To demonstrate that the laboratory is competent, the laboratory can obtain accreditation. In the Netherlands you have to go to the Accreditation Council, a non-profit independent administrative body. What is the value of an RvA accreditation, in the Netherlands, in Europe and worldwide? Two accreditation standards apply to laboratories, ISO/IEC 17025 for testing and calibration laboratories and ISO 15189, based on ISO/IEC 17025, for medical laboratories.
Both standards are tough and boring and in addition to reading, the requirements mentioned must also be interpreted according to your own organization. In general, these tasks are assigned to the quality manager (“however named”), while the laboratory management should also know and be able to apply the content of the standard. Principles can help with this, in other words: if you don't have a map, you need a compass. Principles replace blindly following the requirements of the standard with the understanding that builds trust in a system that should consistently produce valid results. With knowledge of the principles, the standard can be better interpreted and applied. This presentation discusses the principles behind both standards and how these standards are constructed.
Speaker: Peter Kootstra, Lab-QAcademy