RISK MANAGEMENT IN ISO 9000:2015 STANDARDS

The paper presents analyses of changes in the revised ISO 9001:2015 on quality management. Additionally a relatively new requirement emerged in the guidelines to a process approach,. It is the need for a systematic approach to risk assessment. In the three-year transitional period, most organizations will implement such an approach to risk assessment. The most difficult to interpret elements of the new standard is an orientation of activities at risk.  Orientation of activities at risk is the most difficult elements of the new standard to interpret. Especially, that ISO 9001:2015 does not specify exactly how the implementation of risk management should look like. Therefore, in the article, next to the requirements analysis, the concept of the six-level methods of the approach implementation was proposed. The matrix method was used where two elements were evaluated: probability of risks and potential impact of risks. Each element can be assessed, e.g. in a 6-point scale, assigning different weights. The assessment of the risk probability consists in assigning to each of the risk types the score from 0 to 1 (every 0,2), and the impact assessment on a scale from 1 to 6 (analogous to the notes). When assessing the risk one should remember that the norm, especially in the context of the organization, requires attention not only to the so-called negative risk, but also chances (potential benefits). Both avoidance of adverse events and exploitation of opportunities is the foundation of risk management. The use of the proposed concept can contribute to the efficient and effective implementation of the requirements of ISO 9001:2015.

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