QS Pakistan is an exclusive Licensee of QS Zürich AG which  is a Notified Body (NB 1254) for conformity assessments  for :

For Medical Devices according to Directive 93/42/EEC of the European Parliament and the Council of 14 June 1993 concerning medical devices
 

For Equipment and Protective Systems intended for use in potentially explosive atmospheres according to Directive 94/9/EEC of the European Parliament and the Council of 23 March 1994 on the approximation of the laws of the Member States.
 

What is CE Marking

The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA).

 Significance of CE Marking

By affixing the CE marking, the manufacturer, its authorized representative, or person placing the product on the market or putting it into service asserts that the item meets all the essential requirements of the relevant European Directive (s). Examples of European Directives requiring CE marking include Medical Instruments, Personal Protective Equipment, Toy Safety, Machinery, Low-Voltage Equipment. There are about 25 Directives requiring CE marking. .

Officially, CE has no meaning as an abbreviation, but may have originally stood for Communauté Européenne or Conformité Européenne, French for European Conformity.

Declaration of conformity

The CE marking is a mandatory European marking for certain product groups to indicate conformity with the essential health and safety requirements set out in European Directives. To permit the use of a CE mark on a product, proof that the item meets the relevant requirements must be documented. Sometimes this is achieved using an external test house which evaluates the product and its documentation. Often it is achieved by a company-internal self-certification process. In any case the responsible organization (manufacturer, representative, importer) has to issue a EC-Declaration of Conformity (EC-DoC) indicating his/her identity (location, etc.), the list of European Directives he/she declares compliance with, a list of standards the product complies with, and a legally binding signature on behalf of the organization. The EC-DoC underlines the sole responsibility of the manufacturer. Parts of the certification process for the CE marking could be performed by 3rd party test houses or certification bodies; in case that this is mandatory the CE symbol also includes a number that identifies the Notified Body.

To be strictly accurate, there are two forms of Declaration, either a "Declaration of Conformity" or a "Declaration of Incorporation". Generally speaking this is only the case under the Machinery Directive. For example, a stand-alone machine that requires only a power source to operate would be issued with a Declaration of Conformity; whereas a machine that requires additional systems, attachments, feed conveyors etc, before it can provide its intended function must be issued with a Declaration of Incorporation. In this latter case it is illegal to CE Mark such a machine. This can only be achieved once the machine has been finally installed and all other elements incorporated into the system. A final Risk Assessment is performed to verify compliance of the system and a final Declaration of Conformity is then issued.

Furthermore, these directives are based upon what the European Commission calls a New Approach, whereby if any of the Article 100A Directives apply to a product, then they must be followed.

Directives providing the requirements for the CE marking are created by the European Union (EU), but the markings are required throughout the European Economic Area (EEA). According to information provided by the Swiss Government for Swiss Exporters the CE Mark is not compulsory in Switzerland except for products for export to the European Union.)

Origin of mark

According to an article in The Guardian on 23-12-2001, the mark was designed by Arthur Eisenmenger. The various components of the CE marking must have substantially the same vertical dimension, which may not be less than 5 mm..

Mutual recognition of conformity assessment

There are numerous Agreements on Mutual Recognition of Conformity Assessment between the European Union and other countries such as the USA, Japan, Canada, Australia, New Zealand and Israel. Consequently the CE mark is now found on many products from these countries.