Accreditation Of Testing Laboratory For Medical Graz For The Certification Of Management Systems

Original Language Title: Akkreditierung der Prüfstelle für Medizinprodukte Graz zur Zertifizierung von Managementsystemen

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227. Regulation of the Federal Minister of economy, family and youth of the accreditation of the testing laboratory for medical Graz for the certification of management systems

On the basis of § 17 para 1 and the section 38 Z 1 of the accreditation Act, Federal Law Gazette No. 468/1992, as last amended by Federal Law Gazette I no. 85/2002, is in agreement with the Federal Minister of health prescribed:

§ 1. The testing laboratory for medical Graz 8010 Graz, Kopernikusgasse 24,-based is accredited as authority that certified management systems (in accordance with ÖVE/ÖNORM EN ISO/IEC 170211).

§ 2. The certification authority includes the certification of management systems in following areas 1 quality management systems according to ÖNORM EN ISO 90012 according to the extent specified in the annex, 2. quality management systems for medical products according to ÖNORM EN ISO 134853, as amended, Austria implemented 3. within the scope of the EU Directive 93/42/eec4 BGBl. No. 657/19965 amended product / product group



Conformity assessment procedures



Active medical devices

(including their accessories)



Annex II (full quality assurance system)

Annex V (quality assurance production)

Annex VI (quality product)



4. within the scope of Directive 90/385/eec6 as amended, Austria implemented by Federal Law Gazette No. 657/1996 amended product / product group



Conformity assessment procedures



Active implantable

Medical devices

(including their accessories)



Annex 2 (full quality assurance system)

Annex 5 (quality assurance production)



§ 3. The certification authority shall apply to those areas in which the Federal Government for the legislation and execution is responsible, provided that the federal laws governing these areas contain no provisions corresponding to the provisions of the Act of accreditation through the accreditation of such bodies.

Mitterlehner