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## Preventive and risk-based approach to management 

## 1. Purpose 

Managing risks and establishing preventive measures aims at strengthening the effective and efficient functioning of the IQMS by eliminating or controlling threats and by taking opportunities for improvement. 

The adoption of a preventive and risk-based approach shall ensure that risks and potential deviations, shortcomings or failures, and their causes, are identified and acted upon at an early stage to prevent their actual occurrence. 

The pro-active approach shall also enhance desirable effects and opportunities that present an advantage for the Agency and its stakeholders. 

Prev entive action is taken with the aim to foster the Agency’s ability to achieve the objectives and to deliver services with the planned quality, in the agreed timeframe and under minimisation of undesired environmental impacts. 

## 2. Scope 

This procedure applies to the entire Agency. The procedure starts with the identification of a potential issue and ends with the effective implementation of actions that shall prevent the occurrence of that issue. 

## 3. Description 

## 3.1. Proactivity and preventive action concept 

The focus of proaction is to prevent the occurrence of nonconformities and also to identify opportunities for improving effectiveness and efficiency of processes and the overall system (PRO-0080). 

Potential nonconformities are issues that can adversely affect the intended functioning of the IQMS and the achievement of its objectives, if not acted upon. 

Preventive action addresses weaknesses in the IQMS that could cause a nonconforming situation and are mainly targeted at the causes of: 

• potential deviations from applicable legislation, compliance obligations, rules or plans, established procedures, environmental requirements or customer requirements 

• potential technical problems and failures in providing the services and outputs with the intended quality, in the agreed timeframe and under minimisation of undesired environmental impacts 

• shortcomings at the design or implementation of system elements or individual processes. 

