About

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

    Sustainable Development Goals

    This committee contributes with 15 standards to the following Sustainable Development Goals:

    3
    Good Health and Well-being
    8
    Decent Work and Economic Growth
    9
    Industry, Innovation and Infrastructure
    10
    Reduced Inequalities
    11
    Sustainable Cities and Communities
    10

    Published ISO standards *

    7

    ISO standards under development *

    30
    Participating members
    23
    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

    Date Month Location TC/SC Note
    28 May 2024 Virtual () ISO/TC 304  

    * Information definite but meeting not yet formally convened
    ** Provisional

    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
    Web:

    2. Taking part
    3. Who develops standards
    4. Technical Committees
    5. ISO/TC 304