RoHS 2 Technical File Documentation Services
Intertek’s regulatory and technical experts assist EEE product manufacturers create a product technical file to comply with the new EU RoHS Directive (2011/65/EU) conformity assessment requirements.
The recast of the EU RoHS Directive (2011/65/EU) “aka RoHS 2, RoHS Recast, etc…” has introduced new obligations for conformity assessment, declaration, and marking of electrical and electronic products. Manufacturers will need to carry out conformity assessments based on internal production control procedure in conformance with EU Decision 768/2008/EC and EU Regulation 765/2008/EC. RoHS 2 requires that manufacturers, importers, and/or distributors, prior to placing a product on the European market, have technical documentation available to describe the internal product control procedures put in place by the manufacture to ensure there are no restricted substances in EEE.
RoHS 2 Technical Documentation Services
Intertek provides a RoHS 2 Technical Documentation creation service to assist EEE product manufacturers to comply with the new conformity assessment requirements of the recast RoHS Directive (2011/65/EU). Intertek will develop and/or assemble existing documentation sections of technical information to create a technical documentation package based on requirements specified in the RoHS-2 Directive and related standards. Standards are now an important part of RoHS 2 compliance since RoHS 2 is now a CE Mark Directive. In instances where information is to be collected or conformity assessment performed, Intertek can also help support these activities.
The technical documentation file will include:
- General description of the product
- Documentation of Product design structure and information showing the relationship of conformity documentation with material, parts, and subassemblies in the product
- Risk assessment of materials, parts and subassemblies
- Conformity information on materials, parts, and subassemblies
- Manufacturing documentation and records
- Harmonized standards, specifications, and conformity procedures that have been applied to ensuring the conformity of the product
Intertek provides the following additional services in support of RoHS 2 compliance and the technical documentation:
- Education and Training
- RoHS Responsibilities Assessment
- Bill of Materials (BOM) supplier data collection
- Supplier declaration of conformity
- Materials Declaration
- Supplier education
- Risk Assessment of Bill of Materials and Suppliers
- Risk Mitigation
- RoHS data storage
- Analytical Testing (IEC62321)
- Supplier Assessment
- Compliance Assurance System (CAS) with Restricted Substance Controls (RSC)
- Development of conformity assessment procedures
- RoHS program/project management
- RoHS Compliance review / audit
- Intertek Certification to RoHS substance restrictions (Green Mark)
- Maintenance of the Technical Documentation file
- Authorized Representative for manufacturer in Europe
Request more information to see how Intertek can help your organization with RoHS 2 Technical File Documentation Services.