§404 完全品質保証システムの評価

Section 2.3 of Annex X summarises the tasks of the Notified Body with respect to the assessment of the full quality assurance system.

The second paragraph of section 2.3 refers to 'the relevant harmonised standard'. The relevant harmonised standard for a full quality assurance system is standard EN ISO 9001. Application of that standard therefore confers a presumption of conformity with the requirements of Annex X, provided that the full quality system ensures the conformity of the products concerned with all the specific requirements of the Machinery Directive (referred to in the standard as 'statutory and regulatory requirements applicable to the product'). However, application of standard EN ISO 9001 and certification against this standard by a certification body are not mandatory.

The Notified Body carrying out the assessment of a full quality assurance system according to Annex X cannot fully rely on an existing certification of the system according to EN ISO 9001, but it is up to the Notified Body to determine the extent of the further assessment required.

The third and fourth paragraphs of section 2.3 refer to the audit of the full quality system. The audit team must include at least one auditor who is an expert in the assessment of the technology of the categories of machinery concerned by the full quality assurance system. The number of auditors needed depends on the scope and complexity of the design and manufacturing process covered by the full quality assurance system. For example, if the system covers several categories of of this standard is published in the OJEU in the framework of the Decision setting out the conformity assessment modules – see: Commission communication in the framework of the implementation of the Regulation (EC) No 765/2008 of the European Parliament and of the Council, Decision 768/2008/EC of the European Parliament and of the Council, Regulation (EC) No 761/2001 of the European Parliament and of the Council (Publication of titles and references of harmonised standards). OJ C 136, 16.6.2009, p. 8.

machinery with different technology or machinery incorporating complex electronic control systems, more than one technical expert may be needed.

The third paragraph of section 2.3 states that the audit shall include an inspection to be carried out at the manufacturer's premises. Where the design, manufacture, inspection and testing of the machinery are carried out at more than one site, the necessary inspections must be carried out by or under the responsibility of the Notified Body at all sites relevant for ensuring the conformity of the product with the applicable EHSRs, including the sites of subsidiaries of the manufacturer or of significant sub-contractors – see §395: comments on section 2.1 of Annex X. In this respect, manufacturers established within the EU and outside the EU must receive the same treatment.

The duration of the audit shall be determined by the Notified Body taking into account of factors such as, for example, the number of manufacturing sites, the complexity of the manufacturing process, how much work is sub-contracted, the number, variety and complexity of the types of machinery produced and the volume of production. Guidance drawn up by the International Accreditation Forum may be used as a basis for determining a minimum duration for the audit.

The third sentence of the third paragraph of section 2.3 also refers to the review of the technical file(s) submitted with the application for assessment of the full quality assurance system according to the third indent of section 2.1.

The review of the sample technical file(s) is one of the checks to be carried out by the Notified Body to ensure that the manufacturer's full quality assurance system is adequate. The review of technical file(s) to be carried out in the framework of the assessment of a full quality assurance system is similar to that required for EC type- examination, but without a detailed inspection of the machinery – see §398: comments on section 3.1 of Annex IX.

Where harmonised standards are applied for the design of the machinery, the Notified Body shall check that the appropriate standards have been chosen, that the most recent versions are available and that the manufacturer monitors the development of the relevant standards. Where other technical design specifications are applied, the Notified Body shall check that they are justified by the risk assessment and fulfil the applicable EHSRs, taking account of the state of the art.

The review of the technical file also helps the Notified Body to identify the other aspects of the full quality assurance system that should be inspected. During the audit, the Notified Body shall check that the technical files for other models of machinery are compiled using the same approach as that used for the sample technical file(s) submitted with the application.

The fourth paragraph of section 2.3 refers to the notification of the decision of approval of a full quality assurance system. The approval decision that shall be notified to the applicant following the audit shall be accompanied by or refer to a written audit report. The approval decision shall clearly specify the scope of the approval, indicating the categories of Annex IV machinery covered and the addresses of the manufacturing sites that have been inspected. Any particular

Operating Assessment and Certification/registration of Quality Systems, Issue 3 (IAF GD 2: 2003) - Annex 2: Auditor Time: http://elsmar.com/pdf_files/IAF-GD2-2003_Guide_62_Issue_3_Pub.pdf.

limitations to which the approval is subject shall be mentioned. The decision shall indicate its date of issue and date of expiry.

If the Notified Body decides not to approve the full quality assurance system, it shall inform the applicant of its decision, giving the detailed reasons and indicating the procedure for appealing against the decision – see §135: comments on Article 14 (6). In that case, the audit report shall contain sufficient information and explanation to enable the manufacturer to identify the shortcomings of his system and take the appropriate corrective measures prior to requesting a further assessment visit.