DGUV Grundsatz 300-004 - Rules of Procedure for Testing and Certification carrie...

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Abschnitt 12, 12 Auditing, Certification and Monitoring of a...
Abschnitt 12
Rules of Procedure for Testing and Certification carried out by Testing and Certification Bodies in DGUV Test (DGUV Grundsatz 300-004)
Titel: Rules of Procedure for Testing and Certification carried out by Testing and Certification Bodies in DGUV Test (DGUV Grundsatz 300-004)
Normgeber: Bund
Amtliche Abkürzung: DGUV Grundsatz 300-004
Gliederungs-Nr.: [keine Angabe]
Normtyp: Satzung

Abschnitt 12 – 12 Auditing, Certification and Monitoring of a Quality Management System

12.1 The Testing and Certification Body audits and certifies a QM System based on:

  1. a.

    EU legislation (e. g. comprehensive quality assurances under the Machinery Directive, Directive for Personal Protective Equipment or Marine Equipment Directive),

  2. b.

    the DIN EN ISO 9001 or

  3. c.

    other normative documents/legal bases.

12.2 Sections 12.3 to 12.7 apply, under EU legislation, to a QM System only insofar as they do not conflict with the requirements of corresponding EU legislation.

12.3 The Applicant shall make available to the Testing and Certification Body upon request the necessary documents, in particular the QM manual, as well as documented procedures, operating instruction and other applicable documents.

12.4 The Testing and Certification Body conducts QM System audits in the concerned company.

12.5 The Testing and Certification Body shall evaluate the QM System in accordance with the certification criteria and shall issue a certificate in the case of a positive result. The conformity of the QM System with the relevant EU legislation, the DIN EN ISO 9001 or other normative documents/legal bases shall be stated on the certificate.

12.6 A negative decision shall be communicated to the Applicant, stating the reasons.

12.7 The holder of the certificate is to record all complaints that might be causally related to the certified QM System, as well as the actions hereupon taken. The holder shall make these records available to the Testing and Certification Body for inspection.

12.8 To check the conformity of the QM System in use with the certified QM System, the Testing and Certification Body shall conduct annual audits of the QM System. The certificate-holder shall ensure that the auditors have access to the appropriate areas of operation during normal business hours and that the necessary documents are made available to the auditors. In areas governed by law, the Testing and Certification Body has the right in justified cases to conduct additional and unannounced audits.

The costs of monitoring activities are borne by the Applicant. The amount is determined by the Fee Schedule in force at the time of these activities.

12.9 The certificate-holder shall notify the Testing and Certification Body in writing of the following:

  • change of name,

  • change of address and/or location,

  • change of legal form,

  • substantial changes to the QM System and processes,

  • change of owner,

  • cessation of business,

  • bankruptcy.

12.10 The choice and number of auditors to be employed falls to the Testing and Certification Body. The Testing and Certification Body shall name the auditors and shall make background information available to the auditors and to the Applicant upon request.

The Applicant is entitled to reject the auditors proposed by the Testing and Certification Body. In this case, the Testing and Certification Body shall submit a new proposal. The Applicant has the right of rejection only once at the start of the preparation and monitoring phases. If an auditor drops out immediately before or during an audit, the Testing and Certification Body shall agree with the Applicant on how to proceed.