CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, and other applicable provisions that have been imposed upon it by means of European directives, harmonized technical standards, and that the product has been subject to the appropriate conformity assessment procedure(s). It refers to safety rather than to the quality of a product.
Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, ETSI etc).
CEN stands for European Committee for Standardization & CENELEC stands for European Committee for Electro technical Standardization.
Who is it relevant to?
In order to export your product to European Union, it is required that your product bears a CE marking on it.
CPM SERVICES SUPPORT:
- To establish, implement & maintain suitable quality management system
- To carry out risk assessment, choose harmonized standard and prepare test plans
- In preparation of technical file, necessary documentation & revision based on test reports
- In Liaison & co-ordination with certifying / notified agency
- CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries),
- CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country, and
- CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement / vigilance authorities.
- Enhances brand reputationand can be a useful promotional tool. It sends a clear message to all interested parties that this is a company committed to high standards and continual improvement.
- Organizations retain or increase market share, increases sales or revenues and profitability. It removes barriers to trade and Attracts investment.
- Increased customer confidence & satisfaction leads to improved organizational image.
The letters “CE” are the abbreviation of French phrase “Conformité Européene” which literally means “European Conformity”. The term “EC Mark” was initially used but officially replaced by “CE Marking” in the Directive 93/68/EEC in 1993.
- COMPLIANCE PROCESS
- Step 1 : Quality Management System – Establish a QMS as a foundation (ISO 9000 series).
Carry out the following steps for each product
- Step 2 : RISK ASSESSMENT – Determine applicable Directives and hazards
- Step 3 : STANDARDS – Choose Harmonized and other Standards that will apply
- Step 4 : TESTING PLAN – Decide what testing will be carried out to prove compliance with Directives and Standards
- Step 5 : TESTS AND REPORTS – Carry out tests (or have them carried out) and prepare recommendations / Reports
- Step 6 : REVISE PRODUCT & DOCUMENTATION AS NECESSARY – Review results to show that system performs as specified, plus any reservations
- Step 7 : TECHNICAL FILE – Prepare technical documents and supporting reports
- Step 8 : CONFORMITY ASSESSMENT – Select notified body & get conformity assessment carried out by them
- Step 9 : DECLARATION OF CONFORMITY – Prepare Declaration(s) of Conformity
- Step10 : MARK PRODUCT – Begin to CE Marking
- Step11 : PLACE ON MARKET – Control production to comply with Declarations
- Step12 : REVIEW – Periodically review directives for new requirements