ML18275A121

Letter from Nuclear Energy Institute Endorsement of Iso/Iec 17025: 2017, General Requirements for the Competence of Testing and Calibration Laboratories.

ML18275A121
Person / Time
Site:	Nuclear Energy Institute
Issue date:	10/01/2018
From:	Richter M Nuclear Energy Institute
To:	Kerri Kavanagh Office of New Reactors
Hudson, Sharon
References
Download: ML18275A121 (15)

Text

MARK A. RICHTER, PH.D.

Senior Project Manager, Used Fuel and Decommissioning Programs 1201 F Street, NW, Suite 1100 Washington, DC 20004 P: 202.739.8106 mar@nei.org nei.org October 1, 2018 Ms. Kerri A. Kavanagh, Chief Quality Assurance Vendor Inspection Branches 1 & 2 Division of Construction Inspection and Operational Programs Office of New Reactors M/S O-4A17M U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

Subject:

Endorsement of ISO/IEC 17025: 2017, "General Requirements for the Competence of Testing and Calibration Laboratories" Project Number: 689

Dear Ms. Kavanagh:

The United States Nuclear Regulatory Commission (NRC) endorsed the International Laboratory Accreditation Cooperation (ILAC) process through their endorsement of Nuclear Energy Institute 1 (NEI)14-05A, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services" on February 9, 2015. The ILAC process allows nuclear utilities and their suppliers to accept testing and calibration services (in lieu of a commercial grade survey) from laboratories that are accredited to ISO/IEC 17025:2005 by Accreditation Bodies (AB) that are signatories to the ILAC Mutual Recognition Agreement (MRA). Use of the ILAC process is contingent on meeting the conditions specified in NEI 14-05A; one of which is the laboratory must be accredited to ISO/IEC 17025:2005.

On November 30, 2017, ISO (International Organization for Standardization) published a new version of ISO/IEC 17025, "General Requirements for the Competence of Testing and Calibration Laboratories." In order for nuclear utilities and their suppliers to continue to utilize the ILAC process during commercial grade dedication of calibration and testing services, the nuclear industry must first gain the NRCs acceptance of ISO/IEC 17025:2017. The Nuclear Procurement Issues Corporation (NUPIC) in conjunction with NEI is seeking the NRC's endorsement of ISO/IEC 17025:2017.

1 NEI is the organization responsible for establishing unified nuclear industry policy on matters affecting the nuclear energy industry, including the regulatory aspects of generic operational and technical issues. NEIs members include all utilities licensed to operate commercial nuclear power plants in the United States, nuclear plant designers, major architect/engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nuclear energy industry.

Ms. Kerri A. Kavanagh October 1, 2018 Page 2 ISO/IEC 17025:2017 covers all laboratory activities, including testing, calibration and the sampling associated with subsequent calibration and testing. ISO/IEC 17025:2017 includes technical enhancements, definitions of key terms, and provisions for greater use of Information Technology (IT) techniques. The major changes are identified in Attachment 1 ISO/IEC GAP Analysis Summary.

The NUPIC/NEI Committee performed a detailed review of the 2005 and 2017 versions of ISO/IEC 17025 to substantiate that the ISO/IEC 17025:2017 does not reduce technical commitments or quality requirements.

This review verified that the major changes were essentially formatting and additions which enhance the ISO/IEC 17025 standard. A Requirements Traceability/Cross Reference Matrix (Attachment 2) was developed to perform this review. As a result, the NEI/NUPIC Committee concluded that the ISO/IEC 17025:2017 is equivalent to, or better than, ISO/IEC 17025:2005 in technical and quality requirements.

ISO has designated a three (3) year transition for the ISO/IEC 17025:2017. Since the standard was published on November 30, 2017, all re-accreditations and new accreditations to ISO/IEC 17025 must be made to ISO/IEC 17025:2017 by November 30, 2020. In order to meet this deadline, each AB that is a signatory to the ILAC MRA has developed a transition plan for accrediting their laboratories and prospective laboratories. To ensure successful transitions, some ABs have started the process of accrediting laboratories to ISO/IEC 17025:2017. To this end, ILAC/ISO issued a Joint Communication which stressed that during this transition period, ISO/IEC 17025:2005 and ISO/IEC 17025:2017 are valid and equivalent for use. ILAC/ISO strongly recommends that governmental bodies and approval agencies recognize both versions until the 3-year transition period closes. The Joint Communication is attached (Attachment 3.) The NUPIC/NEI Committee is requesting endorsement of ISO/IEC 17025:2017 by the NRC on behalf of the nuclear industry during this transition period. This endorsement should recognize both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 during this transition period. A revision to NEI 14-05A will be subsequently provided to the NRC requesting endorsement of ISO/IEC 17025:2017 beyond the transition period.

Should you have any questions, please do not hesitate to contact me.

Sincerely, Mark A. Richter Attachments

Joint ILAC-ISO Communiqué on the recognition of ISO/IEC 17025 during a Three-Year Transition Laboratories wishing to demonstrate their technical competence can do so via conformity with the international standard ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories. Conformity with this standard also means that the laboratory generally operates a management system in accordance with the principles of ISO 9001.

In 2017, ISO published a revision to ISO/IEC 17025 (previously published in 2005) to ensure that requirements continue to meet the demands of the modern market place. As a consequence, it has been agreed that laboratories that demonstrate conformity through third-party accreditation will need to transition their processes to the new version within a defined timeframe. ILAC, in consultation with ISO, agreed that a three year period from the date of publication shall be allowed for this transition.

During this transition period, it is important to note that both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 are equally valid and applicable. Formal accreditation to either standard granted by an accreditation body that is a signatory to the ILAC Arrangement should be recognised by the market place, and it is strongly recommended that specifiers equally recognise both versions until after the 3-year transition period has closed.

November 2017

ISO/IEC 17025: 2005 and 2017 Requirement Traceability/Cross Reference Matrix 2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Scope Scope Section 1, Page 1 Section 1, Page 1 Equivalent Clause 1.1, 1.2, 1.3, 1.4, 1.5, 1.6 , All Page 1 Normative Normative Section 2 , Page 2 Section 2, Page 1 Equivalent References References Terms and Terms and Section 3, Page 2 Section 3, Pages 1-3 ISO/IEC 17025:2017 improved this area.

Definitions Definitions Key terms are defined.

Management Management Section 4, Page 2 Section 5, Page 4 Equivalent Requirements System Section 6, Page 5 Requirements Section 8, Page 19 Organization Structural Section 4.1, Page 2 Section 5, Page 4 Equivalent Requirements Clause 4.1.1, Page 2 Clause 5.1, Page 4 The requirement to Clause 4.1.2, Page 2 Clause 5.4, Page 4 appoint a deputy for each key managerial Page 1 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 4.1.3, Page 2 Clause 5.4, Page 4 personnel (4.1.5j) was not carried over from Clause 4.1.4, Page 2 Clause 4.1.4, Page 3 ISO 17025:2005 to ISO Clause 4.1.5a, Page2 Clause 5.6a, 5.6b, 5.6c, Page 4 17025:2017. This does not present a problem Clause 4.1.5b, Page 3 Clause 4.1.2, 4.1.3, Page 4 because the new standard still requires a Clause 4.1.5c, Page 3 Clause 4.2, Pages 3-4 laboratory to have the Clause 4.1.5d, Page 3 Clause 4.1.1, Page 3 personnel resources to manage and perform Clause 6.2.1, Page 5 its laboratory activities.

Clause 4.1.5e, Page 3 Clause 4.1.1, Page 3, Clause 5.5a, Page 4 Clause 4.1.5f, Page 3 Clause 4.1.1, Page 3 Clause 5.5b, Page 4 Clause 4.1.5g, Page 3 Clause 6.2.5d, Page 5 Clause 4.1.5h, Page 3 Clause 5.2, Page 4 Clause 4.1.5i, Page 3 Clause 5.2, Page 4 Clause 5.6d, 5.6e, Page 4 Page 2 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 4.1.5j, Page 3 No Equivalent Requirement - See Clause 6.1 Clause 4.1.5k, Page 3 Clause 6.2.3, Page 5, Clause 8.2.1, Page 20 Clause 4.1.6, Page 3 Clause5.7a, Page 5 Management Management Section 4.2, Page 3 Section 8, Page 19 Equivalent Systems Systems Clause 8.1.2 An Annex B has been Requirements Clause 4.2.1, Page 3 Clause 5.5c, Page 4 added to the 2017 Version. This Annex Clause 6.2.4, Page 5 allows the option of using the Management Clause 8.2.1, Page 20 System requirements Clause 8.2.5, Page 20 specified in ISO/IEC 1702:2017 or Clause 8.9.2b, Page 23 implementing Clause 4.2.2a, Page 3 Clause 8.2.1, Page 20 Management System requirements from ISO Clause 4.2.2b, Page 3 Clause 8.2.2, Page 20 9001:2015.

Clause 4.2.2C, Page 3 No Equivalent Requirement In both cases, the Clauses of 4 to 7 Clause 4.2.2d, Page 4 No Equivalent Requirement (Technical Page 3 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 4.2.2e, Page 4 Clause 5.6a Requirements) shall be met.

Clause 4.2.3, Page 4 Clause 5.6e, Page 4 In addition, ISO Clause 5.7a, Page 5 17025:2017 does not Clause 8.2.3, Page 20 include a requirement for having a Quality Manual. However, all of the requirements for Clause 4.2.4, Page 4 Clause 6.2.4, Page 5 implementation of a Clause 4.2.5, Page 4 Clause 8.2.4, Page 20 Management Systems are included through Clause 4.2.6, Page 4 No Equivalent Requirement the standard including Clause 4.2.7, Page 4 Clause 5.7b Clause5 (Structural Requirements) and Clause9 (Management System Requirements)

Document Control of Section 4.3, Page 4 Clause 7.2.1.2, Page 10 Equivalent Control Management Clause 8.1.2, Page 20 ISO 17025:2017 does System Clause 4.3.1, Page 4 Clause 8.3.1, Page 20 not include provisions Documents for making

- General Clause 4.3.2, Page 4 Clause 7.11.5, Page 19 amendments to documents by hand

- Document Clause 4.3.2.1, Page 4 Clause 8.3.2a, Page 20 but the new standard Page 4 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Approval Clause 4.3.2.2a, Page 4 Clause 8.3.2d, Page 21 still requires all changes to be

- and Issuance Clause 4.3.2.2b, Page 4 Clause 8.3.2b, Page 21 approved by

- Clause 4.3.2.2c, Page 5 Clause 8.3.2f, Page 21 authorized personnel.

- Clause 4.3.2.2d, Page 5 Clause 8.3.2f, Page 21 ISO 17025:2017 does not include a provision

- Clause 4.3.2.3, Page 5 Clause 8.3.2e, Page 21 for changing computerized document but does

- Clause 4.3.3.1, Page 5 Clause 8.3.2a, Page 20 include provision for controlling changes to

- Document Clause 4.3.3.2, Page 5 Clause 8.3.2c, Page 21 all documents and Changes Clause 4.3.3.3, Page 5 No Equivalent Requirement acknowledges that documents can be Clause 4.3.3.4, Page 5 No equivalent Requirement controlled in various formats including electronically.

Review of Review of Section 4.4, Page 5 Section 7.1, Page 9 Equivalent requests, requests, tenders and tenders and Clause 4.4.1, Page 5 Clause 7.1.1, Page 9 contracts contracts Clause 7.1.4, Page 10 Page 5 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 4.4.1a, Page 5 Clause 7.1.1a, Page 9 Clause 4.4.1b, Page 5 Clause 7.1.1b, Page 9 Clause 4.4.1c, Page 5 Clause 7.1.1d, Page 9 Clause 4.4.2, Page 5 Clause 7.1.8, Page 10 Clause 4.4.3, Page 6 Clause 7.1.1c, Page 9 Clause 4.4.4, Page 6 Clause 7.1.5, Page 10 Clause 4.4.5, Page 6 Clause 7.1.6, Page 10 Subcontracting Externally Section 4.5, Page 6 Section 6.6, Page 8 Equivalent of tests and Provided calibrations Products and Clause 4.5.1, Page 6 Clause 6.6.1, Page 8 Services Clause 6.6.2b, Page 9 Clause 4.5.2, Page 6 Clause 7.1.1c, Page 9 Clause 4.5.3, Page 6 Clause 6.6.1b, Page 8 Clause 6.6.2d, Page 9 Clause 4.5.4, Page 6 Clause 6.6.2 b& c, Page 9 Page 6 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Purchasing Externally Section 4.6, Page 6 Section 6.6, Page 8 Equivalent services and Provided Clause 4.6.1, Page 6 Clause 6.6.1a&c, Page 8 ISO 17025:2017 does supplies Products and Clause 6.6.2b, Page 9 not specifically state Services that approved sub-Clause 4.6.2, page 6 Clause 6.6.1, 6.61a, Page 8 suppliers are to be listed, it does require Clause 6.6.2c, Page 9 only approved sub-Clause 4.6.3, Page 6 Clause 6.6.3, Page 9 supplier are used and records of their Clause 4.6.4, Page 6 No Equivalent Requirement approval and acceptance of their items and services are required to be maintained.

Service to the Review of Section 4.7, Page 6 Section 7.1 Equivalent customer Requests, Clause 4.7.1, Page 6 Clause 7.1.7, Page 10 While ISO 17025:2017 Tenders and Clause 4.7.2, Page 7 Clause 8.6.2, Page 22 does not include a Contracts section titled "Service to the Customer", the And requirements in this area from ISO Improvements 17025:2005 are addressed in Clauses Page 7 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description 7.1.7 and 8.6.2 of ISO 17025:2017.

Complaints Complaints Section 4.8, Page 7 Section 7.9, Page 17 ISO/IEC 17025:2017 improved this area.

Clause 7.9.1, Page 17 Additional Clause 7.9.2, Page 18 requirements for addressing complaints Clause 7.9.3a, b, c. Page 18 have been added.

Clause 7.9.4, Page 18 Clause 7.9.5, Page 18 Clause 7.9.6, Page 18 Clause 7.9.7, Page 18 Control of Nonconforming Equivalent nonconforming Work Section 4.9, Page 7 Section 7.10, Page 18 testing and/or Clause 7.11.3e, Page 19 calibration work Clause 4.9.1 Clause 7.10.1, Page 18 Clause 4.9.1a Clause 7.10.1a & b, Page 18 Page 8 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 4.9.1b Clause 7.10.1c, Page 18 Clause 4.9.1c Clause 7.10.1b & d, Page 18 Clause 8.7.1a Clause 4.9.1d Clause 7.10.1e, Page 18 Clause 4.9.1.e Clause 7.10.1f, Page 18 Clause 4.9.2 Clause 7.10.3, Page 18 Improvement Management Section 4.10, Page 7 Clause 8.1.2, Page 20 Equivalent System Section 8.6, Page 22 Requirements Clause 8.6.1, Page 22 Option A Clause 8.6.2, Page 22 Improvement Corrective Corrective Section 4.11 Page 8, Section 8.7, Page 22 Equivalent Actions Actions Clause 4.11.1, Page 8 Clause 7.11.3e, Page 19 While ISO 17025:2017

-General Clause 4.11.2, Page 8 Clause 8.7.1b, Page 22 does not include a statement regarding

- Cause analysis Clause 4.11.3, Page 8 Clause 8.7.1c & f, Page 22 performing additional internal audits as a

- Selection and Clause 8.7.2, Page 22 result of corrective implementation of Page 9 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description corrective actions Clause 4.11.4, Page 8 Clause 8.7.1d, Page 22 actions in a given area, ISO 17025-2017 does

- Monitoring of Clause 4.11.5, Page 8 No Equivalent Requirement require effectiveness corrective actions reviews for corrective

- Additional audits action taken and internal audits based

- 4.12 on results of management reviews and management discretion.

Preventive No Specific Section 4.12, Page 8 No Equivalent Section Equivalent action Section for Clause 4.12.1, Page 8 Clause 8.6.1, Page 22 The 2017 Version does Preventive Clause 4.12.2, Page 8 No Equivalent Requirement not have a specific action Section on Preventive Action. However, the basic requirements for corrective action and preventive action are addressed in the Corrective Action and Improvement Sections.

Page 10 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Control of Control of Section 4.13, Page 9 Section 8.4, Page 21 Equivalent Records Records Clause 4.13.1.1, Page 9 Clause 7.10.2, Page 18 General Clause 8.1.2, Page 20 Clause 8.4.1, Page 21 Clause 8.7.3a & b, Page 22 Clause 4.13.1.2, Page 9 Clause 7.11.3d, Page 19 Clause 8.4.1 & 2, Page 21 Clause 4.13.1.3, Page 9 Clause 8.4.2, Page 21 Clause 4.13.1.4, Page 9 Clause 7.11.3a, b, c, Page 19 Clause 4.13.2.1, Page 9 Clause 7.8.1.2, Page 14 Equivalent Technical Technical Records Clause 7.5.1, Page 13 Records Clause 4.13.2.2, Page 9 Clause 7.5.1, Page 13 Clause 4.13.2.3, Page 9 Clause 7.5.2, Page 13 Internal audits Internal Audits Section 4.14, Page 9 Section 8.8, Page 23 Equivalent Clause 4.14.1, Page 9 Clause 8.8.1,8.8.1a, Page 23 ISO 17025:2017 does Page 11 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 8.8.2a, b, c, Page 23 not specifically require follow-up audits to Clause 4.14.2, Page 10 Clause 8.8.1b,8.8.2d, Page 23 verify corrective action Clause 4.14.3, Page 10 Clause 8.8.2e, Page 23 effectiveness, however, the Clause 4.14.4, Page 10 No Equivalent Requirement corrective action process does require effectiveness reviews Management Management Section 4.15, Page 10 Section 8.9, Page 23 Equivalent reviews Reviews Clause 4.15.1, Page 10 Clause 8.9.1, 8.9.2a-o, Page 23 Clause 4.15.1, Page 10 Clause 8.9.3a-d, Page 24 Technical Resource Section 5, Page 10 Section 6, Page 5 Equivalent Requirements Requirements Clause 5.1.1, Page 10 Section 6.1, Page 5 ISO 17025:2017 does Clause 5.1.2, Page 11 No Equivalent Statement not have a single General statement addressing Clause 5.1.2 from ISO 17025:2005, however, various sections such as Section 6.1, Page 12 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description "General", Section 6.2, "Personnel", Section 6.3, "Facilities and Environmental Conditions", Section 6.4, "Equipment" collectively address this area.

Personnel Personnel Section 5.2, Page 11 Section 6.2, Page 5 Equivalent Clause 5.2.1, Page 11 Clause 6.2.1, 6.2.2, 6.2.5a, f, Page 5 Clause 5.2.2, Page 11 Clause 6.2.5b, c, f, Page 5 Clause 5.2.3, Page 11 Clause 6.1, Page 5 Clause 6.2.1, 6.2.2, Page 5 Clause 5.2.4, Page 11 Clause 6.2.2, Page 5 Clause 5.2.5, Page 11 Clause 6.2.3, Page 5 Clause 6.2.5a, d, Page 5 Clause 6.2.6,a,b,c, Page 5 Clause 7.8.7.1, Page 17 Page 13 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Accommodation Facilities and Section 5.3, Page 12 Section 6.3, Page 6 Equivalent and Environment Clause 5.3.1, Page 12 Section 6.1, Page 5 While ISO 17025:2017 environmental Conditions Clause 6.3.1, 6.3.2, Page 6 does not have a conditions statement specifically Clause 6.3.5, Page 6 addressing housekeeping of Clause 5.3.2, Page 12 Clause 6.3.3, Page 6 laboratory areas, Clause 6.3.4b, Page 6 Section 6.3 does address environmental Clause 5.3.3, Page 12 Clause 6.3.4c, Page 6 controls and the Clause 5.3.4, Page 12 Clause 6.3.4a, Page 6 suitability of the laboratory to prevent Clause 5.3.5, Page 12 No Equivalent Requirement conditions that could adversely impact the validity of results including contamination.

Test and Selection, Section 5.4, Page 12 Section 7.2, Page 10 Equivalent calibration Verification and Clause 5.4.1, Page 12 Clause 6.4.3, Page 6 While ISO 17025:2017 methods and Validation of Clause 7.2.1.1, 7.2.1.2, Page 10 does not have a section method Methods titled Non-standard Clause 7.2.1.7, Page 11 Methods, Clause7.2.2,

'Verification of Page 14 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description validation Methods", includes controls for the

- General Selection and Clause 5.4.2, Page 13 Clause 7.1.2, Page 9 verification of non-Verification of Clause 7.1.4, Page 10 standard methods as

- Selection of Methods well as laboratory methods Clause 7.2.1.3, 7.2.1.4, Page 10 developed and

- modified standard Clause 5.4.3, Page 13 Clause 6.2.3, Page 5 Selection and methods.

Laboratory- Clause 6.2.5e, Page 5 Verification of developed methods Methods Clause 6.2.6a, Page 5 Clause 7.2.1.6, Page 11 Clause 5.4.4, Page 13 No Equivalent Requirement Selection and Clause 5.4.5, Page 14 Clause 7.2.2, Page 11 Non-standard Verification of methods Methods Clause 5.4.5.1, Page 14 Clause 3.8 & 3.9, Page 2-3 Validation of Clause 5.4.5.2, Page 14 Clause 7.2.2.1 & 7.2.2.2, Page 11 Methods Clause 7.2.2.4a,d,e, Page 11-12 Validation of methods Clause 5.4.5.3, Page 14 Clause 7.2.1.6, Page 11 Clause 7.2.2.3, Page 11 Clause 7.2.2.4b,c, Page 11-12 Page 15 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 5.4.6, Page 14 Section 7.6, Page 13 Estimation of Evaluation of Clause 5.4.6.1, Page 14 Clause 7.6.2, Page 13 uncertainty of Measurement Clause 5.4.6.2, Page 14 Clause 7.6.1, Page 13 measurement Uncertainty Clause 7.6.3, Page 13 Clause 5.4.6.3, Page 15 Clause 7.6.1, Page 13 Clause 5.4.7, Page 15 Section 7.11, page 19 Control of Data and Clause 5.4.7.1, Page 15 Clause 7.11.6, Page 19 Control of data Information Management Clause 5.4.7.2a, Page 15 Clause 7.11.2, Page 19 Clause 5.4.7.2b, Page 15 Clause 7.11.3a, Page 19 Clause 5.4.7.2c, Page 15 Clause 6.4.3, Page 6 Clause 6.4.12, Page 7 Clause 7.11.3b,c, Page 19 Page 16 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Equipment Equipment Section 5.5, Page 15 Section 6.4, Page 6 Equivalent Clause 5.5.1, Page 15 Section 6.1, Page 4 Clause 6.4.1, 6.4.2, Page 6 Clause 5.5.2, Page 15 Clause 6.4.1, 6.4.4, Page 6 Clause 6.4.5, 6.4.6, 6.4.7, Page 7 Clause 5.5.3, Page 16 Clause 6.4.3, Page 6 Clause 5.5.4, Page 16 Clause 6.4.8, 6.4.13a, Page 7 Clause 5.5.5a, Page 16 Clause 6.4.13a, Page 7 Clause 5.5.5b, Page 16 Clause 6.4.13b, Page 7 Clause 5.5.5c, Page 16 Clause 6.4.13c, Page 7 Clause 5.5.5d, page 16 Clause 6.4.13d, Page 7 Clause 5.5.5e, Page 16 Clause 6.4.3, Page 6 Clause 5.5.5f, Page 16 Clause 6.4.13e, Page 7 Clause 5.5.5g, Page 16 Clause 6.4.13g, Page 8 Page 17 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 5.5.5h, Page 16 Clause 6.4.13h, Page 8 Clause 5.5.6, Page 16 Clause 6.4.3, Page 6 Clause 5.5.7, Page 16 Clause 6.4.9, Page 7 Clause 5.5.8, Page 16 Clause 6.4.8, Page 7 Clause 5.5.9, Page 16 Clause 6.4.4, Page 6 Clause 5.5.10, Page 16 Clause 6.4.10, page 7 Clause 5.5.11, Page 16 Clause 6.4.11, Page 7 Clause 5.5.12, Page 16 Clause 6.4.12, Page 7 Measurement Metrological Section 5.6, Page 17 Section 6.5, Page 8 Equivalent Traceability Traceability A new ANNEX A has General Clause 5.6.1, Page 17 Clause 6.4.4, Page 6 been added to the 2017 version to

- Clause 6.4.6, 6.4.7, Page 7 provided additional information on the subject of Metrological Calibration Clause 5.6.2.1.1, Page 17 Clause 6.5.1,6.5.2a,c, Page 8 Traceability See page 25-26 Clause 5.6.2.1.2, page 18 Clause 6.5.3a,b, Page 8 Page 18 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 7.7.2, Page 14 Clause 5.6.2.2.1, Page 18 Clause 6.4.7, Page 7 Testing Clause 5.6.2.2.2, Page 18 Clause 6.5.3a,b, Page 8 Clause 5.6.3.1, Page 18 Clause 6.4.7, Page 7 Reference standards Clause 5.6.3.2, Page 18 Clause 6.4.10, Page 7 Reference materials Clause 5.6.3.3, Page 18 Clause 6.4.10, Page 7 Intermediate Checks Clause 5.6.3.4, Page 18 Clause 6.4.3, Page 6 Transport and Storage Sampling Sampling Section 5.7, Page 19 Section 7.3, Page 12 Equivalent Clause 5.7.1, Page 19 Clause 7.3.1, 7.3.2a-c, Page 12 Clause 5.7.2, Page 19 Clause 7.3.3c, h, Page 12 Clause 5.7.3, Page 19 Clause 7.3.3a-h, Page 12 Handling of test Handling of Test Section 5.8, Page 19 Section 7.4, Page 12 Equivalent Page 19 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description and calibration or Calibrated Clause 5.8.1, Page 19 Clause 7.4.1,Page 12 items Items Clause 5.8.2, Page 19 Clause 7.4.2, Page 12 Clause 5.8.3, Page 19 Clause 7.4.3, Page 13 Clause 5.8.4, Page 19 Clause 7.4.1, Page 12 Clause 7.4.4, Page 13 Assuring the Ensuring the Clause 5.9, Page 20 Clause 7.7, Page 13 Equivalent Quality of Test Validity of Clause 5.9.1a-e, Page 20 Clause 7.7.1a-k, 7.7.2a-b, Page 13 and Calibration Results Clause 5.9.2, Page 20 Clause 7.7.3, Page 14 Results Reporting the Reporting the Section 5.10, Page 20 Section 7.8, Page 14 Equivalent Results Results General Common Clause 5.10.1, Page 20 Clause 7.8.1.2, 7.8.1.3, Page 14 requirements for

- Test reports and Clause 5.10.2a-k, Page 20 Clause 7.8.1.1, Page 14 reports (test, calibration calibration,, Clause 7.8.2.1a-p, Page 15 certificates sampling)

Page 20 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Test reports

- Specific requirements Clause 5.10.3, Page 21 Clause 7.8.3, Page 15 for test reports Clause 5.10.3.1a-e, Page 21 Clause 7.8.2.1n, Page 15 Clause 7.8.3.1a-e, Page 15-16 Clause7 .8.6.2, Page 17 Clause 5.10.3.2a-f, Page 21 Clause 7.8.3.2, Page 16 Clause 7.8.5a-f, Page 17 Calibration Clause 5.10.4, Page 22 Clause 7.8.4, Page 16 certificates Specific Clause 5.10.4.1a-c, Page 22 Clause 7.8.4.1a-f, Page 16 Requirements for Calibration Clause 5.10.4.2, Page 22 Clause 7.8.4.1e, Page 16 Certificates Clause 7.8.6.1, Page 17 Clause 7.8.6.2a,b, Page 17 Clause 5.10.4.3, Page 22 Clause 7.8.4.1d, Page 16 Clause 5.10.4.4, Page 22 Clause 7.8.4.3, Page 16 Clause 7.8.4.1f, Page 16 Page 21 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description

- Opinions and Clause 5.10.5, Page 22 Clause 7.8.7, Page 17 interpretations Reporting Opinions Clause 7.8.7.1-7.8.7.3, Page 17 and Interpretations

- Testing and Clause 5.10.6, Page 23 Section 6.6, Page 8 calibration results Externally Provided obtained from Clause 6.6.1b, Page 8 Products and Services subcontractors Clause 7.8.2.1p, Page 15

- Electronic transmission of Clause 5.10.7, Page 23 Clause 7.11.2, Page 19 Control of Data and results Information Management

- Format of reports Clause 5.10.8, Page 23 Section 7.8, Page 14 and certificates Reporting of Results Clause 7.8.1.2, 7.8.1.3, Page 14 Page 22 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Amendments to test Clause 5.10.9, Page 23 Clause 7.8.8, Page 17 reports and Amendments to Clause 7.8.8.1 - 7.8.8.3, Page 17 calibration certificates Reports Nominal cross- There is no Annex A, No Equivalent Section Different but no references to Equivalent Page 24 adverse impact.

ISO 9001:2000 Section ISO 17025:2017 does not include an equivalent reference section; however this difference has no impact on acceptability of the 2017 version since it this was a reference section only.

Guidelines for There is no Annex B, No Equivalent Section Different but no establishing Equivalent Page 26 adverse impact.

applications for Section ISO 17025:2017 does Page 23 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description specific fields not include an equivalent section addressing guidelines for establishing applications for specific fields; however this difference has no impact on acceptability of the 2017 version since this section provided additional guidance and not requirements.

Additions to ISO/IEC Comments 17025:2017 New Additions to ISO/IEC implemented in the 17025:2017.

THE NUPIC/NEI team views these additions as enhancements to the Page 24 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description standard. These clauses are listed below in bold and italicized print.

Impartiality Enhancement Clause 4.1.4, 4.1.5, Page 3 Confidentiality Enhancement Clause 4.2.1, Page 3 Clause 4.2.2. Page 3 Clause 4.2.3, Page 4 Clause 4.2.4, Page 4 Structural Requirements Enhancement Section 5.3, Page 4 This new clause requires laboratories to define and document the range of laboratory activities for which it conforms to ISO/IEC 17025:2017. The laboratory can only Page 25 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description claim conformity with the standard for the specified range of activities which excludes externally provided activities on an ongoing basis.

Resource Requirements Enhancement Clause 6.2.5f, Page 5 Equipment Enhancement Clause 6.4.7, Page 7 Clause 6.4.8, Page 7 Clause 6.4.11, Page 7 Clause 6.4.13a, Page 7 Clause 6.4.13f, Page 7 Metrological Traceability Enhancement Clause 6.5.2b, Page 8 Page 26 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Externally Provided Products and Enhancement Services Clause 6.6.2a, d, Page 9 Clause 6.6.3b, c, d, Page 9 Review of Requests, Tenders and Enhancement Contracts Clause 7.1.1c, Page 9 Clause 7.1.3, Page 9 Selection, Verification and Enhancement Validation of Methods Clause 7.2.1.5, Page 11 Sampling Enhancement Clause 7.3.3b, c, e, h, Page 12 Handling of Test or Calibration Enhancement Items Clause 7.4.3, Page 13 Technical Records Enhancement Page 27 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 7.5.2, Page 13 Ensuring the Validity of Results Enhancement Clause 7.7.2a, b, Page 14 Reporting the Results Enhancement Clause 7.8.1.2, Page 14 Clause 7.8.2.1j, Page 15 Clause 7.8.2.2, Page 15 Clause 7.8.4.2, Page 16 Clause 7.8.5f, Page 17 Clause 7.8.6, 7.8.6.1, 7.8.6.2, Page 17 Clause 7.8.7.3, Page 17 Clause 7.8.8.1, Page 17 Complaints Enhancement Clause 7.9.2, Page 18 Page 28 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 7.9.3a, b, c, Page 18 Clause 7.9.4, 7.9.5, 7.9.6, 7.9.7, Page 18 Nonconforming Work Enhancement Clause 7.10.1b, c, Page 18 Clause 7.10.2, Page 18 Control of Data and Information Enhancement Management Clause 7.11.2, Page 19 Clause 7.11.3e, Page 19 Clause 7.11.4, Page 19 Management Systems Enhancement Requirements Clause 8.1.1, Page 19 Actions to Address Risks and Enhancement Opportunities Clause 8.5.1a, b, c, Page 21 Page 29 of 30

2005 Element - 2017 Element - 2005 Section # / Page # 2017 Section # / Page # Comments Description Description Clause 8.5.2a, b, Page 21 Clause 8.5.3, Page 21 Corrective Actions Enhancement Clause 8.7.1e, Page 22 Internal Audits Enhancement Clause 8.8.2a, b, page Management Enhancement Review Clause 8.9.2a, d, k, m, Page 23-24 Clause 8.9.3a, b, c, d, Page 24 Page 30 of 30

ISO/IEC GAP Analysis Summary The United States Nuclear Regulatory Commission (USNRC) previously endorsed the "ILAC" process through their endorsement of Nuclear Energy Institute (NEI)14-05A, "Guidelines for the Use of Accreditation in Lieu of Commercial Grade Surveys for Procurement of Laboratory Calibration and Test Services". The International Laboratory Accreditation Cooperation (ILAC) process allows nuclear utilities and their suppliers to accept testing and calibration services (in lieu of a commercial grade survey) from laboratories that are accredited to ISO/IEC 17025:2005 by Accreditation Bodies (AB's) that are signatories to the ILAC Mutual Recognition Agreement (MRA). Use of the ILAC process is contingent on meeting the conditions specified in NEI 14-05A; one of which is the laboratory must be accredited to ISO/IEC 17025:2005.

On November 30, 2017, ISO (International Organization for Standardization) published a new version of ISO/IEC 17025, "General Requirements for the Competence of Testing and Calibration Laboratories". In order for nuclear utilities and their suppliers to continue to utilize the ILAC process during commercial grade dedication of calibration and testing services, the nuclear industry must first gain the USNRC acceptance of the new version of ISO/IEC 17025 which is known as ISO/IEC 17025:2017. The Nuclear Procurement Issues Corporation (NUPIC) in conjunction NEI has undertaken the effort and is currently seeking the NRC's endorsement of ISO/IEC 17025:2017 version of the standard based on a review of the revision to ISO/IEC 17025 to verify that the new version is equivalent to the previous version.

ISO/IEC 17025:2017 covers all laboratory activities, including testing, calibration and the sampling associated with subsequent calibration and testing. ISO/IEC 17025:2017 includes technical enhancements, definitions of key terms, and provisions for greater use of Information Technology (IT) techniques. The major changes are as follows:

• A new structure has been adopted to align the standard with the other existing ISO/IEC conformity assessment standards such as the ISO/IEC 17000 series on conformity assessment.

• The process approach now matches that of newer standards such as ISO 9001:2015 (quality management), ISO 15189 (quality of medical laboratories) and the ISO/IEC 17000 series (standards for conformity assessment activities), putting the emphasis on the results of a process instead of the detailed description of its tasks and steps.

• The standard has a stronger focus on information technologies. In recognition of the fact that hard-copy manuals, records and reports are slowly being phased out in favor of electronic versions, it incorporates the use of computer systems, electronic records and the production of electronic results and reports.

• A new section has been added introducing the concept of risk-based thinking and describes the commonalities with the new version of ISO 9001:2015, Quality Management Systems Requirements.

• The terminology has been updated. Examples include changes to the International Vocabulary of Metrology (VIM) and alignment with ISO/IEC terminology, which has a set of common terms and definitions for all standards dedicated to conformity assessment.

The NUPIC/NEI Committee performed a detailed review of the 2005 and 2017 versions of ISO/IEC 17025 to substantiate that the ISO/IEC 17025:2017 does not reduce commitments in technical or quality requirements. This review was performed by verifying, via a line by line review, that all of the relevant technical and quality requirements specified in ISO/IEC 17025:2005 are included in ISO/IEC 17025:2017 and that the major changes were essentially formatting and additions which enhance the ISO/IEC 17025 standard. For example, additional restrictions have been added for subcontracting accredited tests or calibrations and the focus on technical competency has increased. A Requirements Traceability/Cross Reference Matrix was developed to perform this review. As a result, it was concluded that the ISO/IEC 17025:2017 is equal to or better than ISO/IEC 17025:2005 in both main areas: technical and quality requirements. The Requirements Traceability/Cross Reference Matrix is included as an attachment. In addition, it was verified that all of the technical and quality requirements specified in the NUPIC Calibration Survey Critical Characteristics Worksheet are appropriately addressed in ISO/IEC 17025:2017. It should be noted that the USNRC utilized the NUPIC Calibration Survey Critical Characteristics Worksheet as an aid during the NRC's original endorsement of the ISO/IEC 17025:2005 when it was concluded the accreditation process is equivalent to a NUPIC Commercial Grade Calibration Survey.

ISO has designated a three (3) year transition for the ISO/IEC 17025:2017. Since the standard was published on November 30, 2017, all re-accreditations and new accreditations to ISO/IEC 17025 must be to ISO/IEC 17025:2017 by November 30, 2020. In order to meet this deadline, each AB that is a signatory to the ILAC MRA has developed a transition plan for accrediting their laboratories and prospective laboratories. Due to the logistics involved with this massive workload and to ensure successful transitions, some AB's have started the process of accrediting laboratories to 17025:2017. To this end, ILAC/ISO issued a Joint Communication which stressed that during this transition period, both ISO/IEC 17025:2005 and ISO/IEC 17025:2017 are equally valid and applicable. Formal accreditation to either standard granted by an accreditation body that is a signatory to the ILAC Arrangement should be recognized by the market place. ILAC/ISO strongly recommended that governmental bodies and approval agencies equally recognize both versions until after the 3-year transition period has closed.

The Joint Communication is attached to this document. It should be noted that the US Federal Communications Commission (FCC) and US Consumer Product Safety Commission (CPSC) have both endorsed ISO/IEC 17025:2017 during this transition period. The NUPIC/NEI is requesting a similar endorsement from the USNRC on behalf of the nuclear industry during this transition period. In addition, a revision to NEI 14-05A will be subsequently presented to the NRC requesting a permanent endorsement to ISO/IEC 17025:2017.