Telecom MRAs: What is New?

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Telecom MRAs What is New?

• TCB Council Meeting
• April 8, 2014
• Presented by Ramona Saar
• MRA Program Office NIST Dept. of Commerce

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Outline of Topics

• New EMC Directive
• Key Dates
• Changes
• Role of Accreditation
• Next Steps for NIST
• MRA Program Office Activities
• What is Available for US CABS?
• News - Israel
• News - Vietnam
• Next Meetings

3

• New EMC Directive
• EMC Directive (Directive 2014/30/EU) was
  published in the Official Journal of the European
  Union (OJEU)
• on
• March 29, 2014.

4
Rationale for Revisions

• Across various industry sectorsExperiencehas
  shown
• non-compliant product on market, mistrust of CE
  mark
• competitive disadvantages to those following the
  rules
• ...varying enforcement practices
• Differing practices in the designation of CABs by
  national authorities
• Problems with the quality of certain notified
  bodies
• In 2008 - New Legislative Framework (NLF)
• NLF Regulation on accreditation and market
  surveillance
• NLF Decision establishing common framework for
  marketing of products
• Process to align various Directives was initiated

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Important Dates

• Entry into Force Date for new EMC Directive
  (2014/30/EU)
• April 20, 2014 (Art. 46)
• Member State Transposition Date
• by April 19, 2016 (Art.44)
• Old EMC Directive (2004/108/EC) Repeal Date
• April 20, 2016 (Art. 45)
• Products placed on the EU market on or after
  April 20, 2016 must comply with the new
  Directive. (Art. 43)
• U.S. NBs must be re-notified to the new Directive
  before this date.
• Timing and process for re-notification not yet
  determined

6
Additional Guidance To Be Made Available

• New 2014 Blue Guide on Implementation of EU
  Product Rules has just been published.
• Guidance from EUANB (Group of Notified Bodies
  Under the EMC Directive
• May 20, 2014 Meeting Amsterdam
• Guide for the EMC Directive to be revised
• Commission to provide U.S. with details on
  implementation of the Directive under the MRA

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Key Sections on NBs

• Chapter 4 Notification of Conformity Assessment
  Bodies
• Notifying Authorities (Art. 21)
• Requirements Relating to Notifying Authorities
  (Art. 22)
• Information Obligations on Notifying Authorities
  (Art. 23)
• Requirements Related to Notified Bodies (Art. 24)
• Application for Notification (Art. 27)
• Notification Procedures (Art. 28)
• Identification numbers and Lists of Notified
  Bodies (Art. 29)
• Challenge of the Competence of Notified Bodies
  (Art. 31)
• Operational Obligations of Notified Bodies (Art.
  32)
• Information Obligations on Notified Bodies (Art.
  34)
• Coordination of Notified Bodies (Art. 36)
• Annex III Module B EU-Type Examination
  Certificate

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Notifying Authority

• One in each Member State and in MRA Countries
• Responsible for setting up and carrying out the
  necessary procedures for
• Assessment of CABS
• Notification of CABS
• Monitoring of NBs
• Restrict/Suspend/Withdraw Notification (Art. 30)
• NIST serves as the Notifying Authority to the
  Commission for the U.S.

These two functions can be carried out by an
accreditation body
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Notifying Authority - Qualifications

• Must
• Not have any conflict of interest with CABS
• Be objective, impartial, and safeguard
  confidentiality
• Ensure that a decision on notification of a CAB
  is taken by persons different than those carrying
  out the assessment.
• Have a sufficient number of competent personnel
  to properly perform tasks.
• Provide Commission with procedures for assessment
  and notification of CABs and monitoring of NBs.
  The Commission will make this information public.

10
EU-Type Examination Certificate (Annex III)
Supporting Evaluation Report

• Replaces NB Statement of Opinion
• Module B NB must determine if product design
  complies with relevant legislative requirements.
• Certificate Manufacturer name, address,
  conclusions, essential requirements covered,
  validity conditions, data for type
  identification, any other relevant information
• - made available to Commission, Member States
  and other NBs upon request
• Supported by NB evaluation report that
  indicates what activities were done to examine
  manufacturers technical documentation to assess
  the adequacy of the technical design with
  relevant essential requirements.
• - made available to Commission and Member States
  upon request

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Information Obligations from Manufacturer

• Manufacturer must select a single NB (supported
  by a written declaration in application process
  to NB)
• Manufacturer must notify the NB of modifications
  that affect the conformity of the apparatus with
  essential requirements or validity conditions for
  the Certificate
• - A new Certificate may be required

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Information Obligations to Manufacturer

• NB must monitor state of the art and notify
  manufacturer if any changes impact compliance of
  apparatus with applicable Directive requirements
• What is state of the art?
• (27) Harmonized standards reflect the generally
  acknowledged
• state of the art as regards electromagnetic
  compatibility
• in the Union

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Information Obligations to NIST (Art. 34)

• NB shall inform NIST (Notifying Authority) of
• Refusals, restrictions, suspension, withdrawals
  of EU-Type Examination Certificates
• Any requests received from Market Surveillance
  Authorities
• CAB activities performed as NB (upon request)

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Information Obligations to Other NBs

• (Art. 34)
• NB shall inform other NBs of
• Relevant information on issues relating to
  negative and (on request) positive conformity
  assessment results.
• (Annex III 8)
• NB shall inform other NBs
• concerningcertificates and/or additions to
  which it has refused, withdrawn, suspended or
  otherwise restricted.

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Coordination of NBs Requirements Relating to
NBs (Art. 24)

• 11 - Added
• The NB must participate in (or be informed about)
• Relevant standardization activities
• Activities of the NB coordination group
• Must apply administrative decisions and documents
  produced by the group.
• EUANB for EMC Directive

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Changing Role of Accreditation in the
Notification Process
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Accreditation As Preferred Route

• Text in new EMC Directive
• Since accreditation is an essential means of
  verifying competence of CABs, it should also be
  used for the purposes of notifications.
• New Blue Guide on the Implementation of EU
  Product Rules
• accreditationfavored instrument for evaluating
  competence and integrity of the bodies to be
  notified (page 70).
• European Cooperation for Accreditation (EA)
  http//www.european-accreditation.org/role
• The process of achieving notification has
  changed such that accreditation is now the
  preferred route by which a conformity assessment
  body demonstrates its competence to become a
  Notified Body.

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Accreditation for NB functions

• (Art. 27 2) Application for notification shall
  be accompanied by.accreditation certificate,
  where one exists, issued by a national
  accreditation body attesting that the CAB fulfils
  the requirements of Article 24. (Requirements
  for Notified Bodies.)
• Note that for the accreditation to be accepted,
  the NB functions would need to be included under
  the Scope of Accreditation.
• Until now, this has not been the case for US NBs.
  
• Accreditation to ISO/IEC 17025 has been a
  prerequisite only - to demonstrate to NIST
  knowledge of harmonized standards.
• All other requirements for NB functions have been
  evaluated directly by NIST, not the ABs.

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When NB is Not Accredited for NB functions

• Must Release Evidence of Competency Evaluation to
  Commission and Others
• (Art. 28 -4) Where a notification is not based
  on an accreditation certificatethe notifying
  authority shall provide.documentary evidence
  which attests to the CABs competence and
  arrangements for monitoring
• See Blue Guide, 5.3.2.4 for guidance on the
  evaluation procedure to be followed in
  accreditation is not used as basis for
  notification

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When NB Not Accredited for NB functions

• The NB Will Face a Longer Commission Decision
  Process
• Timing of Decision on NB status (Art. 28 5)
• 2 weeks with accreditation certificate
• 2 months without accreditation certificate (for
  NB functions) - and release of all NB documents
  to demonstrate compliance with NB requirements as
  noted on previous slide.

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Accreditation of NBs in the EU

• Competent/National Authority in each Member State
  may elect to have NB assessment/accreditation
  role for their AB.
• NB functions are not an exact fit with current
  accreditation standards such as ISO/IEC 17025
  and/or ISO/IEC Guide 65 (ISO/IEC 17065).
• European Co-Operation for Accreditation EA has
  published
• EA-2/17 EA Guidance on the Horizontal
  Requirements for the Accreditation of CABS for
  Notification Purposes.
• Connects key NB requirements with key clauses of
  several accreditation standards such as EN 45011
  (G65), EN ISO/IEC 17025..
• Example of EU AB reference document UKAS
• P16 Accreditation for the purposes of
  appointment as approved and notified bodies

22
EMC Directive Notified Bodies (NBs)

• EU lists 178 NBs for the EMC Directive
  (2004/108/EC)
• 22 of these NBs are in the U.S.
• All 22 are ISO/IEC 17025 accredited but NB
  functions not covered.
• 14 of 22 are also ISO/IEC Guide 65 accredited
  NB functions not covered.
• Blue Guide (p. 120, 3.2)
• For Module B, ISO/IEC 17025 not appropriate
• ISO/IEC 17020 and ISO/IEC 17065 can be
  considered

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Conclusions

• Changes to EMC Directive are significant for NBs
  and NIST.
• Formal ISO/IEC 17065 accreditation for NB
  functions is now preferred (for Module B).
• Alternative NIST led NB evaluation/assessment
  program is not seen as a good option if private
  sector accreditation bodies can meet the
  necessary requirements to conduct this conformity
  assessment activity.

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Next Steps for NIST

• Attend EUANB Meeting and confirm transition
  process and timing with Commission
• Obtain stakeholder input for (and keep
  stakeholders informed of) development of NB
  Notification scheme requirements
• Publish NB Notification scheme requirements and
  conduct workshops/training as needed
• Process re-designation applications for
  notification from qualified CABs that meet NB
  requirements.
• Formally withdraw all NB notifications to the old
  Directive on April 19th (or 20th) 2016.
• Follow applicable steps for the RED Directive.

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• Part II MRA Program Office Activities

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What is available?

• Lab recognition is available for 8 economies for
  specific standards/regulations
• Australia, Canada, Chinese Taipei, Hong Kong,
  Korea, Singapore, and Vietnam
• Israel
• Certification Body (CB) recognition is available
  for 4 economies for specific standards/regulations
  
• Canada, Hong Kong, Singapore, and Japan
• Notified Body (NB) status is available for the EU
  for the EMC Directive and the RTTE Directive
• TCB designation to the FCC is available through
  NIST. Formal recognition is issued by the FCC

27
Current Activities

• The NIST MRA Program includes 83 CABS in 112
  locations holding 381 separate formal MRA Partner
  recognitions for specific standards/regulations.
• MRA signed but not implemented yet with one
  economies
• Mexico
• The U.S. Government is engaged in dialogue for
  new agreements with two economies
• Korea (CB recognition) and Malaysia (lab
  recognition)

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Israel Now Available

• Signed October 15, 2012
• Test lab recognition Phase I
• NIST Criteria Document published February 7,
  2014.
• NIST is accepting applications for designation as
  of March 31, 2014. No CABs designated yet.
• Link to MRA text http//www.ustr.gov/sites/defau
  lt/files/US-Israel20MRA20Text.pdf

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Vietnam - Update

• Vietnam/MIC Annex I Update
• Release of updates to Annex I for Vietnam/MIC on
  February 7, 2014 and March 14, 2014.  here.   
•  
• New Vietnam/MIC Designation Requirement
  Template/Sample Test Report
• For CABs newly seeking designation requirement
  is now effective.  See the Required Documents
  (Item 7) and the Vietnam Specific Requirements
  page.   
•  
• For CABs already recognized by MIC NIST will be
  contacting each recognized CAB directly with a
  request for a template/sample test report.  CABs
  will be given at least 30 days to send NIST the
  template/sample.  

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Next MRA-Related Meetings

• APEC TEL Working Group MRA Task Force
• Yangzhou, China
• April 21-26, 2014
• RTTE CA EUANB Meetings
• Amsterdam, The Netherlands
• May 19-20, 2014

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• NIST MRA Program Office Information - Website

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• NIST MRA Team
• Staff Gerry Baker, Nathalie Rioux, Ramona Saar
• Contractors Joe Dhillon, Dan Hoolihan
• Questions about MRAs
• Please send your request to mra_at_nist.gov
• Direct Contact Information
• Ramona J. Saar
• NIST, Program Manager
• ramona.saar_at_nist.gov
• Thank you.