Common use of PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES Clause in Contracts

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES. The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community’s requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia’s requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives and be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: (a) Inspection bodies operating in accordance with the requirements of EN 45004 or ISO Guide 39, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. (b) Testing laboratories operating according to the requirements of EN 45001 or ISO Guide 25, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement: (a) Testing laboratories: — accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement on Calibration and Testing, or — recognised within the IECE CB scheme, or — able to demonstrate competence under an equivalent accreditation scheme. (b) Certification bodies — accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement on Certification — membership of the IECEE CB scheme — accredited by an accreditation body with which ▇▇▇-ANZ has a mutual recognition agreement, or — able to demonstrate competence under an equivalent accreditation scheme.

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES. The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community’s requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia’s requirements The conformity assessment bodies listed in Section II will meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives directives, and be are designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: In accordance with the specific requirements set out in the legislation, regulations and administrative provisions listed in Section I, and where these make compliance with Australian standards for plant mandatory, the conformity assessment bodies listed in Section II are designated by the designating authorities specified in Section III in accordance with the following criteria: — Design verification for compliance with technical standards may not be required under all legislation listed in Section I. (a) For the purpose of Directive 89/392/EEC of 14 June 1989 on the approximation of the laws of the Member States relating to machinery: Inspection bodies operating in accordance with to the requirements of EN 45004 or ISO Guide 39, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. — If design verification is required it must be conducted by a design verifier who has not been involved in the machinery design and who has acquired through training, qualification, or experience, or a combination of these, the knowledge and skills enabling that person to perform this task. Where the designer and design verifier are employed or engaged by the same person the whole of the design process must, if the legislation requires, operate: (ba) Testing laboratories within a quality system meeting requirements of ISO 9001 and be certified by a quality systems certification body operating according to the requirements of EN 45001 or ISO Guide 2562 or EN 45012, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement: (a) Testing laboratories: — accredited by an accreditation bodies body which are signatories is a signatory to the European cooperation for Accreditation (EA) Multilateral Agreement on Calibration and TestingCertification, or — recognised within the IECE CB scheme, or — able to demonstrate competence under an equivalent accreditation scheme. (b) Certification bodies — accredited by accreditation bodies which are signatories to the European cooperation for Accreditation (EA) Multilateral Agreement on Certification — membership of the IECEE CB scheme — accredited by an accreditation body with which ▇▇▇-ANZ has a mutual recognition agreement, and (b) in conformity with EN 45004 or — able ISO Guide 39 and accredited by an accreditation body meeting the requirements of ISO Guide 58 or EN 45002/3. For Victoria there are no mandatory conformity assessment requirements under the legislation listed in Section I other than that the design must be verified by someone who did not participate in the design of the plant subject to demonstrate competence under an equivalent accreditation schemedesign verification.

PROCEDURES FOR DESIGNATING CONFORMITY ASSESSMENT BODIES. The procedures to be followed by Australia in designating conformity assessment bodies to assess products against the European Community’s requirements The procedures to be followed by the European Community in designating conformity assessment bodies to assess products against Australia’s requirements The conformity assessment bodies listed in Section II will must meet the requirements of the Directives listed in Section I, taking into account Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives and be designated on the basis of the procedures defined in the Annex to the Agreement. This may be demonstrated through: (a) — Product certification bodies operating according to the requirements of EN 45011 or ISO Guides 28 and 40. — Quality system certification bodies operating according to the requirements of EN 45012 or ISO Guide 62. — Inspection bodies operating in accordance with according to the requirements of EN 45004 or ISO Guide 39, and either: — accredited by NATA, or — able to demonstrate competence by other means . Conformity assessment bodies will be designated in accordance with Sections A and B of the Annex to the Agreement. (b) Testing laboratories operating according to the requirements of EN 45001 or ISO Guide 25, and either: — accredited by NATA, or — able to demonstrate competence by other means in accordance with Sections A and B of the Annex to the Agreement. The following procedures are deemed to be consistent with the procedures set out in the Annex to the Agreement: (a) Testing laboratories: — accredited by accreditation . Conformity assessment bodies which are signatories Notified Bodies under Annex XI of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices or Annex VIII of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medicinal devices in conjunction with Council Decision 93/465/EEC of 22 July 1993 concerning the European cooperation modules for Accreditation (EA) Multilateral Agreement on Calibration the various phases of the conformity assessment procedures and Testingthe rules for the affixing and use of the CE conformity marking, or — recognised within the IECE CB scheme, or — able to demonstrate competence under an equivalent accreditation scheme. (b) Certification bodies — accredited by accreditation bodies which are signatories intended to be used in the European cooperation technical harmonisation directives shall be presumed competent to carry out conformity assessment to Australian requirements for Accreditation (EA) Multilateral Agreement on Certification — membership of the IECEE CB scheme — accredited those devices and procedures for which they have been correspondingly notified by an accreditation body with which ▇▇▇-ANZ has a mutual recognition agreement, or — able to demonstrate competence under an equivalent accreditation schemetheir competent authorities in Europe.