ABSTRACT
ISO 9001:2015 includes the concept of risk in the form of definition, guidance and requirements. This chapter explores the common definition of risk and the new definition of risk. TC 176, the committee responsible for the development of ISO 9001, has been placed under an obligation from ISO to adopt a new common structure for management system standards, commonly referred to as Annex SL (ISO/IEC, 2015). There are different types of risk and not all may be addressed by the QMS, but should the loss be incurred it may influence the performance of the QMS. Risks associated with compliance are those subject to regulatory and statutory requirements, including legal infringements and rule breaches. In every instance of the use of the term in the new standard the word risk is used in the negative sense and not once in the sense of a positive effect.
