Laboratory Accreditation – Getting there is Just the Beginning
- Product Id : FDB2545
- Category : Clinical & Laboratory, FDA Compliance, Food, Drugs & Biologics, Medical Devices, Quality
- Presenter : Michael Brodsky
- Duration : 60 Minutes
Developing a Quality Management System (QMS) as a prerequisite for getting accredited is relatively easy. Maintaining the QMS to retain your accreditation status is the real challenge and a measure of the robustness your System.
Many laboratories struggle with developing and implementing a functional quality management system that not only complies with the management and technical requirements of ISO/IEC 17025:2005 but also meets their needs. Once accreditation has been achieved many laboratories have difficulty maintaining the QMS as evidenced by the number of non-conformances cited during the subsequent biannual audits.
– Why do you want to become accredited?
– Where do you start?
For laboratories that are already accredited, how do you ensure staff adherence and ongoing compliance to minimize corrective actions arising from accreditation audits? Getting there is relatively easy. Staying there is hard part.
- Defining a Quality Management System (QMS)
- Management Components of a QMS
- Technical Components of a QMS
- Method Selection, Validation and Verification
- Ensuring analytical competency
- Ensuring analyst competency
- Laboratory Management/Supervision
- Laboratory Quality Development
- Laboratory Quality Management
- Laboratory Quality Control
- Analytical Support