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Home  > CE Mark & Product Certification > CE-Mark
  
Establish the European Community(EC) in 1958 -> Join a integrated Europe law in December 1985 (Main matter: Remove the technical and physical boundary of regional markets in Europe) -> Create CE mark by 93/68/EEC in directives of EC board of directs in July 1993.
Create by objectives to guarantee safety of products manufactured and distributed in Europe markets.
Mark for conducting to evaluate the relevant suitability by manufactures, importers, and third parties(certification bodies, etc.) that product can distribute to markets without limitation.
CE mark doesn’t mean reliability and quality guarantee, it means that the product complies requirements of EC regulations & directives and Europe standard related to health, safety and consumer protection.
 
 
  
 
 
  
The subjects for CE mark and its timeframe in accordance with 19 directives are as below.
If products are applied by some directives, all directives are satisfied.
(Ex. Machinery have to meet machine directives and EMC directives in 1996, is added directives of low-voltage equipment from 1997.)
 
DIRECTIVES
NO.
Enforced on
Duty to be applied on
Example of modules applied
Target items
CE MARKING, etc.
93/68/EEC
01-01-1995
31-12-1996
   
Low Voltage Equipment
2006/95/EEC
21-08-1994
31-12-1996
A
Under
AC 100V, DC 150V
Simple pressure Vessel
2009/105/EC
01-07-1990
01-07-1992
B
Over 0.5bar
(Exclude nuclear energy, ship, and etc.)
Toy Safety
2009/48/EC
01-01-1990
31-12-1989
A,Aa,B
Toy goods
Construction Product
89/106/EEC
 
27-06-1991
A, B, etc.
Various constructional materials including cements and tiles
Electromagnetic Compatibility
2004/108/EC
01-01-1992
31-12-1995
A,B
Wireless equipment and home electric appliances
Machinery
2006/42/EC
01-01-1993
01-07-1994
31-12-1994
31-12-1996
A,B
Machines and electric tools for making/woodworking/ foods
Personal Protective Equipment
89/696/EEC
01-01-1995
01-01-1997
B+C,B+D,G
Devices for personal protective
Non automatic Weighting Instruments
2009/23/EC
(ex-90/384/EEC)
01-01-1993
31-12-2002
B
General weighing scale for industry and medicine
Active implant
Medical Devices
Gas Appliance
90/385/EEC
01-01-1993
31-12-1994
B+C,B+D,H
Implantable medical devices
Gas Appliance
2009/142/EC
01-01-1992
31-12-1995
 
Gas appliance including a heater, a water heater, etc.
Telecommunications
Terminal Equipment
99/5/EC
06-11-1992
-
 
FAX,MODEM
Hot Water Boilers
92/42/EEC
01-01-1994
   
How water boiler by using oil/gas
Medical Devices
93/42/EEC
01-01-1995
31-06-1998
 
Various medical devices
Satellited Earth Station
Equipment
93/97/EEC
01-05-1995
-
 
Satellited earth station equipment
Explosive for civilian
93/15/EEC
01-01-1995
31-12-2002
 
Explosive
Blaster resistance devices
94/9/EEC
01-03-1996
30-06-2002
 
Blaster resistance products
 
 
  
8 modules are prepared and are divided to methods to evaluate suitability, also they are divided to the standard examination procedure according to combining of each module. → It can select modules by feature of each product.
Evaluation of suitability includes all of design and production.

E, H, and D of modules have to acquire the certificate of ISO 9000.
 
Module
A
Internal producing management
B
Type examination
G
Unit verification
H
Final quality guarantee
Design
Producer

1. Hold technical construction file(TCF)for 10 people of accredited authorities

Aa

1. Adjusted by accredited authorities

Producer submits
Accredited body submits

1. Technical construction file(TCF)and
2. Form(sample) to an accredited body

1. Check suitability according to requirements,
2. Test if necessary, and
3. Examine EC type.

Producer

1. Submits technical documents
Producer

1. Operate the quality system for design.

Accredited body

1. Monitor the quality system
2. Check suitability of design
3. Issue a certificate to examine EC design

Production
Producer

1. Notify suitability for requirements
2. Check products by un-regular intervals
C
Type suitability
D
Guarantee of production quality
EN29002
E
Guarantee of product quality
EN 29003
F
Product verification

Producer

1. Submit products
2. Declare suitability
3. Attach CE mark

Accredited body

1. Meet between requirements of directives and each product
2. Issue a certificate of suitability

Producer

1. Operate the quality system according to accredited manufacturing and testing
2. Notify suitability
3. Attach CE mark

Accredited body

1. Monitor the quality system

Producer

1. Notify suitability with accredited types
2. Attach CE mark

Accredited body

1. Test items for features of a product
2. Check products by un-regular intervals

Producer

1. Operate the quality system according to accredited manufacturing and testing
2. Notify suitability with accredited types
3. Attach CE mark

Accredited body

1. Approve the quality system
2. Monitor the quality system
Producer

1. Operate the quality system according to examining and testing
2. Notify suitability with accredited types
3. Attach CE mark

Accredited body


1. Approve the quality system
2. Monitor the quality system
Producer

1. Notify suitability according to accredited types or requirements
2. Attach CE mark

Accredited body

1. Check suitability
2. Issue a certificate of suitability
 
 
  
It is written in English or French which are official languages in EU.
(But, a manual like machine or operating instructions have to be written in its local language.)
It has to be kept for 10years.

If contents change, it has to be kept the changing version when it notifies itself and notifies to the local branch in Europe. And if it passes the accredited body, it has to be re examined by notifying the changing matters.
 
 
  
4 methods for follow-up control are divided to select by a random sampling, by a type, by submitting a claim, and by occurring an incidence.
Selecting by a clam is largest from their methods, its reason is increasing to supply its sources by competitors.

Declaration of conformities(DOC) and Technical Construction File(TCF) used as documents of CE marking have to be kept for follow-up control and PL responsibility in10 years.
If exposed, measures are divided in paying additional costs , penalty, and imprisonment basically. Also it is required to re-examine.
 
 
  
1. Directive for low voltage equipment 2006/95/EC
2. Directive for suitability of electromagnetic waves 2004/108/EC
3. Directive for machinery 2006/42/EC
4. Directive for pressure devices 2009/105/EC
5. Directive for personal protective equipment 89/686/EEc
6. Other directives