Hospital ISO Certification

Hospitals now actively seek ISO certification. The American Legion Hospital in Crowley, La., was the first hospital to register for ISO quality management certification in 1996. Although hospitals operate under strict regulatory agencies such as the Food and Drug Administration, medical errors cost $37 billion and result in 44,000 deaths each year in the United States, according to The Institute of Medicine (IOM). ISO certification may implement practices that decrease these errors and increase patient safety.

Background

• The International Organization for Standardization (ISO) seeks to harmonize the industry practices of several countries to ease interoperability and provide a vocabulary that can be commonly shared between industries of different corporate cultures. Founded in 1947, this organization's portfolio of guidelines holds more than 18,000 standards. Today, 163 nations participate in the standards' definition; their endorsement and deployment of ISO guidelines affects about 98 percent of the global workforce.

Value

• Several ISO standards align well with the operations of hospitals. They promote using practices that protect patient safety and privacy. For instance, some of the rules force clarity of communications between the patient and the doctors and among the medical staff to promote patient safety. The ISO calls for centralized databases of patient information that doctors can access at any time from any location. ISO guidelines require the implementation of measures that maintain integrity of supplies from the time of their reception, as well as clear labeling to support accurate dosage.

ISO 9001 in the Hospital

• ISO 9001:2008, the most recent version of the ISO 9001 quality management standard, is applicable to and can be beneficial for a hospital. In an ISO 9001-compliant world, all levels of the organization champion quality management. When ported to the hospital setting, the executives, administration and medical staff all focus on delivering quality services to the patients. This covers, for instance, accurate patient information, an infection-controlled environment or diagnostic equipment that works well. Continuous process improvement creates ways to improve patients' comfort, accelerating their recovery time; promote reduction in billing errors; or eliminate inventory management disconnects.

ISO 22870:2006 in the Hospital

• ISO 22870:2006 provides requirements that guide the testing of patients with portable, typically hand-held equipment in the hospital (point-of-care testing). This guideline discusses what optimal practices lead to accurate diagnostics and precise documentation to link the information from the tests to the patient. This set of standards works in conjunction with ISO 15189:2007, which targets medical laboratories.

Hospital ISO Certification

• In a similar approach to other industries involved with the ISO, an accreditation firm grants the certificate to the hospital after a third party representing an auditing firm verifies that the hospital complies with the intent of the ISO standards. Compliance consists of a comparison of each standard requirement to the practices of hospital staff. Auditors work from the process documentation and randomly explore staff compliance to the ISO rules. Deviations observed by the examiners are categorized into major or minor gaps: Major gaps must be removed immediately to receive the ISO certificate; minor issues can be corrected within one year.