CE MARKING CERTIFICATION - CE MARK
What is CE Mark Certification?
The CE marking is the manufacturer’s declaration that the product meets EU standards for health, safety, and environmental protection.
Here are some regulations for which the CE mark is mandatory:
- RoHS
- Low Voltage Directive
- Toy Safety Directive
- Personal Protective Equipment Directive
- Medical Devices Directive
- Machinery Directive
- EMC
- Custome Product Directive
Benefits of CE Mark Certification
Sell your product in the countries of the European Economic Area
Reduce the risk of customer dissatisfaction
Make Trading Easier
Improve Product Credibility
Ensure Product Safety
Increase Market size
Who can be certified CE Mark Certification?
Many consumer goods marketed in the EU, such as toys and electrical appliances, must have CE marking. CE marking indicates that the product meets certain statutory requirements connected with things like safety, health, and the environment. It can be recognized by the letters ‘CE’.
Medical Devices
Machinery
Lifts
Measuring Instruments
Safety of Toys
Construction Products
Personal Protective Equipment
Electronics
LED Lighting Products
Electrical
Mobile Equipment
Computers
Wrist Watches
IVD Testing
Document required for CE Mark Certification
- Technical File, Product Master File (TCF)
- Product Testing
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Plant Master File
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Product and it's uses
- Testing requirement of products
- Directive in which product classified
- Self Certification or Compliance Certification
- Notify body Certificate
Role of Shamkris and Process of CE Mark Certification
Shamkris adopts a results-oriented approach to compliance product certification, A simple & practical method of product certification organization in timely compliance and fulfills the product certification requirement. Shamkris support 100% on documentation required to comply with product certification either by self-certification or notify body certification to depend on directives.
The implementation process is described below:
Time Frame
Task
Process
Day 1
Scope defined
Self Certification/NoBo
Selection
Cost Estimates
- Finding directive and EN standard applicable to the product
- Selecting the appropriate certification scheme
- Based on the scope of the product and certification scheme
Week 1
Developing Documents
- Technical file, Plant Master file and Test Protocol
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Product Management System
- CE Mark Awareness training to QC manager and Production Manager
- Implementing a well-documented manual throughout the life cycle of the product
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to CE Mark requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Self Certification/NoBo
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the Self Certification/NoBo
Week 12
Self Certification/NoBo
- CE Mark certificates issued for 5 years
- Surveillance Audits yearly
- If CE Mark is issued for customize project then their is no Validity.
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”.
What is a CE mark and is it equivalent to a UL Listing Mark? A CE Marking is a European marking of conformity that indicates that a product complies with the requirements of the applicable European laws or directives.
“CE” is sometimes indicated as an abbreviation of “Conformité Européenne” (French for “European Conformity”), but is not defined as such in the relevant legislation.