American Association for Laboratory Accreditation
R322 – SPECIFIC REQUIREMENTS – NOTIFIED BODY
ACCREDITATION REQUIREMENTS
Document Issued:
January 4, 2016
Page 1 of 4
On November 23, 2015, the National Institute of Standards and Technology (NIST) released
requirements for United States Conformity Assessment Bodies (CABs) seeking Notified Body
(NB) status for the European Union Radio Equipment Directive (RED) 2014/53/EU, Annex
III (Module B: EU-Type Examination) and Electromagnetic Comparability (EMC) Directive
2014/30/EU, Annex III – Part A (Module B: EU-Type Examination).
The role of the NB under Module B is to examine a manufacturer’s technical documentation
and supporting evidence to verify and attest that the technical product design meets the
relevant European Union (EU) legislative requirements. The NB then writes an evaluation
report (that may be released only upon agreement with the manufacturer), and issues an
EU-Type Examination Certificate. The manufacturer maintains the EU-Type Examination
Certificate in the technical documentation that supports its Declaration of Conformity.
When the manufacturer is assessing compliance of radio equipment under the essential
requirements covered by the Radio Equipment Directive (RED) Articles 3.2 and 3.3, and
when harmonized standards (as published in the Official Journal of the European Union) are
(1) applied only in part, (2) available but not applied, or (3) are not available – per RED
Article 17.4, the manufacturer is required to use an NB. In all other cases (such as when the
manufacturer has used the harmonized standards in full), use of an NB is voluntary. Under
the Electromagnetic Compatibility (EMC) Directive, use of an NB is voluntary.
PART A
INTRODUCTION
NIST’s Requirements & Application for U.S. Conformity Assessment Bodies Seeking EU
Radio Equipment Directive (RED) 2014/53/EU Notified Body Status and Requirements &
Application of U.S. Conformity Assessment Bodies Seeking Electromagnetic Compatibility
(EMC) Directive 2014/30/EU Notified Body Status, Section 4 states “The CAB shall obtain
formal accreditation for its Notified Body activities.” A2LA is recognized to accredit NBs for
the RED and EMC Directive.
Since there is no transition period for the new EMC Directive (2014/30/EU), the notifications
of all current EMC Directive (2001/108/EC) NBs expire on April 19, 2016. Therefore, it will
be necessary to obtain A2LA accreditation and then re-apply to NIST to be notified to the
European Commission (hereafter referred to as Commission) as an NB under the new EMC
Directive.
There is a one year transition period for the RED but NIST will not withdraw the NB status
of the Radio and Telecommunication Terminal Equipment (R&TTE) Directive NBs until the
end of the transition period. During the transition year between June 2016 and June 2017,
there will be two separate lists – the NBs notified to the R&TTE Directive under the old
process, and the new NBs notified under the RED. Accreditation applies for RED only, not
for the R&TTE Directive.
L:\Requirements\R322 – Specific Requirements – Notified Body Accreditation Requirements
American Association for Laboratory Accreditation
R322 – SPECIFIC REQUIREMENTS – NOTIFIED BODY
ACCREDITATION REQUIREMENTS
Document Issued:
January 4, 2016
Page 2 of 4
PART B
CONDITIONS FOR ACCREDITATION
In order to attain and maintain accreditation, NBs must comply with A2LA R102 Conditions for Accreditation published by A2LA.
PART C
A2LA ACCREDITATION PROCESS
All applicants must agree to comply with R102 - Conditions for Accreditation (see Part B of
this document), pay the appropriate fees (including surcharges, where applicable), and
provide detailed supporting information. For further information, refer to F309 - Application
for Accreditation: ISO-IEC 17065 Product Certification Bodies (see Part D of this document Option I), F301 - Application for Accreditation: ISO-IEC 17020 Inspection Bodies (see Part D
of this document - Option II), or F101 - Application for Accreditation: ISO-IEC 17025
Laboratories (see Part D of this document - Option III).
PART D
Specific Program Requirements
NIST Requirements for CABs seeking EU NB status are publically available on the NIST
website.
Section 4 of NIST’s Requirements & Application for U.S. Conformity Assessment Bodies
Seeking EU Radio Equipment Directive (RED) 2014/53/EU Notified Body Status and
Requirements & Application for U.S. Conformity Assessment Bodies Seeking EU
Electromagnetic Compatibility (EMC) Directive 2014/30/EU Notified Body Status outline
the NB accreditation requirements.
The Blue Guide identifies the following two basic conformity assessment standards as the
most appropriate for Module B Assessments: ISO/IEC 17020 (Inspection Body Accreditation)
or ISO/IEC 17065 (Product Certification Body Accreditation).
EA-2/17 INF: 2014 further specifies that for Module B, supplemental (secondary basic
standard requirements) apply as follows:
 Option I – ISO/IEC 17065:2012 Accreditation plus the following secondary basic
standard requirements:
o ISO/IEC 17025:2005 Section 5
o ISO/IEC 17020 Clauses 6.1.2, 6.1.3, and 6.1.6 through 6.1.10
(Ability to make professional judgements related to product requirements
where required.)

Option II – ISO/IEC 17020:2012 Accreditation plus the following secondary basic
standard requirements:
o ISO/IEC 17025:2005 Section 5.
L:\Requirements\R322 – Specific Requirements – Notified Body Accreditation Requirements
American Association for Laboratory Accreditation
R322 – SPECIFIC REQUIREMENTS – NOTIFIED BODY
ACCREDITATION REQUIREMENTS

Document Issued:
January 4, 2016
Page 3 of 4
Option III – ISO/IEC 17025:2005 Accreditation plus the following secondary basic
standard requirements:
o ISO/IEC 17065:2012 Clauses 4.1, 7.5, and 7.6
(Capability of and procedures for judging and deciding based on results of
tests, if the essential requirements are fulfilled and/or the Harmonized
Standards have been applied where required.)
CABs accredited by A2LA to ISO/IEC 17020 or ISO/IEC 17065 that wish to seek NB Status
can apply to NIST under the processes covered in RED Article 29.2 and/or EMC Directive
Article 27.2. The notification process is simplified in these cases, with minimal information
needing to be forwarded to the Commission. The Commission’s decisions will normally take
two weeks if there are no objections from Member States.
CABs accredited by A2LA to ISO/IEC 17025 (only) that wish to seek NB Status must follow
alternative paths listed below for notification, since this basic conformity assessment
standard is not considered sufficient on its own for Module B (per The Blue Guide). The
alternative paths are described in RED Article 29.3 and EMC Directive Article 27.3. These
alternative paths include the following additional steps:
o Submittal of key NB application documentation by NIST to the Commission for
review by Member States;
o Longer Commission decision process for initial NB notification (two months if no
objections are expressed by Member States after review of NB information)
(RED Article 30.5 and EMC Directive Article 28.5).
ISO/IEC 17025 accreditation ensures that the NB will be monitored regularly (RED Article
30.4 and EMC Directive Article 28.4).
Under this option, NIST requires that the ISO/IEC 17025 Scope of Accreditation contains the
NB activities and reference to EA-2/17 INF: 2014 (providing it references ISO/IEC 17025 for
Module B). Refer to EA 2/17 Annex A, Description of the Accreditation Scope of NBs.
1. NIST – Radio Equipment Directive
CABs seeking NB status for the RED shall meet the requirements of NIST’s Requirements &
Application for U.S. Conformity Assessment Bodies Seeking EU Radio Equipment Directive
(RED) 2014/53/EU Notified Body Status, in addition to the requirements of European
Union Radio Equipment Directive 2014/53/EU. The NB will be evaluated against A2LA
C322a - Specific Checklist: Notified Body Accreditation Requirements – Radio Equipment
Directive.
2. NIST – Electromagnetic Compatibility (EMC) Directive
CABs seeking NB status for the EMC Directive shall meet the requirements of NIST’s
Requirements & Application for U.S. Conformity Assessment Bodies Seeking EU
Electromagnetic Compatibility (EMC) Directive 2014/30/EU Notified Body Status, in
addition to the requirements of European Union Electromagnetic Compatibility Directive
2014/30/EU. The NB will be evaluated against A2LA C322b - Specific Checklist: Notified
Body Accreditation Requirements – Electromagnetic Compatibility Directive.
L:\Requirements\R322 – Specific Requirements – Notified Body Accreditation Requirements
American Association for Laboratory Accreditation
R322 – SPECIFIC REQUIREMENTS – NOTIFIED BODY
ACCREDITATION REQUIREMENTS
Document Issued:
January 4, 2016
Page 4 of 4
APPENDIX A - Document Revision History
Date
01/04/2016
Description
- Initial Release
 2016 by A2LA
All rights reserved. No part of this document may be reproduced in any form or by any
means without the prior written permission of A2LA.
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