Risk Management at the Notified Body in the Aspect of Its Impartiality

State-of-the art management systems are oriented onto supporting a competiveness of organizations and a continuous quality improvement of products, services and processes. One of essential elements of management is the risk management process which enables to manage uncertainty and risk in relation to the conducted activity by an organization. Managing risk assists organizations in setting strategy, achieving objectives and making informed decisions. Managing risk is part of governance and leadership, and is fundamental to how the organization is managed at all levels. It contributes to the improvement of management systems. A competent use of risk management mechanisms enables each organization to use its potential to a full extent and undertake proper decisions. The issues concerning a standardization of requirements in the case of standards from the management scope; in particular from the point of view of issues connected with risk management, are presented in the first part of the article. A model of the process, oriented onto a risk in the quality management system which enables to conduct managing activities in the situation of uncertainty and to take decisions oriented onto preventing mistakes in managing the organization and onto ensuring the appropriate quality, is described. The subject – matter concerning risk analysis, in particular from the point of view of meeting the EA Guidelines, concerning horizontal requirements related to the bodies assessing the conformity for notification purposes, is brought nearer. The most essential requirements, which must be met by such a body to guarantee a competent and impartial process of the product assessment, are described. In the following chapters the basic elements of the risk analysis process are discussed and an exemplary description of the risk assessment methodology is presented