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Lecture 18 Regional certification

 

Lecture plan:

1 The functions of the committees CEN certification includes the following tasks:

2 For each member of CEN wishing to participate in the system SENSER is necessary to adopt the following conditions:

3 Define the term "harmonization"

18.1 Certification at the regional level has developed in parallel with the development of certification by international organizations. The need to create regional systems and the development of agreements on specific regions in the fact that the spread of international certification systems is limited, and the fact that in some regions of mutually sharper quality issues of products, development of uniform standards and rules of acceptance of the product.

One characteristic of the systems and arrangements at the regional level is the inclusion of provisions that establish mutual trust in the objectivity and technical competence of the national authorities responsible for the testing of products in their countries , and for this purpose, as a rule , provides for the establishment of close contacts between the national authorities , which are responsible for the implementation of systems and arrangements .

Such contacts may take the form of regularly scheduled meetings, seminars, visits and aim to exchange experience on applicable in the means and methods of quality control , mutual training of experts and trainers in quality.

Most of the regional systems and agreements provide for the recognition of certificates of conformity, if they are issued or obtained in the other contracting countries. An important feature of regional systems and agreements is the possibility of participation of third countries. Although many of them allow the participation of third countries, but the admission of their involvement is quite complex , which is associated with the study of the relevant regional body of rules of certification, its work on the site , including the assessment of technical competence and administrative capacity of the designated national authorities of the candidate countries . In some cases, require the presence of a candidate country for the assessment of specialists from other countries for a certain period of time by the candidate country .

18.2 Certification Association of the European Committee for Standardization (SENSER) comprises the national standards bodies of the European countries. Its activities are carried out under the overall supervision of the European Committee for Standardization ( CEN) .

Rules of Procedure of the Association provides for the establishment of separate certification systems for certain types of products. Management of these systems is distributed among the members of CEN or other organizations of the allocated funds for the purpose of certification works . These systems SENSER based on mutual recognition as members of the certification activities under the conditions specified separately for each system.

The most " authoritative " system , operating within the framework of the Association, is a system of third-party certification to the granting of the right manufacturer for the test results of samples of products and production estimates branding products , certifying compliance with the European standards.



For the purposes of this system SEN register with the conformity mark SEP and its use is protected by law.

At the heart of these systems are based on standard tests of product samples, as well as periodic testing of items directly in the factories, in the field of marketing .

The functioning of such systems , the responsibilities of its members determined the "Rules for creating and managing systems SENSER ", approved by the General Assembly of SEN .

Another type of certification is intended only mutual recognition of test results. This kind of certification has certain advantages in those cases when the European standard does not exist and between national standards are different.

Procedures for the establishment and management of the aforementioned types of certification are identical.

How to start a study on the establishment of the system ( the scheme ) certification for specific products

When proposing the development of a CEN standard for any kind of product CEN member indicates whether the products are subject to certification. This takes into account the following circumstances :

Standard shall regulate the requirements for safety , health , protection of the environment;

guarantee compliance with the requirements of this standard can not be maintained existing systems and forces to create a new system of certification;

In some countries - members of the SEP for this type of product is subject to national certification system.

In the created system may be interested : public institutions and government agencies that can refer to the standard in legislation and regulations , consumer organizations (to protect the interests of consumers by and their information) organized groups of buyers ley or consumers ( such as insurance companies , community organizations, hospitals) ; manufacturers ( in order to overcome the technical barriers to trade ) .

After the consent of the SEP as proposed secretariat of the relevant technical committee CEN organizes the development of the necessary European standards or decide upon the so-called " harmonized document " reflecting the degree of harmonization of national standards requirements . SENSER Committee may appoint expert to take part in the meetings of the relevant technical committee . This expert , in close cooperation with other members of the technical committee is involved in the development of standards to ensure that the purposes of certification, and maintains constant . Contact SENSER Committee with technical committee and the education committee of CEN certification , which must have to develop a system of certification of products. It is necessary to clarify that for practical guidance system ( Scheme ) certification for a specific type of products are created by committees of CEN certification. However, if more than one- third of the members of the committee SENSER oppose , Certification Committee of the product is created.

The functions of the committees CEN certification includes the following tasks:

- make recommendations to the Committee SENSER the suitability standard or standards for certification ;

- technical committees collaborate with SEN , responsible for the development of European standards , which is created on the basis of this or that system , especially in cases where the standards need to be harmonized ;

- make rules of procedure for this type of product , and make the appropriate materials to the Committee SENSER ;

- clarify the rules of procedure in the implementation of the system, and propose amendments to the standards ;

- approval of the Committee to prepare new SENSER clarify the existing rules ;

- monitor the application of the rules of procedure of the participating organizations ;

- in the management system to control the creation and inspection organizations for testing and inspection;

- monitor and promote the development of the system , for which the committee is responsible;

- determine the minimum amount of information needed for the successful implementation of the committee of its functions and to negotiate with its members and with the CEN Central Secretariat to provide such information .

Membership of committees CEN certification is open to all members of the Committee SENSER involved in the system or group of systems for which the committee is responsible for certification . The admission of new members is carried out in accordance with established rules. Each member of the CEN - party system and appoints the members of the delegation. Delegations should consist of a maximum of three people , including the head , to represent the interests of all national authorities involved in the system (manufacturers , consumers , customers , government circles , the centers for testing and monitoring , etc.) .

In consultation with the chairmen of the committees CEN certification for individual meetings by members of the delegation may be increased. Typically , committees CEN certification and related technical committees CEN have common members.

Committee CEN certification forms the secretariat of the system, which is administered by the Central Secretariat SEN . The Central Secretariat is circulating among members of CEN information necessary for the effective ' certification works , publishes lists of members of certification , authorized to work for the certification , lists of companies , firms and other organizations who qualify for the notation of the marks of conformity SEP , as well as pointers and centers testing laboratories .

Decisions of the committees CEN certification accepted not vote, but are based on an agreed point of view of all the participating delegations . If the party were received from any formal objection , the decision is not accepted. Issues on which no agreement was reached , addressed to the Committee for consideration SENSER . The Committee shall meet at least once a year , the records of their activities are presented to the Committee SENSER .

The content of the rules of procedure of certification of individual depends on the content of the standard and the technology of production. These regulations , in particular, be established:

- Requirements for quality assurance in production. These requirements , in particular, pre-determined by the need to designate a person responsible for compliance with the standard of the finished product , the presence of internal documentation, including design specifications , quality assurance programs , "related " standards , changes in product design and manufacturing process , the checks materials , raw materials , components, in-plant controls, including process controls and culling products; regularity of sampling ( sampling) and re-test , control and testing equipment, calibration of instrumentation and equipment, inspection and testing of the finished product ; reworking defective products or liquidation ; keeping records of quality management ;

- Requirements for type testing of product samples . These requirements govern the number of samples for tests , methods of selection, the amount of information that must be submitted by manufacturers , as well as the standard form of the test report ;

- Requirements for acceptance inspection , a report on which is the standard form;

- Requirements for inspection, conducted by certifying the member or members designated by them for testing and monitoring .

- Requirements include : the frequency of site visits , analysis of the quality management system that operates with the manufacturer , frequency and method of sampling for tests , the standard form of the inspection report states acceptance control and a standard reporting form on the baseline test ( if different from the type test reports ) ;

- Requirements for the verification carried out by other certification bodies involved in the system, or their designated for this purpose organizations to test and control;

- Particular requirements for laboratory testing and monitoring , in their assessment and accreditation;

- The amount of fees charged ;

- The conditions for private label products , including the method of notation mark of conformity SEN .

The rules of procedure also give the full designation of the relevant standard ( ie, its name, number and year of publication ) .

Draft rules of procedure are sent simultaneously to the project of European harmonized standards or documents. Their acceptance is usually timed to coincide with the approval of the relevant European standard or harmonized document .

A negative decision on the adoption of the rules of procedure for a specific certification system should not affect the final vote on the draft European standard or harmonized document. These two decisions are made independently .

After the special rules approved for use , they are made available to each interested party.

SENSER Committee oversees the operation of the certification systems. Committees CEN certification work in close cooperation with the Committee SENSER , on the one hand, and with the relevant technical committees of CEN , on the other . They need to maintain a central Secretariat necessary contacts with the technical committees for each problem that arises in the application of standards and , in particular, on the different interpretations of the requirements of the standards , which can manifest itself in the management of the system.

CEN Technical Committee shall inform the committee of certification of its intentions in respect of the amendments , the revised standard, etc.

Basic rules for financing activities in the certification systems to develop and adopt the Committee SENSER .

Each committee CEN certification is responsible for ensuring that all costs of his work, the work of the Secretariat , as well as costs associated with the activities of the certification have been apportioned and paid.

Mark of conformity SEP applies within SENSER to mark conformity with the European standards or guaranteed documents.

For each member of CEN wishing to participate in the system SENSER is necessary to adopt the following conditions:

- adopt the standard rules and procedures for the system in which it is involved , and thus confirm that in his country there are no technical barriers to the sale and use of products in the system ;

- ( as satisfactory certification activities CEN members involved in the system;

- endorse the " Design Guidelines " SENSER management systems ";

- perform the work required for certification of the respective products , including the accreditation of testing centers ;

- carry out work in the country of certification in accordance with the "Rules for creating and managing systems SENSER ";

- bear all the responsibility under the agreement with SEP for certification activities that it conducts .

National certification body involved in the SENSER , should not have the interests of the commercial or financial information relating to the manufacture or sale of certified products. This body should be competent in their field.

As part of certification measures are taken to ensure that the information is not intended to be a broad disclosure, particularly regarding the activity of enterprisement , be kept confidential , unless otherwise stated.

In organizing and carrying out the certification of specific types of products are taken into account : the ISO "Guidelines for Certification Bodies for the recognition of the competence of testing and control" and " Guidelines on the assessment of the technical competence of testing laboratories".

Participating in the system when necessary, can receive technical assistance from the Center for Research and Special Agents .

Participants in the system , with the right to issue licenses for the use of a mark of conformity SEP based on certain standards and rules of procedure of the system , should not grant this right to the use of another mark of conformity (eg national) based on the same standard. The same applies to the products - not accepted the application for conformity mark for products SAINT received from the country from which a participant in the system. However, the party system can provide the right product certification by the manufacturer or any other organization in the country , a member of the SEP which does not participate in the system if it has agreed to comply with all the rules of procedure.

In order to protect the mark of conformity CEN member of the system when it detects cases of improper use of the mark in his country is obliged to immediately inform the offender that if no action is taken to ensure compliance with the certification requirements due , he may be sued in the courts.

If cases of misuse occurred in another country , the party system has to do the same , and if the system is represented by a member of the country's SEP , the responsibility for this issue lies , " and him.

All responsibility for the sign marking SENSER lies on the actors in the system certification.

The basic principle SENSER systems for mutual recognition of test results, standards-based , is that the product test conducted in only one of the participating countries. Test results are sent in the prescribed form to the other members SEP , are involved in the system. Each member of the SEP can then based on the notice to allow the use of its mark of conformity or to include the item in the list of products that meet the requirements of national standards without further testing products in the country.

The system is controlled by a Committee SENSER. The system is open to all members of the SEP.

It is assumed that if the member participates in the CEN system (certification) for the particular product and obstacles judicial or law that would prevent the action of the e his country, no.

When checking the testing laboratories also come from the leadership of the ISO . SENSER Committee may send an expert to conduct a survey of laboratories , the proposed scheme participant to determine their compliance with the principles and guidelines of ISO rules SENSER .

Participants in the system are required to publish reports on the types of test reports on primary and periodic monitoring products in the enterprise and on the other checks in accordance with the "Rules for the creation and management of systems " SENSER "and carry out other activities arising from the rules of procedure.

If you find that a product does not meet a certain standard , all members of the system are informed immediately about it , and indicated the abnormality in order to give the opportunity to take the necessary steps at the national level. Those measures should be taken in the event that when inspecting the control system for the production of non-fulfillment of fact it turns out the relevant requirements.

SENSER committee that monitors the work of the Association for SEP certification establishes and revises the rules SENSER , which are approved by the General Assembly of SEN. The same committee ensures the unity of the principles of systems .

SENSER SENSER and application of the rules , controls the use of a mark of conformity SEP determines the suitability of a particular European standard harmonization document for the purposes of certification , as well as the international standard.

Committee SENSER creates committees CEN certification , coordinates and monitors their activities , including the rules of the individual claims of certification , as well as keep records of who are authorized members of CEN involved in certification systems , to carry out certification activities .

The functions of the secretariat of the Committee SENSER carried out by the Central Secretariat of CEN .

In order to address the Committee SENSER legally valid , must be present at the meeting at least half of the members of the committee. If the meeting an agreement is not reached , the decision is taken by vote. Decisions on voting during the meeting taken by a majority of not less than two-thirds of the votes.

Nationally, the certification systems run by a member of the Association of SENSER SENSER authorized in the country to carry out certification work .

18.3 The aim of the session , as well as the IEC is to create conditions for the development of international trade through the harmonization of technical requirements for the IEP and quality control procedures in the participating countries in order to IEP taken in one country as the relevant requirements of the standards and specifications , could be taken in other countries without re-testing .

As in IEC countries are represented in the session by designated national authorities and national supervisors . Each participating in the country must confirm the creation of the country's National Authority for certification , the national standards body , the national supervisory authority and the national service verification of measuring instruments .

Closed session is the regional certification system , it involves countries - members of the EEC and EFTA countries. Participating in the country are members of the sessions with full voting rights . Country participation in the committee to assess the quality of the IEP provides for two types of membership: full membership and membership in a consultative capacity , depending on the presence of the country's national supervisory authority.

The standards and specifications for the IEP developed by the working groups sessions, based on IEC standards . After the adoption of the session, the Working Group's documents based on them , the participating countries publish national LP , which should be technically equivalent document of the session . Session, set a national standard documentation for the equivalence of the relevant documents IEP meeting.

The certification system Sess controls at three stages : Certify companies, manufacturers , holds a particular type tests on the product type , provides for acceptance testing of products. System session will include either the issuance of certificates for adopted party or marking.

In accordance with the directives of low voltage equipment on the basis of the removal of barriers to trade, security-related standards are harmonized EU. However, the directive does not define what is the harmonized standard . In the case of adoption of a harmonized European standard , this standard is directly applicable in the countries . When a harmonized standard is the basis for the harmonization of technical content with harmonized national standards , there are questions about the completeness of such conformity . For this purpose, the following definitions of terms developed by CENELEC.

Harmonisation - is the elimination of any measurable barrier to trade between Member States as a result of the technical content of national standards. The harmonization of these standards is considered to have been reached when the product made according to the standard of one country may be considered as conforming to another Member State without any changes. The European standard - for this object is also considered the harmonization achieved when all the member countries issued national standards to the same objects that are identical to the European standard .

Harmonization document . Harmonisation is achieved when the countries concerned have introduced a harmonized technical content of the document in their national standards . The lack of a national standard for the given object is not a barrier to trade. However , if a country decides to develop a national standard in this area , it must comply with the harmonized document.

If the relevant national standard provides only a few sizes of products prescribed harmonization document , it is considered that such a restriction is not an impediment to trade.

Work on the mutual recognition of national certificates and test results carried out in the European Free Trade Association (EFTA ) . One of the main goals of the EFTA was the elimination of technical barriers to trade among the member countries of the Association. EFTA countries and strongly supports the use of the results of work of international standardization organizations and , above all , ISO and IEC. In every case where there is an international standard, it is possible, using the EFTA . When in selected fields of technology there are no international standards and there are difficulties in international trade, preparing appropriate ND EFTA or taking steps to develop the necessary documents to the International Organization for Standardization .

It should be recognized that, in connection with the expansion of the Common Market due to some countries - members of EFTA has declined significance of the work on the removal of technical barriers to trade, conducted by the EFTA , but they have not lost their relevance.

Special attention is given to testing of EFTA mutually supplied products and the mutual recognition of test results. In order to eliminate possible discrimination of individual countries in the field of testing and certification of products has produced a number of agreements EFTA countries, members of the Association on the mutual recognition of test results. In addition, measures are being taken to ensure the participation of the countries - members of EFTA in international agreements

 

Control questions :

1. What are the characteristics of systems and agreements at the regional level?

2. The activities SENSER

3. What are the rules and procedures of the Association for the Certification of the European Committee for Standardization SENSER?

4. How to start a study on the establishment of the system (the scheme) certification for specific products?

5. What tasks are included in the functions of the committee on certification SEP?

6. What are the rules of procedures of certification systems in committee CEN?

7. What are the rules for each participant member of the SEP?

8. Define the term "harmonization"

 


Date: 2016-01-03; view: 759


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