Understanding standards

The International Electrotechnical Commission defines a standard as:

A standard is a document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context.

(See (ISO/IEC GUIDE 2:2004 Standardization and related activities — General vocabulary for further definitions)

Apart from product standards, other examples include: terminology standards, testing standard, service standards, process standards and management systems standards. (See ISO/IEC GUIDE 2:2004 Standardization and related activities — General vocabulary). Note that a ‘technology’ or ‘technical’ standard is not defined at the international level, but is instead covered by the above categories of standards.

Standards are normative documents that document that provides rules, guidelines or characteristics for activities or their results, but does not contain provisions related to conformity assessment activities [except some sampling/testing methods].  They can, however, anticipate and formulate requirements that can be used in the subsequent conformity assessment activities. An example would be the International Standards Organization ISO 13131 Health informatics — Telehealth services — Quality planning guidelines. Other classes of documents that can also address products, terminology, testing, service, processes and management systems and in the case of healthcare, safety and quality of care.

Technical Specifications address work still under technical development, or where it is believed that there will be a future, but not immediate, possibility of agreement on an International Standard. A technical specification can contain normative requirements. An example would be the Standards Australia AS ISO 13131:2017 | Health informatics Telehealth services – Quality planning guidelines

A Technical Report contains information of a different kind from that of the previous two publications. It may include data obtained from a survey, for example, or from an informative report, or information of the perceived “state of the art”. A Technical Report does not contain normative requirements.

Technical Regulation provides technical requirements, either directly or by referring to or incorporating the content of a standard, technical specification or code of practice, that is adopted by an authority. An example would be a Medicare Benefits Schedule item number or the Therapeutic Goods Administration regulation of medical devices.

A Code of Practice recommends practices or procedures for the design, manufacture, installation, maintenance or utilization of services, equipment, structures or products. An example would be a guideline developed by a professional association developed by the RACGP, ACRRM or the Medical Board of Australia.

Clinical Standards are documents that aim to protect the public from harm and improve the quality of health service provision. The Australian Commission on Safety and Quality in Healthcare clinical care standards, and National Safety and Quality Health Service Standards. An example would be the forthcoming National Safety and Quality Digital Mental Health Standards.

Potential guidance for telehealth services can be found in standards, specifications, reports, regulations, codes of practice and clinical standards documents.

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