This chapter examines the concept of quality assurance and the responsibilities of people within an organization for carrying out the activity. It defines a quality system and traces the background of quality system standards. Next, the chapter examines the key features of the ISO 9000 series (2015) and outlines the implementation guidelines and issues. It then reviews the quality system assessment and registration and highlights the benefits and limitations. A model is also presented which outlines what is required for a small company to successfully achieve ISO 9000 series registration. A quality system design must also maximize ownership, allow flexibility without loss of control, and be able to be developed to cope with changes in the business and capture improvements; above all it must be ‘user-friendly’. It is important that organizations do not view ISO 9001 registration as their pinnacle of success in relation to quality assurance and quality management.