CE Marking Implementation and Management
CE Marking is the compliance mechanism that allows international manufacturers to sell products in Europe. It covers minimum standards for health and safety and is not a catch-all quality standard.
The onus is on manufacturers to gain CE Mark compliance and then display CE Marking on products, packaging, instructions and other service literature. Importers are encouraged to ensure compliance because they can be held liable for defective products
CLM Training can provide expertise on all aspects of CE Marking and we have particular experience in the field of CE Marking for Medical Devices.
CE Marking Schedule
- Research and identify the key Directives and Harmonised European Standards relevant to the product.
- Agree which Conformity Assessment procedure is required (e.g. self-declaration, Notified Body testing, inspection or QS Audit, or a combination).
CE Marking Audit
- Health and safety reports
- Hazards testing
- Product testing
- Technical specification
- Operational documentation
- Maintenance documentation
- Sales and service documentation
- Quality processes
CE Marking Actions
- Rework of any problem areas located in the CE Marking Audit
- Production of Technical Files (mandatory).
- Production of Declaration of Conformity.
CE Marking Training
CLM Training offers customised CE Marking training packages for key managers and staff involved in product or systems compliance.
Our packages focus on the need for constant vigilance across a number of areas of business operation to ensure compliance is successfully achieved and then properly maintained .
Contact CLM Training now for a free confidential review of your CE Marking process.