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ISO 31000 is a set of international standards for risk management.It was developed in November 2009 by International Organization for Standardization. [1] The goal of these standards is to provide a consistent vocabulary and methodology for assessing and managing risk, resolving the historic ambiguities and differences in the ways risk are described.
The European version of the risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN 14971:2012 are nearly identical to ISO 14971:2007.
ISO 31000 is an International Standard for Risk Management which was published on 13 November 2009, and updated in 2018. An accompanying standard, ISO 31010 - Risk Assessment Techniques, soon followed publication (December 1, 2009) together with the updated Risk Management vocabulary ISO Guide 73.
ISO 31000:2018 Risk management – Principles and guidelines; ISO/TR 31004:2013 Risk management – Guidance for the implementation of ISO 31000; ISO/IEC 31010:2009 Risk management – Risk assessment techniques; ISO 31030:2021 Travel risk management — Guidance for organizations; ISO/IEC/IEEE 31320 Information technology – Modeling Languages
Risk management is predicting and managing risks that could hinder the organization from reliably achieving its objectives under uncertainty. Compliance refers to adhering with the mandated boundaries (laws and regulations) and voluntary boundaries (company's policies, procedures, etc.).
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