INTRODUCTION FOR ISO 17025:2017 LABORATORY QUALITY MANAGEMENT SYSTEM AWARENESS
COURSE OBJECTIVES
At the end of program, participant will be able to:
- Apply the guidelines for building up an effective new quality management system (QMS) for laboratory operation
- To interpret the specific requirements of ISO 17025:2017.
- To be able to apply the requirements of the LATEST standard in day to day operations towards LABORATORY compliance with the standard
WHO MUST ATTEND
All Laboratory staff (Microbiology, Chemistry & Physical), Middle management (QC Executives & QA Executives, Lab Managers and Internal Laboratory or GMP/GLP Auditors.
METHODOLOGY
- Lively interactive two-way training facilitation.
- Group Exercises/Role play
- Case Studies and Practice
- Video Presentation/Power point Presentation
COURSE CONTENT
DAY 1
- Laboratory management operation system
- Overview and definition
- New international standards and development
- Structural requirement
- Organization of lab and line of reporting
- Resource requirement
- Personnel
- Laboratory facilities & environmental conditions
- Equipment
- Metrological traceability
- External provided product & service
- Process requirement
- Review of requests, tenders and contracts
- Selection, verification and validation of methods
- Sampling
- Handling of test or calibration items
- Technical records
- Evaluation of measurement uncertainty
- Group Exercise 1: Drafting Lab Quality Manual (Part 1)
DAY 2
- Process Requirement
- Assuring the quality of results
- Reporting of results
- Complaints
- Management of nonconforming work
- Control of data – Information management
- Management requirement
- Management system documentation
- Control of management system documents
- Control of records
- Actions to address risks and opportunities [NEW]
- Improvement
- Corrective actions
- Internal audits
- Management reviews
- Establishment of new QMS
- Documentation of the quality manual and quality procedures
- Group Exercise 2: Drafting Lab Quality Manual (Part 2)
- Question & Answer (Q&A)
- Written Knowledge Assessment- 1 hour (MCQ 40 Questions & 10 Questions Short answer)
