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Testing Laboratory Practices
            and ISO 17025




www.cebos.com
Maintaining Strict Quality Control
    Testing and calibration laboratories work within
    strict guidelines
•   Sampling identification
•   Labeling
•   Testing
•   Analysis
•   Documenting test results


    ISO 17025 certification
•   Same accreditation as ISO 9001 is for manufacturing and service
    organizations
•   Can attract more business & expand client base and profitability




Page 2
Two Main Clauses of ISO 17025
    Management                           Technical
    Requirements                       Requirements
  Same as ISO                        Pertains to lab
  9001:2000                          operations
• Focus on effectiveness of the   • Reporting of tests & calibrations,
  quality management system         equipment, testing and staff
                                    competency
                                     Requires extensive
                                     documentation
                                  • Creation of a detailed quality
                                    system & quality manual
                                  • Company should weigh benefits
                                    vs. time/costs involved

Page 3
ISO 17025 – Five Clauses
1. Scope
   • Covers technical operations that ensure lab is operated in a
     quality manner
2. Normative References
3. Terms and Definitions
4. Management Requirements
   • Covers documentation, document control, corrective action &
     internal audit
5. Technical Requirements
   • Most come from ISO Guide 25
   • Include personnel, selection methods, validation of methods,
     estimation of uncertainty of methods and measurement
     traceability


Page 4
Certification Process

     Complete in-
     house or hire      • Thorough understanding of ISO 17025

      consultant

         Conduct gap    • Determine current stage of compliance

           analysis     • Identify any components that are lacking




    Quality plan &      • Utilize results of gap analysis
                        • Conduct internal audit once standard requirements
   implementation         are satisfied
                        • Contact ISO 17025 registrar to conduct an
      strategy            independent certification audit




Page 5
Benefits of ISO 17025 Certification
  Several benefits to completing the certification
  process
• Industry recognition
• Competitive edge over non-certified competitors
• Processes & procedures are clearly documented
• System to continuously improve
• Improved customer service & higher customer satisfaction
• Internal process to identify non-conformance to standards and corrective
  action process




Page 6
Thank You
                                                         Phone: 810.534.2222
                                                       E-mail: info@cebos.com




www.cebos.com   Images used with permission from Microsoft.

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Testing Laboratory Practices and ISO 17025

  • 1. Testing Laboratory Practices and ISO 17025 www.cebos.com
  • 2. Maintaining Strict Quality Control Testing and calibration laboratories work within strict guidelines • Sampling identification • Labeling • Testing • Analysis • Documenting test results ISO 17025 certification • Same accreditation as ISO 9001 is for manufacturing and service organizations • Can attract more business & expand client base and profitability Page 2
  • 3. Two Main Clauses of ISO 17025 Management Technical Requirements Requirements Same as ISO Pertains to lab 9001:2000 operations • Focus on effectiveness of the • Reporting of tests & calibrations, quality management system equipment, testing and staff competency Requires extensive documentation • Creation of a detailed quality system & quality manual • Company should weigh benefits vs. time/costs involved Page 3
  • 4. ISO 17025 – Five Clauses 1. Scope • Covers technical operations that ensure lab is operated in a quality manner 2. Normative References 3. Terms and Definitions 4. Management Requirements • Covers documentation, document control, corrective action & internal audit 5. Technical Requirements • Most come from ISO Guide 25 • Include personnel, selection methods, validation of methods, estimation of uncertainty of methods and measurement traceability Page 4
  • 5. Certification Process Complete in- house or hire • Thorough understanding of ISO 17025 consultant Conduct gap • Determine current stage of compliance analysis • Identify any components that are lacking Quality plan & • Utilize results of gap analysis • Conduct internal audit once standard requirements implementation are satisfied • Contact ISO 17025 registrar to conduct an strategy independent certification audit Page 5
  • 6. Benefits of ISO 17025 Certification Several benefits to completing the certification process • Industry recognition • Competitive edge over non-certified competitors • Processes & procedures are clearly documented • System to continuously improve • Improved customer service & higher customer satisfaction • Internal process to identify non-conformance to standards and corrective action process Page 6
  • 7. Thank You Phone: 810.534.2222 E-mail: info@cebos.com www.cebos.com Images used with permission from Microsoft.