IHE International IHE Conformity Assessment Committee

1. IHE International IHE Conformity Assessment Committee Report from the IHE Board Conformity Assessment Committee Notes from discussions April 6, 2014

2. Proposed Approach (needs update) • Provide update of work between the December 04, 2013 and February 26, 2014 Board Meeting • Work toward consensus on overall vision and 2014 – 2015 constrained proof of concept • Where possible obtain Board approval for: • CAS-1 (Conformity Assessment Scheme Volume 1) key components • Establishment of CAC (Conformity Assessment Coordination) Committee and a path to administrative support • Short term deliverables for CAC Committee • CAC Kickoff F2F meeting in Vienna at European Connectathon – 6 April

3. CAC Proposed Change to the Conformity Assessment Governance Create parent between CAC and T&T, and the Board? “Conformity Assessment and Tools” IHE International Board Conformity Assessment (CAC) Coordination Committee Priority Balancing for Tools for Accredited Testing and Development Work Testing & Tools Coordination Committee Global Deployment Coordination Committee Deployment Committees that use test labs (Category 1) Promoters Categories 2&3 Testing ToolsDevelopment Coordination Testing ToolsValidation and Distribution Nat/Reg Deployment Cttee • Open Source • Integrated, Deployment Committee Funded Development plan • Added scope: Connectathon + Conformity Assessment (17025) Nat/Reg Deployment Cttee Update slide from 04/24 discussion Nat/Reg Deployment Cttee Nat/Reg Deployment Cttee Nat/Reg Deployment Cttee Nat/Reg Deployment Cttee Nat/Reg Deployment Cttee Nat/Reg Deployment Cttee

4. Roles of Deployment CommitteesFunding for Accredited Testing Development work responsibility of National / Regional Deployment Committeesgrouped into categories defined by: • the level and type of control/resources committed Regional Deployment Committees have the right to not participate in terms of funding and conformity assessment management activities. 1 slide defines categories, 1 that talks about extensions and 1 that defines provisional and full membership; and 1 last summary slide to provide list of options. CAC will then specify commitments, and then solicit • Category 1 – Retains a Test Lab - Core grouping of active/ fully engaged National/Regional Deployment Committees committing resources to a) testing and tools infrastructure and sponsoring one or more Test Labs (initially the US and Europe). This grouping finances most of IHE International testing and tools development and maintenance work. • Category 2 - Funds specific requirements and promotes. This grouping does not necessarily want to sponsor an accredited Test Laboratory but does fund IHE International for conformity assessment testing and tools for specific profiles of interest in its region that may not have been included in current year priorities. • Category 3 – Promotes only. This grouping does not necessarily want to sponsor an accredited Test Laboratory but does “promote” the use of the IHE International testing mark in its region/country, or supports an IHE based local certification program. Could do this without funding by utilizing an accredited and IHE approved external test lab (in another country or region) and fund with fees from customers, the local committee recognizing the testing mark from another country (going through a Category 1 or 2 entity) to provide either an international testing mark or a local certification? Extensions to IHE International profiles or use of profiles outside the scope of CAS-2 for a local certification are outside the scope of the IHE International conformity assessment program and funding, but should be easily appended. If desiring international development or scope increase effectively will become a Category 2 entity. Does the fact that a deployment committee enters into a business agreement with an external lab make them a Category 1 or 2 recognizing the importance of the development to meet their needs, at least as an option? Extensions can be part of Category 1, 2 or 3. Note: Test tooling for Connectathon should continue to be funded from a part of Connectathon Fees

5. IHE CAS Organization and Workflow IHE International Board Is a member of IHE Conformity Assessment Coordination (CAC) Committee Applies for Authorization of a TL Authorizes TL IHE Deployment Committee Member of ILAC or IAF Retains a TL Applies for accreditation Accreditation Report Accreditation Body IHE Intl Authorized Testing Laboratory Assess and provide Report Renews accreditation

6. IHE CAS Organization and Workflow IHE International Board Is a member of IHE Conformity Assessment Coordination (CAC) Committee Published Reports Summaries Applies for Authorization of a TL Validation Entity Authorizes TL IHE Deployment Committee Test Report Summary Member of ILAC or IAF Retains a TL Applies for accreditation Accreditation Report Accreditation Body IHE Intl Authorized Testing Laboratory Assess and provide Report Test Report Summary Renews accreditation Conformity Assessment Customer Submit a system for testing

7. From CAS to Trial Implementation IHE International Board 2015 Conformance Assessment (Accreditation + Trial Implementation) Establishes Approves Nat/Reg Deployment Cttee IHE CAS-1 Nat/Reg Deployment Ctee CAC Committee Testing and Tools Committee Board Conformity Assessment WG (6 months) IHE CAS-2 Tool Development Committee

8. CAC Start-up – Prior to April 6 kickoff in Vienna • One or two deployment committees (Cat 1) who agree to provide support for CAC establishment coordination : need to define resource commitments for all in CAC meeting subsequent to Board meeting in order to obtain commitments from respective deployment committees • Recruit deployment committee representatives for CAC across Deployment Committee categories (1s for sure, 2s or 3s as well) • Begin 6 month hand over Conformity Assessment Workgroup (CAWG) to CAC; CAWG initially provides resources and guidance to CAC to insure a good, positive handoff

9. Establishment ofConformity Assessment Committee Scope and Structure

10. Proposed CAC Short Term Charter (1 of 2) • Drive 2015 Trial Implemenation • Identify and confirm target market segments (Profiles) and business needs (customers) for 2015 TI • Review and finalize CAS-2 by June 2014 with an initial set of profiles that match the market segmentation • Needs analysis with stakeholders to leave enough time to offer in 2015 (low number of profiles – low risk, high value, stable profiles) • Obtain deployment committee resources sufficient to carry out the trial without the use of IHE International funding

11. The Proposed CAC Short Term Charter (2 of 2) • Work with existing T+T to establish a framework for working Test Tool Development Coordination – and Establish guidelines • Open source • Architecture and portfolio of test tools drawing on ICSA, Gazelle and NIST reports • Etc. • Set up new line of business (In synergy with Connectathon) • Operational plan starting from work already completed by CAWG task forces covering governance and administration • CAC “Products”: IHE-CAS, Test Tools/Scripts, Published Test-Reports • Funding plan/shared resources for IHE-CAS-2 support

12. IHE-CAS-1 Conformity Assessment Scheme Part 1 V15 Distributed

13. IHE-CAS-1IHE Conformance Assessment Scheme-Part 1 1 General Information 2 Establishment, development and implementation of the IHE International CAS 3Testing Laboratory Accreditation Process 4Management Requirements • Technical Requirements Appendix A - Referencing IHE International Conformance Assessment Scheme Accreditation Appendix B - General process for establishing IHE authorized Testing Laboratories Appendix C - Regional or National Extensions to the IHE International CAS Appendix D – Validation of test Reports

14. IHE-CAS-1Section 1 General Information • The IHE-CAS is compliant and based on with ISO/IEC 17025 • Test Outcomes either used for: • An IHE International “Testing mark” (Not yet defined) • A Formal certification, awarded by an accredited certification body selected by an IHE Deployment Committee • Accreditation can serve: • Public and private Test Laboratories, including commercial laboratories, • University Laboratories, • Local government laboratories. Manufacturers’ in-house laboratoriesnot included at this time • IHE International makes information publicly available to the extent permitted by laws protect confidentiality of information

15. IHE-CAS-1Section 3 - Testing Laboratory Accreditation Process • IHE Deployment Committees retain Test Labs • Test Labs accredited to IHE-CAS by Accreditation Bodies members of ILAC and IAF • Once the Test Laboratory(ies) is accredited, Authorization is granted by CAC Committee. Authorization establishes a business relationship between the IHE Intl/CAC Committee, the Deployment Committee and the Authorized Test Laboratory. • Authorized Test lab commits to conduct Test according to IHE-CAS. • An on-site assessment of the Testing Lab shall be conducted at a minimum every four years by retained Accreditation Body. • Yearly remote assessments shall be conducted for changes in CAS-2 • Appeals of decisions made by CAC Committee (e.g. final authorization, revocation of authorization) are handled by the IHE International Board.

16. IHE-CAS-1Section 4 Management Requirements • Major changes to the IHE-CAS Vol 1 require 45 days of public comment. Final Version approved by the Board. • IHE-CAS-2 will reference IHE profiles that have reached Final Text. • Each major version of IHE-CAS-2 is typically updated each year. • New version of CAS Volume 2 require 30 days of public comment. Final Version approved by the Conformity Assessment Committee. • Accredited Test Laboratories shall update their own test process within a period of six months from the effective date of the new version of IHE-CAS-2

17. IHE-CAS-1Section 5 Technical Requirements • Reports on validation of the standard methods (test scripts, reference test data and test tools) are reviewed by the CAC Committee • Estimation of Uncertainty of Measurement Report is reviewed by the Relevant Entity of IHE International that approves the uncertainty of measurement process. • IHE International will be providing to the Authorized Test Laboratories the software for the standard test methods • The Test Report Summary once validated are published.

18. Conformity Assessment Scheme – Volume 1Main Discussion Points • Accreditation Bodies members of ILAC and IAF suitable. Others  CAC approval. • CAC Committee workload: • Small - Authorize Test Labs (receive accreditation report + 3 party agreement) • Small - Receive and Publish Test Report Summaries for tested systems • Large - Planning for CAS-2 including alignment with resources • Medium - Issue resolution about CAS-1 and CAS-2 • Large (test tools and scripts development, distribution and maintenance) • Authorized Test Labs revoked when: • Accreditation was revoked by accreditation body • Deployment Committee fails its business commitment for resources • Deployment Committee consensus on priorities: • No different than profile prioritization: category 1 & 2 Deployment Committees weight per their contribution • If priorities not addressed extends scheme with own profile (plan for future CAS-2 adoption-App C) • Test Tool Development • Test tool validation process (connectathon in early versions). Synergy with connectathon tools • Contributors (any entity as long as “endorsed” by a category 1 & 2 deployment Committee) • Quality program required (ISO 9001) • Manufacturers’ in-house laboratories not included at this time

19. List of Committees – who are involved currently • IHE Europe • IHE USA • Austria • Japan • Need to circulate to deployment committees: offer interim or full membership in categories 1, 2 or 3 (observers would be in Cat 3)