{"id":9343,"date":"2024-12-10T19:06:57","date_gmt":"2024-12-10T18:06:57","guid":{"rendered":"https:\/\/extali.eu\/docs\/gute-hospitalpraxis\/1-kontext-des-krankenhauses\/1-1-auftrag-und-vision\/1-1-08-anwendungsbereich-des-qm-systems\/"},"modified":"2025-11-11T11:05:04","modified_gmt":"2025-11-11T10:05:04","slug":"1-1-08-scope-of-application-of-the-qm-system","status":"publish","type":"docs","link":"https:\/\/gutehospitalpraxis.de\/en\/handbuch\/1-kontext-de-krankenhauses\/1-1-auftrag-und-vision\/1-1-08-anwendungsbereich-des-qm-systems\/","title":{"rendered":"1.1.08 Scope of application of the QM system"},"content":{"rendered":"

Download process instruction<\/a><\/p>\n\n\n\n

1 Purpose and objective<\/h1>\n\n\n\n

Definition of the scope of application of the QM system by determining the limits and the extent of applicability.<\/p>\n\n\n\n

2 Scope of application<\/h1>\n\n\n\n

The entire QM system and relationship to subsystems<\/p>\n\n\n\n

3 Description<\/h1>\n\n\n\n

3.1 General information<\/h2>\n\n\n\n

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.<\/p>\n\n\n\n

3.2 The geographical scope of application (locations of the facility)<\/h2>\n\n\n\n

Presentation of the locations \/ properties \/ facilities that are covered by the QM system and are under the responsibility of the organisation.<\/p>\n\n\n\n

These can be (non-exhaustive list)<\/p>\n\n\n\n

- Clinics, institutes such as radiology, laboratory<\/p>\n\n\n\n

- MVZ<\/p>\n\n\n\n

- Attending physicians<\/p>\n\n\n\n

- Affiliated practices<\/p>\n\n\n\n

- Data centres, cloud service providers<\/p>\n\n\n\n

- Internal or external services such as pharmacy, typing services, security service, sterilisation, bed preparation (see chapter 3.6 Services)<\/p>\n\n\n\n

3.3 Type and scope of services (processes)<\/h2>\n\n\n\n

Specialised disciplines, individual services. They are listed in VA 2.1.02<\/p>\n\n\n\n

The scope of diagnostic, therapeutic and nursing services is presented in the quality report.<\/p>\n\n\n\n

Operation of training centres, teaching facilities<\/p>\n\n\n\n

Carrying out research<\/p>\n\n\n\n

3.4 Technical infrastructure used<\/h2>\n\n\n\n

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).<\/p>\n\n\n\n

The exclusion of requirements as not applicable must be justified for the entire scope of application.<\/p>\n\n\n\n

4 Resources<\/h1>\n\n\n\n

5 Risks and opportunities<\/h1>\n\n\n\n

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.<\/p>\n\n\n\n

Changes to the area of application are not sufficiently taken into account, so that they are no longer covered by the QM system.<\/p>\n\n\n\n

6 Documentation<\/h1>\n\n\n\n

Documented information required<\/p>\n\n\n\n

Site plan; floor plans; organisational charts showing staff allocation and responsibilities; brief description of the service in section 3.6<\/p>\n\n\n\n

Changes to the scope of application may affect the validity of the certificate. They must therefore be reported to the CAB.<\/p>\n\n\n\n

7 Responsibilities<\/h1>\n\n\n\n

Top management<\/p>\n\n\n\n

8 Notes and comments<\/h1>\n\n\n\n

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.<\/p>\n\n\n\n

9 Applicable documents<\/h1>\n\n\n\n

9.1 Literature, regulations<\/h2>\n\n\n\n

DIN EN ISO 9001:2015 DIN EN 15224:2017 Tz 4.3<\/p>\n\n\n\n

9.2 Terms<\/h2>\n\n\n\n

10 plants<\/h1>","protected":false},"excerpt":{"rendered":"

Verfahrensanweisung herunterladen 1    Zweck und Ziel Festlegung des Anwendungsbereiches des QM-Systems, indem die Grenzen und das Ma\u00df der Anwendbarkeit bestimmt werden. 2    Anwendungsbereich Das gesamte QM-System und Verh\u00e4ltnis zu Untersystemen 3    Beschreibung 3.1              Allgemeines Der Anwendungsbereich muss die externen und internen Themen ber\u00fccksichtigen, die in der Darstellung des Kontextes der Einrichtung identifiziert wurden. Die relevanten […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":9323,"menu_order":8,"comment_status":"open","ping_status":"closed","template":"","doc_tag":[],"doc_badge":[],"class_list":["post-9343","docs","type-docs","status-publish","hentry","no-post-thumbnail"],"acf":[],"author_avatar":"https:\/\/secure.gravatar.com\/avatar\/c6b2616140d9fcd6a1c5d6d2ebbf43422308c9322c032ef03f88ec3235855dcf?s=96&d=mm&r=g","author_name":"admin","_links":{"self":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/9343","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs"}],"about":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/types\/docs"}],"author":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/comments?post=9343"}],"version-history":[{"count":6,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/9343\/revisions"}],"predecessor-version":[{"id":14269,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/9343\/revisions\/14269"}],"up":[{"embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/docs\/9323"}],"wp:attachment":[{"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/media?parent=9343"}],"wp:term":[{"taxonomy":"doc_tag","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_tag?post=9343"},{"taxonomy":"doc_badge","embeddable":true,"href":"https:\/\/gutehospitalpraxis.de\/en\/wp-json\/wp\/v2\/doc_badge?post=9343"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}