Hundreds of ISO International Standards for all aspects of healthcare help to implement the aims of World Health Day 2007, 7 April, of which this year’s theme is on international health security, urging governments, organizations and business to “Invest in health, build a safer future”.
World Health Day is an occasion for raising awareness of key global health issues. The date of 7 April is chosen because it marks the founding of the World Health Organisation (WHO), which is a partner in 57 of the ISO technical bodies that develop ISO standards.
Out of the total of more than 16 500 International Standards so far published by ISO, there are over 700 standards and related documents for aspects of healthcare.
The February 2007 issue of ISO Focus magazine highlighted ISO’s work in the field of healthcare information technology (HIT) to develop standards facilitating the implementation and worldwide diffusion of innovative initiatives such as electronic health records (EHR) and digitized healthcare services (e-Health).
However, ISO standardization related to healthcare goes far beyond HIT. Standards for various aspects of healthcare are developed by the following ISO technical committees.
- ISO/TC 48, Laboratory equipment
- ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use
- ISO/TC 84, Devices for administration of medicinal products and intravascular catheters
- ISO/TC 106, Dentistry
- ISO/TC 121, Anaesthetic and respiratory equipment
- ISO/TC 150, Implants for surgery
- ISO/TC 157, Mechanical contraceptives
- ISO/TC 168, Prosthetics and orthotics
- ISO/TC 170, Surgical instruments
- ISO/TC 173, Assistive products for persons with disability
- ISO/TC 194, Biological evaluation of medical devices
- ISO/TC 198, Sterilization of health care products
- ISO/TC 210, Quality management and corresponding general aspects for medical devices
- ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems
- ISO/TC 215, Health informatics.
In addition, there are a number of ISO standards or guides relevant to healthcare that are produced by other ISO technical bodies, including the following:
- ISO’s management system standards, ISO 9001 (quality management) and ISO 14001 (environmental management) are also implemented by healthcare organizations.
- ISO has published additional guidance for implementing quality management in the sector: the International Workshop Agreement IWA 1:2005, Quality management systems – Guidelines for process improvements in health service organizations.
- The conformity assessment standard, ISO/IEC 17025:2005, General requirements for the competence of testing and calibration laboratories, is used in the health sector.
- ISO/IEC Guide 71:2001, Guidelines for standards developers to address the needs of older persons and persons with disabilities.
ISO Secretary-General Alan Bryden commented: “In healthcare, ISO standards address both technical and economic aspects and also provide benefits in the societal dimension. In this sector as in others, ISO standards are tools for helping to implement many of the goals of sustainable development.”
- IWA 1:2005 [Withdrawn]Quality management systemsGuidelines for process improvements in health service organizations
- ISO/IEC 17025:2005 [Withdrawn]General requirements for the competence of testing and calibration laboratories
- ISO/IEC Guide 71:2001 [Withdrawn]Guidelines for standards developers to address the needs of older persons and persons with disabilities