ISO 9001 - ISO / IEC 17025 - INTEGRATED MANAGEMENT SYSTEMS - ISO 14001 - ISO 13485 - OHSAS 18001

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Ashbrooke QA Ltd.

78038 - 3295 Coast Meridian

Port Coquitlam, B.C.

Canada  V3B 7H5

 

Phone 604 - 552 - 0496

Fax  604 - 552 - 0497

 

Email ashbrooke@ashbrooke.com

 

 

Designing the Quality Management System to ISO / IEC 17025:2005  - Syllabus

(3 Days)

Day 1

8:30 - 5:30

 The start …

  • Creating a Course of Action … The Implementation Programme

  • Implementation Planning

 Quality Management System Structure

  • Policy Document

  • Process Procedures

  • Task Instructions

  • Planning     

 Documents and Records 

 System Management and Controls

 Quality Management System Model

  • Technical Competence and Test Result Validity

  • Customer Focus

  • Continual Improvement  

  • Corrective and Preventive Action

  • Quality Objectives and Targets

 Workshop - Case Study 1 - The Implementation Programme 

  Workshop - Case Study 2 - Defining the QMS Structure 

 Mapping ISO / IEC 17025 Requirements

  • Looking at the Organization

 Discussion and Wrap-up 

Day 2

8:30 - 5:30

  Flowcharting Processes 

  • Systemic Level

  • Process Level

  • Task Level

 Workshop - Case Study 3 - Process Mapping   

 Building the Quality Management System 

  • Commitment to Quality Policy (Policy Document)

  • Procedures Manual (Process Documents)

  • Work Instructions (Task Documents)

  Workshop - Case Study 4 - Building the Quality Management System 

 Discussion and Wrap-up 

Day 3

8:30 - 5:30

 

  Accommodation and Environment 

 Samples and Sample Handling 

  • Items for Test and/or Calibration

 Technical Document Requirements 

  System Procedures

  • Other Documents (master lists (equipment, procedures, etc), training records, subcontractors, etc)

  • Records

  • Procedures for Accredited vs. Non-Accredited Tests, Scope

  Laboratory Equipment

  • Calibration and Traceability

  • Maintenance

  Measurement Traceability 

  • Calibration

  • Reference Standards and Reference Materials

 Method Validation

  • Estimation of Uncertainty of Measurement

  • Standard Methods

  • Non-Standard Methods

  • Laboratory-Developed Methods

  Assuring Quality of Test and Calibration Results

  • Proficiency Testing

  • Statistical Process Charts (control charts calibration checks, calibration standards and test results)

  • QA and QC checks

  • The “Second Set of Eyes

  Reporting Results

  • Results Approval

  • Test Reports and Calibration Certificates - Original Results

  • Retests and Non-Conforming Results

  • Reporting Uncertainties of Measurement

 Workshop - Case Study 5 - ISO / IEC 17025 Process Audit 

 Discussion and Wrap-up 


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This page was last updated: September 17, 2009