What is CE Mark Certification?
CE marking is an administrative marking that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). It is not a quality indicator or a certification mark. The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area. It is in that sense like the FCC Declaration of Conformity used for selling certain electronic devices in the United States. The CE marking is the manufacturer’s declaration that the product meets EU standards for health, safety, and environmental protection.
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
Certified Ecotel Certification Video
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
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 effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.
The implementation process is described below:
Day 1
GAP Analysis, Certification Body, 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 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 certification body
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
The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”.
The CE mark is required for all new products which are subject to one or more of the European product safety Directives. It is a visible sign that the manufacturer of the product is declaring conformity with all of the Directives relating to that product.
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.
The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives.