Global Approach in Brief

by admin last modified 2006-03-09 16:30

Internationally Recognised Conformity Assessment and Consumer Protection System in Libya

In order to facilitate trade within the European market and here in particular the free movement of goods, one of the most important requirements was in the past the harmonization of certification and accreditation. After all, creating uniform principles for the approval of products throughout EU territory was tantamount to harmonizing the rules of competition and to remove still existing non-tariff trade barriers.

The goal of the European certification policy was to facilitate the mutual recognition of tests and certificates and therefore to avoid multiple assessments and the costs incurred thereby. The certification policy was, on the one hand, part of the harmonization policy, i.e. of EU legal harmonization with the help of harmonization directives which also stipulated uniform certification procedures, in addition to requirements for product properties, while, on the other hand, Europe’s certification policy went beyond harmonization, since it also covered the non-regulatory area where there are no legal regulations.

The basis of the EU harmonization policy was the New Approach that was adopted in 1985, which states that EU directives - contrary to earlier practice - should no longer contain all technical details but be limited to the essential requirements, leaving the detailed provisions to European standards. That Council Resolution already referred to issues of certification in the chapter on "Certification of Conformity" (with the requirements of the respective directive). At that time, there was general awareness of the fact that further efforts and decisions would be necessary. The Council therefore called upon the Commission to supplement the New Approach by providing measures for conformity assessments and asked to give priority attention to this matter by stepping up relevant work.

In 1989, the Commission then published a paper entitled "A Global Concept for Certification and Testing - Instruments to Guarantee the Quality of Industrial Products", which served as a basis for two Council resolutions: The resolution on a global approach to conformity assessment (Global Approach) of 21 December 1989, and - one year later - the decision of 13 December 1990, "concerning the modules for the various phases of the conformity assessment procedures which are intended to be used in the technical harmonization directives" (Modular Approach).

What are the characteristics of the Global Approach? The objective of the Global Approach - which was given this name since it covers both the regulatory and the non-regulatory sector - is to facilitate the mutual recognition of examinations and certificates, also outside the harmonized sector.

The Commission underlined that confidence is the essential prerequisite for the recognition of examinations and certificates, i.e. confidence in the quality of the products, in the quality of competence of the manufacturer, but also in the quality of the testing and certifying bodies, and last, but not least, in those bodies that accredit testing and certifying bodies. The procedures proving conformity serve the primary purpose of creating and strengthening the confidence of the involved operators in the product, i.e. in the goods and services that can be found on the market.

The product standards, which manufacturers are called upon to apply, are the methods that should create and/or strengthen that confidence. After all, persons manufacturing their goods according to European standards can expect that the buyer/client will assume that the products meet the material requirements of the EU directives.

The methods also include the introduction and certification of quality management systems, if possible in compliance with the international series of standards ISO 9000 and last, but not least, the accreditation of examining and certifying bodies in compliance with international standards.

Furthermore, the Commission proposes, in this connection, to create a European infrastructure for certification.

 

Mutual recognition of Testing, Certification and Accreditation

Mutual recognition by two partners or multilateral recognition through several partners will only be possible where mutual trust exists, where transparency exists, and where adequate, regular exchange of information takes place.

Further prerequisites are the same technological level, the use of the same technological standards and process procedures as well as the same technical understanding.

In order to fulfil these prerequisites, many international organizations were founded in the area of accreditation, certification and testing which in the extended sense all have the following goals:

 

        to facilitate international trade,
        to harmonize accreditation, testing, and certification processes
        to mutually recognize Accreditations, certificates as well as testing
        and calibration results
        to promote quality in testing.
One can imagine that neither testing laboratories nor certification offices require mutual recognition of their results in the forefront.

It holds that the more tests and certifications are needed, the safer their balances and their future. More than likely, they are essentially more interested in recognition of Accreditations as this offers an accredited laboratory the possibility of offering its services unrestricted on the European market. The Accreditation body itself promises itself great advantages from mutual recognition of Accreditations since its Accreditation receives more weight.  The manufacturers and customers are certainly interested in mutual recognition of test results and certificates, since they promise better prices for products and services.

Mutual recognition always assumes that is known exactly what should be recognized.  This means that a process of information, enlightenment and mutual arrangements must precede every recognition.

Mutual recognition is easy and quick to achieve on a bilateral level on the basis of mutual trust.  Bilateral treaties have been made in the past between some accreditation systems.

Such recognition is only of real value to a common European market, however, when it effects broad circles, involves many member states and the recognition is made known correspondingly.

This is the reason the European and international organizations have especially sought paths to make multilateral treaties for mutual recognition of accreditations. They should offer a possibility to achieve the recognition of test results and certificates concerning mutual recognition of Accreditations. This ensures the commensurate value of the documents of the competence and the monitoring of testing laboratories.

A multilateral treaty between accreditation offices assumes that determined relationships and criteria of cooperation are listed and mutually accepted.  This occurs normally through documents pertaining to understanding, e.g., a Memorandum of Understanding (MoU).  Among others ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum) have created such documents and have had them signed by their members.  The rights and duties of the members, of the associated members and observers are described as well as the tasks of the various committees and secretary's offices.  A mixed group of members who are signatories to the MoU see to a multilateral treaty.

Before such a multilateral treaties (MLA) can be signed, the accreditation offices must build up mutual trust in their manner of work and the execution of the accreditation.  This happens in a special process of building trust. Not only the accreditation systems have to build trust in their activity among themselves.

Along with mutual recognition, the next question is:

Who accredits the Accreditation bodies?

 Who sees to it that the accreditation offices work according to standards, and who tests this?

Along with the concept of the multilateral treaty, the accreditation systems and European organizations have attempted to give an answer to this question.

The Accreditation bodies close a MLA in which the process is set down how and under what conditions one can become a party to this treaty.

 The following steps are necessary:

 

§          exchange of experience in appropriate professional circles and/ or
            organizations (e.g. ILAC, IAF, EA, EUROLAB, EURACHEM, ISO etc.).

§          consultation and harmonization of the accreditation criteria, testing and
            certification processes,

§         development of a process for entry as a party to the "Multilateral
           Treaty"(MLA),

§         mutual evaluation for the testing and building of trust as well as for the
           preparation of admission into the MLA.

 

In order to be able to enter the MLA, requirements exist such as the following:

§         certain experiences must exist in the accreditation,

§         uniform accreditation criteria must be used,

§         the comparative measurements between the Accreditation bodies and
           laboratories must have proof of an identical technical basis,

§         participation in an evaluation process must take place, i.e., the Accreditation
           bodies test one another mutually through a commission of this organization.

 

It is important that not only the Accreditation bodies alone make an intensive contribution in the determination of the accreditation criteria and also the harmonized test procedure, but rather the cooperation of the laboratories here too must be ensured.

 

What does the Global Approach mean for Libya?

 Although the Global Approach was mainly defined to facilitate trade within Europe, nowadays this system is world-wide accepted and many countries and regions outside of Europe had adopted this approach to national legislation. On national level, the tools like testing, certification and accreditation are main elements of a national quality infrastructure needed for a functional consumer protection system, which is important to protect local citizens and to guarantee a minimum of safety in all industrial areas. Therefore the Global Approach is very important to improve national safety and to support international trade.

As Libya is an important trading partner world-wide and is well participating in global trading, various products are exported as well as imported day by day. In order to support Libyan companies as well as to guarantee a minimum of safety of incoming products towards national citizens, Libya also needs a national system of conformity assessment and consumer protection, which is harmonized according to international requirements and which is also internationally accepted. The full membership in WTO is one of the priority targets at a first stage. Later on when the national system is established and harmonized, the full membership in relevant associations and networks, like ILAC or IAF is aimed at.

The Libyan government recognized the importance of implementing a national system of Conformity Assessment and Consumer Protection. Besides of starting the accession process to WTO / TBT first actions took place in the recent past and considerable efforts are planned for the near future to establish such an internationally harmonized system and to improve the national quality infrastructure. In the future laboratories, certification and inspection bodies, market surveillance institutions as well as the LNCSM as national Accreditation body will cooperate intensively and act as main player in such a system.  It is the clear political wish of the responsible national authorities to introduce Libya as a peer partner in the Conformity Assessment community in the near future (Figure 2).

 

The principal guidelines for the affixing and use of the CE marking

 

It is the aim of the ‘Global Approach for Certification and Testing’ to ensure conformity of products with guidelines through defined procedures and to make this recognisable for everyone through a CE-marking.

 It is necessary for the CE-marking of a product by the manufacturer or by someone who puts this product into circulation that they verify the conformity of the products by means of a statement and in addition prove that the product has undergone a conformity assessment by a body registered for the relevant guideline. The EC guidelines lay down which conformity assessment procedure may be chosen and when a registered body has to be included.

The CE marking symbolizes conformity to all the obligations incumbent on manufacturers for the product by virtue of the Community directives for its affixing.

Thus, such conformity is not limited to the essential requirements relating to safety, public health, consumer protection, etc., as certain directives may impose specific obligations not necessarily forming part of the essential requirements.

The CE marking affixed to industrial products symbolizes the fact that the natural or legal person having affixed or having been responsible for the affixing of the said marking has verified that the product conforms to all the Community total harmonization provisions which apply to it and has been the subject of the appropriate conformity evaluation procedures.

Where the industrial products are subject to other directives concerning other aspects and which also provide for the affixing of the CE marking, the latter must indicate that the products are also presumed to conform to the provisions of those other directives.

However, where one or more of these directives allow the manufacturer, during a transitional period, to choose which arrangements to apply, the CE marking indicates conformity to the provisions only of those directives applied by the manufacturer. In this case, particulars of the directive applied, as published in the "Official Journal of the European Communities", must be given in the documents, notices or instructions accompanying the products or, where appropriate, on the data plate.

Any industrial product covered by the technical harmonization directives based on the principles of the global approach must bear the CE marking, except where the specific directives provide otherwise; such exceptions constitute derogations not from the marking requirement but from the administrative procedures for conformity evaluation, which may in certain cases be considered too cumbersome. Appropriate grounds must accordingly be given for any exception to or derogation from the marking requirement.

The CE marking is the only marking which certifies that the industrial products conform to the directives based on the principles of the global approach.

Member States must refrain from introducing into their national legislations any reference to a conformity marking other than the CE marking in connection with conformity to all the provisions contained in the directives on the CE marking.