Requirement = a need or expectation that is stated, generally implied or obligatory.
A requiment can become: 1) non-fulfilment of a requirement related to an intended or specified use (defect) 2) non-fulfilment of a requirement (nonconformity) 3) fulfilment of a requirement (conformity)
8.2.2 When determining requirements for products and services to be offered to customers, the organization must ensure that all requirements are defined, including regulatory requirements.
According to SAK10 ยง10-1 a you need to have a system that helps you to "Identify, address, verify and document compliance with relevant requirements".