Laboratory Accreditation Building Confidence on Testing Quality

Transcription

1 Laboratory Accreditation Building Confidence on Testing Quality Dr. George Anastasopoulos, Director (Conformity Assessment) & Prasanth S Ramakrishnan, MS, LEED-AP (Principal Staff & Program Manager) ASME V&V Symposium, May 4, 2017, Las Vegas

2 About IAS - Accreditation Programs Building Department Accreditation Inspection Agencies-ISO/IEC Building Department Service Providers Management Systems-ISO/IEC Calibration Laboratories-ISO/IEC Metal Building Systems Curriculum Development Personnel Certification Bodies-ISO/IEC Fabricator Inspection Product Certification Agencies-ISO/IEC Field Evaluation Bodies Special Inspection Agency Fire Prevention and Life Safety Testing Laboratories ISO/IEC Departments Training Agencies 2

3 Conformity Assessment Conformity assessment, is any activity to determine, directly or indirectly, that a process, product, or service meets relevant technical standards and fulfills relevant requirements. Conformity assessment activities may include: Testing. Surveillance. Inspection. 3

4 Quality - Introduction What is Quality? The suitability of a product for use as perceived by the user. 4

5 Accreditation Means to determine the technical competence of laboratories to perform specific types of testing, measurement and calibration. Provides formal recognition to competent laboratories, thus providing a confidence in the quality of test/calibration results. 5

6 Benefits of Accreditation Provides assurance, through accreditation, that testing laboratories have been evaluated against internationally accepted standards. Ensures the services of accredited laboratories are consistent and of high quality. 6

7 Benefits of Accreditation Provides proof of compliance with the standard ISO/IEC General requirements for the competence of testing and calibration laboratories. Provides evidence that laboratories render competent and consistent services in line with international standards. 7

8 Accreditation Body (AB) Accredits testing/calibration laboratories by verifying technical competence and assessing their management systems to the international standard ISO/IEC 17025:

9 Accreditation Body - Recognition Needs to be evaluated and recognized by International Laboratory Accreditation Cooperation (ILAC) and the Asia Pacific Laboratory Accreditation Cooperation (APLAC). 9

10 Conformity Assessment Structure ISO/IEC IAF/ILAC, Regional Accred. ISO/IEC IPC, IQNET 1 ISO/IEC Laboratories, Testing & Calibration ISO/IEC ISO/IEC CB s Inspection & Product Cert. Accreditation Bodies CB s Management Systems Cert. ISO/IEC ISO/IEC PCB s Personnel Certification 2 3 End Users - Consumers - Industry - Professionals 10

11 Costs Determination Scope applied for accreditation Laboratory resources Geographical location Specialized expertise needs 11

12 Accreditation Turn Around Time Adequacy of Quality Documentation. Preparedness of the Laboratory. Awareness of personnel about the standard ISO/IEC and appropriate regulations. Nature of findings noted during the assessment. Time taken to respond by the laboratory. Processing time by the AB on certificate issuance. 12

13 ISO/IEC Requirements 4 Management requirements 4.1 Organization 4.2 Management system 4.3 Document control General Document approval and issue Document changes 4.4 Review of requests, tenders and contracts 13

14 ISO/IEC Requirements 4 Management requirements 4.5 Subcontracting of tests and calibrations 4.6 Purchasing services and supplies 4.7 Service to the customer 4.8 Complaints 14

15 4 Management requirements 4.9 Control of nonconforming testing and/or calibration work 4.10 Improvement 4.11 Corrective action General Cause analysis Selection and implementation of corrective actions Monitoring of corrective actions Additional audits ISO/IEC Requirements 15

16 ISO/IEC Requirements 4 Management requirements 4.12 Preventive action 4.13 Control of records General Technical records 4.14 Internal audits 4.15 Management reviews 16

17 ISO/IEC Requirements 5 Technical requirements 5.1 General 5.2 Personnel 5.3 Accommodation and environmental conditions 17

18 ISO/IEC Requirements 5 Technical requirements 5.4 Test and calibration methods and method validation General Selection of methods Laboratory-developed methods Non-standard methods Validation of methods Estimation of uncertainty of measurement Control of data 18

19 ISO/IEC Requirements 5 Technical requirements 5.5 Equipment 5.6 Measurement traceability General Specific requirements Reference standards and reference materials 19

20 ISO/IEC Requirements 5 Technical requirements 5.7 Sampling 5.8 Handling of test and calibration items 5.9 Assuring the quality of test and calibration results 5.10 Reporting the results General Test reports and calibration certificates Test reports Calibration certificates 20

21 ISO/IEC Requirements 5 Technical requirements Opinions and interpretations Testing and calibration results obtained from subcontractors Electronic transmission of results Format of reports and certificates Amendments to test reports and calibration certificates 21

22 New ISO Approx. 50,000 accredited labs globally Next ISO-CASCO-WG44 meeting July 10-14, 2017 New ISO expected end of

23 THANK YOU 23