Competence Directives

Directive 2009/48/CE that abrogates the Directive 88/378/CEE

Italian transposition: D.lgs 54/2011 abrogation (since 20.07.2011) of the D.lgs 313/1991


Management of activities of release of product during the production or before import. This service is intended to manufacturers or importers and it consists in:

  • evaluation of conformity of products to european and national standards;
  • assessment of technical documentation supplied by the manufacturer.


This service includes:

  • Identification of Directives and Rules that must be applied
    SQM carries out, for each type of product, an investigation in order to determine all Directives and then the relative Standards to guarantee the conformity of the products. For each kind of product SQM will take care to obtain all necessary information to you to permit you to ask to the manufacturer for all correct technical documentation.
    SQM will issue a document with directions to communicate to supplier regarding the documents to enclose to the product before import it and the details that supplier must give with samples during the evaluation of the product.

  • Evaluation of technical documentation that manufacturer must supply
    SQM controls the documentation supplied by manufacturer, together with sample, to verify that they are in according to the instructions. SQM draw up a Technical construction file that must be shown to inspectors in case of checks from Authority.

  • Evaluation of samples
    Our laboratory is equipped to execute all tests in compliance with Harmonized European Standards of electromagnetic compatibility, safety and RoHS analysis. SQM can execute the specific measures for electronic consumer products, electrical household appliances, toys, lighting, etc.

  • Release of TCF and Declaration of Conformity
    SQM draw up the Technical Construction File and Declaration of Conformity in according with regulation. This document should be made available to the Authorities.


SQM assists all economic operators involved in the European market entry of the goods, providing specialized support for the correct application of all relative Directives.



R&TTE 99/5 CE

It applies to radio equipment and telecommunications terminal equipment

R&TTE 99/5 CE

It applies to radio equipment and telecommunications terminal equipment

EMC 2004/108/EC: Electromagnetic Compatibility

It applies to products and systems that can create electromagnetic interference or who might be affected.

LVD 2006/95/EC: Low Voltage

It applies to electrical equipment, products and components powered within certain voltage limits, which could cause risk to people, animals and things.

TSD 2009/48/EC: Toys

It applies to toys defined as products manifestly intended or not intended for children within 14 years for recreational purposes

RoHS 2011/65/UE

Restrictions in the use of banned substances. It applies to electrical and electronic products.

ErP 2009/125/EC: Energy Related Products

It applies to any good that has an impact on energy consumption during use which is placed on the market and/or put into service, and includes parts intended to be incorporated into energy-related products covered by this Directive which are placed on the market and/or put into service as individual parts for end-users and of which the environmental performance can be assessed independently;

REACH 1907/2006

The legislation applies to all chemical substances: manufactured, imported, sold, used on their own, in mixtures or in products. Many can be found in our daily lives as cleaning products, paints or in electrical appliances.

COSMETIC 1223/2009

Makes cosmetics products sold in the EU safer by tightening safety requirements.

FOOD CONTACT 1935/2004

It lays down common rules for packaging materials and articles such as bottles and containers, which come, or may come, into contact with food, either directly or indirectly.


SQM performs many activity in support of the quality manager/ department of the manufacturer (who produces or affix his own brand on the product). Here below the most important activities:

  1. Implementation of the factory audit procedures to ensure the ability to produce in accordance with Regulation.
  2. Arrange quality agreement to ensure that manufacturers respect the operating procedures required by the applicable directives and technical standards.
  3. Execution of risk assessment (safety assessment).
  4. Project management, issue technical documentation that ensure that the products are designed and manufactured in accordance with the technical specifications agreed and the relevant European Directives requirements imposed.
  5. Check test reports available from supplier. If necessary execution of technical tests and involvement of a Notified Body Laboratory.
  6. Preparation of the EC declaration of conformity according to the new standards set by the Directive and in accordance with the essential rules.
  7. Regular review of the technical files as a result of regulatory updates or changes in the product and inform always the manufacturer to ensure and guarantee that the documentation is always up to date.


SQM can support also companies that import and buy products from foreign manufacturer which does not have a representative office in Europe. Here below the most important activities:

  1. Verification and maintenance of technical documentation and the EC declaration of conformity for 10 years after the last product put into the market.
  2. Inspection of the lots in the factory or verification of mass production phases to ensure that production to remain in conformity.
  3. Perform random checks of the products put into the market.
  4. In collaboration with the company, dealing with their complaints, maintaining and managing the register of complaints of non-compliant products.
  5. In collaboration with the customer: management of corrective measures necessary for aligning the products may not conform, in case of withdrawal or recall from the market, as appropriate. Where the product presents a risk SQM can, always in cooperation with importer, handle the information activities to the relevant national Authority of the Member State where the product has been sold.
  6. Following a reasoned request from a competent national Authority SQM, on behalf of the customer, interfaces and provides all the information and documentation necessary to demonstrate the conformity of the product and cooperates with the Authorities in any action to eliminate the risks posed by the products placed on the market.


Pass4CE - Strumenti Qualità e Misure srl
Via Palermo, 10/12 - 20090 Buccinasco | Tel.: 024409235 | E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
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