Federal Department of Economic Affairs,
Education and Research EAER
State Secretariat for Economic Affairs SECO
Swiss Accreditation Service SAS
SAS Rules for Accreditation Purposes in the
context of Notification - Designation of Conformity Assessment Bodies (CAB)
Document N°. 729.ew
Edition March 2015, rev. 06
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Table of Contents
Introduction ............................................................................................................................................. 3
Simplified definitions ................................................................................................................................. 4
A
Harmonised standards which are referred to by modules of the New and Global
Approach .............................................................................................................................. 7
B
Interpretation of harmonised standards for the application of conformity assessment
procedures according to the selected modules ................................................................. 12
1.
Accreditation of CAB according to Module H (ISO/IEC 17021) ......................................... 12
1.1
General Requirements ....................................................................................................... 12
1.2
Technical Requirements .................................................................................................... 12
1.3
Specific Technical Tasks ................................................................................................... 13
1.4
Specific Criteria for the Auditing Personnel ....................................................................... 13
1.5
Boards Associated with or Superior to the Certification Body (e.g. Committees for
safeguarding Impartiality [ISO/IEC 17021, Article 6.2]) ..................................................... 14
2.
Accreditation of CAB according to Modules D and E (ISO/IEC 17021) ............................ 14
3.
Sub-contracting by Designated / Notified bodies (Blue Guide) ......................................... 14
4.
Application of Mandatory or Informative EA Rules (EA document 2/17) and Subordinate
European Legal Bases (Regulation (EC) No 765/2008 / Decision No 768/2008/EC) ....... 15
C
Application in the Context of Accreditation ........................................................................ 15
6.
References ......................................................................................................................... 18
7.
Amendments to the version of March 2015, rev. 06 of this document .............................. 18
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Introduction
Accreditation serves to formally acknowledge the competence to conduct certain conformity assessments according to relevant international standards. Accreditation is the internationally accepted instrument of confidence building. In Switzerland, the accreditation of conformity assessment bodies is
formally based on the Accreditation and Designation Ordinance (OAccD) SR 946.512, regarding content on the standards cited in the attachment of this ordinance.
The accreditation confirms that a conformity assessment body possesses the competence to perform
a range of clearly defined services. Competence entails professional skills as well as management
knowledge. Accredited bodies operate a quality management system and assure in that way the quality of their every-day services. Therefore, the reports and certificates of accredited bodies enjoy high
trustworthiness.
According to the OAccD, the Swiss Accreditation Service SAS grants accreditation following a positive
assessment. Insofar as international agreements in designation refer to accreditation, an accreditation
according to OAccD will justify the assumption that the requirements for the designation of the respective
field of activities are fulfilled. If the accreditation concerns procedures regulated by law, the SAS will
involve the responsible public authorities.
According to the OAccD, the Federal Authority competent in the field is the Designation Body. If with
regard to the qualification of the competence of the body is referred to accreditation, the designation
body acts in accordance with the SAS.
Beside the legal regulations in the context of the New and Global Approach of the EC, there exist
purely national regulations and decrees which are, in some cases, only relevant on the national level.
In principle, the criteria specified in this document are valid correspondingly in all areas in which the
accreditation refers to legally regulated conformity assessment procedures, insofar as they are not replaced by specific regulations.
In the fields subject to the Mutual Recognition Agreement (MRA - RS 0.946.526.81) with the European
Community, accredited bodies can obtain notification for a specified field from the responsible Authorities. In this event, the rules and national ordinances are recognised as equivalent to the Directives by
the Commission and the corresponding specific rules of the EA are applicable. In Switzerland, it is the
national legal framework which takes precedence.
The regulations specified in this document define the accreditation criteria for the legally regulated
area and also serve for the consultation of the responsible Federal Office with the SAS.
In 2012 and 2013 the accreditation standards SN EN ISO/CEI 17020 - inspection, SN EN ISO/CEI
17065 – product certification and SN EN ISO/CEI 17024 – certification of persons, were respectively
updated and will be implemented by the bodies in question and assessed by the SAS. The transition
conditions and deadlines are published on the SAS website. Accordingly, we only refer to the new versions of these standards in this document.
Note: the French version of this document is the SAS official reference.
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Simplified definitions
Quality1)
Degree up to which a set of inherent characteristics fulfils requirements.
Conformity
Accordance with determined requirements.
Testing2)
Technical procedure consisting of the determination of one or more characteristics of a product, a procedure or a service, according to a specified method.
Conformity assessment4)
Demonstration that specified requirements relating to a product, process, system, person or body are
fulfilled.
Testing Body
Body who performs tests (generally of products)
Conformity Assessment Body
Bodies that evaluate and confirm the conformity of products, management systems or personnel. Such
bodies are
- Inspection bodies (non-recurring assessment)
- Certification bodies: assessment of conformity and subsequent surveillance of the mass production
phase.
- Testing bodies
Note: the term “Certification Body” is sometimes generically used in EU documents in place of Conformity Assessment Body, normally used by accreditation bodies. The distinction between inspection
and product certification bodies is provided in Chap. 10.6 - ANNEX 6 of the Blue Guide (see definition
below).
Accreditation4)
Procedure in which a body grants as an authority the formal approval for a body to perform certain
tasks.
Notified Body - NB
Notified Bodies are responsible for applying conformity assessment procedures as defined in the “New
Approach” Directives applying when a third party is required (Blue Guide).
Notification
Notification is an act whereby a Member State informs the Commission and the other Member States
that a body, which fulfils the relevant requirements, has been designated to carry out conformity assessment according to a directive.
Designation
Regarding formal recognition within the framework of an international agreement, designation attests
that a body satisfies the conditions to perform examinations, conformity assessments, record-taking
and certification as per the requirements of the relevant agreement (AkkBV).
1)
2)
according to ISO 9000:2005
according to ISO/CEI 17000:2004
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Competent / Responsible Authority
The Notifying Authority, in Switzerland these are the Federal Offices responsible for the areas covered
by the MRA. Formally, the SECO AFNT (Non-Tariff measures) sector is responsible for officially notifying Swiss bodies to the Commission.
Essential Requirements
The essential requirements are elements necessary to the protection of the public interest. They are
mandatory, only products meeting the essential requirements may be marketed or put into service. Essential requirements are applied in respect of the hazards inherent in a given product. They are set out
in the Annexes of the Directives (Blue Guide)
Old Approach
The old approach imposes strict product specifications for marketing. These are traditional national
regulations following requirements itemised in the legislation.
New Approach (Blue guide)
The new approach is a re-working of technical harmonisation within the European Union (EU) on a
new basis, limited to harmonisation of essential product requirements alone, in application of the “reference to standards” and the principle of mutual recognition to eliminate technical barriers to the free
movement of goods. It is based on technical harmonisation and standardisation under the following
principles:
- Legislative harmonisation is limited to the adoption of essential requirements that products in the
Community Market must fulfil if they are to benefit from free circulation.
- The technical specifications of products corresponding to the essential requirements of the Directives will be laid down in harmonized standards;
- The application of harmonised standards and other standards is left to the manufacturer, who may
still apply other specifications to meet the requirements;
- Manufactured products conforming to harmonised standards benefit from a presumption of conformity to the corresponding essential requirements.
In the new approach, the essential requirements are harmonised and rendered mandatory by the Directives.
Global Approach (Blue guide)
The global approach has introduced a modular approach in which conformity assessment is split into
several operations (modules). These modules differ for each product development stage (e.g. design,
prototyping, production), the type of assessment (e.g. documentation controls, type approval, quality
assurance) and the person performing the assessment (manufacturer or third party).
Harmonised Standard
Harmonised standards are European standards adopted by European standardisation bodies and defined as per the general guidelines agreed by the Commission and the European standardisation bodies, under a mandate awarded by the Commission and after consultation with Member States.
NANDO – “New Approach Notified and Designated Organisations”
This is the electronic database of the EU used to publish notified bodies. The Member States are responsible for the content for their national area of responsibility
(http://ec.europa.eu/enterprise/newapproach/nando/).
MRA (Mutual Recognition Agreement)
Mutual Recognition Agreement (MRA) for declarations of conformity between Switzerland and the European Community. On this basis, the Community and Switzerland mutually accept reports, certificates, authorisations and conformity marks delivered by recognised bodies conforming to the proce-
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dures provided for in the agreement and the producer’s declaration of conformity attesting to conformity with the requirements of the other Party in the areas covered by Art. 3 – see: http://www.admin.ch/opc/fr/classified-compilation/19994644/index.html. See also Blue Guide Chap. 9.2.2.
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A
Harmonised standards which are referred to by modules of the
New and Global Approach
The following applicable table is reproduced from the “‘Blue Guide’ on the implementation of EU
product rules” (version of 04/2014) by the European Commission, Chap. 10.6. Annex 6 - using
harmonised standards to assess the competence of conformity assessment bodies:
Module EN Standard(s) applicable
EN ISO/IEC 17025 (+ability to decide on conformity),
A1, A2 or
EN ISO/IEC 17020 (EN ISO/IEC 17025 to be taken into account for testing required),
or
EN ISO/IEC 17065 (EN ISO/IEC 17025 to be taken into account for testing required)
EN ISO/IEC 17020 (EN ISO/IEC 17025 to be taken into account for testing required),
B
or
EN ISO/IEC 17065 (EN 17025 to be taken into account for testing required)
EN ISO/IEC 17025 (+ability to decide on conformity),
C1, C2 or
EN ISO/IEC 17020 (EN ISO/IEC 17025 to be taken into account for testing required),
or
EN ISO/IEC 17065 (EN ISO/IEC 17025 to be taken into account for testing required)
EN ISO/IEC 17021 (+product related knowledge)
D, D1
EN ISO/IEC 17021(+product related knowledge)
E, E1
EN ISO/IEC 17025 (+ability to decide on conformity),
F, F1
or
EN ISO/IEC 17020 (EN 17025 to be taken into account for testing required),
or
EN ISO/IEC 17065 (EN 17025 to be taken into account for testing required)
EN ISO/IEC 17020 (EN 17025 to be taken into account for testing required),
G
or
EN ISO/IEC 17065 (EN 17025 to be taken into account for testing required)
EN ISO/IEC 17021 (+product related knowledge)
H
EN ISO/IEC 17021 (+product related knowledge) + EN ISO/IEC 17020 (EN ISO/IEC
H1
17025 to be taken into account for testing required),
or
EN ISO/IEC 17021 (+product related knowledge) + EN ISO/IEC 17065 (EN ISO/IEC
17025 to be taken into account for testing required)
The titles and current revision statuses of the standards are available at www.sas.admin.ch;
the SN EN versions apply in Switzerland.
Important note concerning the corresponding tabulated statement in EA document 2/17: in
the case that, as is also partially the case in the aforementioned table, an accreditation standard must be supplemented with criteria from other accreditation standards, the SAS will, in
principle, award “multiple” accreditations (a body with several accreditations). For areas in
which certification of persons is required, the SAS applies the standard EN ISO/IEC 17024.
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Regulation (EU) No 305/2011 (CPR) concerning construction products does not refer to the
modules. In this case, the table below is the applicable table:
Annex V (modified on 27/05/2014) to CPR on the AsAssessment and verification
sessment and Verification of Constancy of Perforsystems for constancy of
mance of Construction Products
performance
1+
1
2+
3
4
Manufacturer - M
The manufacturer shall draw up the declaration of performance and determine the product-type based on the
M
M
M
M
M
constancy of performance assessments and verifications
performed according to the 5 systems:
Performance is assessed on the basis of testing (inc.
sampling), calculations, values drawn from tables and
M
M
product description documentation
Factory Production Control (FPC)
M
M
M
M
M
Additional testing of samples taken by them at the facM
M
M
tory according to the prescribed test plan
Product Certification Body Pc (NB)
Certificate of constancy of performance on the basis of
Pc
Pc
the following assessment and verification results:
Performance is assessed on the basis of testing (inc.
sampling), calculations, values drawn from tables and
Pc
Pc
product description documentation
Initial inspection of the manufacturing plant and of facPc
Pc
tory production control
Continuous surveillance, assessment and evaluation of
Pc
Pc
factory production control (FPC)
Testing of samples taken by the certification body at
the manufacturing plant or the manufacturer’s storage faPc
cilities
FPC Certification Body (NB)
Certificate of conformity of factory production control on
FPc
the basis of the following assessments and verifications:
Initial inspection of the manufacturing plant and of facFPc
tory production control
Continuous surveillance, assessment and evaluation of
FPc
factory production control (FPC)
Test Laboratory - L (NB)
Assesses performance on the basis of tests (sampling
done by the manufacturer), calculations, values taken
L
from tables and the product’s descriptive documentation
Notified Body (NB) – notification as:
Product Certification Body ISO/IEC 17065*
X
X
X
Test Laboratory ISO/IEC 17025
X
* EN ISO/IEC 17065, Chap. 6.2.1 / 6.2.2 to be considLetter = task re. corresponding
ered (EN ISO/IEC 17025 / EN ISO/IEC 17020 to be
accreditation (NB)
taken into account for testing and inspections / surveillance)
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Explanation - Definition of Modules (Blue guide):
Here again, the SAS refers directly to the guide and the following table in particular (Chap.
5.1.7 –for further information also see the table in Chap. 10.4 - ANNEX 4 of the Blue Guide):
Modules
A
Internal production
control
A1
Internal production
control plus supervised product testing
A2
Internal production
control plus supervised product checks
at random intervals
B
EU-type examination
C
Conformity to EU-type
based on internal production control
C1
Conformity to EU-type
based on internal production control plus
supervised product
testing
C2
Conformity to EU-type
based on internal production control plus
supervised product
checks at random intervals
D
Conformity to EU-type
based on quality assurance of the production process
D1
Quality assurance of
the production process
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Description
Covers both design and production.
The manufacturer himself ensures the conformity of the products to
the legislative requirements (no EU-type examination).
Covers both design and production.
A + tests on specific aspects of the product carried out by an inhouse accredited body or under the responsibility of a notified body
chosen by the manufacturer (the legislator may restrict manufacturer’s choice).
Covers both design and production.
A + product checks at random intervals carried out by a notified body
or in-house accredited body (the legislator may restrict manufacturer’s choice).
Covers design.
It is always followed by other modules by which the conformity of the
products to the approved EU-type is demonstrated.
A notified body examines the technical design and or the specimen
of a type and verifies and attests that it meets the requirements of
the legislative instrument that apply to it by issuing an EU-type examination certificate. There are 3 ways to carry out EU-type examination: 1) production type, 2) combination of production type and design type and 3) design type.
Covers production and follows module B.
The manufacturer himself ensures the conformity of the products to
the approved EU-type.
Covers production and follows module B.
C + tests on specific aspects of the product carried out by an inhouse accredited body or under the responsibility of a notified body
chosen by the manufacturer (the legislator may restrict manufacturer’s choice).
Covers production and follows module B.
C + product checks at random intervals tests on specific aspects of
the product carried out by a notified body or in-house accredited
body (the legislator may restrict manufacturer’s choice).
Covers production and follows module B.
The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure
conformity to EU-type. The notified body assesses the quality system.
Covers both design and production.
The manufacturer operates a production (manufacturing part and inspection of final product) quality assurance system in order to ensure
conformity to legislative requirements (no EU-type, used like D without module B). The notified body assesses the production (manufacturing part and inspection of final product) quality system.
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Modules
E
Conformity to EU-type
based on product
quality assurance
E1
Quality assurance of
final product inspection and testing
F
Conformity to EU-type
based on product verification
G
Conformity based on
unit verification
H
Conformity based on
full quality assurance
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Description
Covers production and follows module B.
The manufacturer operates a product quality (=production quality
without the manufacturing part) assurance system for final product
inspection and testing in order to ensure conformity to EU-type. A notified body assesses the quality system.
The idea behind module E is similar to the one under module D: both
are based on a quality system and follow module B. Their difference
is that the quality system under module E aims to ensure the quality
of the final product, while the quality system under module D (and D1
too) aims to ensure the quality of the whole production process (that
includes the manufacturing part and the test of final product). E is
thus similar to module D without the provisions relating to the manufacturing process.
Covers both design and production.
The manufacturer operates a product quality (=production quality
without the manufacturing part) assurance system for final product
inspection and testing in order to ensure conformity to the legislative
requirements (no module B (EU-type), used like E without module B).
The notified body assesses the quality system.
The idea behind module E1 is similar to the one under module D1:
both are based on a quality system. Their difference is that the quality system under module E1 aims to ensure the quality of the final
product, while the quality system under module D1 aims to ensure
the quality of the whole production process (that includes the manufacturing part and the test of final product). E1 is thus similar to module D1 without the provisions relating to the manufacturing process.
Covers production and follows module B.
The manufacturer ensures compliance of the manufactured products
to approved EU-type. The notified body carries out product examinations (testing of every product or statistical checks) in order to control
product conformity to EU-type.
Module F is like C2 but the notified body carries out more systematic
product checks.
Covers both design and production.
The manufacturer ensures compliance of the manufactured products
to the legislative requirements. The notified body verifies every individual product in order to ensure conformity to legislative requirements (no EU-type).
Covers both design and production.
The manufacturer operates a full quality assurance system in order
to ensure conformity to legislative requirements (no EU-type). The
notified body assesses the quality system.
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Modules
H1
Conformity based on
full quality assurance
plus design examination
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Description
Covers both design and production.
The manufacturer operates a full quality assurance system in order
to ensure conformity to legislative requirements (no EU-type). The
notified body assesses the quality system and the product design
and issues an EU design examination certificate. Module H1 in comparison to module H provides in addition that the notified body carries out a more detailed examination of the product design.
The EU-design examination certificate must not be confused with the
EU-type examination certificate of module B that attests the conformity of a specimen “representative of the production envisaged”, so
that the conformity of the products may be checked against this
specimen. Under EU design examination certificate of module H1,
there is no such specimen. EU design examination certificate attests
that the conformity of the design of the product has been checked
and certified by a notified body.
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B
Interpretation of harmonised standards for the application of
conformity assessment procedures according to the selected
modules
1.
Accreditation of CAB according to Module H (ISO/IEC 17021)
1.1
General Requirements
The following regulations are valid for certification bodies that are already accredited according
to the standard ISO/IEC 17021 for the certification of quality management systems and SAS
Document No. 509 “SAS Interpretation of particular requirements of the EN 45000 and ISO/IEC
17000 series standards for the accreditation of certification bodies”. Insofar as they exist, the
relevant documents of the EC and EA3) and the IAF4) are also applicable.
The tabulated statement in Chap. 10.5 ANNEX 5 of the Blue Guide provides important details
concerning ISO 9000 and the modules referring to quality assurance systems.
1.2
Technical Requirements
Certification bodies performing conformity assessments according to Module H are tasked
with controlling and approving the quality control system implemented by the manufacturer for
the design, manufacture, final control and testing of the product intended to be marketed according to current legislation (see table above for definitions of the modules).
As such, the management of the certification body must have competent auditing personnel
according to the requirements of the standards in the ISO/CEI 17021 series. They will apply
their staff purposefully, evaluate their performance at regular intervals and are responsible for
the decision of certification.
To comply with these demands, they themselves need professional skills comparable with
those necessary to manage a product certification body (according to standard ISO/CEI
17065) or an inspection body (according to standard ISO/IEC 17020). These professional
skills also include knowledge of
 the legal regulations and subject-specific technical standards
 the essential requirements in the applicable Directive which must be fulfilled by the product
in question and the risks associated with these products
 general advances in the technical field (State of the art) re. the technology involved.
3)
4)
EA
IAF
European Co-operation for Accreditation
International Accreditation Forum
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1.3
Specific Technical Tasks
Within the framework of the management system, the management of the certification body
appoints personnel competent to intervene in a specific regulated field. The personnel establishes the procedure and subject-specific criteria for the certification in order to hand over corresponding information to the manufacturer in a timely manner.
The persons or committee(s) responsible for the decision on certification must also be technically skilled.
The certification body controls and ensures that personnel responsible for a specific technical
field have, through ongoing training, the technical skills required in point 1.2.
The certification body maintains a directory that provides information about the audit personnel
(qualified personnel in the body, qualified auditors and technical experts) responsible for a
specific field. Their expertise, experience and continuing education in the field, as well as the
experience in auditing (for auditors) are apparent in the directory. The directory is compiled in
a manner to primarily assist the administrative department in putting together auditing teams.
1.4
Specific Criteria for the Auditing Personnel
The auditing teams possess the necessary technical skills to evaluate the requirements of the
management system according to standard ISO 9001 and further standards as well as
 the design of the products (specifically the assessments to ensure the safety and reliability
of the product - essential requirements of the Directives) and
 the measures to guarantee the quality of all particular products in their mass production
phase and final controls.
The auditing teams possess in particular detailed knowledge about legally binding and fundamental requirements of the products to be assessed as well as associated risks. They know
the legal regulations as well as the relevant product-specific standards.
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This means that the certification body has qualified audit personnel available, who are either
 permanent employees or
 working as freelance auditors under a valid contract or
 external technical experts also under a valid contract.
The certification body makes sure that the technical skills of the auditors re. the technical experts correspond to the current level of knowledge. Extensive knowledge about products as
well as knowledge about production, use and disposal of the products is necessary to assess
risks and evaluate the producers' quality assurance measures.
Technical experts as well as freelance auditors are informed about the procedures of certification and special technical requirements of the corresponding bodies.
1.5
Boards Associated with or Superior to the Certification Body (e.g. Committees for safeguarding Impartiality [ISO/IEC 17021, Article 6.2])
No specific technical skills are required for these committees. However, the groups interested
in certification are adequately represented in them. The manufacturers of products within the
specific field are granted appropriate access to such boards.
The persons and boards taking part in the decision on certification must possess an overview
of the field, the applicable standards and the legal regulations, and they must be capable of
assessing the risks associated with the products.
2.
Accreditation of CAB according to Modules D and E (ISO/IEC 17021)
For the assessment of risks and the corresponding product-specific measures to ensure quality
by producers, the same set of subject-specific skills and criteria are valid for both the central
bodies and the audit personnel, analogue to Module H. Not stipulated is the competence for the
assessment of the product design, since a type examination (Module B) by a notified body has
taken place.
3.
Sub-contracting by Designated / Notified bodies (Blue Guide)






Chap. 5.2.5 of the Blue Guide is applicable, as are all corresponding accreditation requirements (standards), requirements of the EA, the EU, the OAccD and the equivalent Swiss
legal bases (MRA). In short:
A notified body can have part of its work carried out by another body, whether a subcontractor
or a subsidiary, on the basis of established and regularly monitored competence.
The notified body’s subcontractor must be technically competent and meet, under the same
conditions, the same criteria of impartiality and objectivity applying to the notified body. However, notification is not necessary.
The conformity assessment procedure may be subcontracted when subdivided into technical
and assessment operations and the methodology used to perform technical operations is
sufficiently precise. All subcontractors of the notified body must nevertheless be entrusted
with a substantial and coherent portion of the technical operations.
Subcontracting is subject to a contract providing transparency and trust in all operations of
the notified body.
A notified body using subcontractors will remain, under all circumstances, responsible for the
activities covered by notification. Subcontracting will not imply any delegation of powers or
responsibilities. Certificates will be issued in the name of and under the responsibility of the
notified body. The certification body also possesses the expertise to handle such tasks themselves. It needs therefore the skills defined under 1.2 in any case. Concerning the expertise
of the subcontractors, see Art. 18 of the OAccD requiring the corresponding accreditation.
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
4.
The subcontracting conditions apply to all subcontractors, whether established within the
Community or not.
Application of Mandatory or Informative EA Rules (EA document 2/17)
and Subordinate European Legal Bases (Regulation (EC) No 765/2008 /
Decision No 768/2008/EC)
As a non-EU State, Switzerland has its own legal basis recognised as equivalent by the EU
based on the MRA and its 20 product sectors:
 Agreement between the Swiss Confederation and the European Community relating to
mutual recognition regarding conformity assessment (MRA)
 Federal law on Technical Barriers to Trade (LETC)
 Ordinance on Accreditation and Designation (OAccD)
SAS document 730 provides a list of the Swiss legal bases equivalent to European Directives /
Regulations for the technical fields in question.
This document describes the general basis of application.
In application of these bases, the SAS, re. most of the responsible Authorities, applies the following accreditation principles for the purposes of notification:
- Accreditation, according to the OAccD (including the harmonised reference standards listed
in the Annex), is the basis for the recognition of competence and the organisation of designated / notified bodies. The Blue Guide and this document, Chap. A, govern the choice of
standards to be applied. The decision is taken in conjunction with the Authorities, in exceptional cases, the decision and responsibility for the same belong to the responsible Authorities.
- The SAS systematically practices, as applicable, the principle of additional requirements,
by incorporating additional harmonised standards (generally by multiple accreditations) including the requirements for notified bodies defined in the corresponding legal bases, which
themselves include, select and occasionally specify the criteria defined in Decision 768 re.
the non-mandatory Annex of EA document 2/17. Therefore, the recommendations of EA
document 2/17 for the selection of harmonised standards and additional requirements are
systematically covered - see also Chap. C below.
- As is noted in Chap. B, in the accreditation process, an assessment of competence always
includes a technical assessment of the ability of the body to be notified to perform technically
competent conformity assessments as described in the module or its equivalent (CPR).
- “Scoping” - definition and publishing of areas / scopes under notification: the principles set
forth in EA document 2/17 form the basis for compliance: transparency, comprehension,
completeness, compatibility with NANDO as far as possible. Implementation is described
later in this document.
C
Application in the Context of Accreditation
Responsibilities
For each regulated area - in particular those belonging to the MRA - a SAS lead assessor (LA)
will be appointed. The competent Authority and the contact person are also recorded by the
SAS. SAS document 730 sets forth this information as well as the Swiss and European legal
bases for reference. This LA is central for the treatment of internal and external applications,
national and international collaborations, internal and external training for its field and deci-
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Bodies (CAB)
sions (as accreditation proposals in the official form) directly relating to its field and for the development of application documents, publications, etc. e informs and instructs other SAS LA
involved in the area (see internal training below), all of this again in collaboration with the area
Head of Unit who is himself responsible for appointing the assessment teams.
Collaboration with the Authorities
The principle of collaboration and the obligation to do so is set forth in the OAccD Ordinance,
Article 11. In practice, the designated SAS LA (SAS doc. 730) is in regular contact, several
times per year, with the competent Authority. The SAS is in a collegial relationship of equals
with the Authorities that is highly effective. The contact person is invited to participate in SAS
assessments concerning them - an agreement is sometimes established with this person on
the collaboration method, in particular the degree of delegation to the SAS to proceed with the
assessment of the body based on the legal bases for a designated / notified body. In many
cases, this person is present and is also holds the role of technical accreditation expert. Certain Authorities do not wish to participate but to be kept informed. Decisions of the SAS on the
granting, extension or withdrawal of accreditation in these areas, are reported to Authorities by
the SAS. Certain authorities do not use the accreditation system and in this case there are no
tasks or obligations for the SAS.
Documents issued by international Accreditation Umbrella Organisations, Authorities
and the Commission
Documents issued by international Accreditation Umbrella Organisations and the Commission
are systematically received through the official channels (EA / ILAC / IAF / Authorities, etc.)
and analysed by the area appointed LA and Heads of Unit. The SAS uses the following practices regarding the principal international documents in force for this area:
- EA document 2/17: see Chap. 4 above. The non-mandatory Annex identifies potential gaps
in the accreditation standard used, previously selected according to Chap. A. An old unofficial checklist based on this Annex is, on request and following an interview, provided to the
SAS LA by the Head of Unit. But the national legal basis and, in particular, its requirements
for notified bodies, must still be referred to. This means to perform the assessment also
based on the corresponding requirements for the notified bodies of the Directives re. equivalent Swiss Laws and Ordinances (see MRA). In Switzerland only national Laws and Ordinances are to be considered.
- Documents and information of EA “directive networks”: SAS area appointed LA are registered in the EA directive network. They are tasked with all activities and communication relating to it. Copies of documents published by EA are available to all SAS employees on
the Official SAS server (\M).
- Guidelines and other subject-specific EU and Swiss documents: all subject-specific, technical and administrative documents published by the Commission (eur-lex.europa.eu /
ec.europa.eu, etc.) and the competent Authorities are recognised and used as the bases
for assessment of the NB by the Authorities and the SAS. The Blue Guide is one of the fundamental references, as are the documents issued by the Standing Committees
(construction), and CERTIF documents. Their occasional non-mandatory status is known
and recognised. Information essentially circulates via the responsible Authorities and the
Group of Notified Bodies (GNB).
Definition and Publication of Accredited Scopes
For each specific area, a publication system for scopes of notified bodies has been gradually
created (the first Swiss bodies were notified many years ago). Essentially, it refers to:
- the standard and accreditation type - if relevant referring to an additional accreditation
(see multiple accreditations above);
- the relevant Swiss Law (RS xxx.xxx);
- the corresponding EU Directives / Regulations;
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Bodies (CAB)
-
the corresponding modules, Annexes and other relevant elements of the Directive / Regulation;
the NB number or other NANDO reference;
the technical area in question - products / product types (varies according to Directives
and accreditations);
the product specifications / characteristics;
the harmonised technical standards or documents summarising them;
any other additional information required (comments, Annexes, restrictions etc.).
Documentation
The electronic database of the SAS contains four fields for documentation concerning the status and notification of the accredited body. All elements and documents produced and received concerning accreditation re. notification (from the perspective of the SAS) of an accredited notified body are documented according to SAS rules, as are all documents relating to an
accredited body. The SAS report provides summarised information about proof of the NB’s
technical and organisational “skills and abilities” based on this document and valid references
(see above).
Planning - Assessment - Notification Procedure
The requirements relating to a notification, in particular technical, are fully assessed for initial
notification and then by sampling during each SAS assessment activity with a notified body.
During renewal (no sampling but full coverage) or modification of the content / area of notification, an official confirmation / report is drafted for the competent Authorities.
The SAS notification procedure includes at least the following activities (unless otherwise decided by the Authorities):
- An exchange of information with the authorities regarding the notification application made
by the body to the Authority. The SAS / Authority collaboration process is defined.
- During preparation and assessment of the notified body, the LA incorporates the requirements for the area (according to these rules and elements of the legal bases in particular)
in his work.
- The notified body must demonstrate its technical and organisational “skills and abilities” according to the MRA Annex 2, letter A, figure 1 for the notified area, confirmed by the SAS
team and the accreditation awarded.
- The SAS informs the Authorities of the results of its assessments re. the accreditation of
NB and publishes scopes with the particulars specified in this document.
The SAS notification procedure may - by agreement with the competent authorities - include
the following additional activities:
- a review of the official notification application regarding the accredited area
- direct collaboration with a representative of the Authority who may act as technical expert
if necessary
- participation by the Authority in the information meeting or during the preliminary visit with
the (future) NB
- an assessment of additional and specific requirements laid down by the competent Authority
- if required, an addition extraordinary assessment
- direct collaboration with a representative of the Authority in the publication of scopes and
listing on NANDO
SAS Communication in Technical Areas
The LA in charge of the case re. area (see SAS document 730) is available to colleagues and
applicants (interested bodies) to answer questions and to provide all documentation and information required, the latest versions in particular. They may also draft instructional documents
for colleagues and third parties. Some of these can be found on the SAS website.
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6.
References
See document “Link-Sammlung: Bezeichnung und Notifizierung im Rahmen des Mutual
Recognition Agreement (MRA) Bauprodukte und Bauproduktegesetz (BauPG)“ published on
the sas.ch website with useful links.
7.
Amendments to the version of March 2015, rev. 06 of this document
 Document fully reviewed, updated and supplemented.
Annex 1: EA-2/17
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Federal Department of Economic Affairs,
Education and Research EAER
State Secretariat for Economic Affairs SECO
Swiss Accreditation Service SAS
Unclassified
EA-02/17 INF: 2014
Document on accreditation for notification
purposes
Document no. 729ew Annex1
729ew Annex1, December 2015
1/1
EA-2/17  EA Document on Accreditation for Notification Purposes
Publication
Reference
EA-2/17 INF: 2014
EA Document on
Accreditation
For Notification Purposes
PURPOSE
The document presents the policy agreed by EA Members for accreditation of Conformity
Assessment Bodies for notification purposes.
March 2014_rev02 – Re published May 2015
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EA-2/17  EA Document on Accreditation for Notification Purposes
Authorship
This document has been written by the Horizontal Harmonization Committee.
Official language
The publication may be translated into other languages as required. The English language
version remains the definitive version.
Copyright
The copyright of the publication is held by EA. The publication may not be copied for resale.
Further information
For further information about this document, please contact the EA Secretariat. Please check
the EA website for updates (http://www.european-accreditation.org).
Category:
Members Procedural Document, with an informative status
Date of approval:
11th November 2014
Implementation:
12th November 2014
Transitional period:
None
Editorial changes :
25 May 2015 – without a change in the revision number
Vocabulary adjustment to be in line with the status of
Informative Document approved with EA Resolution 2014(34)16
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EA-2/17  EA Document on Accreditation for Notification Purposes
CONTENTS
1.
SCOPE .............................................................................................................................. 3
2.
GENERAL PROVISIONS ................................................................................................... 4
2.1 Competence, impartiality and consistent performance of the Notified Body ................................. 4
2.2 The fulfilment by the Notified Body of the requirements established by each Union
Harmonization Legislation .................................................................................................. 4
3.
HARMONIZED STANDARDS TO BE USED BY NABs TO ASSESS
COMPETENCE FOR EACH MODULE INCLUDING THE ADDITIONAL
REQUIREMENTS ............................................................................................................. 5
3.1.
Harmonized Standards suitable for the accreditation Notified Bodies (table) ...................... 6
ANNEX A. ......................................................................................................................................... 9
ANNEX B ……………………………. ................................................................................................ 11
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EA-2/17  EA Document on Accreditation for Notification Purposes
1. SCOPE
This document contains the policy agreed by EA for accreditation of Conformity Assessment
Bodies by National Accreditation Bodies as a basis for notification by Notifying Authorities to
become Notified Bodies to work within the scope of Union Harmonization Legislation.1
This document is a “Members’ procedural document” with an informative status. It is intended
to apply to all National Accreditation Bodies (NABs) that assess and accredit Conformity
Assessment Bodies (CABs) for notification purposes, unless the Notifying Authority has
officially established and published different requirements.
It identifies the requirements that should be used by National Accreditation Bodies when
accrediting Conformity Assessment Bodies seeking notification.
Note 1 In the context of this document, the term “Notified Body” (NB) is used for all
Conformity Assessment Bodies (CABs) which are seeking notification or which are already
notified.
Note 2 In this document the following abbreviations are used:
CAB
Conformity Assessment Body.
NB
Notified Body (In the context of this document the term “Notified Body” has been used
for all Conformity Assessment Bodies which have applied to become notified or which
are already notified to work within the scope of Union Harmonized Legislation.)
NAB
National Accreditation Body
NA
Notifying Authority
UHL
Union Harmonization Legislation
HS
Harmonized Standard with requirements for the operations of Conformity Assessment
Bodies
NLF
New Legislative Framework
BSN
Body Seeking Notification
1
See:
http://ec.europa.eu/enterprise/policies/single-market-goods/documents/internal-market-forproducts/new-legislative-framework/index_en.htm
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EA-2/17  EA Document on Accreditation for Notification Purposes
2. GENERAL PROVISIONS
The main purpose of accreditation, when used as a tool to support notification of CABs in the
framework of UHL elaborated according to the provisions of Decision (EC) 768/2008, is to
give confidence to the NA on:
1) competence, impartiality and consistent performance of the Notified Body to perform
the tasks it is notified for;
2) the fulfillment by the Notified Body of the requirements established by each Union
Harmonization Legislation.
2.1 Competence, impartiality and consistent performance of the Notified Body
Accreditation is defined in Regulation (EC) 765/2008 as “an attestation by a National
Accreditation Body that a Conformity Assessment Body meets the requirements set by
Harmonized Standards and, where applicable, any additional requirements including those
set out in relevant sectoral schemes, to carry out a specific conformity assessment activity”.
Therefore, NABs have to use Harmonized Standards (HS) for assessment when
accreditation is used as the basis for notification.
It is widely accepted, however, that the conformity assessment activities described in the
modules defined in Decision (EC) 768/2008, do not restrict the use of Harmonized Standards
to one for each module, as the conformity assessment activities are not described in a way
which fits exactly with the descriptions in the HS.
This means that, for each module, different standards could be used for accreditation of the
Conformity Assessment Bodies seeking notification, but some of them have to be
supplemented by “additional requirements”. In this respect, NABs, as the bodies responsible
for declaring fulfillment of the requirements for the NB, are responsible for identifying those
standards that are suitable to be used for accreditation, considering the conformity
assessment activities for which the CAB is seeking accreditation. It is the responsibility of the
national authorities to judge whether accreditation granted by the NAB is suitable for
notification purposes.
EA has developed a table (see Table in section 3.1 of this document) which identifies those
Harmonized Standards that NABs may use to assess Conformity Assessment Bodies and
their competence for each module. The table includes the additional requirements (taken
also from other Harmonized Standards) which are needed to underpin the standard for an
appropriate assessment of the competence and performance of the NBs operating under
each module.
2.2 The fulfilment by the Notified Body of the requirements established by each
Union Harmonization Legislation
The specific requirements to be fulfilled by NBs are established in each Union Harmonization
Legislation.
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EA-2/17  EA Document on Accreditation for Notification Purposes
To be accredited, Notified Bodies should be assessed by NABs using:
1) one Harmonized Standard identified in table of section 3.1 in this document as applicable
to the module requested; and
2) the requirements for Notified Bodies included in the relevant Union Harmonization
Legislation (the one the applicant has requested accreditation for).
The accreditation certificate should make reference only to the Harmonized Standard used
as reference (see table in section 3.1) and granted for a given scope according to annex A of
this document.
This document applies only to the accreditation activities when accreditation is used by
National Notifying Authorities to support its notification decision. The Accreditation Body does
not assume the responsibility of the Notifying Authority. It is acknowledged that accreditation
and notification are two different activities which are performed separately.
3.
HARMONIZED STANDARDS TO BE USED BY NABs TO ASSESS
COMPETENCE FOR EACH MODULE INCLUDING THE ADDITIONAL
REQUIREMENTS
The table in section 3.1 identifies those Harmonized Standards technically valid to assess
competence of NBs for a given module, and identifies the additional requirements to be
assessed in each case.
Note: to develop the table, EA has taken into account the recommendations from the
European Commission such as the Blue Guide or SOGS document N612 EN as well as the
comparison produced by CEN/CENELEC TC1 in N460 document.
The table in section 3.1 hereafter is based to some extent on the current practice in several
EU Member States. The table elaborates on the activities in brackets in the Blue Guide table
in details, identifying for each HS the additional requirements and procedures needed to
assess the competence of CABs.
It is for the national Notifying Authorities, preferably in close cooperation with its NAB, to
allow accreditation of a NB against any of the suitable HS or to limit accreditation to some or
one of them. If Notifying Authorities allow more than one standard to be used, then
applicants may choose to use the one that better fits its needs.
The table may be interpreted or modified by EA if individual Union Harmonisation
Legislations differ in the conformity assessment activities from the identified modules (as
defined in Decision (EC) 768/2008).
In the accreditation process, the assessment of competence always includes a technical
assessment of the capacity of BSN to perform in a technically competent manner the
conformity assessment activities described in the module. The NAB has to assure that the
outcome of this assessment (in terms of “technical competence” level) is the same
irrespective of the standard used as reference, as the competence of the CAB to perform the
activities described in a given module should not depend on the HS chosen for the
assessment; only the way the BSN demonstrates such competence is different depending on
the standard (see annex 2).
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This document applies to EU directives and regulations which follow the standard New
Approach Model which are aligned with Decision (EC) 768/2008.
The document should also be used for UHL that does not follow the standard New Approach
Model (for example, the systems covered by the Construction Products Regulation or the
modules for the Rail interoperability Directive (EC) 713/2010), or which are not aligned with
Decision (EC) 768/2008. In these cases, further guidance to the use of this table may be
needed.
3.1.
Harmonized Standards suitable for the accreditation Notified Bodies
(table)
Module Description
A
A1
A2
B
C
C1
C2
D
D1
E
E1
F
F1
G
H
H1
Internal production control
Internal production control
plus supervised product
testing
Internal production control
plus supervised product
checks at random intervals
EC type examination
Conformity to type based on
internal production control
Conformity to type based on
internal production control
plus supervised product
testing
Conformity to type based on
internal production control
plus supervised product
checks at random
intervals
Conformity to type based on
quality assurance of the
production process
Quality assurance of the
production process
Conformity to type based on
product quality assurance
Quality assurance of final
product inspection and
testing
Conformity with type based
on product verification
Conformity based on
product verification
Conformity based on unit
verification
Conformity based on full
quality assurance
Conformity based on full
quality assurance plus
March 2014_rev02 – Re published May 2015
EN/ISO/IEC EN/ISO/
17065
IEC
17020
N/A
N/A
1+ t
1+ t
EN/ISO/
IEC
17021
N/A
EN/ISO
/IEC
17025
N/A
1 + cd
1 +t
1 +t
1 + cd
1+ t + pk
N/A
1+ t
N/A
1 + cd
N/A
1+ t + pk
1+ t
1 + cd
1+ t + pk
1+ t
1 + cd
1 + qa
1 + qa
1 + pk
1 + qa
1 +qa
1 + pk
1 + qa
1 +qa
1 + pk
1+ qa
1+ qa
1 + pk
1 + t + pk
1+t
1+ cd
1 + t + pk
1+t
1+ cd
1 + t + pk
1+t
1 + cd
1 + qa
1 +qa
1 + pk
1+qa
1+qa
1 + pk
N/A
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EA-2/17  EA Document on Accreditation for Notification Purposes
design examination
Key
1
The possible Harmonized Standards used for accreditation. In all cases, the
Harmonised Standard has to be used in full, i.e. CABs have to meet all of the
requirements of the Harmonised Standard as the basis for the assessment of the
CAB. Requirements cannot be subtracted from the selected standard; however a
requirement may be declared not applicable, if objectively demonstrated.
+
Additional applicable requirements of the other pertaining Harmonized Standards
used for assessing the NB, as relevant to the situation.
t
Additional applicable requirements of EN ISO/IEC 17025 if testing is required. To
this end fulfilment of the applicable requirements of clause 5 in EN ISO/IEC 17025
shall be demonstrated.
cd
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 when required. To this end, fulfilment of clauses 4.1, 7.5 and 7.6 in
EN ISO/IEC 17065 (or equivalent in EN 45011) shall be demonstrated.
pk
Ability to make professional judgments related to product requirements where
required. To this end fulfilment of clauses 6.1.2, 6.1.3 and 6.1.6 to 6.1.10 in EN
ISO/IEC 17020 shall be demonstrated.
qa
Ability to assess and approve manufacturer’s quality systems where required. To
this end, fulfilment of clause 9 in EN ISO/IEC 17021 shall be demonstrated.
Notes
1. It is noted that the detailed requirements taken from the “+” standards will vary according
to the level of coverage of that requirement within the baseline standard being used.
2. For EN ISO/IEC 17020, only Type A inspection bodies are valid for a Notified Body
activity, unless otherwise stated in the Legislation.
3. Specification of “t”, “cd”, “pk”, “qa” has been introduced to harmonize the understanding
and clarify the content of the assessment in the particular context of accreditation for
notification purposes, even if the concerned standard is already mentioned in the standard
which is used in full.
The option retained has been to specify for all modules the technical competencies to be
checked in addition to the standard used in full, despite the fact that EN ISO /IEC 17065
makes reference respectively to EN ISO/IEC 17020, 17021 and 17025. This option gives the
advantage to clarify which clauses of the additional standard have to be assessed during the
assessment of the NB, in addition to the requirements mentioned in the accreditation
standard, such as clause 6.2.1 of EN ISO/IEC 17065. For accreditation using EN ISO/IEC
17065 and EN ISO/IEC 17020, there is no additional requirement (as those requirements
come from a standard which is already prescribed); it is only a clarification of the
requirements to be fulfilled in the context of accreditation for the purpose of notification.
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4. Any formal findings raised by the NAB using the flexible approach shall be primarily
referenced to the nearest relevant clause in the selected baseline (1) standard. Reference to
the “+” standards can be made in the text.
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EA-2/17  EA Document on Accreditation for Notification Purposes
ANNEX A
DESCRIPTION OF THE ACCREDITATION SCOPE OF NOTIFIED BODIES
This document (Annex A) sets out guidelines which should be used by all EA member
Accreditation Bodies for the description of scopes when granting accreditation to Conformity
Assessment Bodies wishing to become notified to a New Approach Directive or Regulation.
A1 Considerations
The following should be considered when defining scopes of accreditation for notification
purposes:
1) the needs of the persons using information (primarily the customers of the NBs)
2) the needs of the notifying authorities
3) the type of data needed as input to the NANDO database
4) the conformity to EN ISO/IEC 17011 and the relevant Harmonized Standards for
Conformity Assessment Bodies.
A2 Main elements to be included in the scope
a) Harmonized Standard which is used as reference and applied in full for the
accreditation of the CAB. The scope should include a reference to EA-2/17 to confirm
that the NB complies with the additional requirements, and to confirm that the
accreditation may be considered suitable for notification purposes;
b) the identification of the directive or regulation (complemented, if requested by a
Notifying Authority, with a reference to the national regulations);
c) the conformity assessment procedure used (module, article or annexes, and systems
of a particular directive/regulation);
d) products/category – family – homogeneous groups of products;
e) product specification (harmonized product standard, other standard or technical
documents) as appropriate or product characteristics (such as mechanical properties,
electrical properties, etc.);
f) as an option, the assessment procedure/method used, only if this is required in the
directive or by the national authorities.
Elements a-b-c-d should be explicitly mentioned in the publicly available accreditation
documents.
The detailed information related to elements d) and e) should always be available on
request, but may be presented in a separate document in order to allow easier update.
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A3 Examples of presentation
Directive
89/686/EEC
Personal
protective
equipment
Conformity
Assessment
procedure/
Module/article
B, C2, D/ Articles
10, 11A, 11B
2003/44/EC
Aa, B, D, E, F , G
Recreational Craft tai/or H/ Annex I,
Directive
A
Category of products Essential requirements:
or individual products Product specification /
Properties/Standards
Hearing protectors
Mechanical and acoustical
properties
Personal eyeprotection
Mechanical and optical
properties
Small craft - Hull
identification – Coding
system
Personal watercraft
Small craft - Man
overboard prevention and
recovery
The first three columns include the information which is to be published in the NANDO
database. The fourth column and any other supplementary information should only be for
use by the NAB and the CAB.
Exceptions and limitations should also be communicated to the market and to the Notifying
Authority.
In cases when NANDO does not have a harmonized approach, EA together with the
Notifying Authorities may wish to discuss a harmonization of the nomenclature.
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ANNEX B
CRITERIA LAID DOWN IN THE HARMONIZED STANDARDS USED AS A BASIS FOR
ACCREDITATION THAT DEAL WITH THE REQUIREMENTS FOR NOTIFIED BODIES
LAID DOWN IN DECISION (EC) 768/2008 OF THE EUROPEAN PARLIAMENT AND OF
THE COUNCIL ON A COMMON FRAMEWORK FOR THE MARKETING OF PRODUCTS
B1 Preamble
Decision (EC) 768/2008 of the European Parliament and of the Council of 9 July 2008 on a
common framework for the marketing of products, and repealing Council Decision
93/465/EEC (The Decision) reads in Article R18:
Where a Conformity Assessment Body demonstrates its conformity with the criteria laid down
in the relevant Harmonized Standards or parts thereof the references of which have been
published in the Official Journal of the European Union it shall be presumed to comply with
the requirements [for Notified Bodies] in so far as the applicable harmonized standards
cover those requirements.
The following table document identifies which requirements laid down in the Harmonized
Standards used as a basis for accreditation deal with those for Notified Bodies set out in
Decision (EC) 768/2008. The numbering in the table follows the new structure of ISO/IEC
standards for CABs and therefore starts with Chapter 5.
It should be noted that the fact that a particular standard clause or section deals with a
requirement of Decision (EC) 768/2008 does not necessarily mean that the referenced
standard clause or section covers all aspects required by the Decision. When accrediting for
notification purposes, both the requirement of the particular standard and the requirement of
Decision (EC) 768/2008 shall be fulfilled.
Note that other requirements apply as well. Requirements related to specific modules,
articles and annexes are specified in Decision (EC) 768/2008 and UHL.
.
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Requirements on Decision (EC) 768/2008
EN ISO/IEC
17065
EN ISO/IEC
17025
(1)
(2)
(3)
EN
ISO/IEC
17020
(4)
EN
ISO/IEC
17021
(5)
EN
ISO/IEC
17024
(6)
4.1
5 GENERAL REQUIREMENTS
5.1 Legal and contractual matters
5.1.1 A notified body shall be established under national law and have legal
personality (Decision (EC) 768/2008 Article R17,2)
4.1.1
4.1.1
5.1.1
5.1.1
4.2
4.1.4 +
Note 1 and
2
4.1.5(b), (d)
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6a)
5.2.1
6.1.12
5.2
6.2
4.2.4
5.2 Management of impartiality
5.2.1 A notified body shall be a third-party body independent from the
organization or the product it assesses.
A body belonging to a business association or professional federation
representing undertakings involved in the design, manufacturing, provision,
assembly, use or maintenance of products which it assesses, can, on condition
that its independence and the absence of any conflict of interest are
demonstrated, be considered to be such a body.
(Decision (EC) 768/2008 Article R17, 3)
March 2014_rev02 – Re published May 2015
4.3.2
4.3.5
4.3.6
4.3.7
4.3.8
5.2.3
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Requirements on Decision (EC) 768/2008
(1)
5.2.2 A notified body, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be the designer,
manufacturer, supplier, installer, purchaser, owner, user or maintainer of the
products which they assess, nor the authorized representative of any of those
parties. This shall not preclude the use of assessed products that are necessary
for the operations of the Conformity Assessment Body or the use of the products
for personal purposes.
A notified body, its top level management and the personnel responsible for
carrying out the conformity assessment tasks shall not be directly involved in the
design, manufacture or construction, the marketing, installation, use or
maintenance of those products, nor represent the parties engaged in those
activities. They shall not engage in any activity that may conflict with their
independence of judgment or integrity in relation to conformity assessment
activities for which they are notified. This applies in particular to consultancy
services. (Decision (EC) 768/2008 Article R17, 4)
March 2014_rev02 – Re published May 2015
EN ISO/IEC
17065
EN ISO/IEC
17025
(2)
4.2.1
4.2.2
4.2.5
4.2.6
4.2.7
4.2.8
4.2.9
4.2.10
4.2.11
4.2.12
(3)
4.1.4 +
Note 2
4.1.5 (b),
(d)
EN
ISO/IEC
17020
(4)
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6a)
5.2.1
6.1.12
EN
ISO/IEC
17021
(5)
5.2
4.2.4
7.2.3
EN
ISO/IEC
17024
(6)
4.3.2
4.3.5
4.3.6
5.2.1
6.2.1
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Requirements on Decision (EC) 768/2008
EN ISO/IEC
17065
EN ISO/IEC
17025
(3)
EN
ISO/IEC
17020
(4)
6.3.1
6.1.12
6.1.13
(1)
5.2.4 Notified bodies shall ensure that activities of their subsidiaries or
subcontractors do not affect the confidentiality, objectivity and impartiality of its
conformity assessment activities. (Decision Article R17, 4)
(2)
4.2.3
4.2.6
4.2.7
4.2.8
6.2.2
5.2.5 Notified bodies and their personnel shall carry out the conformity
assessment activities with the highest degree of professional integrity and the
requisite technical competence in the specific field and must be free from all
pressures and inducements, particularly financial, which might influence their
judgment or the results of their conformity assessment activities, especially from
persons or groups of persons with an interest in the results of those
activities.(Decision (EC) 768/2008 Article R17, 5)
4.2.2
4.2.3
4.2.5
4.2.12
6.1.1.2
6.1.2
6.1.3
4.1.4
4.1.2
4.1.3
4.1.6 a)
6.1.1
6.1.2
6.1.3
6.1.11
5.2.8 The impartiality of the notified body, its top level management and
assessment personnel shall be guaranteed. The remuneration of the notified
body’s top level management and assessment personnel shall not depend on the
number of assessments carried out or on the results of such assessments.
(Decision (EC) 768/2008 Article R17, 8)
4.2.3
4.2.4
4.4.4
5.2
4.1.5 (b)
4.1.2
4.1.5
4.1.6 a)
6.1.11
4.5
EN
ISO/IEC
17021
(5)
4.6
5.2.3
5.2.5
5.2.6
5.2.7
5.2.11
5.2.12
7.5.1
7.5.3b),c)
8.5
5.2.2
7.1
7.2
EN
ISO/IEC
17024
(6)
4.3.6
4.3.7
5.1.1
5.2.3
6.3
5.2.1
5.2.2
5.2.12
4.3.1
6.1.3
6.1.6
6.1.7
6.2.1
6.2.2
5.3 Liability and financing
March 2014_rev02 – Re published May 2015
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EA-2/17 INF - EA Document on Accreditation for Notification Purposes
Requirements on Decision (EC) 768/2008
(1)
5.4 Identification number of notified bodies
5.4.1 The CE marking shall be followed by the identification number of the notified
body where such body is involved in the production control phase.
The identification number of the notified body shall be affixed by the body itself or
under its instructions, by the manufacturer or his authorized representative.
(Decision (EC) 768/2008 Article R12, 3)
EN ISO/IEC
17065
EN ISO/IEC
17025
(2)
(3)
EN
ISO/IEC
17020
(4)
EN
ISO/IEC
17021
(5)
EN
ISO/IEC
17024
(6)
This chapter reflects specific requirements on CE marking for
notified bodies according to the requirements of the relevant
community harmonization legislations. Therefore, these will have
to be implemented based on the requirements in the specific
legislation for which the Conformity Assessment Body wishes to
be notified
6 STRUCTURAL REQUIREMENTS
6.1 Role as notified body
6.1.1 At all times and for each conformity assessment procedure and for each
kind or category of products in relation to which it has been notified, a Conformity
Assessment Body shall have at its disposal the necessary descriptions of
procedures according to which conformity assessment is carried out, ensuring the
transparency and the ability of reproduction of these procedures. It shall have
appropriate policies and procedures in place that distinguish between tasks it
carries out as a notified body and other activities (Decision (EC) 768/2008 Article
R17, 6(b))
4.6a)
5.1.2
6.2.1
7.1.1
7.1.2
7.1.3
5.4
5.2.4
7.1.1
7.1.2
7.1.3
7.1.4
8.1.1
8.6.1
8.2
8.3
9.2.1
9.2.2
9.2.3
6.2 Cooperation with other bodies
6.2.1 Notified bodies shall participate in, or ensure that their assessment
personnel is informed of, the relevant standardization activities and the activities
of the notified body coordination group established under the relevant Community
harmonization legislation and apply as general guidance the administrative
decisions and documents produced as a result of the work of that group.
(Decision (EC) 768/2008 Article R17, 11)
March 2014_rev02 – Re published May 2015
In general standards on Conformity Assessment Body
Competence Criteria do not “require” cooperation with other
bodies. This requirement is specific for notified bodies and is to be
assessed based on the requirements of the harmonized
community legislation to the degree required by such legislation.
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Requirements on Decision (EC) 768/2008
EN ISO/IEC
17065
EN ISO/IEC
17025
(1)
(2)
(3)
EN
ISO/IEC
17020
(4)
EN
ISO/IEC
17021
(5)
EN
ISO/IEC
17024
(6)
7 RESOURCE REQUIREMENTS
7.1 Personnel
7.1.1 At all times and for each conformity assessment procedure and for each
kind or category of products in relation to which it has been notified, the
Conformity Assessment Body shall have at its disposal the necessary personnel
with technical knowledge and sufficient and appropriate experience to perform the
conformity assessment tasks; (Decision (EC) 768/2008 Article R17, 6(a))
6.1.1.1
6.1.1.2
6.2.1
5.2.1
6.1.2
6.1.3
7.1
7.2
6.1.2
7.1.2 The personnel responsible for carrying out the conformity assessment
activities shall have the following:
a) sound technical and vocational training covering all the conformity assessment
activities of the relevant scope for which the Conformity Assessment Body has
been notified;
b) satisfactory knowledge of the requirements of the assessments they carry out
and adequate authority to carry out such operations;
c)appropriate knowledge and understanding of the essential requirements, of the
applicable Harmonized Standards and of the relevant provisions of the relevant
Community harmonization legislation and relevant implementing regulations;
d) the ability required to draw up the certificates, records and reports to
demonstrate that the assessments have been carried out. (Decision (EC)
768/2008 Article R17, 7.)
6.1.1.2
6.1.2
6.2.1
5.2.1 +
Note 2
6.1.1
6.1.2
6.1.3
6.1.8
6.1.9
7.1
7.2
6.1.3
6.2.2.1
March 2014_rev02 – Re published May 2015
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Requirements on Decision (EC) 768/2008
EN ISO/IEC
17065
EN
ISO/IEC
17025
(3)
EN
ISO/IEC
17020
(4)
EN
ISO/IEC
17021
(5)
EN
ISO/IEC
17024
(6)
(1)
(2)
4.3.2
6.2
7.3.1
5.3.1
5.5.1
6.2.1
6.2.2
4.3
6.1.3
7.1.1
7.1.4
6.4
7.3.1 Where the notified body subcontracts specific tasks connected with the
assessment of conformity or has recourse to a subsidiary, it shall ensure that the
subcontractor or the subsidiary meets the requirements set out in Article R17 (of
the Decision (EC) 768/2008) and inform the notifying authority. (Decision (EC)
768/2008 Article R20, 1.)
6.2.2.1
6.2.2.2
6.2.2.3
4.5.1
6.3.1
7.5.1
7.5.3 b)
7.5.4
6.3.1
6.3.2
7.3.2 Notified bodies shall take full responsibility for the tasks performed by
subcontractors or subsidiaries wherever these are established. (Decision (EC)
768/2008 Article R20, 2.)
6.2.2.4a)
4.5.3
6.3.3
7.5.3a)
6.3.1
6.3.2
7.3.3 Activities may be subcontracted or carried out by a subsidiary only with the
agreement of the client. (Decision (EC) 768/2008 Article R20, 3.)
6.2.2.4f)
4.5.2
6.3.2
7.5.1
7.3.4 Notified bodies shall keep at the disposal of the notifying authority the
relevant documents concerning the assessment of the qualifications of the
subcontractor or subsidiary and the work carried out by them. (Decision (EC)
6.2.2.1
6.2.2.4c) d)
4.1.2
4.5.4
6.3.4
7.5.4
This
standard
does not
require
agreement
of the client.
6.3.2
7.1.6 Monitoring
7.2 Equipment
7.2.1 The notified body shall have the means necessary to perform the technical
and administrative tasks connected with the conformity assessment activities in
an appropriate manner and shall have access to all necessary equipment or
facilities. (Decision (EC) 768/2008 Article R17, 6.)
7.3 Outsourcing (subcontracting)
March 2014_rev02 – Re published May 2015
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Requirements on Decision (EC) 768/2008
EN ISO/IEC
17065
(1)
(2)
EN
ISO/IEC
17025
(3)
EN
ISO/IEC
17020
(4)
EN
ISO/IEC
17021
(5)
EN
ISO/IEC
17024
(6)
768/2008 Article R20, 4.)
8 INFORMATION REQUIREMENTS AND CONFIDENTIALITY
8.1 Information requirements
8.1.1 Notified bodies shall inform the notifying authority of the following:
1. any refusal, restriction, suspension or withdrawal of certificates;
2. any circumstances affecting the scope of and conditions for notification;
3. any request for information on conformity assessment activities performed
which they have received from market surveillance authorities;
4. on request, conformity assessment activities performed within the scope of
their notification and, any other activity performed, including, cross-border
activities and subcontracting. (Decision (EC) 768/2008 Article R28, 1.)
See
comments
to 8.1
See
comments
to 8.1
See comments to
8.1
See comments to
8.1
See comments to
8.1
8.1.2 Notified bodies shall provide the other bodies notified under the same
community harmonization legislation carrying out similar conformity assessment
activities and covering the same products with relevant information on issues
relating to negative and, on request, positive conformity assessment results.
(Decision (EC) 768/2008 Article R28, 2.)
See
comments
to 8.1
See
comments
to 8.1
See comments to
8.1
See comments to
8.1
See comments to
8.1
March 2014_rev02 – Re published May 2015
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Requirements on Decision (EC) 768/2008
(1)
8.2 Confidentiality
8.2.1 The personnel of the notified body shall be bound to observe professional
secrecy with regard to all information gained in carrying out its tasks under the
relevant community harmonization legislation or any provision of national law
giving effect to it, except in relation to the competent administrative authorities of
the Member State in which its activities are carried out. Proprietary rights shall be
protected. (Decision (EC) 768/2008 Article R17, 10.)
EN ISO/IEC
17065
(2)
4.5
6.1.1.3
EN
ISO/IEC
17025
(3)
EN
ISO/IEC
17020
(4)
EN
ISO/IEC
17021
(5)
EN
ISO/IEC
17024
(6)
4.1.5(c)
4.2
6.1.13
8.5
6.1.6
6.1.7
7.3.3
7.3.4
9 PROCESS REQUIREMENTS
9.1 General requirements
9.1.1 The Conformity Assessment Body shall be capable of carrying out all the
conformity assessment tasks assigned to such a body by the provisions of the
relevant community harmonization legislation and for which it has been notified,
whether those tasks are carried out by the Conformity Assessment Body itself or
on its behalf and under its responsibility. (Decision (EC) 768/2008 Article R17, 6.)
6.1.2
6.2.2
7.1.1
7.4.4
7.6.6
5.4
5.1.3
5.2.2
6.1.3
6.3
7.1.
7.1.1
7.1.2
7.2.1
7.2.2
9.2.1
9.1.2 At all times and for each conformity assessment procedure and for each
kind or category of products for which it is notified, the Conformity Assessment
Body shall have at its disposal the necessary procedures to perform their
activities taking into consideration the size, the sector, the structure of the
undertakings, the degree of complexity of the product technology in question and
the mass or serial nature of the production process. (Decision (EC) 768/2008
Article R17, 6.)
4.4
7.1.1
7.3.2
7.4.4
7.10.1
7.10.2
5.4
7.1.
9.1.1
9.1.2
9.1.3
9.1.4
8.1
8.2
9.2 Scope of activities
March 2014_rev02 – Re published May 2015
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Requirements on Decision (EC) 768/2008
EN ISO/IEC
17065
(1)
(2)
EN
ISO/IEC
17025
(3)
EN
ISO/IEC
17020
(4)
EN
ISO/IEC
17021
(5)
EN
ISO/IEC
17024
(6)
9.3 Operational obligations for notified bodies
9.3.1. Notified bodies shall carry out conformity assessments in accordance with
the conformity assessment procedures provided for in the relevant community
harmonization legislation. (Decision (EC) 768/2008 Article R27, 1)
7.1.2
7.4.3
7.4.4
5.4
7.1.
9.1.1.1
9.2
9.2.1
9.3.2. Conformity assessments shall be carried out in a proportionate manner,
avoiding unnecessary burdens for economic operators. The Conformity
Assessment Bodies shall perform their activities taking into consideration the size,
the sector, the structure of the undertakings involved, the relative complexity of
the technology used by the products and the serial character of production.
4.4
7.1.
7.4.4
5.4
7.1.
9.1.1
9.1.4
9.1.2.2
9.2.1
In so doing they shall nevertheless respect the degree of rigor and the level of
protection required for the compliance of the product by the provisions of the
relevant community harmonization legislation. (Decision (EC) 768/2008 Article
R27, 2)
March 2014_rev02 – Re published May 2015
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Requirements on Decision (EC) 768/2008
EN ISO/IEC
17065
(1)
9.3.3 Where a notified body finds that requirements laid down in of the relevant
community harmonization legislation or corresponding Harmonized Standards or
technical specifications have not been met by the manufacturer, it shall require
the manufacturer to take appropriate corrective measures and it shall not deliver
any conformity certificate. (Decision (EC) 768/2008 Article R27, 3)
(2)
7.4.6
7.4.7
7.11.1
9.3.4 Where, in the course of the monitoring of conformity following the delivery of
certificate, a Notified Body finds that a product does not comply any more, it shall
require the manufacturer to take appropriate corrective measures and shall
suspend or withdraw its certificate if necessary. (Decision (EC) 768/2008 Article
R27, 4)
7.4.6
7.4.7
7.6.6
7.11
March 2014_rev02 – Re published May 2015
EN
ISO/IEC
17025
(3)
5.8.3
EN
ISO/IEC
17020
(4)
This is not
part of the
work of an
inspection
body. It
can be
done if
requested
in the
specific
directive
Monitoring of
conformity after the
testing or inspection
has been performed
and report issued, is
not part of the work of a
laboratory or an
inspection body. This
can be done if
requested in the
specific directive.
EN
ISO/IEC
17021
(5)
9.1.11
9.1.12
9.1.15
9.6
EN
ISO/IEC
17024
(6)
9.4.6
9.1.11
9.3.3
9.6
8.3
9.5
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Requirements on Decision (EC) 768/2008
(1)
9.3.5. Where corrective measures are not taken or do not have the required
effect, the notified body shall restrict, suspend or withdraw any certificates, as
appropriate.(Decision (EC) 768/2008 Article R27, 5)
EN ISO/IEC
17065
(2)
7.11
EN
EN
ISO/IEC
ISO/IEC
17025
17020
(3)
(4)
Monitoring of
conformity after the
testing or inspection
has been performed
and report issued, is
not part of the work of a
laboratory or an
inspection body. This
can be done if
requested in the
specific directive.
EN
ISO/IEC
17021
(5)
9.6.1
9.6.2
EN
ISO/IEC
17024
(6)
9.5.2
9.4 Conformity assessment criteria
9.5 Preparation for assessment and contract review
9.6 Assessment
March 2014_rev02 – Re published May 2015
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