|
Abstract: . . . international initiatives Establish links with stakeholders OLA Advisory Panel Provides direction to OLA Reviews requirements and guidance information May review files of laboratories with provisional status, and those for which an intention to withdraw accreditation is recommended May review some follow-up documentation to determine if a non-compliance has been resolved by a facility Accreditation Defined A peer-review process by which an authoritative body ensures that laboratories meet explicit quality management criteria, in order to give formal recognition that the laboratory is competent to carry out examinations. International Organization for Standardization (ISO) The concept of a quality management system is based on principles described in ISO 9001-2000, Quality Management Systems It can be applied to any business or service and has been standard in other fields such as the automotive industry and aviation for many years. 500,000 organizations are already registered to ISO 9001 ISO 17025 (General requirements for the competence of testing and calibration laboratories) and 15189 (Medical laboratories ISO and OLA Requirements The OLA draft program requirements were based on both of the laboratory ISO standards: ISO 17025 and 15189 . . . . . . of step-by-step instructions that each individual follows Form the classical procedure manual Example: Procedure for performing an ABO group (the step-by-step instructions for a technologist to follow when performing the test) Continual Quality Improvement Once the Quality Management system is fully documented, do not expect it to stay static for long. The next phase is continual improvement through the use of quality indicators, internal auditing, investigation of non-conformities, and management review. This is a primary objective of the QMS. Continual improvement is a never-ending loop wherein a facility : Guidance Information Click to add text . . . --2509,2,627,2067,12545
|