To alleviate the potential problems of a non compliant Surveillance Audit by any of the 18+ Surveillance Authorities, RPQ Consulting is now offering Continuing Compliance Management services.

Background

The Low Voltage Directive 73/23/EEC (1973) was designed to cover Safety of all electrical equipment designed for use with an input voltage rating of 50-1000Vac and 75-1500Vdc with a very few exceptions. The Low Voltage Directive was transformed into a New Approach directive with the CE Marking Directive 93/68/EC (1993). Formal safety certifications for individual EU countries were then no longer required. The new Low Voltage Directive 2006/95/EC (2006) as of January 16, 2007 replaced directive 73/23/EEC, however, there is no need for a transition provision or to update Declarations of Conformity to refer to the new directive because it's an editorial condensation of directive 73/23/EEC plus its amendments.

Similarly, the EMC Directive 89/336/EEC (1989) replaced national legislation to cover EMC conformance of all electrical equipment. The EMC Directive was also transformed into a New Approach directive with the CE Marking Directive 93/68/EC (1993). The new EMC Directive 2004/108/EC (2004) as of July 1, 2007 replaced directive 89/336/EEC and there is a 2 year transition provision to update Declarations of Conformity to refer to the new directive.

The R&TTE Directive 1999/5/EC (1999) was issued as a New Approach directive to cover EMC and Safety conformance of Radio and Telecommunications Terminal Equipment. The R&TTE Directive imposes no input voltage rating restrictions.

The EMC, Low Voltage and R&TTE Directives all mandate that equipment shall continue to comply with the Essential Requirements against which compliance was originally declared.

Surveillance Authorities in each Member State of the European Union proactively police the market place to ensure that equipment placed on the market meets these Essential Requirements; they will also react to complaints concerning equipment which is suspected of non compliance. Surveillance Authorities can and have demanded that non-compliant equipment be removed from the market place throughout the entire European Union. Additional penalties for non-compliance can be restrictive and prohibitively expensive for a manufacturer wanting to market equipment in the European Union. In some instances, manufacturers have been required to withdraw equipment from the market place, ship all non compliant products out of the European Union back to its point of manufacture.

The probability at some point in a product's life is that it's quite likely that at it will be audited by one of the Surveillance Authorities to ensure compliance with the Essential Requirements.

Compliance Management Services

Compliance Management Services include, but are not limited to the following:

• Review the Manufacturer's existing Compliance Folder
• Review Manufacturing ECO's and check if these raise Continuing Compliance issues
• Review Manufacturing Quality System documentation and procedures
• Management of all Continuing Compliance queries and correspondence with European Union Surveillance Authorities
• Management of all claims, investigations and litigation associated with audit of Compliance Folders and compliance documentation by the European Union Surveillance Authorities

The first investigation by a surveillance authority will likely be the scrutiny of the Compliance Folder. It is imperative that the Compliance Folder and product compliance are kept up to date from the product's introduction to its end of life.