INTRODUCTION FOR ISO 17025:2017 AWARENESS
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the International Organization for Standardization in 1999.
COURSE OBJECTIVES
At the end of program, participant will be able to:
- Understand the guidelines for building up an effective new quality management system (QMS) for laboratory operation
- Interpret the specific requirements of ISO 17025:2017.
- Attempt to apply the requirements of the LATEST standard in day to day operations towards LABORATORY compliance with the standard
LEARNING OUTCOMES
At the end of the seminar/workshop, the participants are expected to be able to:
- to create, implement and maintain an effective testing laboratory management system
- to demonstrate compliance with principles of good and efficient laboratory management system and to strive for audit and certification
METHODOLOGY
- Lively interactive two-way training facilitation.
- Group Exercises
- Powerpoint Presentation
- Written Knowledge Assessment
WHO MUST ATTEND
All Laboratory staff (Microbiology/Chemistry/Physical Testing, Quality Control, Calibration, etc.), Middle management (QC Executives & QA Executives, Lab Managers and Internal Laboratory or GMP/GLP Auditors.
COURSE CONTENT
Day 1
Clause 1: Laboratory management operation system
Clause 2: Overview and definition
Clause 3: New international standards and development
Clause 4: Impartiality & Confidentiality
Clause 5 : Structural requirement
- Organization of laboratory and line of reporting
Clause 6 : Resource requirement
- Personnel
- Laboratory facilities & environmental conditions
- Equipment
- Metrological traceability
- External provided product & service
Clause 7 : 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
Day 2
Clause 7 : Process Requirement
- Assuring the quality of results
- Reporting of results
- Complaints
- Management of nonconforming work
- Control of data – Information management
Clause 8 : 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 review
- Group Exercises & Presentation
- Case Studies
- Written Assessment
