Product Announcement from DNV GL - Business Assurance North America
In a modern world everybody is surrounded by products. Products which in most cases contribute to ease our everyday life, but which could also pose a threat to our health and/or the environment.
What if the power supply of your laptop suddenly caught fire, or the pressurized air condition unit blew up in your face, or the electric hedge trimmer suddenly cut off your finger, or your cell phone interfered with your elderly neighbor's pacemaker?
Fortunately for the end user, most products are subject to rules and regulations which address these risks and place pressure on the seller to make safe products. The rules and regulations could come from an official authority, an interest group, or from a reputable independent body. There are numerous examples of these regulations which could be taken from any region/ continent of the world.
DNV is a Notified Body for the following key services offered:
• Pressure Equipment Directive (PED) (97/23/EC)
Encompasses design verification, material selection, manufacturing/fabrication practices and qualification, product testing, product marking and user instruction compilation.
• (ATEX) Directive (94/9/EC)
Covers equipment and protective systems used on fixed offshore platforms, in plants, mines, flour mills, and other areas where an explosive atmosphere may be present.
• Machinery Directive (MD)(98/37/EC) (In Transition to 06/42/EC)
The MD defines machinery as "an assembly of linked parts or components, at least one of which moves, with the appropriate actuators, control and power circuits, etc., joined together for a specific application, in particular for the processing, treatment, moving or packaging of a material".
• Medical Device Directive (MDD) (93/42/EC)
DNV's notification covers approximately 6000 products. The Medical Devices Directive (MDD) applies to all general medical devices not covered by the Active Implantable Medical Devices Directive or the In Vitro Diagnostics Directive.
• Electromagnetic Compatibility Directive (EMC) (04/108/EC)
Products must be constructed so that they do not cause excessive electromagnetic interference and are not unduly affected by electromagnetic interference. Certain radio transmitting equipment must be subjected to EC type-examination by a Notified Body.
• Low Voltage Directive (LVD)(06/95/EC)
The Low Voltage Directive is, with a few exemptions, mandatory and applicable for all types of electrical equipment with a voltage rating between 50-1000VAC or 75 1500 VDC. The Directive covers all risks arising from the use of electrical equipment, including mechanical and chemical equipment, health aspects of noise and vibrations, and ergonomic aspects. The Directive lays down 11 safety objectives, which represent the essential requirements.
Other Key Services Offered
• CE marking of products to applicable European Union (EU) Directives. Applies to a wide range of products sold or exported to the EU member states and European economic Area.
• Waste Electrical & Electronic Equipment Directive (WEEE) (2002/96/EC and 2003/108/EC)
Assigns electronics manufacturers the responsibility of collecting, recycling and recovering all types of electrical products, equipment and components. This directive came into full producer responsibility July 2007.
• Restriction of Hazardous Substances Directive\(RoHS)
Restricts the use of Lead, Mercury, Cadmium, Hexavalent Chromium, and two Brominated flame retardants (PBB & PBDE) which affect a broad range of products. The RoHS directive affects everyone within the electronics supply chain as a result of the end producer's capabilities to comply with the RoHS Directive is entirely dependent upon the complete supply chain of all arts, materials, subassemblies and components used to construct the electrical equipment.
• Hazardous Substance Process Management (HSPM) through certification to the IECQ QC 080000 Specification HSPM certification provides a comprehensive, common sense platform to ensure that hazardous materials present as part of the production processes are identified, managed and controlled, with the goal of continuously improving the process to achieving hazardous substance free operation and finished products. QC 080000 is designed to be integrated with and complements the ISO 9001 Quality Management System (compliance to ISO 9001:2008 us a prerequisite for QC 08000 certification), as well as providing a basis to satisfy compliance with the EU directivesfor RoHS and WEEE as well as other regulatory requirements for hazardous material content and management. DNV is recognized by IECQ as a Supervisory Inspectorate (SI) for HSPM certification to IECQ QC 080000.
• Process Management for avionics (ECMP) is based on the recognition that the aerospace industry can no longer control the design, quality, reliability, configuration, or availability of the majority of electronic components that are used in avionics systems. Instead, the avionics purchaser of the parts must develop, document, and implement processes to manage electronic components, which meet the reliability requirements of the aerospace industry.
• International Electro technical Commission (IECEx)
An international approval scheme that covers equipment and protective systems used on fixed offshore platforms, petrochemical plants, mines, flour mills, and other areas where an explosive gas, vapor or dust atmosphere may be present. DNV is an approved Certification Body (ExCB) and Test Laboratory (ExTL) for this scheme.
DNV will guide you through the process of selecting the relevant rules and regulations for your product, including relevant standards and specifications for which you need to document compliance. They can perform testing or help you find a suitable laboratory. When you are ready to show your compliance documentation, DNV will examine these in a professional and systematic manner.
Do you have efficient routines to manage the quality of the production? Let DNV go through them together with you to see whether there is something to improve.