Better Regulatory Outcomes & the CASCO Toolbox

Transcription

1 2011/SOM1/SCSC/CON1/013 Session 8 Better Regulatory Outcomes & the CASCO Toolbox Submitted by: Underwriters Laboratories 6 th Conference on Good Regulatory Practice Washington, D.C., United States 1-2 March 2011

2 Better Regulatory Outcomes & the CASCO Toolbox Keith Mowry Underwriters Laboratories Inc Underwriters Laboratories Inc. Better Regulatory Outcomes - Maximum fulfillment of regulatory requirements at minimal cost - How can conformity assessment, and the CASCO Toolbox in particular, contribute? 2 1

3 Conformity assessment demonstration that specified requirements... are fulfilled ISO/IEC 17000, 2.1 Conformity Assessment - NOT a means of controlling fulfillment of specified requirements -A partof the activities undertaken for regulatory enforcement not always utilized - How does conformity assessment drive maximum fulfillment of regulatory requirements if it does not control or guarantee fulfillment? 4 2

4 Conformity Assessment - Confidence - Conformity assessment can assure regulators that regulatory requirements are being fulfilled it provides confidence - While that assurance for the regulator is useful, it does not drive the supplier of the regulated product or service to fulfill regulatory requirements 5 Conformity Assessment - Value - Completion of conformity assessment creates some amount of value for the supplier - The amount of value is perceived as the benefit the supplier receives compared to the cost of conformity assessment - At some level, the value of conformity assessment becomes desirable to attain and protect 6 3

5 Conformity Assessment - Value - The most critical action to attain and protect this value is to achieve and maintain fulfillment of requirements - When of sufficient value, conformity assessment creates an incentive to achieve and maintain fulfillment of requirements 7 Conformity Assessment - Value - When utilized in regulatory enforcement, conformity assessment that delivers maximum value should be chosen - Maximum value conformity assessment drives fulfillment of requirements IF

6 Conformity assessment is performed competently, consistently and impartially! Conformity Assessment Confidence & Value - Without competence, consistency and impartiality conformity assessment can not deliver confidence nor achieve high levels of value - The ISO CASCO Toolbox addresses competence, consistency and impartiality of conformity assessment 10 5

7 CASCO Toolbox - The CASCO Toolbox is a series of International Standards and Guides providing requirements and guidance for conformity assessment - Generally, the CASCO Toolbox has groups of documents related to conformity assessment bodies, conformity assessment activities, and conformity assessment information 11 CASCO Toolbox Bodies ISO/IEC Inspection Bodies ISO/IEC Testing & Calibration Labs ISO/IEC Personnel Certification Bodies ISO/IEC Management System Certification Bodies ISO/IEC Guide 65 Product Certification Bodies (Future ISO/IEC 17065) ISO/IEC Accreditation Bodies 12 6

8 CASCO Toolbox Bodies ISO/IEC Inspection Bodies ISO/IEC Testing & Calibration Labs ISO/IEC Personnel Certification Bodies ISO/IEC Management System Certification Bodies ISO/IEC Guide 65 Product Certification Bodies (Future ISO/IEC 17065) ISO/IEC Accreditation Bodies 13 CASCO Toolbox Activities ISO/IEC Guide 23 Methods of indicating conformity ISO/IEC Guide 27 Misuse of marks ISO/IEC Proficiency testing ISO/IEC Guide 68 Mutual recognition & acceptance ISO/IEC Third party marks ISO/IEC Peer assessment ISO/IEC Suppliers declaration of conformity (Parts 1 & 2) 14 7

9 CASCO Toolbox Information ISO/IEC Vocabulary & general principles ISO/IEC Normative documents ISO/IEC Guide 60 Code of good practice ISO/IEC Guide 67 Product certification fundamentals (future 17067) ISO/IEC Guide 28 Model product certification system ISO/IEC Guide 53 Use of a supplier s quality management system in product certification 15 The CASCO Toolbox is critical to The CASCO Toolbox is critical to driving fulfillment of specified requirements through conformity assessment 8

10 THANK YOU. 9