Creating Conformant Quality Management Systems for Laboratories, Inspection Bodies, and Product Certification Bodies

Conformant implementation of Risk Based Thinking in QMS based on CASCO standards. (J.E.J. (Ned) Gravel) Creating Conformant Quality Management Systems for laboratories, inspection bodies, and product certification bodies are based on ISO/IEC 17020, ISO/IEC 17025, and ISO/IEC 17065. These three standards are written by the Conformity Assessment Committee of the ISO (CASCO) and differ significantly from ISO 9000, written by ISO Technical Committee 176. This chapter provides an overview of the QMS requirements for these three types of conformity assessment bodies (CABs) that have implemented one, or more, of these three standards. Each of the three CASCO standards being discussed has similarities and differences in their QMS requirements. This chapter will list these similarities and differences and provide users with ideas on how to develop and implement a QMS that meets the requirements of one, or more, of them within their own CAB. With the demise of Option B from all ISO/CASCO revisions of current standards, including 17025 and 17065, there is a need to understand impending changes of QMS requirements before revisions of these standards are published. The opinions expressed in this chapter are based on 30 years’ experience in accreditation of these CABs, 14 years’ experience in managing them, and 10 years’ experience in working on ISO/CASCO, TMB, and International Laboratory Accreditation Cooperation (ILAC) working groups and committees. Finally, this chapter details approaches in implementing risk-based thinking (RBT) by identifying the simple tools that are already available to CAB staff within the standard used for their own QMS.