Accreditation role in the regulated area

Having considered fundamental criteria specified in the Directives, state administrative bodies responsible for conformity assessment nominations, stipulate the procedure according to which the bodies in the selecting process should be preassessed so the criteria and procedures include the following assessment:

1. Technical capabilities
2. Capability for implementing the required conformity assessment procedure
3. Proof of adequate independency, impartiality and integrity
4. Security of personnel and equipment

• Proof of technical competitiveness in respect with the assessed products in regard with the technology production

1. Proving and maintaining of necessary level of confidence
2. Accepting obligation for implementing regular competence surveillance and resources
3. Ready to cooperate with competent supervisory bodies on the market
4. Ready to cooperate in European and national standardization

• Liabilities insurance

In the general approach documentation , Council Resolution of 21.12.1989, Council Decision 93/465/EEC strongly advised accreditation bodies for conformity assessment as the best way for assessing and proving their competence.

General approach - Council Decision of 22 July 1993 in respect with modules for different conformity assessment procedures and regulations for implementation and use of CE conformity assessment used for directives on technical harmonization (93/465/EEC, Official magazine EZ br. L 220, August 1993.)

It is determined that competence may be proved in other ways, which should be documented.

Conformity assessment in the regulated area in the Republic of Croatia

Accreditation or the conformity assessment procedure is a prerequisite for nomination of a relevant conformity assessment administrative body.

In the regulations from the scope of New and Sector (old approach) issued by authoritative ministries stipulate that the bodies implementing conformity assessment as per regulations should comply with the specific standard requirements as per standard series EN 45 000 or EN ISO/IEC 17 000. Also, the role of the accreditation agency for assessing capabilities of bodies, as per regulations, has been determined through:

• Certificate on accreditation or
• Other assessing and certification of competence of conformity assessment bodies

Croatian Accreditation Agency has so far issued many Certificates about professional and technical competence to laboratories that implement testing in specific professional areas (vine analysis, ionizing emission protection) in accordance with the regulation requests. Certificate on professional and technical competence is a prerequisite for a laboratory to be certified by a competent Ministry.