The transition of the quality management systems to the new requirements regarding the approach based on the risk assessment in the organization’s processes

On the basis of implementing a quality management system is ISO 9001 - Quality Management Systems. Requirements. This standard is one of the most used worldwide ISO standards and is revised periodically. The current revision process began in 2011, is carried out to ensure the relevance and update with the new global economic issues and will end in late of September, when it will also be published.
This revision of ISO 9001 proposes a number of changes of which the most important is the risk-based approach in developing quality management systems. At present, approach based on processes is considered insufficient because it does not consider the events that may affect the achievement of objectives and activities.
These events constitute risks with potential impacts on business results and efficiency of resource use. Thus, these risks should be identified and must be established and undertaken those actions that reduce and maintain the risks within acceptable limits.
Taking into consideration these issues, INCD ECOIND has proposed the development of a methodology of transition the current management systems based on processes to the management systems based on risks’ consideration.
The methodology will include:
• Establishing the transition Strategy of existing QMS to the requirements of ISO 9001-201;
• Awareness managers and all staff on the requirements of the new standard ISO 9001-2015;
• Integrating risk management process at SMC level;
• Reviewing the system documents according to the requirements of standard ISO 9001-2015;
• Evaluating and improving QMS.
The proposed methodology will be useful for organizations that have already implemented a quality management system, as well as for organizations that want to implement this system.