9 rating
A. Internal audit
To ensure compliance of the documentation with practice and standards, an internal audit is planned, carried out and documented annually by the management and the QMB. The audits are also used to:
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to check whether the corrective measures taken bring the desired success
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to check the QMS for its conformity to standards
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to see whether the procedures used in the company are efficient and effective
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to provide the management with results regarding the effectiveness of the QMS.
The QMB appoints an external auditor with sufficient professional qualification to carry out the internal audit. The QMB creates the audit plan and ensures the availability of the auditors to carry out the audits. The employees are informed of the audit plan after it has been approved by the GF.
The internal audit process is described in the audit process .
The management evaluation is based on the results of the audits. They are used to evaluate the effectiveness of the QMS.
In the event of serious deviations from the norm, a date for a follow-up audit will be set and carried out. Not only the deviations are checked, but the entire scope of the previous audit. The results are recorded again in the audit report and handled as above.
Co-Applicable Documents:
B. Management review
The management must evaluate the quality management system of the organization at planned intervals in order to ensure its continued suitability, appropriateness and effectiveness as well as its alignment with the strategic direction of the organization.
The corporate goals are provided with measurable specifications (parameters, yardstick) and, analogous to the organizational chart, broken down to the lowest level of the organization. They are communicated to the employees and posted and followed up in the company.
The management evaluates and assesses the status and effectiveness of the management system at least once a year by means of a management review based on the results of the internal audits, evaluation of reports, training courses carried out and their effectiveness, corrective and preventive measures introduced and other information.
The management's assessment of the management system is documented and stored by them.
The management is responsible for planning and carrying out the management review. She is supported by the quality management officer in planning the review, in determining the participating employees, in preparing the review report and in initiating and monitoring corrective measures.
The following are used as input data for the management evaluation:
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Audit results
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Feedback from customers
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Process performance and product conformity
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Status of preventive and corrective actions
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Follow-up actions from previous management reviews
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Changes that could affect the quality management system and
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Recommendations for improvement
The results are summarized in a review report. This also contains conclusions and recommendations that were reached as a result of the review and which
can be used as a basis for course corrections of the management system. Audit plans, audit reports and records of corrective or preventive measures carried out are documented by the management representative. The results of the management review must end in concrete decisions and measures on opportunities for continuous improvement and any changes affecting the QM system. The associated form is used to structure the management review.
The following are used as output data for the management evaluation:
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Evaluation results from the management processes (review)
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Feedback from the root cause analyzes
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Deviations and repetition errors
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Service improvements related to customer requirements
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Determination of training effectiveness, needs and resources
Co-Applicable Documents:
| version | Creation: 04.03.2018 | Examination: 09.05.2022 | Approval: 12.05.2022 |
| 1.3 | Alexander Kohl, external | Kavin SOMASUNDARAM, QMB | Gerald Unger, CEO |