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1 Purpose and objective

Definition of the scope of application of the QM system by determining the limits and the extent of applicability.

2 Scope of application

The entire QM system and relationship to subsystems

3 Description

3.1 General information

The scope must take into account the external and internal issues identified in the presentation of the organisation's context. The relevant interested parties must be named.

3.2 The geographical scope of application (locations of the facility)

Presentation of the locations / properties / facilities that are covered by the QM system and are under the responsibility of the organisation.

These can be (non-exhaustive list)

- Clinics, institutes such as radiology, laboratory

- MVZ

- Attending physicians

- Affiliated practices

- Data centres, cloud service providers

- Internal or external services such as pharmacy, typing services, security service, sterilisation, bed preparation (see chapter 3.6 Services)

3.3 Type and scope of services (processes)

Specialised disciplines, individual services. They are listed in VA 2.1.02

The scope of diagnostic, therapeutic and nursing services is presented in the quality report.

Operation of training centres, teaching facilities

Carrying out research

3.4 Technical infrastructure used

Which technical departments are included in the QM system? These may include: the technology for the ventilation and air conditioning systems, water treatment, waste disposal, administration of medical products, room cleaning and others (see also 3.6 Services).

The exclusion of requirements as not applicable must be justified for the entire scope of application.

4 Resources

5 Risks and opportunities

Requirements that affect the organisation's ability or responsibility to ensure the conformity of its products and services and to increase customer satisfaction are misjudged and not taken into account.

Changes to the area of application are not sufficiently taken into account, so that they are no longer covered by the QM system.

6 Documentation

Documented information required

Site plan; floor plans; organisational charts showing staff allocation and responsibilities; brief description of the service in section 3.6

Changes to the scope of application may affect the validity of the certificate. They must therefore be reported to the CAB.

7 Responsibilities

Top management

8 Notes and comments

Great care must be taken when excluding requirements. From a critical point of view, almost all requirements must be met in order to demonstrate the organisation's ability to provide compliant services.

9 Applicable documents

9.1 Literature, regulations

DIN EN ISO 9001:2015 DIN EN 15224:2017 Tz 4.3

9.2 Terms

10 plants