The article is devoted to the risks and ethical issues of quality systems audit in health care facilities, which became possible after the release of the new version of ISO 19011:2011. It is shown that the audit involves risks both objective and subjective. The recommendations of an adequate audit method are proposed. Global implications of biomedical technologies and increasingly broad medicalization of everyday man life require a changing of the business ethics priorities in the quality management systems audit in the bioethics context. Values and principles of bioethics should be included to audit risk assessment. There is an urgent need to develop special bioethical code and behavior in specific situations for auditors of medical institutions.
