ACC Global Compliance
Sunday, 25 March 2018

Safety - Frequently Asked Questions

Q - We manufacture packaging equipment. Which European safety laws and standards apply to our equipment?
A - On a typical packaging machine at least 3 Directives apply: The Electromagnetic Compatibility Directive, The Machinery Directive and The Low Voltage Directive. Depending on the intended use of the equipment (residential laboratory, industrial, etc.) different standards can apply within the same Directive. Additional Directives may apply depending on the equipment specifications.

Q - When is ISO9000 Certification important if we want to CE Mark our products?
A - ISO 9000 can become a major part of product certification. Under the Personal Protective Equipment Directive for instance, in addition to laboratory tests, manufacturers can choose either to be subject to Notified Body visits and product sampling, or to be ISO 9000 certified by an approved and recognized Registrar. Cost savings can also be realized by becoming ISO 9000 Certified. ACC works closely with various registrars for companies interested in Quality System Certification.

Q - Our equipment is listed under Annex IV of the Machinery Directive, what do we need to do?
A - Annex IV of the Machinery Directive lists categories of equipment which require the involvement of a Notified Body to approve the equipment prior to export. If applicable other Directives must also be complied with in order to receive Notified Body approval.

Q - What happens if we sell equipment to our customers in the EU without complying to the Directives?
A - Enforcement is carried out on a member state basis. Heavy fines can be imposed on the manufacturer and current and future products banned from the market.

Q - What if our tool must comply with both SEMI Guidelines and the CE Marking requirements?
A - A combined certification with the same company is suggested in order to reduce your time and expenses. Your customer may request partial compliance to the SEMI Guidelines, yet full compliance to EU Directives is mandated. It is critical that as much technical information on the system be submitted to correctly determine the scope of the compliance project.

Q - A dozen safety standards apply to our equipment or product, how can we reduce the complexity, time and expenses related to their purchase, review and implementation?
A - To make matters worst, safety standards and requirements are often subject to revision and only a portion of a standard may apply to your product. The best answer is to talk with an experienced organization such as ACC that will guide you and simplify the process.



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