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Machinery Safety Directive (2006/42/EC)
This Directive applies to a wide range of products. It is intended to reduce accidents by the inherent safe design and construction, and proper installation and maintenance of machinery.
It's scope includes machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices, and partly completed machinery. There are exclusions, which are described in the Directive
For a Manufacturer, the requirements of the Directive include:
- Assessing your product against the Essential Health and Safety Requirements (EHSR) of the Directive. In practice this usually involves confirming that the product complies with relevant harmonized standards.
- Conducting Risk Assessments in support of claims made for compliance with the EHSR or Standards.
- Creating a technical construction file.
- For a Manufacturer located outside of the EU, appointing a contact inside the EU who is able to provide access to the technical file on request by the appropriate authorities.
- Involving a Notified Body in the correct conformity assessment procedures, where necessary.
- Applying the CE Mark to the product, and issuing an EC Declaration of Conformity.
- Making available any necessary instructions for use of the product.
Assessment of Conformity
For many products the conformity assessment procedures are carried out by the Manufacturer, and consist of drawing up the technical file, and taking all measures necessary in order that the manufacturing processes ensure compliance of the product with the type described.
For certain types of product (as listed in Annex IV of the Directive), a Notified Body has to be engaged to carry out such procedures as Type Examination and Quality System Assessment.
Baseefa services include:
- Advising on the applicability and completeness of standards to products.
- Providing assistance on gap analysis and pre-compliance testing.
- Carrying out, or assisting with the conducting of safety testing of the product, as required by the relevant standards.
- Providing assistance with technical file preparation, quality system preparation, and arranging for appropriate Notified Body services.
- Evaluation of technical documentation.
- Providing specially arranged training courses and seminars on compliance tailored specifically to your needs.
- Issue of compliance reports and certificates of compliance.
- Storage of technical construction files and acting as the contact point for Manufacturer's located outside of the EU.
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