Quality Auditor Question:

organization. In all cases, though, personnel must understand the product requirements. ISO 9001:2000 specifically requires that organizations identify product requirements in four ways:

☛ As stated by the customer
☛ Unstated by the customer but necessary for intended use
☛ As statutory and legal regulations related to the product
☛ As any additional requirements determined by the organization
☛ The standard additionally requires that information describing the product be available (i.e., documented). Asking how personnel access product requirements is an important audit question because when requirements aren’t accessible, big problems often result. Employees don’t need to know product requirements by heart, but they should certainly be able to find the current versions of requirements and describe how they carry them out.