Abschnitt 3.4 - 3.4 Auditing, Certification and Monitoring of a Quality Management System
The Testing and Certification Body audits and certifies a QM system based on
- a.
EU legislation (e. g. comprehensive quality assurance under the Machinery Directive, Directive for Personal Protective Equipment or Marine Equipment Directive),
- b.
DIN EN ISO 9001 as amended at any time, or
- c.
other normative documents/legal provisions
The following provisions apply to a QM system based on EU legislation only insofar as they do not conflict with the requirements of the relevant EU legislation:
The Applicant shall make the necessary documents available to the Testing and Certification Body, in particular the QM manual, and upon request procedural and operating instructions as well as other relevant documents.
The Testing and Certification Body shall conduct audits of the QM system in the relevant enterprise.
The Testing and Certification Body shall evaluate the QM system in accordance with the certification criteria and in case of a positive result shall issue a certificate confirming the conformity of the QM system with the relevant EU legislation, DIN EN ISO 9001 as in force at any time and other normative documents / legal provisions.
A negative decision stating the relevant reasons shall be communicated to the Applicant.
The Certificate Holder shall promptly record all complaints that might be causally connected to the certified QM system, as well as the actions hereupon taken, and shall promptly make these records available to the Testing and Certification Body for inspection.
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 relevant 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 is entitled to conduct additional and unannounced audits in justified cases.
The costs of monitoring shall be borne by the Applicant. The amount shall be determined by the Fee Schedule in force at the time the monitoring takes place.
The Certificate Holder shall inform the Testing and Certification Body at least in text form about changes that could impair its ability to satisfy the certification requirements. These are, in particular:
change in the name
change in the address or contact address
change in the legal form
change of proprietor
closing down of business
insolvency
Likewise, should the Certificate Holder establish that it no longer satisfies the certification requirements, it shall inform the Testing and Certification Body without undue delay.
The Testing and Certification Body shall be responsible for the selection, number and appointment of auditors to be deployed. On request it shall provide background information on the selected persons to the Applicant. The Applicant is entitled to reject the persons proposed by the Testing and Certification Body. In that case the Testing and Certification Body shall submit a new proposal. The Applicant’s right of rejection may be exercised once at the start of the preparation and the monitoring phase respectively. 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.