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 [email protected] Questions about MRAs Please send your request to [email protected]