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ISO 17025:2017 LABORATORY QUALITY MANAGEMENT SYSTEM AWARENESS

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This training topic is currently available for in-house sessions only, with a minimum requirement of 5 participants. Public program sessions are not available at the moment. The public program date will be announced when scheduled.

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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)
ISO 17025:2017 Laboratory QMS Awareness

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