Pharmaceutical Regulatory Affairs and IPR

Quality Management System in Testing Laboratories

Testing laboratories provide vital services to their customers who expect accurate results produced at appropriate time and at reasonable cost. Adoption of the quality management system (QMS) by a laboratory would facilitate achieving these goals. The International Organization for Standardization (ISO) has developed an international standard, known as ISO 17025: 2005 ‘General requirements for the competence of testing and calibration laboratories’, for the accreditation of testing laboratories to a wide range of testing environments. Compliance with this quality standard requires that the laboratory shall establish and maintain a systematic way to ensure and improve its performance. Compliance with the ISO 17025 provides a unique focus for assuring implementation of the QMS and technical competence of a laboratory.