ML20237E162

9-1-2020 NEI Meeting - Attachment 1- NEI 17-06 Accreditation Body Observations Presentation

ML20237E162
Person / Time
Site:	Nuclear Energy Institute
Issue date:	03/12/2021
From:	Nuclear Energy Institute
To:	Office of Nuclear Reactor Regulation
Otto N
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ML20237E160	List: ML20237E162 ML20237E163
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Download: ML20237E162 (8)

Text

Accreditation Body Observation Checklist and Strategy 1 September 2020

©2020 Nuclear Energy Institute

Addressing QA Aspects of the Certifying Body (CB) by Leveraging the Accreditation Body (AB)

©2020 Nuclear Energy Institute 2

Overall Methodology Dedication of a Programmable Digital Device with Accreditation and Certification (NEI 17-06)

Oversight by US Nuclear Accreditation Body Industry Accreditation Licensee Or Dedicating Entity

• CGD of Service Certification Body ISO 17065

• CGD of Equipment/

Components

- Dependability CCs SIL Certificate Evaluation Service

-Performance CCs

-Physical CCs Equipment/ OEM Components IEC 61508

• Note that CGD activities include a technical evaluation

©2020 Nuclear Energy Institute 3

Overall Methodology Dedication of a Programmable Digital Device with Accreditation and Certification (NEI 17-06)

Oversight by US Nuclear Accreditation Body Industry Accreditation Licensee Or Dedicating Entity

• CGD of Service Certification Body ISO 17065

• CGD of Equipment/

Components

- Dependability CCs SIL Certificate Evaluation Service

-Performance CCs

-Physical CCs Equipment/ OEM Components IEC 61508

• Note that CGD activities include a technical evaluation

©2020 Nuclear Energy Institute 4

Previous and On-going Work

• Comparison Performed of Commercial Grade Survey to ISO 17065 Accreditation

• Potential Gaps Identified

• High-level Checklist Developed for Evaluating Potential Gaps

• Based on EPRI TR-106439

• Detailed Checklist Developed

• Based on IEC 61508

©2020 Nuclear Energy Institute 5

Potential Gaps

• From the Conclusion of the CGS/ ISO 17065 Comparison:

• The only aspect that still needs further investigation is how the accreditation relates to ensuring the CBs scheme is in compliance with the requirements of IEC 61508.

• CGS Critical Characteristic: Standards, procedures, and/or schemes validity, Acceptance Criteria: Basis documents are appropriate for the evaluation being performed.

• Relevant Requirements of ISO 17065 are Primarily in Section 7

©2020 Nuclear Energy Institute 6

Detailed Checklist For Evaluating the Potential Gap

• Main Topic Areas Identified in the High-level Checklist

• Based on EPRI TR-106439

• Scope is focused the CB Scheme

• The CB Scheme is required to comply with IEC 61508

• Sub-topic Areas Expanded Using Relevant Requirements of IEC 61508

• Completing this Detailed Checklist will Result in a Conclusion on the Potential Gap. The Gap will be confirmed or disproved.

©2020 Nuclear Energy Institute 7

©2020 Nuclear Energy Institute 8