1. Developing the Process for Quality Labelling / Certification Schemes – Framework Considerations Presented by John O’Brien to 2 nd ARGOS Plenary Meeting – Certification Session Washington DC Friday, 12 th November, 2010 This project is funded by the European Union

2. Introduction Certification Schemes – Comprise Structure and Process Structure Structure -High Attention - Scheme Standards / Criteria -Content Convergence Process Process -Less Attention -How person / product / organisation becomes certified -Content highly variable / frequently localised Emerging Key Framework Characteristics for Process Certification Focus – Product Domain / EHR’s

3. Key Framework Considerations – Certification Process Scheme Owner Scheme Owner Certification Bodies Certification Bodies Global vs National Certification Global vs National Certification Mandatory vs Voluntary Status Mandatory vs Voluntary Status Supplier Participation Supplier Participation Audit vs Self-Assessment / Peer Review Audit vs Self-Assessment / Peer Review Audit / Surveyor Workforce Audit / Surveyor Workforce Quality Assurance vs Quality Improvement Quality Assurance vs Quality Improvement Scoring / Rating Schemes Scoring / Rating Schemes Certification Award Construct Certification Award Construct Evaluation Event Evaluation Event Payment / Fees Payment / Fees Scheme Review and Evaluation Scheme Review and Evaluation

4. Position of the Certification Process Arguably – Certification Schemes more likely to fail on Process than Structure Arguably – Certification Schemes more likely to fail on Process than Structure Requires understanding and appreciation of and empathy with key Stakeholders Requires understanding and appreciation of and empathy with key Stakeholders For product certification, key Stakeholders: For product certification, key Stakeholders: -Product Suppliers -Users of Products -Procurers / Funders of Products Process is, inter alia, mechanism by which Schemes engage and secure buy-in participation of Stakeholders Process is, inter alia, mechanism by which Schemes engage and secure buy-in participation of Stakeholders Must balance value and requirements of Certification with respect to respective Stakeholders while realising overarching purpose of Certification – improvement in quality, promulgation and deployment success of products (in this case EHR’s) Must balance value and requirements of Certification with respect to respective Stakeholders while realising overarching purpose of Certification – improvement in quality, promulgation and deployment success of products (in this case EHR’s)

5. Developing the Certification Process Must have regard to and at minimum provide for all process framework considerations set out above Must have regard to and at minimum provide for all process framework considerations set out above Options within each framework consideration – sometimes Stakeholder countervailing Options within each framework consideration – sometimes Stakeholder countervailing For Global advancement of EHR Certification – must increase consistency and convergence For Global advancement of EHR Certification – must increase consistency and convergence Discussion Paper attached Discussion Paper attached