانداردهای مربوطه از مرجع ذیصلاح
7) تهیه مدارک اثبات انطباق ارزیابی و مطابقت محصول با استانداردهای هماهنگ شده بر اساس اظهار نامه تولیدکننده و یا نتایج تست و آزمون (مندرج در بند فوق)
8) بررسی نقشه ها و نمودارهای جریان فرآیند تولید و یا پدیدآوری محصول OPC
9) ارزیابی ، شناسایی و بررسی جنبه های ریسک Risk Assessment
10) تکمیل مدارک ممیزی و یا اثبات سیستم مدیریت کیفیت در سازمان
11) تکمیل پرونده فنی و چک لیست های مؤسسه Notify Body
12) اخذ گواهینامه و درج نشان CE روی محصول ، بسته بندی و دفترچه راهنمای محصول مورد نظر
CE Marking is an association sign which were prepared within the context of new approach policy and shows the conformity of the products which are related to New Approach Directives and conformed to conformity assessments and which were adopted as a part of accordance to the regulation in 1985 by The European Union. CE Marking is a sign which shows that in case the products are used accordance with the purposes, they cannot damage for human life and property, plant and animal being; in other words, is a sign shows that the product is safe.
The European Union, new approach, global and modular approach directives which act an important part for European Union to reach the European single market target and are one of the corner stone for technical conformance, are listed below.
The directives which were improved as a part of this policy have been published firstly in 1987 and are growth 20 directives at the present day. These directives have two basic purposes: First is supplying free flow of goods, second is performing the maximum protection. The common points of these directives are basic requirements which are compulsory to suit and to be performed, description of conformity assessment and usage of CE marking. For this purpose, The European Union standardization institutes have being charged to technical specifications which perform the conformance in an only
NEW APPROACH DIRECTIVES WHICH NEEDS CE MARKING
The new EU product directives deal with large families of products or horizontal risks such as those addressed in the Electromagnetic Compatibility Directive. The manufacturer and exporter are responsible for ensuring the product meets the requirements for all applicable directives. The following directives (with the reference between brackets) have been adopted:
Low Voltage (73/23/EEC)
Simple Pressure Vessels (87/404/EEC)
Safety of Toys (87/378/EEC)
Construction Products (89/106/EEC)
Electromagnetic Compatibility (EMC) (89/336/EEC)
Machine Safety (98/392/EEC)
Personal Protection Equipment (89/686/EEC)
New Hot-water Boilers (92/42/EEC)
Gas Appliances (90/396/EEC)
Explosives for Civil Uses (93/15/EEC)
Recreational Craft (94/25/EC)
Non-automatic Weighing machines (90/384/EEC)
Active Implantable Medical Devices (90/385/EEC)
Equipment for Explosive Atmospheres (94/9/EEC)
Telecommunications Terminal Equipment (91/263/EEC)
General Product Safety Directive (2001/95/EC)
The Directives Which Were Improved Within Context of New Approach and
Global Approach However CE Marking Usage Is Not Compulsory:
94/62/EC Packaging and Packaging Waste Directive (20.12.1994 dated and 94/62/EC
numbered European Parliament and Council Directive)
96/48/EC Trans-European High Speed Rail System (23.07.1996 dated and 96/48/EC
numbered Council Directive)
2001/16/EC EC Conventional Rail System (19.03.2001 dated and 2001/16/EC
numbered European Parliament and Council Directive)
Global Approach Directives
96/98/EC Marine Equipments
96/57/EC Energy efficiency requirements for household electric refrigerators, freezers and their combinations
1999/36/EC Transportable pressure equipment
2000/14/EC Noise emission in the environment by equipments for use outdoors
2000/55/EC Energy efficiency requirements for ballasts of fluorescent lighting
Conformity Assessment - Modules
A. Internal control of production
B. EC type-examination
C. Conformity to type
D. Production quality assurance
E. Product quality assurance
F. Product verification
G. Unit verification
H. Full quality assurance (ISO 9001)
Technical Documentation
A general description of the product
Design and manufacturing drawings, descriptions and explanations necessary for the understanding of drawings, results of design calculation made, examinations
A list of the standards referred to in specific article of the Directive, applied in full or in part, and descriptions of the solutions adopted to meet the essential requirements where standards have not been applied,
A detailed description of manufacture
A description of the means (such as the use of test report or technical file), whereby the manufacturer ensures conformity with the approved model.
Copies of the documents the manufacturer has submitted to an approved body in accordance with specified article for some directives.
The test certificate for the sample or a certificated copy thereof.
Declaration of Conformity
The name and address of the manufacturer or the authorized representative issuing the declaration;
The identification of the product (name, type or model number, and any relevant supplementary information, such as lot, batch or serial number, sources and numbers of items)
All relevant provisions complied with; the referenced standards or other normative documents (such as national technical standards and specifications) in a precise, complete and clearly defined way;
All supplementary information that may be required
The date of issue of the declaration; signature and title or an equivalent marking of authorized person
The statement that the declaration is issued under the sole responsibility of the manufacturer and, if applicable, the authorized representative.
A manufacturer in Iran must do followings in order to affix CE Marking
Determinations of new approach directives regarding the product
Determination of the standards referred in product directives or if no reference, determination of general security standards.
To plan appropriate production to standard
Determination of a module appropriate its structure as defined in directives
If mandatory, applying to a NOTIFIED BODY and conformity assessment operation.
Preparing the technical file
Affixing CE Marking by Declaration of Conformity
