Risk Based Thinking in ISO 9001 Quality Management System

Risk Based Thinking in ISO 9001 Quality Management System

The term “Risk” is defined in a simplified form as an event that affect something or someone, and may lead to a threat, harm or injury.

The concept of risk in the ISO Quality Management System standard (ISO 9001:2015) is completely different from the above linguistic definition, where Risk has two meanings: threats and opportunities.

The risk in this standard is an event results from a lack of information and leads to negative or positive results. The threats that the organization may face represent the negative results, and the opportunities available to the organization that would help the organization grow represent the positive results.

The concept or term “Risk” is a newly emerged concepts in the latest f ISO 9001:2015 standard revision.

Additionally, the term “Risk Based Thinking” is not new to the ISO standards family only, but to the risks management in general as well.

Therefore, the identification of risks, both threats and opportunities, has become one of the most important requirements of the standard, as it gives organization the option of how to document the process of identifying and evaluating risks, which is currently known in the standard as the “risk-based thinking” methodology.

One of the main objectives of the quality management system is to work Proactively to prevent or reduce the risks resulting from any fault that causes a deviation from the basic requirements of a product or service, and to ensure this, the preventive action clause has been deleted and replaced with the “risk-based thinking methodology” part which has been incorporated into the planning requirements of the quality management system.

In summary, the two sides of risks – threats and opportunities-, represents two sides of the same coin. And Through risk analysis, some opportunities that help the growth of the organization can appear. For example, risk analysis may lead to find a risk such as “the apear of new competitors in the market” 2hich will have an impact On the company’s market share, and by analyzing the environment and internal and external conditions of the organization using strategic planning tools such as analysis of opportunities and risks (SWOT)), we find that this analysis has resulted in find of new opportunities for the organization that will create an additional competitive advantage.

It can be said that the methodology of risk-based thinking is applicable to any process, whether service or products. And risk-based thinking is not new, but it is a logical process that we practice daily, starting from choosing the clothing type according to the weather condition before going to work, looking right and left before crossing the road to avoid the dangers of cars and other daily life patterns. But the most important thing and the biggest challenge remain in how to apply this methodology and transform it into a culture within organizations.