3.7.10 Internal audits

1 Aim and purpose

For regular audits, the requirements from the "regulated area" (laws, regulations, etc.) and from the hospital's quality objectives are transferred to checklists. The same procedure can also be used to check requirements for other hospital services. Compliance with the requirements can also be checked by spot checks or by monitoring indicators.

Audit planning, reporting and checklists are set out in an audit manual.

2 Application

According to the specifications of the audit programme in the planned departments and areas.

2.1 General information

Audits can be carried out routinely or on special occasions, such as significant changes in management, in the quality management system, in the service, in the service delivery process or in the follow-up of corrective actions.

With internal audits in particular, care must be taken to ensure that they do not lead to responsibility for achieving the quality objectives being shifted from the operating personnel to the quality assurance unit.

2.2 Audit objectives

An audit can have the following objectives:

• Determining whether or not the elements of the QM system fulfil the specified requirements
• Determining the effectiveness of the QM system with regard to the fulfilment of the defined quality objectives
• Fulfilment of requirements from regulations
• to show the audited organisation ways to improve the QM system.
• The standard gives the following examples:
• Improvement of a management system and its performance
• External requirements, e.g. certification according to a management system standard
• Verification of contractual requirements
• Confidence in the ability of a supplier
• Evaluation of the effectiveness of the management system
• Assessment of the compatibility and alignment of these objectives with the policy of the management system and the overall corporate objectives

1.3 Reasons for an audit

An audit can be carried out in order to

• to obtain an initial assessment of a supplier before concluding a contract;
• To prove that a supplier's QM system fulfils and implements the specified requirements on an ongoing basis
• evaluate its own QM system;
• To prove that the company's own QM system fulfils the specified requirements on an ongoing basis and has been implemented.

The DIN EN ISO 19011 standard lists further aspects that should be considered when defining an audit programme:

a) Management priorities;

b) commercial and other business intentions;

c) Characteristics of processes. products and projects as well as changes to these;

d) Management system requirements;

e) legal and contractual requirements and other requirements to which the organisation is committed;

f) Requirement of supplier assessment:

g) Requirements and expectations of interested parties, including customers;

h) Performance level of the organisation to be audited, as reflected in the occurrence of errors, incidents or customer complaints;

i) Risks for the organisation to be audited;

j) Results from previous audits;

k) Maturity of the management system.

Description of the

Text of the VA 3.7.10 Internal audits

9 Systems

Appendix 1: Communication techniques

Appendix 2: Requirements for the competence of the auditor

Appendix 3: Proof of competence of the auditor

Appendix 4: Audit procedure (flow chart)