The ISO 9001:2015 covers Risk in a number of sections (e.g. 4.4, 5.1,
6.1, 6.1.1, 6.1.2, 9.1.3, 9.3.2, & 10.2.1). The objective of the emphasis
on risk is to have the organization, through its QMS, address
uncertainty in processes that will affect the quality of the delivered
goods or services to customers.
The need to identify, analyze, and consider actual and potential risks
was covered in various clauses of ISO/TS 16949:2009. The new IATF
16949:2016 standard continues to expect organizations to identify and
address risks affecting compliance of products and services, resulting
in improved customer satisfaction.
Besides identifying the risks, automotive organizations need to
address opportunities for improvements, and corrective and preventive
actions based on the risk analysis.