Accreditation and Designation of U.S. RCBs for Japan

Japan MRA Workshop February 19, 2014 Presented by Ramona Saar Program Manager, NIST

Topics

About NIST U.S. Participation in Telecom MRAs Japan-US MRA Accreditation Requirements of U.S. RCBs for Japan Designation of U.S. RCBs to Japan Questions/Answers

NIST

Campus in Gaithersburg, Maryland

About NIST Part of the U.S. Department of Commerce

Non-regulatory agency

Serves as U.S. National Metrology Institute (NMI)

Mission: To promote U.S. innovation and industrial

competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life.

Supports research and programs to help U.S. industry

• Serves on the U.S. government delegation for Telecom MRA negotiations with MRA partners

• Works closely with the Federal

Communications Commission (FCC) - the U.S. regulatory authority

• Serves as the Designating Authority for Telecom MRAs

• Sponsors Telecom MRA workshops

and training sessions for conformity assessment bodies (CABs).

NIST MRA Program Office

U.S. Participation in Telecom MRAs

Multilateral agreements Europe

EMC and R&TTE Directives – Notified Bodies

APEC 7 economies – testing (Phase I) 3 economies – certification (Phase II)

Bi-lateral agreements Japan – certification - signed in 2007

(Note - special arrangement with VCCI for testing) Israel – testing – entry in force December 2013 Mexico – testing – delayed – expected by end of

2014

Designation/Recognition Activities – by the numbers.

83 U.S. organizations located at 113 locations Recognitions obtained by these CABS:

Japan: 5 RCBs Canada Phase II: 19 CBs Hong Kong Phase II: 3 CBs Singapore Phase II: 4 CBs EU - EMC Directive: 35 NBs EU - R&TTE Directive: 24 NBs APEC TEL Phase I: 311 individual recognitions

issued by MRA partners U.S. TCBs designated by NIST and recognized by FCC: 20

U.S. Stakeholders in Telecom MRAs Role Organization

Office of the United States Trade Representative

USTR – lead negotiator

Regulatory Authority FCC

Designating Authority NIST

Accreditation Bodies for Laboratories Standard: ISO/IEC 17025

A2LA, ACLASS, NVLAP Evaluated by NIST for MRA Role

Accreditation Bodies for Certification Bodies Standard: ISO/IEC Guide 65 Transition to ISO/IEC 17065 Occurring

A2LA, ANSI Evaluated by NIST for MRA Role - NVCASE

Conformity Assessment Bodies (CABs) U.S. Testing laboratories U.S. Certification bodies (CBs) Application to NIST for MRA Designations

NIST Role as Designating Authority

NIST Supports Telecom MRA Implementation:

1. Evaluates qualified U.S. accreditation bodies for ability to assess to the MRA requirements of MRA partners 2. Designate U.S. CABS to MRA partners

3. Monitors recognized U.S. CABS

4. Helps facilitate communications between U.S. CABs and MRA partners

Japan-US MRA

Timeline

Timeline and Status February 2007 – MRA Signed 2007 to 2010 – Information Exchanges and Training October 2010 – NIST publishes Japan Designation Criteria November 2010 – NIST begins to accept US CB applications for designation to Japan March 2011 – First 2 RCBs from U.S. are recognized by MIC

Today - 5 U.S. RCBs are recognized by MIC

Scopes of Japan-US MRA

For certification bodies only

A1/A2: Terminal Equipment

B1/B2/B3: Radio Equipment

CAB must have capability to certify all classes of equipment covered under each scope (B1, for example).

NIST Criteria for Designation Published Document: Criteria for Designation of U.S. Conformity

Assessment Bodies under the U.S.-Japan Mutual Recognition Agreement – Oct. 1, 2010 (V1); Oct. 1 2012 (V2)

Identifies information

…to be applied by the ISO/IEC Guide 65 (17065) accreditation body when assessing the prospective U.S. RCB

…that the U.S. CABs must submit to NIST for designation to Japan

Requirements for U.S. RCBs for Japan

NIST Criteria Document Addresses

Scope of the US-Japan MRA Applicable Laws and Ordinances Test Methods Notified by MIC Requirements for U.S. CAB Designations Application Checklist Excerpts of Information on Affidavit Excerpts on Technical and Educational Requirements

for the Radio Law Information on Additional Resources

Accreditation Requirements for Japan

Must be legally identifiable Must be located in the U.S. Must be accredited to ISO/IEC Guide 65 (transition to

ISO/IEC 17065 occurring) for one or more US-Japan MRA scopes Expert knowledge in Japan’s laws, ordinances,

technical regulations, and administrative requirements

Educational and experience requirements for personnel

Translation of Documents

CB must demonstrate access to MIC technical requirements in English OR the capability to accurately translate the technical requirements from Japanese into English

CB must demonstrate capability to access latest

changes to MIC requirements and obtain English translations

RCB - Laboratory and Test Method Requirements

The U.S. RCB must have an ISO/IEC 17025 lab that is accredited for

for relevant MIC test methods OR For test methods that are equal to or surpass

the MIC test methods Procedures for determining equivalency Maintain records of equivalency

determination Contractual arrangements with other labs OK Maintain procedures for acceptance of test data

from other labs Must use a U.S. lab AB formally listed by NIST

Affidavit

Submit written affidavit

signed by top management

Confirming that the CAB (and personnel) do not fall under certain categories related to crimes and/or previous withdrawal of registration as provided for under the Acts.

Documents CAB must submit to NIST

1. Designation application checklist 2. Cover letter that includes scopes being sought 3. Copy of certification procedures for Japan 4. Sample certification report/package for each scope 5. Qualifications of at least 2 technical experts 6. ISO/IEC G65 (or G17065) Scope and Certificate of

Accreditation 7. 17025 Scope/Certificate with test methods identified

- Scope of contracted lab and contractual arrangements

8. Procedures for determining equivalency of test methods

9. Procedures for acceptance of test data 10. Affidavit 11. CAB Declaration Form

Review, Designation, Recognition

NIST reviews all documents submitted and prepares Designation letter Nomination form Joint Committee Decision form

NIST designates CAB – all documents are sent to MOFA & MIC

MIC recognizes CAB as RCB and notifies NIST. Publication in Gazette RCB number assigned

NIST confirms recognition to RCB NIST provides the Excel Spreadsheet for periodic

reporting of certified products

Summary of Designation Process for RCBs

MRA Partner

Regulatory Authorities

MIC

NIST MRA Program office

NVCASE Program NIST Recognition

ANSI & A2LA ISO/IEC 17011 IAF Signatories

CB ISO/IEC Guide 65 with transition

to ISO/IEC 17065 (new)

Laboratory AB Program

NIST Listing

ACLASS, A2LA, NVLAP

ISO/IEC 17011 ILAC Signatories

CB’s Lab or Other Lab ISO/IEC 17025

Additional Information

30 to 60 day NIST application review period

30 day MRA decision by MIC (Joint Committee)

NIST provides MIC with on-going notification about any changes to the accreditations that support the NIST designation (and MIC recognition) Change in/Addition to the RCB’s Scope Change in accreditation body used by the RCB Change in location/address of the RCB

NIST supports the MIC MRA workshop and requests

that all RCBs attend this event annually.

5 Recognized U.S. RCBs

American Certification Body, Inc. (ACB, Inc.) Bay Area Compliance Laboratories, Corp. (BACL) MiCOM Labs SIEMIC, Inc. UL CCS

NIST Website Information

NIST Global Standards Information Page http://gsi.nist.gov

Standards & Trade > EMC/Telecom MRAs > Japan-US MRA Web page includes:

General Information on MRA NIST Criteria Document General Information on EMC Arrangement MRA Resources

Questions?

Thank you.

Contact Information Ramona J. Saar NIST, Program Manager ramona.saar@nist.gov Questions about MRAs Please send your request to mra@nist.gov