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Risk based thinking, like normal risk management, is to control and manage your risks to prevent issues from occurring.
Risk is inherent in all aspects of a quality management system. There are risks in all systems, processes and functions. Risk-based thinking ensures these risks are identified, considered and controlled throughout the design and use of the quality management system.
Risk based approach in ISO 9001:2015 involves the following four key steps:
Identifying and understanding the risks and opportunities
Planning actions to address them
Implementing them in a quality management system
Evaluating their effectiveness
Risk-based thinking is not new, it is something you already do. An on-going risk-based thinking ensures greater knowledge of risks and improves preparedness, increases the probability of reaching objectives, reduces the probability of negative results and makes prevention a habit.
ISO 9001 risk-based thinking requirements don’t mandate that companies implement a formal risk management process, and does not specify how to implement it. It is always left to the organizations to adopt the best methodology defined by many international models or frameworks that best suits them.
To know more and get additional information on the risk based thinking for your ISO 9001 certification, schedule a free 30-minute consultation with an IBEC expert.