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Scope

Standardization in the field of healthcare organization management comprising, terminology, nomenclature, recommendations and requirements for healthcare-specific management practices and metrics (e.g. patient-centered staffing, quality, facility-level infection control, pandemic management, hand hygiene) that comprise the non-clinical operations in healthcare entities.

Excluded are horizontal organizational standards within the scope of:

  • quality management and quality assurance (TC 176);
  • human resource management (TC 260);
  • risk management (TC 262);
  • facility management (TC 267), and;
  • occupational health and safety management (TC 283).
  • Also excluded are standards relating to clinical equipment and practices, enclosing those within the scope of TC 198 Sterilization of health care products.

    Quick links

    13

    Published ISO standards *

    6

    ISO standards under development *

    29
    Participating members
    25
    Observing members

    * number includes updates

    Reference Title Type
    ISO/TC 304/WG 1   Vocabulary Working group
    ISO/TC 304/WG 4   Pandemic preparation and response Working group

     

    Joint working groups under the responsibility of another committee
    Reference Title
    ISO/CASCO/JWG 63 Joint ISO/CASCO - ISO/TC 304 WG: Development of ISO/IEC 17021-15
    Liaison Committees to ISO/TC 304

    The committees below can access the documents of ISO/TC 304:

    Reference Title ISO/IEC
    ISO/COPOLCO Committee on consumer policy ISO
    ISO/IEC JTC 1 Information technology ISO/IEC
    ISO/TC 94/SC 13 Protective clothing ISO
    ISO/TC 106 Dentistry ISO
    ISO/TC 168 Prosthetics and orthotics ISO
    ISO/TC 170 Surgical instruments ISO
    ISO/TC 176 Quality management and quality assurance ISO
    ISO/TC 176/SC 2 Quality systems ISO
    ISO/TC 194 Biological and clinical evaluation of medical devices ISO
    ISO/TC 198 Sterilization of health care products ISO
    ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO
    ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
    ISO/TC 215 Health informatics ISO
    ISO/TC 249 Traditional Chinese medicine ISO
    ISO/TC 251 Asset management ISO
    ISO/TC 260 Human resource management ISO
    ISO/TC 262 Risk management ISO
    ISO/TC 267 Facility management ISO
    ISO/TC 276 Biotechnology ISO
    ISO/TC 283 Occupational health and safety management ISO
    ISO/TC 314 Ageing societies ISO

     

    Liaison Committees from ISO/TC 304

    ISO/TC 304 can access the documents of the committees below:

    Reference Title ISO/IEC
    ISO/CASCO Committee on conformity assessment ISO
    ISO/COPOLCO Committee on consumer policy ISO
    ISO/TC 94/SC 13 Protective clothing ISO
    ISO/TC 106 Dentistry ISO
    ISO/TC 168 Prosthetics and orthotics ISO
    ISO/TC 170 Surgical instruments ISO
    ISO/TC 176 Quality management and quality assurance ISO
    ISO/TC 194 Biological and clinical evaluation of medical devices ISO
    ISO/TC 198 Sterilization of health care products ISO
    ISO/TC 210 Quality management and corresponding general aspects for products with a health purpose including medical devices ISO
    ISO/TC 212 Medical laboratories and in vitro diagnostic systems ISO
    ISO/TC 228 Tourism and related services ISO
    ISO/TC 249 Traditional Chinese medicine ISO
    ISO/TC 251 Asset management ISO
    ISO/TC 260 Human resource management ISO
    ISO/TC 262 Risk management ISO
    ISO/TC 267 Facility management ISO
    ISO/TC 276 Biotechnology ISO
    ISO/TC 283 Occupational health and safety management ISO

     

    Organizations in liaison (Category A and B)
    Acronym Title Category
    ETUC European Trade Union Confederation A
    ISQua International Society for Quality in Health Care (ISQua) A
    ITUC International Trade Union Confederation A

    ISO/TC 304 - Secretariat

    ANSI [United States]

    American National Standards Institute
    1899 L St NW, 11th Floor
    Washington 20036 DC
    United States

    Tel: +1 212 642 49 00 / +1.202.293.8020
    Fax: +1 212 398 00 23 / +1.202.293.9287