3.7.10 Internal audits

1 Aim and purpose

The audit programme defines:

• Objectives for the audit programme

Determination of the effectiveness of the management system of the organisation to be audited. Proof that the processes in parts of the organisation or the entire organisation meet the requirements of one or more standards for QM systems.

Uncover hidden weaknesses, identify the need for correction, assess the reliability of the organisation, evaluate the degree of penetration of the organisation by the QM system.

If necessary, a process or product audit can also be combined with the internal audit.

• Selection of the audit team;

Assignment of one or more persons to manage and direct the audit programme.

• resources, including travelling time and accommodation;

Determination of the information and resources required to organise and carry out the audits effectively and economically within the specified time frame.

• Scope/number/types/duration/locations/schedule of audits;
• Application of audit criteria;
• Development of audit methods;
• Confidentiality. Information security. Occupational health and safety and other similar aspects.
• Implementation and monitoring of the audit programme

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 Scope of application

The audit programmes are applied to system, process, product and service audits carried out on behalf of the IQ-Institut.

2.1 General information

Audits can be carried out routinely or for special reasons, 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 result in responsibility for achieving 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
• Determination of 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 of improving 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

2.3 Reasons for an audit

An audit can be carried out in order to

• obtain an initial assessment of a supplier before concluding a contract
• demonstrate that the supplier's QM system fulfils the specified requirements on an ongoing basis and that it has been implemented
• evaluate your own QM system
• demonstrate that its own QM system fulfils the specified requirements on an ongoing basis and that it 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 and changes to these;
d) management system requirements;
e) legal and contractual requirements and other requirements to which the organisation is committed;
f) supplier assessment requirements:
(g) requirements and expectations of interested parties. including customers;
h) Performance level of the organisation to be audited as reflected in the occurrence of nonconformities, incidents or customer complaints;
i) Risks to the organisation being audited;
j) Results from previous audits;
k) Maturity level of the management system being audited.

Description of the

Documentation

Resources

Responsibility and qualification

Notes and comments

Applicable documents

Literature

Terms

9 Systems