Several ISO standards, mainly those concerned with quality, health, safety or the environment, have been adopted in some countries as part of their regulatory framework or are referred to in legislation for which they serve as the technical basis. However, such adoptions are sovereign decisions by the regulatory authorities or governments of the countries concerned. ISO itself does not regulate or legislate. This chapter addresses some criticisms and misconceptions whether the standard remains a requirement for doing business and the extent to which certification is perceived as the goal. It also explores whether the standard remains a prescription for conformance and whether it is designed for auditors or for the business. ISO 9001 requires organizations to establish a quality management system as a means of ensuring that customer requirements are met. ISO 9001 has indeed encouraged the notion that following the correct procedures was all that was needed to provide a quality product or service.