Course Description:
The initial assessment is designed with the aim to identify the gaps in quality management system (QMS) implementation as defined in ISO/IEC 17025:2017 standards and WHO GPPQCL TRS 105, Annex 4, 2024. The assessment will be performed in combination of document review, interview, and analytical method demonstration of key test parameters. Stepwise assessment tool towards accreditation (SATTA) tool is used for this assessment to support the assessment of different aspects of QMS since it incorporates all elements of quality control from both ISO 17025 and WHO PQ. This tool also supports to identify which area in quality management system the laboratory is deficient and need to improve in order to be in compliance with standard.
The program delivers the following objectives:
- Identify the degree of compliance of laboratory to ISO/IEC 17025:2017 by assessing the compliance of the laboratory infrastructure, equipment, organizational setup, and operational procedures against ISO/IEC 17025:2017
- Evaluate the current technical capacity (capacities) and status of implementation for Good Laboratory Practices
- Provide a gap analysis showing the detail deficiencies or gaps in QMS implementation as defined in ISO/IEC 17025 and possible corrective action to eliminate current gaps and prevent future occurrences (CAPA Plan)
- Identify the future support in terms of TTA (training technical assistance) towards ISO 17025 Accreditation and WHO PQ
- Establish an Institutional Development Plan for accelerating the ISO/IEC 17025:2017 accreditation and WHO Prequalification requirements.
Pricing varies. Please inquire for more info at https://go.usp.org/Services.Who should participate:
- National regulatory authorities
- National control laboratories
- Private QC laboratories
- QC lab in manufacturer