Risk Management is an integral part of Quality Management Systems. All Quality Management Systems (e.g. ISO 9001, IATF 16949, AS 9100 & ISO 13485) clearly define the requirements to manage the risk to achieve intended outcomes. Customers and other interested parties have some expectations and they are very concerned that how we manage risk in our business to meet their expectations. The risk management requirement was in Quality Management Systems (QMS) from day one but after release of ISO 9001:2015, it became one of the most concerned requirements of interested parties including the auditors to qualify your organization for certification. In this short presentation we will try to understand the risk management requirement for effective implementation of QMS and to achieve our intended outcomes. We will cover the following during our presentation:
- What is Risk?
- What is Risk-based-Thinking?
- Is there any ISO standard for Risk Management?
- What is ISO 31000?
- Which clauses of QMS Standards require to identify and manage the risk?
- Why we need to identify and manage the risk?
- What are the tools and techniques to identify and manage the risk?
- Can we use Risk-based-Thinking in Auditing?