Accreditation and Designation

of U.S. RCBs for Japan

Japan MRA Workshop

February 27, 2013

Presented by Ramona Saar

Program Manager, NIST

Topics

U.S. Participation in Telecom MRAs

Status of Japan-US MRA

About NIST

NIST Program - NVCASE

Accreditation Requirements of U.S. RCBs for Japan

Designation of U.S. RCBs to Japan

Questions/Answers

U.S. Participation in Telecom MRAs

Multilateral agreements

Europe EMC and R&TTE Directives

APEC 7 economies – testing (Phase I)

3 economies – certification (Phase II)

Bi-lateral agreements

Japan – certification - signed in 2007

Mexico – testing - in process

Israel – testing - in process

Number of U.S. CABs Participating in MRAs

83 U.S. organizations located at 113 locations

Recognitions obtained by these CABS:

Japan: 5 RBCs

Canada Phase II: 22 CBs

Hong Kong Phase II: 3 CBs

Singapore Phase II: 4 CBs

EMC: 36 NBs

R&TTE Directives: 25 NBs

APEC TEL Phase I: 325 U.S. lab recognitions issued by MRA partners

[U.S. TCBs designated by NIST to FCC]: 19

Status of Japan-US MRA

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

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

Scopes of US-Japan 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).

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 Certification Bodies Standard: ISO/IEC Guide 65

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

About NIST

Part of the U.S. Department of Commerce

Founded in 1901

Non-regulatory agency

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.

Serves as U.S. National Metrology Institute

Supports research and programs to help U.S. industry

NIST

Campus in Gaithersburg, Maryland

• 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

Process to Qualify as U.S. RCB for Japan

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

Laboratory AB Program

NIST Listing

ACLASS, A2LA, NVLAP

ISO/IEC 17011

ILAC Signatories

CB’s Lab or Other Lab

ISO/IEC 17025

Summary of 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

NVCASE – Competence of Accreditation

Bodies

National Voluntary Conformity Assessment Systems Evaluation Program (NVCASE) Program administered by NIST MRA Office

Program provides regulatory authorities with a basis for having confidence that qualifying U.S. conformity assessment bodies are competent

Facilitates the acceptance of U.S. products in foreign regulated markets based on U.S. conformity assessment results.

ANSI and A2LA are NIST/NVCASE Recognized. http://gsi.nist.gov/global/index.cfm/L1-4/L2-38/L3-97

ABs are assessed every two years

AB must meet ISO/IEC 17011

AB must assess to ISO/IEC Guide 65 plus MRA partner technical requirements

AB must demonstrate competence of assessor (to apply foreign MRA partner requirements)

NIST also observes assessors conducting assessments

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 accreditation body when assessing the prospective U.S. RCB

That 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 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 accredited lab

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 Lab AB listed by NIST

Test Equipment

Test equipment used to support certification activities shall be calibrated annually

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.

Designation of U.S. RCBS to Japan

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 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 by NIST

NIST reviews all documents submitted and prepares

Designation letter

Nomination form

Joint Committee Decision form

Documents are sent to MOFA & MIC

MIC notifies NIST of recognition

Publication in Gazette

RCB number assigned

NIST confirms recognition to RCB

NIST provides the Excel Spreadsheet for periodic reporting of certified products

Additional Designation Information

30 to 60 day NIST review period

30 day MRA decision by MIC (Joint Committee)

On-going notification about any changes to the accreditations that support the designation

Change in/Addition to the Scope

Change in accreditation body

Change in location/address

5 Recognized U.S. RCBs

American Certification Body, Inc (ACB, Inc.)

Bay Area Compliance Laboratories, Corp. (BACL)

MiCOM Labs

SIEMIC, Inc.

UL CCS

Key Challenges

Which test method applies?

Obtaining notification of changes.

Where are changes posted?

How do RCBs get notification of changes?

Language translation

NIST Website Information

NIST Global Standards Information Page

http://gsi.nist.gov

Standards & Trade

EMC/Telecom MRAs

NVCASE

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