accreditation and designation of u.s. rcbs for japan...iso/iec g65 scope and certificate of...
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Accreditation and Designation
of U.S. RCBs for Japan
Japan MRA Workshop
February 27, 2013
Presented by Ramona Saar
Program Manager, NIST
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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
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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
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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
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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
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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).
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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
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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
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NIST
Campus in Gaithersburg, Maryland
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• 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
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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
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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
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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
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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
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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
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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
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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
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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
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Test Equipment
Test equipment used to support certification activities shall be calibrated annually
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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.
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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
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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
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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
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5 Recognized U.S. RCBs
American Certification Body, Inc (ACB, Inc.)
Bay Area Compliance Laboratories, Corp. (BACL)
MiCOM Labs
SIEMIC, Inc.
UL CCS
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Key Challenges
Which test method applies?
Obtaining notification of changes.
Where are changes posted?
How do RCBs get notification of changes?
Language translation
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NIST Website Information
NIST Global Standards Information Page
http://gsi.nist.gov
Standards & Trade
EMC/Telecom MRAs
NVCASE
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Questions?
Thank you.
Contact Information Ramona J. Saar NIST, Program Manager [email protected] Questions about MRAs Please send your request to [email protected]