COMMISSION STAFF WORKING DOCUMENT Accompanying the report from the Commission to the European Parliament, the Council and the European economic and social Committee on the implementation of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 Guidance papers on accreditation
Date: 2013-02-13
Institutions: European Commission
Subjects: Community certification, application of EU law, customs inspection, exchange of information, intergovernmental cooperation (EU), market supervision, marketing standard, product safety, quality control of industrial products, single market

EUROPEAN 
COMMISSION 

Brussels, 13.2.2013  
SWD(2013) 35 final 

PRODUCT SAFETY AND MARKET SURVEILLANCE PACKAGE 

COMMISSION STAFF WORKING DOCUMENT 
Accompanying  

the report from the Commission to the European Parliament, the Council and the 
European economic and social Committee 

on the implementation of Regulation (EC) No 765/2008 of the European Parliament and 
of the Council of 9 July 2008 setting out the requirements for accreditation and market 
surveillance relating to the marketing of products and repealing  
Regulation (EEC) No 339/93 

Guidance papers on accreditation 

{COM(2013) 77 final} 
{SWD(2013) 36 final} 

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   EN 

 
 
 
 
  
 
 
 
COMMISSION STAFF WORKING DOCUMENT 
Accompanying  

the report from the Commission to the European Parliament, the Council and the 
European economic and social Committee 

on the implementation of Regulation (EC) No 765/2008 of the European Parliament and 
of the Council of 9 July 2008 setting out the requirements for accreditation and market 
surveillance relating to the marketing of products and repealing  
Regulation (EEC) No 339/93 

Guidance papers on accreditation 

1. 

INTRODUCTION 

This  Commission  staff  working  document  gives  an  overview  of  the  so-called 
'CERTIF'  documents  which  were  discussed  with 
the  Senior  Officials  for 
Standardisation  and  Conformity  Assessment  Policy  Group  ('SOGS')  and  which, 
following  the  discussions,  represent  a  consensus  between  the  Commission  and 
Member  States  representatives  on  how  to  approach  certain  matters  concerning  the 
implementation of Chapter II on accreditation of Regulation (EC) No 765/2008. The 
objective of these 'CERTIF documents' is to provide informal guidance on question 
raised by national authorities and accreditation bodies throughout the Union1. 

This  staff  working  document  therefore  contains  all  the  documents  on  which  a 
consensus  was  reached  between  2008  (the  year  of  the  adoption  of  the  Regulation) 
and autumn 2012. 

IMPACT  OF  THE  EU  ACCREDITATION  FRAMEWORK  AT  INTERNATIONAL  LEVEL 
(CERTIF 2008-03) 
The new Regulation (EC) No 765/20082 embodies the European accreditation policy 
in relation to conformity assessment. It introduces for the first time a common legal 
base  for  accreditation  by  providing  for  a  horizontal  framework  for  accreditation 
which lays down at European level the principles for its operation and organisation. 
This framework covers accreditation linked to conformity assessment independently 
whether  the  conformity  assessment  is  performed  in  the  mandatory  or  voluntary 
sphere.  Moreover  it  applies  beyond  the  New  Approach  legislation  covering 
conformity assessment activities carried out in industrial sectors not covered by the 
New Approach as well as in other areas such as environment, health and agriculture.  

This document attempts to explain the impact of the new accreditation framework at 
international level. This includes outlining the main features and specific principles 
of  the  European  accreditation  policy,  the  effects  on  the  international  cooperation 

Further CERTIF documents are currently being discussed between the Commission and Member States. 
A  full 
list  of  CERTIF  documents,  not  only  concerning  accreditation  can  be  found  on: 
http://ec.europa.eu/enterprise/policies/single-market-goods/documents/certif_doc_en.htm.  
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out 
the  requirements  for  accreditation  and  market  surveillance  relating  to  the  marketing  of  products  and 
repealing Regulation (EEC) No 339/93 

2. 

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between accreditation bodies and its significance for the Community’s external trade 
policy in the field of conformity assessment. 

2.1. 

Background  

Accreditation  as  an 
impartial  means  of  assessing  and  conveying  formal 
demonstration of the technical competence, impartiality and professional integrity of 
conformity  assessment  bodies  is  an  effective  quality  infrastructure  tool  used 
worldwide.  

At  international  level,  cooperation  between  accreditation  bodies  takes  place  within 
two  organizations:  namely  within  the  International  Accreditation  Forum  (IAF) 
between  accreditation  bodies  accrediting  certification  and  inspection  bodies  and 
within  the  International  Laboratory  Accreditation  Cooperation  (ILAC)  between 
accreditation  bodies  accrediting  laboratories  and  inspection  bodies.  Both  entities 
provide  for  multilateral  mutual  recognition  arrangements  between  its  accreditation 
body members. IAF manages a Multilateral Recognition Arrangement (MLA), while 
ILAC  operates  a Mutual  Recognition  Arrangement (MRA). Although the names of 
the  arrangements  changes,  both  organizations  have  the  aim  through  these 
arrangements to establish confidence concerning the equivalence of the operation of 
the  signatories  to  the  agreement  and  that  the  results  of  accredited  conformity 
assessment bodies issued under accreditation of the signatories are equally reliable. 
These  multilateral  mutual  recognition  arrangements/agreements  of  competence  at 
technical level between accreditation bodies have the ultimate aim to allow products 
and  services  accompanied  by  accredited  conformity  attestations  to  enter  foreign 
markets without a re-testing or re-certification in the import country. The objective of 
such  recognition  arrangement/agreements  between  accreditation  bodies  is  therefore 
to contribute to reinforce the acceptance of conformity assessment certificates. 

At  the  regional  level,  cooperation  organizations  between  accreditation  bodies  have 
been established in3: 

• 

• 

• 

• 

Europe: European co-operation for accreditation (EA) 

America: Inter America Accreditation Cooperation (IAAC) 

Asia  –  Pacific:  Asia  Pacific  Laboratory  Accreditation  Cooperation 
(APLAC) and Pacific Accreditation Cooperation (PAC) 

Africa:  Southern  African  Development  Community  Accreditation 
(SADCA) 

the 

listed 

above 

cooperation 

Except  for  SADCA  which  is  currently  developing  its  regional  mutual  recognition 
arrangement, 
have 
agreements/arrangements  in  place  within  their  region  on  which  the  ILAC/IAF 
arrangements  build  upon.  By  granting  special  recognition  IAF  accepts  the  mutual 
recognition arrangements established within EA and PAC: accreditation bodies being 
member of IAF and signatories to the EA Multilateral agreement (EA MLA) or the 
PAC Multilateral Recognition Arrangement (PAC MLA) are automatically accepted 
into  the  IAF  MLA4.  ILAC  accepts  the  mutual  recognition  arrangements  and 
underlying  evaluation  procedures  of  EA,  APLAC,  and  IAAC.  Accreditation  bodies 

organisations 

3 
4 

Only the main accreditation cooperation organisations at regional level are listed.  
While the special recognition by IAF granted to EA and PAC covers the IAF Product MLA, the IAF 
Quality  Management  System  MLA  and  the  IAF  Environmental  Management  Systems  MLA,  special 
recognition granted to IAAC is limited to the IAF Quality Management Systems MLA. http://www.iaf.nu/ 

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which  are  not  affiliated  to  any  recognised  regional  cooperation  entity  may  apply 
directly to ILAC and/or IAF for evaluation and recognition.5  

2.2. 

The New Legal Environment 

Regulation  (EC)  No  765/2008  provides  for  a  comprehensive  horizontal  legal 
framework  for  the  operation  and  organisation  of  accreditation  in  the  European 
Economic  Area  (EEA)6  applicable  as  from  1  January  2010.  It  imposes  obligations 
and requirements on European national accreditation bodies, Member States and the 
European Commission and sets out the respective responsibilities as well as the co-
ordinating  role  of  the  European  co-operation  for  Accreditation  (EA).  Under 
Regulation  (EC)  No  765/2008  EA  is  recognised  as  the  official  European 
infrastructure  for  cooperation  in  the  field  of  accreditation  responsible  for  the 
management of the European peer evaluation which ascertain the competence of the 
European accreditation bodies7.  

The stabilization of accreditation as authoritative and therefore last level of control of 
conformity assessment activities from a technical competence point of view is at the 
core  of  the  European  accreditation  policy.  In  this  respect  Regulation  (EC)  No. 
765/2008  formalizes  a  set  of  requirements  in  particular  for  accreditation  bodies. 
These requirements are in line with the globally accepted requirements laid down in 
the  relevant  ISO/IEC  international  standards,  although  some  of  them  can  be 
perceived  as  being  more  rigorous,  going  beyond  the  requirements  set  out  in  the 
applicable standards. In particular  

• 

• 

• 

• 

Accreditation  is  carried  out  by  one  single  national  accreditation  body 
appointed by its Member State (Art 4.1) 

Accreditation is performed as a public authority activity (Art 4.5) 

National accreditation bodies operates free from commercial motivations 
(Art 8.1) and on a not-for- profit basis (Art 4.7) 

National  accreditation  bodies  do  not  compete  with  conformity 
assessment bodies and among each other (Art 6.1 and Art 6.2) 

Cross  frontier  accreditation  is  carried  out  only  under  certain  limited  circumstances 
(Art 7): European conformity assessment bodies are required to request accreditation 
by the national accreditation body of the Member State in which they are established. 
The possibility of a conformity assessment body to request accreditation in another 
Member States is limited to the cases where in its Member State there is no national 
accreditation  body,  where  the  national  accreditation  body  does  not  offer  the 
requested  accreditation  service  or  where  the  national  accreditation  body  has  not 
received  a  positive  result  in  the  peer  evaluation  in  relation  to  the  conformity 
assessment activity for which accreditation is requested 

By  laying  down  these  specific  “supplemental”  requirements,  Regulation  (EC)  No 
765/2008  protects  accreditation  in  Europe  against  the  risk  to  become  an  additional 
layer  of  commercial  certification  which  would  jeopardize  its  reliability,  neutrality 

5 

6 

7 

For  more  detailed  information  on  the  IAF  MLA  and  the  ILAC  MRA  and  their  signatories: 
http://www.iaf.nu/ and http://www.ilac.org/ilacarrangement.html  
The Agreement creating the European Economic Area which came into force 1 January 1994 extends 
the Single Market to the EEA EFTA States (Norway, Iceland, Liechtenstein) therefore covering, among 
others, all the acquis relevant to the free circulation of products.  
The  peer  evaluation  managed  by  EA  forms  the  basis  for  the  EA  multilateral  agreement  (EA  MLA), 
underpinning the ILAC MRA and IAF MRA. 

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and credibility. Accreditation would in this case not only entail added and unjustified 
cost  without  added  value  but  would  also  be  unable  to  provide  the  necessary 
confidence to the market creating the need for an extra layer for supervision.  

2.3. 

The Impact on the Relation between EA and ILAC and IAF 

According to Regulation (EC) No 765/2008 European national accreditation bodies 
fulfilling  the  requirements  of  the  Regulation  are  member  of  EA  (Article  4.10). 
Different  from  European  national  accreditation  bodies,  accreditation  bodies  not 
members of EA may not necessarily meet all the above outlined EU requirements as 
these  do  not  apply  outside  the  EEA  and  are  not  addressed  to  third  country 
accreditation  bodies.  Although  Regulation  (EC)  No  765/2008  does  not  provide  for 
rules regarding the relationship between EA and international co operations between 
accreditation bodies, the question arises on the impact for the co-operation between 
European  and  third  countries  accreditors  at  international  level  taking  place  within 
ILAC and IAF and within their respective global Mutual Recognition Arrangement 
and  Multilateral  Agreement  to  which  EA  belongs  as  a  Region.  If  EA  would 
recognise  the  equivalence  among  accreditation  bodies  and  the  equal  reliability  of 
accredited  conformity  assessment  bodies’  only  by  accreditation  bodies  meeting  the 
same  requirements,  EA  would  undermine  the  international  multilateral  mutual 
recognition  arrangement/agreements  and  isolate  itself.  As  this  is  in  no  way  the 
intention  of  Regulation  (EC)  No  765/2008,  EA  recognizes  that  attestations  of 
conformity  issued  in  accordance  with  the  requirements  of  ISO/IEC  17011  under 
accreditation bodies signatories to the ILAC MRA and IAF MLA but not signatories 
to  the  EA  MLA  or  BLAs8  and  not  complying  with  all  the  requirements  of  the  EU 
regulation  are  considered  to  be  equally  reliable  from  a  technical  point  of  view  to 
those issued within the EA MLA and BLAs.9 

2.4. 

The impact on trade relations in the field of conformity assessment between the 
EU and Third Countries  

The international mutual recognition between accreditation bodies allow certificates 
and reports accompanying exported goods and services to be more readily accepted 
on the international and the European market, but the ultimate acceptance in the EU 
of  conformity  assessment  attestations  issued  under  accreditation  by  non-European 
bodies  not  necessarily  complying  with  the  new  European  requirements  does  not 
depend  on  the  cooperation  and  mutual  recognition  of  accreditation  bodies.  The 
ultimate  acceptance  of  conformity  assessment  attestations  is  decided  by  the  public 
authorities and,  from an economic  point of view, by industry users and consumers. 
The  voluntary  multilateral  mutual  recognition  agreements  between  accreditation 
bodies  taking  place  at  technical  level  support,  further  develop  and  enhance 
intergovernmental trade agreements.  

8 

9 

Nationally recognized accreditation bodies not established in one of the EU Member States or EFTA or 
a candidate country to the EU, which according to the current Articles of Association of EA may not 
become EA “full members”, may enter into a contract of cooperation with EA. An accreditation body 
that has signed a contract of cooperation with EA may apply to be a signatory of a Bilateral Agreement 
(BLA). The BLA conveys the same benefits in relation to mutual recognition as the MLA: recognition 
of the equivalence of the operation of the Bilateral Signatory accreditation body to those of EA MLA 
signatories  and  equal  reliability  of  conformity  assessment  attestations  issued  by  organizations 
information: 
accredited  by 
http://www.european-accreditation.org/content/mla/what.htm 
Such a statement has been formally endorsed by the EA General Assembly the 19 November 2008. 

the  Bilateral  Signatory  accreditation  body.  For  more  detailed 

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The  requirements  set  out  above  affect  the  acceptance  of  non-European  certificates 
and test results accredited by non-European Accreditation bodies not complying with 
the  new  EU  requirements  but  signatories  to  the  ILAC/IAF  MRA/MLA  in  the 
following way: 

2.4.1.  Conformity assessment delivered in the voluntary sphere  

It  will  be  up  to  the  non-European  conformity  assessment  body  operating  on  the 
European  market  to  decide  if  and  where  to  get  accredited.  In  order  to  boost  the 
acceptance  of  its  conformity  assessment  attestations  by  the  European  market 
(industry  as  purchasers  of  conformity  assessment  attestations  and  ultimately 
consumers)  the  non-European  conformity  assessment  body  opting  for  accreditation 
may choose whether to resort to the service of a third country accreditation body not 
necessarily  conforming  to  the  new  European  requirements  but  signatory  to  the 
ILAC/IAF  MRA/MLA  or  rather  to  that  of  a  European  accreditation  body. 
Unchanged compared to the present situation, non-European Conformity assessment 
attestations  issued  under  accreditation  by  non-European  Accreditation  bodies  not 
fulfilling the new European requirements, can continue to be used on the European 
Market.  

2.4.2.  Conformity assessment delivered in the mandatory sphere 

Where  conformity  assessment  is  legally  regulated,  national  authorities  of  European 
Member  States  may  refuse  to  accept  attestations  of  conformity  issued  under 
accreditation  by  non-European  accreditation  bodies  not  complying  with  the  new 
European  requirements  but  signatories  to  the  ILAC/IAF  MRA/MLA.  However  this 
refusal  cannot  be  based  on  the  sole  argument  of  the  non-fulfilment  by  the  third 
country accreditation body as such. The conformance to the EU requirements by the 
third  country  accreditation  body  is  not  a  condition  for  recognition,  but  non-
conformance  could  reinforce  doubt  as  to  the  quality  and  value  of  the  accreditation 
and therefore as to the quality and confidence in the accredited certificates or reports.  

However, where government-to-government Mutual recognition agreements (MRAs) 
between the Community and a third country in relation to conformity assessment are 
in place10, national authorities of European Member States will accept the test reports 
and certificates issued by bodies that the foreign party has designated under the MRA 
for  assessing  conformity  in  the  categories  of  products  or  sectors  covered  by  the 
MRA.  The  products  accompanied  by  such  conformity  attestations  can  be  exported 
and  placed  on  the  other  party’s  market  without  undergoing  additional  conformity 
assessment  procedures.  Each  importing  party  agrees,  by  the  terms  of  the  MRA,  to 
recognize  the  conformity  assessment  attestations  issued  by  agreed  conformity 
assessment bodies of the exporting party, independently of whether accreditation has 
been  used  to  back  up  the  designation  process  of  the  conformity  assessment  bodies 
under  the  MRA  or  not,  and  independently  of,  in  case  accreditation  is  used  by  the 
non-European Party, the fulfillment by the third Party accreditation body of the EU 
requirements.  

Accreditation  contributes  to  a  quality  driven  and  reliable  conformity  assessment 
infrastructure. It provides for confidence which is of great importance for Regulators, 
purchasers  of  conformity  assessment  services  and  consumers  and  facilitates  cross-
border  trade  of  goods  and  services.  By  providing  mutual  confidence  in  the 

10 

Currently  MRAs  between  the  European  Union  and  the  following  countries  are  in  place:  Australia, 
Canada, Israel, Japan, New Zeeland, Switzerland, United States 

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competence  of  CABs  and  attestation  issued  by  them,  accreditation  technically 
underpins  trade  by  promoting  mutual  recognition  and  the  global  acceptance  of 
conformity  assessment  results  within  the  Internal  Market  and  in  relation  to  third 
countries.  The  “additional”  requirements  for  accreditation  bodies  set  out  in 
Regulation 765/2008 designed to consolidate the added value of accreditation do not 
create  a  technical  barrier  impeding  trade.  The  level  of  acceptance  of  conformity 
attestations  issued  under  accreditation  of  accreditation  bodies  not  meeting  the  EU 
requirements  in  the  European  Union  will  continue  to  be  accepted  or  refused  in  the 
same way as they are today. 

3. 

CROSS BORDER ACCREDITATION ACTIVITIES (CERTIF 2009-06 REV 6) 

3.1. 

Introduction  

This  document  concerns  the  interpretation  of  the  cross  border  accreditation 
provisions of Article 7 of Regulation (EC) 765/2008 (“the Regulation”) in relation to 
multinational conformity assessment bodies. Bearing in mind that the ultimate say on 
matters of EU law rests with the European Court of Justice, this draft paper contains 
a  proposal  for  a  common  understanding  and  pragmatic  solution  on 
the 
implementation  of  the  cross-border  accreditation  regime  which  is  the  result  of  the 
discussions held between  all  interested parties involved (public authorities,  EA and 
its members, conformity assessment bodies and the Industry). 

The application of Article 7 of the Regulation must be done in the light of the Single 
market principles such as the freedom of establishment and the freedom to provide 
services  and  account  must  be  taken  of  other  pieces  of  legislation  such  as  Directive 
123/2006/EC  on  Services  in  the  Internal  Market  (the  "Services  Directive"),  whilst 
guaranteeing  the  full  respect  and  application  of  the  fundamental  principles  and 
objectives  of  the  European  accreditation  policy.  This  is  valid  in  particular  for  the 
non-competition principle, which is a necessary condition for accreditation to be the 
last level of control of the adequacy of conformity assessment services. 

3.2. 

Background 

According  to  Article  7.1  of  the  Regulation,  conformity  assessment  bodies  (CABs), 
whether  third-party  or  first-party/in-house  bodies,  are  required  when  requesting 
accreditation  to  do  so  with  the  national  accreditation  body  (NAB)  of  the  Member 
State  in  which  they  are  established.  This  general  rule  allows  for  exceptions:  the 
possibility of a conformity assessment body to request accreditation with a NAB in 
another Member State is limited to cases where 

• 

• 

• 

there is no NAB in its own Member State [Article 7.1(a)], 

the  NAB  does  not  offer  the  requested  accreditation  service  [Article 
7.1(b)]  

the  NAB  has  not  received  a  positive  outcome  in  the  peer  evaluation  in 
relation to the conformity assessment activity for which accreditation is 
requested [Article 7.1(c)]. 

Article 7.1 of the Regulation is closely linked to and is a logical consequence of the 
non-competition  principle  embodied  in  Article  6  of  the  same  Regulation.  It  is 
important  to  prevent  conformity  assessment  bodies  from  shopping  around  for 
accreditation  certificates,  thus  creating  a  “market  for  accreditation”  leading  to  the 
commercialisation  of  accreditation  which  jeopardizes  the  added  value  and  role  of 

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accreditation as a public authority activity and last level of control of the conformity 
assessment chain. 

3.3. 

Problem Definition 

Against  this  background,  the  issue  to  be  tackled  concerns  multinationally  active 
CABs, i.e. CABs having their head office in one Member State and which exercise 
their activity in another or several Member States. This activity can be carried out in 
another  Member  State  on  a  temporary  basis  (free  provision  of  services)11  or  on  a 
permanent basis by means of one or more local entities such as subsidiaries, branches 
or agencies (freedom of establishment)12.  

CABs  may  provide  their  services  to  clients  in  other  Member  States  on  the  basis  of 
free  provision  of  services  without  having  to  be  established  there.  The  accredited 
conformity assessment results given on the basis of free provision of service will be 
recognised  by  the  public  authorities  and  accepted  on  the  basis  of  the  mutual 
recognition  principle  set  out  in  Article  11(2)  of  the  Regulation.  Indeed,  under  this 
provision,  "National  authorities  shall  recognise  the  equivalence  of  the  services 
delivered  by  those  accreditation  bodies  which  have  successfully  undergone  peer 
evaluation  under  Article  10,  and  thereby  accept,  on  the  basis  of  the  presumption 
referred  to  in  paragraph  1  of  this  Article,  the  accreditation  certificates  of  those 
bodies and the attestations issued by the conformity assessment bodies accredited by 
them."  

Business  operators  are  free  to  organise  and  structure  themselves  in  the  way  they 
think is best to serve their clients, for example to get established in various Member 
States and to operate via local entities.  

In this case the question arises for the need for an accreditation for the multinational 
organisation as a whole or of parts of that organization in the locations  where they 
are established and operate: can the operations of the local entity be covered by the 
accreditation  of  the  head  office  issued  by  the  NAB  where  the  head  office  is 
established or shall the local entity be accredited by the local NAB?  

The  cross-border  provision  laid  down  in  Article  7  is  perceived  to  be  very  stringent 
and  unnecessarily  burdensome  for  multinational  CABs  with  local  entities/sites 
established in other Member States working under the supervision of the head office 
and under the same quality system and management, as implying costly duplications 
of assessments. The risk of suffering a competitive disadvantage compared to third-
country  organizations  is  feared.  The  Regulation  does  not  apply  to  third-country 
bodies which are therefore free to request accreditation (even multiple accreditations) 
with the European NABs of their own choice. In case of a strict legal interpretation 
of  Article  7,  due  to  their  structures,  multinational  CABs  may  not  benefit  from  the 

11 

12 

This can happen in the four following modes: a) the CAB (service provider) moves temporarily to the 
service recipient's Member State to provide its services and then comes back; b) the service recipient 
moves  temporarily  to  the  Member  State  of  the  CAB  to  receive  the  service;  c)  neither  the  service 
recipient nor the CAB moves, whereas the service is done from a distance (for ex. over the email and/or 
by phone); d) both the CAB and the service recipient move to another (third) Member State where the 
service will be provided 
Differently from subsidiaries which have separate legal personality, agencies or branches or offices do 
not  need  to  be  separate  legal  entities.  It  follows  from  Art.  49  TFEU  providing  for  the  freedom  of 
establishment and the case law of the ECJ that the same undertaking can be established at the same time 
in one or more other Member States. 

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advantage of one accreditation certificate sufficient for the whole territory of the EU, 
although avoiding multiple accreditation is one of the objectives of the Regulation13. 

Practice  shows,  however,  that  for  a  long  time  the  majority  of  multinational  CABs 
have been having their local entities accredited by local NABs, resulting in multiple 
accreditations from various NABs, for reasons linked to commercial arguments more 
than to necessity. Moreover, it appears that a number of these organizations are fully 
prepared  to  continue  with  this  practice,  for  the  same  reasons.  According  to  the 
concerned  parties,  such  multiple  accreditations  are  due  to  the  demand  from  local 
regulators  and/or  from  the  local  market  not  recognizing  the  equivalence  of  the 
accreditations issued by the different NABs signatories to the European Co-operation 
for 
MLA).  
In  light  of  the  mutual  recognition  principle  provided  for  in  Article  11.2  of  the 
Regulation, such statements in relation to public authorities are no longer acceptable, 
as  national  authorities  are  obliged  to  recognize  the  equivalence  of  the  services 
delivered and to accept the accreditation certificates issued by the NABs which have 
successfully  passed  the  peer  evaluation  managed  by  EA  and  which  are  as  a  result, 
signatories to the EA MLA for the relevant accreditation activity. 

accreditation 

multilateral 

agreement 

(EA 

The  acceptance  by  the  market  place  indeed remains  a  challenge  and  problem  to  be 
tackled.  End  users  still  perceive  some  European  NABs  and  related  accreditation 
certificates  and  logos  to  be  more  valuable  than  others.  To  overcome  these 
perceptions  and  resistances  the  EA  MLA  should  be  promoted  through  activities 
targeting the CABs and their clients. CABs should contribute to convince the market 
that the accreditation given by the EA MLA signatories are equivalent by abstaining 
from promoting one or another NAB which hinders the process of acceptance of the 
equivalence  of  services  offered  by  the  NABs  and  fosters  the  use  of  multiple 
accreditations. Instead, the value and quality of accredited certificates, independently 
of  which  NAB  has  accredited  them,  should  be  promoted.  Within  this  context  a 
statement  on 
the 
accreditations  issued  by  EA  MLA  signatories  and  the  introduction  of  a  single 
European accreditation symbol, an EA symbol, to be used by the signatories to the 
EA MLA could be further considered. Such measures, in particular the latter, may go 
beyond  the  Regulation  but  could  possibly  be  an  effective  tool  to  foster  the 
understanding  and  visibility  of  the  EA  MLA  and  thereby  the  acceptance  of  the 
equivalence of the EA MLA signatories.  

the  accreditation  certificate  attesting 

the  equivalence  of 

3.4. 

Solution 

3.4.1.  General terms  

(1)  Duplication  of  unnecessary  assessments  and  burdens  on  multinational  CABs 
should be avoided. This is required by the principle of non-duplication, which 
is to be inferred from the case law about Article 56 TFEU and is explicitly set 
out in Article 10(3) of the Services Directive.  

(2)  Market  needs  in  relation  to  accreditation  should  be  met,  but  without 
compromising the fundamental principles of the European accreditation policy.  

(3)  Adequate controls of local entities of multinational CABs must be assured.  

13 

Recital  19:  “….The  objective  of  this  Regulation  is  to  ensure  that,  within  the  European  Union,  one 
accreditation  certificate  is  sufficient  for  the  whole  territory  of  the  Union,  and  to  avoid  multiple 
accreditation, which is added cost without added value….” 

EN 

9 

   EN 

 
                                                 
(4)  Exchange  of  information  and  effective  cooperation  between  NABs  for 
assessment,  re-assessment  and  surveillance  of  local  sites  of  multinational 
CABs is necessary. Based on mutual recognition of all assessments carried out 
by  EA  members,  any  duplication  of  assessments  of  organisational  aspects  or 
requirements should be strictly avoided. 

(5) 

If  necessary  and  on  reasoned  request,  relevant  information  on  carrying  out 
accreditation against national legislative requirements of another Member State 
and/or  requirements  set  out  in  relevant  national  sectoral  schemes  shall  be 
provided  by  the  local  NAB  to  the  national  authorities  of  the  other  Member 
State.  National  authorities  of  the  Member  Stats  in  which  the  local  NAB  is 
established should be kept informed thereof. 

(6) 

It  should  be  underlined  that  the  solution  proposed  has  no  effect  on  the  civil 
liability regimes across the European Union. 

3.4.2.  Multi-site accreditation 

The  CAB  with  local  sites(regardless  of  their  legal  personality),  provided  that  the 
latter  operate  under  the  same  global  quality  system  and  management  and  that  the 
head office has the means to substantially influence and control their activities, can 
be  considered  as  being  only  one  organisation  with  regard  to  the  conformity 
assessment  activity  carried  out.  Such  a  CAB  is  therefore  allowed  to  request 
accreditation  with  the  NAB  of  the  head  office  whose  scope  can  also  cover  the 
activities  performed  by  the  local  site,  including  those  located  in  another  Member 
State.  

The  multi-site  accreditation  is  however  only  permitted  under  the  Regulation  if  the 
accredited  CAB  maintains  the  final  responsibility  for  the  activities  performed  by 
local  sites  covered  by  the  scope  of  the  multi-site  accreditation.  The  accreditation 
certificate issued by the NAB where the head office is established names one legal 
entity - the head office - and it is this legal entity which holds the accreditation and 
which is responsible for the accredited activities of the CAB, including any activity 
performed by the local site that forms part of the scope of the accreditation. Where 
these local sites carry out key activities (as listed in EN ISO/IEC 1701114), then the 
accreditation certificate (in its annexes) shall clearly identify the address of these site 
offices.  

The local site is entitled to offer directly to the local market conformity attestations 
under  the  multisite  accreditation,  but  only  on  behalf  of  the  accredited  CAB.  These 
accredited certificates and reports are therefore issued under the accreditation, name 
and address of the head office without the logo of the local site. However this does 
not impede mentioning on the conformity assessment certificate or report the contact 
details of the local site issuing the certificate or report in question.  

The  multi-site  accreditation  is  meant  for  use  only  by  companies  within  the  same 
organisation and where the head office maintains the responsibility for the activities 
performed  and  certificates/reports  issued  by  the  local  sites.  The  responsibility  shall 
be demonstrated on the basis of contractual or equivalent legal relationships between 
the head office and the local entity and internal regulations that further specify these 
relationships in terms of management and responsibilities.  

14 

Key activities include: policy formulation, process and/or procedure development and, as appropriate, 
contract  review,  planning  conformity  assessments,  review,  approval  and  decision  on  the  result  of 
conformity assessments 

EN 

10 

   EN 

 
                                                 
The solution of the multi-site accreditation can be applied to all types of local entities 
(subsidiaries,  branches,  agencies,  offices  etc),  regardless  of  their  legal  personality 
and is in principle valid for all types of CABs, including laboratories, inspection and 
certification bodies as long as they carry out clearly identified and relevant activities 
for the purpose of accreditation. 

The  multi-site  accreditation  solution  is  excluded  when  the  above  mentioned 
conditions are not fulfilled, i.e. the CAB can not be considered as one organisation 
with  regard  to  conformity  assessment  and  the  head  office  does  not  maintain  the 
ultimate  responsibility  for  the  activities  of  the  local  entities.  In  this  case  the  local 
sites  being  separate  legal  entities  should  apply  for  their  own  accreditation  with  the 
local NAB. As a consequence it can be considered that the local entity carries out the 
conformity assessment service completely independently of the head office.  

In case of the multi-site accreditation, initial assessment and reassessments must be 
carried out in close cooperation between the respective local NAB and the NAB of 
the head office taking the accreditation decision, while surveillance must be carried 
out  in  cooperation  with  or  by  the  local  NAB.  The  multinational  CAB  must  fully 
cooperate  with  the  NABs  involved.  Local  entities  cannot  reject  the  participation  of 
the  local  NAB  in  the  assessment,  reassessments  and  surveillance  process. 
Harmonised rules for co-operation between NABs exist in the form of the EA cross 
frontier  policy.  Multi-site  accreditation  needs  to  be  managed  under  the  EA  cross 
frontier  policy  in  order  to  guarantee  the  involvement  of  the  local  NAB.  EA  is 
therefore  requested  to  review  its  existing  cross  frontier  policy  for  cooperation 
between EA members, so as to fully implement the multi-site accreditation, without 
complicating or compromising the proper execution of the peer evaluation.  

3.4.3.  About Subcontracting 

The  multi-site  accreditation  does  not  supersede  sub-contracting,  which  remains  a 
viable solution in case a CAB may wish to sub-contract part of its activities to legal 
entities located and operating in the same or other Member States, which however do 
not belong to the same organisation, i.e. are not part of a multinational CAB. In this 
case,  the  subcontractor  is  not  covered  by  the  accreditation  of  the  CAB.  The 
accredited  CAB  may  subcontract  specific  parts  of  its  conformity  assessment 
activities  to  a  different  legal  entity  according  to  the  applicable  CAB  standard  to 
which it is accredited and only to the extent allowed in this standard. The CAB must 
be able to demonstrate to the NAB that subcontracted activities are carried out in a 
competent  and  reliable  manner  consistent  with  relevant  requirements  of  the 
applicable  normative  documents  for  the  activities  in  question.  The  accredited 
conformity  assessment  attestation  must  be  issued  exclusively  under  the  name  and 
responsibility  of  the  accredited  CAB,  i.e.  the  legal  entity  holding  the  accreditation. 
The contractual relationship with the client remains with the accredited CAB. 

4. 

SYSTEMATIC  APPROACH  TO  ADDRESSING  ACCREDITATION  ISSUES  WITHIN  SOGS 
(CERTIF 2009-07 REV 1) 

This draft document represents a revised version of a proposal on how accreditation 
should  be  systematically  addressed  within  SOGS  and  on  how  to  manage  the 
attendance  and  presence  of  the  representatives  of  the  European  Co-operation  for 
accreditation  (EA)  during  SOGS  meetings.  The  draft  document,  representing  the 
views of the Commission in accordance with the national authorities college of the 
EA Advisory  Board (EAAB-NAC), can be interpreted as a set of informal rules of 

EN 

11 

   EN 

 
procedures,  supplementing  the  existing  draft  terms  of  reference  of  SOGS.  A 
diagramme  has  been  added  explaining  the  relations  and  communication  channels 
between the main actors of the European accreditation policy.  

4.1. 

Rationale 

SOGS  is  an  informal  a  group,  i.e.  a  forum  where  Commission  services  and 
representatives  from  national  administrations  of  Member  States  can  have  an  open 
discussion  and  reach  a  common  understanding  on  general  policy  related  to 
standardization  and  conformity  assessment.  Accreditation  exists  in  relation  to 
conformity  assessment  (forming  the  last  level  of  control  in  the  conformity 
assessment  chain  ensuring  conformity  with  the  applicable  requirements)  and  is 
essential  for  a  competent,  trusted,  quality-driven  and  transparent  conformity 
assessment structure, able to play its part in the protection of public interests. As a 
result,  accreditation  issues  have  been  tabled  for  discussion  within  SOGS  whenever 
the Commission felt that there has been a need to do so.  

Regulation  765/2008,  which  enshrines  the  new  European  accreditation  policy, 
reinforces  considerably  the  role  of  accreditation,  thereby  giving  to  accreditation  a 
level  of  significance  and  recognition  which  it  never  had  before.  Under  technical 
harmonisation  legislation  the  use  of  accreditation  is  intensified  as  it  constitutes  the 
privileged technical instrument in support of notification, i.e. the decision of national 
authorities  by  which  conformity  assessment  bodies  are  authorised  to  carry  out 
specific  conformity  assessment  in  support  of  technical  harmonisation  legislation. 
Accreditation  must  therefore  be  operated  in  such  a  manner  as  to  provide  national 
authorities with the necessary sound technical base they can rely on in order to back 
up their notification decisions.  

Continuous  and  comprehensive  substantial  discussions  on  the  needs  in  relation  to 
accreditation are required. As a consequence accreditation and related issues should 
not  be  put  on  the  SOGS  agenda  sporadically,  but  should  instead  be  discussed  on  a 
regular  basis,  and following a set  of common rules of procedure. The creation of a 
special SOGS subgroup dedicated exclusively to accreditation is not envisaged – as 
has  been  the  case  with  market  surveillance.  Instead  a  part  of  the  plenary  meeting 
should be devoted to accreditation.  

It  essential  that  the  Community  has  a  common  understanding  of  the  interpretation, 
implementation and future development of the European policy on accreditation. In 
the framework of this policy EA is placed in the position of an organisation of major 
European  interest,  similar  to  the  European  Standardisation  Organisations  (CEN, 
CENELC and ETSI) in the field of the European standardisation policy. Pursuant to 
Article  14  of  Regulation  765/2008  EA  is  recognized  as  the  official  European 
Infrastructure for Accreditation. The operation and management by EA of a robust, 
uniform  and  transparent  peer  evaluation  system  in  accordance  with  the  Regulation 
and the further developments of such a system is at the centre of the European policy 
on  accreditation.  In  light  of  Article  11  of  Regulation  765/2008  having  successfully 
undergone the EA peer evaluation implies  

– 

– 

presumption  of  conformity  for  the  evaluated  national  accreditation  bodies  to 
the requirements of the Regulation 

mutual recognition by the national authorities of accreditation certificates and 
accredited conformity assessment attestations.  

EN 

12 

   EN 

 
EA is expected to fulfill its new role and related tasks by providing Europe with the 
necessary reliable, effective and trustworthy infrastructure which meets the evolving 
needs  of  the  market,  regulators  and  society.  EA  shall  be  fully  accountable  for 
technical  expertise,  impartiality,  cost  efficiency  and  cost  effectiveness,  capacity  of 
response to arising needs and challenges - also in view of the Community financing 
which  may  be  granted  to  EA  on  the  basis  of  the  Framework  Partnership 
Agreement.15 

Particular  attention  should  therefore  be  given  to  the  co-operation  with  EA,  by 
translating into practical terms the commitment to cooperate effectively to implement 
the European policy on accreditation contained in the General Policy Guidelines for 
Cooperation between the European co-operation for Accreditation and the European 
Commission,  the  European  Free  Trade  Association  and  the  competent  national 
authorities,  which  have  been  signed  by  EA,  EFTA,  the  Commission  and  the  vast 
majority of SOGS members. 

SOGS  is  deemed  to  be  the  appropriate  platform  where  a  substantial  and 
comprehensive exchange between the Commission, national authorities and EA takes 
place in order to assure that EA serve the aims and needs of national authorities and 
the Commission in particular in relation to the operation of accreditation in support 
of the implementation and development of Community harmonisation legislation. 

In  no  way  does  this  document  intend  to  compromise,  to  replace  or  to  put  into 
question  the  existence  and  function  of  the  EAAB-NAC,  which  continues  to 
guarantee the representation of the interests of national authorities of EU and EFTA 
Member  States  within  the EAAB,  thereby providing advice to EA and input to EA 
policies, strategies and related documents. 

5. 

NOTIFICATION  WITHOUT  ACCREDITATION  -  ARTICLE  5.2  OF  REGULATION 
765/2008 (CERTIF 2010-08 REV1) 

5.1. 

Objective of the paper 

The present paper provides guidance with regard to the assessment process not based 
on  accreditation  to  support  the  notification  of  conformity  assessment  bodies  under 
technical harmonisation legislation. It describes the main elements on which such an 
assessment  process  should  be  based  on.  It  is  not  the  aim  of  this  paper  to  set  up  an 
“Article 5.2” assessment methodology or to provide a detailed description and list of 
documents to be sent in by the notifying authorities.  

5.2. 

Background 

Member States notify - via the designated notifying authorities - to the Commission 
and  to  the  other  Member  States  those  conformity  assessment  bodies  they  have 
decided  to  authorise  to  carry  out  specific  tasks  pertaining  to  the  conformity 
assessment procedures laid down in the applicable piece of technical harmonisation 
legislation.  

By taking the political and legal decision which bodies to notify, Member States take 
the final responsibility for the technical competence and independence of such bodies 
which they must therefore verify by the means of an adequate assessment process.  

15 

Currently under negotiation 

EN 

13 

   EN 

 
                                                 
According  to  the  New  Legislative  Framework,  the  verification  of  the  technical 
competence and independence during a notification process can be supported form a 
technical  point  of  view  either  by  an  accreditation  according  to  the  17000  series  of 
harmonised standards taking into account the sector specific requirements stemming 
from  the  applicable  harmonisation  legislation  and  other  normative  documents  if 
applicable, or, if it is decided not to use accreditation, by an alternative assessment 
process.  

While  not  obligatory  under  the  New  Legislative  Framework,  and  although 
accreditation  and  the  alternative  evaluation  procedure  are  legally  equivalent,  the 
preference of the use of accreditation to support notification is clearly expressed in 
the  New  Legislative  Framework  through  the  facilitated  notification  procedure  for 
notification  based  on  accreditation.  Accreditation  as  an  independent  and  impartial 
assessment  carried  out  by  a  competent  authoritative  third  party,  i.e.  the  designated 
national accreditation body, should be considered by the notifying authorities as the 
privileged instrument for the assessment of the technical competence and impartiality 
of a candidate notified body. This because  

– 

– 

– 

– 

– 

 accreditation  being  a  standard  based  total,  reduces  the  differences  in  the 
criteria applied for notification  

 accreditation provides for established complaint and appeal procedures  

 accreditation provides for the possibility to object to an assigned assessor 

 accreditation  provides  for  established  procedures  and  plans  for  regular 
surveillance  at  close  intervals  to  monitor  the  continued  fulfillment  by  the 
accredited CAB of the applicable requirements 

 the existence of the EA peer evaluation system ascertaining conformity to the 
requirements of Regulation 765/2008, EN ISO/IEC 17011 and other applicable 
the  competence  of 
requirements  and 
the  national 
accreditation  bodies 
in  view  of  notification,  makes 
accreditation  the  most  transparent  assessment  system  in  place,  able  to  give 
sufficient guarantees and confidence.  

therefore  verifying 
to  assess  CABs 

To  date,  we  do  not  have  a  comparable  and  substantially  equivalent  alternative 
assessment  system  based  on  codified  rules  and  procedures,  which  entails  a  similar 
level  of  harmonisation  and  transparency  in  comparison  with  accreditation.  In 
particular  no  other  assessment  method  provides  for  a  systematic,  structured  and 
widely  accepted  process  of  evaluation  of  those  assessing  the  competence  of 
conformity  assessment  bodies,  which  clearly  represents  an  added  value  of  the 
accreditation  tool.  This  is  why  the  New  Legislative  Framework  has  considerably 
strengthened the role and use of accreditation in the regulated area. 

5.3. 

Assessment under Article 5.2 of Regulation 765/2008 

When  a  Member  State  nevertheless  decides  for  whatever  reasons  to  use  an 
alternative  assessment  method  and  not  to  base  its  notification  on  accreditation, 
according  to  Article  5.2  of  Regulation  765/2008  “it  shall  provide  the  Commission 
and  the  other  Member  States  with  all  the  documentary  evidence  necessary  for  the 
verification of the competence of the conformity assessment bodies it selects for the 
implementation of the Community harmonisation legislation in question”.  

In order to ensure the necessary level of confidence in the impartiality and technical 
competence  of  conformity  assessment  bodies  and  in  the  issued  test  reports  and 

EN 

14 

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conformity  assessment  certificates  issued  by  them,  national  authorities,  when 
carrying  out  the  assessment  without  accreditation,  should  give  detailed  and 
comprehensive information describing on how the candidate Notified Body has been 
assessed as qualified to carry out the tasks for which it is notified and showing that it 
fulfils the applicable criteria relating to Notified bodies. This information linked to a 
given  notification  is  made  available  through  the  NANDO  tool  to  the  Commission 
and the other Member States.  

The  alternative  evaluation  procedure  should  be  based  at  least  on  the  following 
elements:  

– 

– 

– 

– 

– 

– 

– 

 candidate  Notified  Bodies  should  be  made  aware  of  general  conditions,  their 
rights and  obligations and  requirements relating to  the assessment  carried out 
in view of notification  

 existence of a formal application procedure  

 Assessment  process  against  applicable  requirements.  The  assessment  should 
consist in  

• 

• 

a  review  of  documents  verifying  the  completeness  and  appropriateness 
from  a  substantial  point  of  view  with  regard  to  conformity  to  the 
applicable requirements  

an on-site assessment to check technical and procedural aspects such as 
availability  and  appropriateness  of 
technical 
competence of staff, existence of an appropriate management system and 
to check  other aspects demonstrating that conformity to requirements is 
properly  implemented.  The  assessment  must  include  witnessing  of 
technical activities 

facilities/equipment, 

 production of an assessment report 

 decision making process 

 existence  of  a  systematic  surveillance  and  related  sanction  mechanism 
providing  for  periodic  surveillance  including  on-site  visits,  in  order  to  verify 
the continued fulfillment of requirements by the Notified Body  

 demonstration  of  the  national  authorities  own  technical  competence  for 
assessing  conformity  assessment  bodies  for  the  purpose  of  notification  under 
technical harmonisation legislation  

When  choosing  to  go  down  the  route  of  the  alternative  assessment  process  rather 
than  of  formal  accreditation,  national  authorities  should  indicate  the  reasons  why 
accreditation  is  not  chosen  to  back  up  the  notification  process.  Moreover,  national 
authorities should not outsource the assessment of conformity assessment bodies that 
seek to become Notified Bodies to the national accreditation body, without asking for 
accreditation.  Such  “light  accreditation”  using  the  service  and  competence  of 
national accreditation bodies without the recourse to accreditation is a practice which 
undermines  the  accreditation  and  should  therefore  not  be  used.  It  should  be  noted 
that  in  some  cases  national  accreditation  bodies  are  obliged  to  carry  out  the 
assessment of candidate Notified Bodies as this is required by existing national laws 
or bylaws. 

EN 

15 

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6. 

WITNESSING FOR NEW SCOPES OF ACCREDITATION (CERTIF NO 2012-03) 

6.1.  Witnessing for new scopes 

This  paper  aims  to  provide  a  common  understanding  on  the  interpretation  of 
Regulation  (EC)  765/2008  (“the  Regulation”)  in  relation  to  granting  accreditation 
relating to new activities of conformity assessment bodies.  

This  can  either  relate  to  new  conformity  assessment  bodies  wishing  to  enter  the 
market, to existing conformity assessment bodies wishing to extend the scope of their 
accreditation, or to new regulatory requirements. 

According  to  EN-ISO  17011,  accreditation  cannot  be  granted  without  a  witnessing 
having  taken  place.  The  results  of  the  on-site  assessment  have  to  be  taken  into 
account in the decision-making. 

However, especially when it comes to new regulatory requirements and accreditation 
for the purposes of notification, this may lead to a “catch-22” situation: 

A conformity assessment body will not be accredited because it has never performed 
a  certain  activity  –  and  may  encounter  difficulties  finding  clients  as  it  is  not 
accredited or may not be able to be notified for this reason. Such a situation would 
effectively lead to a closure of the conformity assessment market for new actors or 
activities. 

6.2. 

Solution 

In  order  to  maintain  the  accessibility  as  well  as  quality  of  accreditation  and  not  to 
create  contradictory  administrative  requirements,  a  pragmatic  approach  to  this 
problem  is  suggested.  A  number  of  EA  members  already  follow  this  approach.  It 
seems advisable to reach a consensus to adopt it as a general approach across Europe 
and to enable EA peer evaluation to take the solution into account.  

In  the  case  of  a  new  activity,  a  conditional  attestation  should  be  granted  to  the 
conformity assessment body, if all other conditions for accreditation are fulfilled by 
the conformity assessment body, and a simulation does not present itself as a viable 
option. However, this should only be granted without witnessing under the condition 
that,  before  any  accredited  certificate  is  issued,  a  witnessing  takes  place. 
Furthermore,  the  conformity  assessment  body  should  have  procedures  in  place  that 
ensure a continued competence in areas where there is little activity. 

Once  the  witnessing  has  taken  place  an  accreditation  certificate  may  be  issued.  In 
practice,  this  means  that  the  conformity  assessment  body  has  to  ensure  that  a 
witnessing takes place, the first time before it finalises its assessment for this specific 
activity. 

Another solution in the regulated area, where the accreditation certificate represents 
the preferred means for demonstrating the technical competence of a body, could be 
a temporary notification of the new entrant conformity assessment body on the basis 
of  the  documents  reviewed.  Unless  the  accreditation  is  confirmed  by  a  witnessing 
within  a  given  timeframe,  the  notification  is  automatically  withdrawn  by  the 
notifying  authority.  This  approach  has  the  double  benefit  of  being  a  pragmatic 
solution  that  is  in  line  with  the  relevant  international  standards  while  ensuring  that 
accreditation  is  not  weakened,  and  maintains  its  role  as  last  level  of  control  in  the 
conformity assessment system. 

EN 

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7. 

PUBLISHED  AUDITED  ANNUAL  ACCOUNTS  OF  ACCREDITATION  BODIES  (CERTIF 
2012-05) 

7.1. 

Objective of the paper 

This  paper  aims  to  provide  a  common  understanding  on  the  interpretation  of 
Regulation  (EC)  765/2008  (“the  Regulation”)  in  relation  to  its  Article  8(11)  that 
requires national accreditation bodies to publish audited annual accounts prepared in 
accordance with generally accepted accounting principles. 

The  goal  of  the  present  paper  is  to  clarify  the  intentions  of  this  provision,  namely 
safeguarding  the  principle  on  non-commerciality  and  demonstrating  that  the 
accreditation  body  has  sufficient  resources  to  perform  its  tasks  adequately.  Both 
aspects are fundamental to the correct functioning of accreditation as the last level of 
control in the conformity assessment system. Thus when implementing this provision 
these  objectives  should  be  borne  in  mind  rather  than  a  pure  focus  on  whether  the 
accounts are presented in detail in compliance with accounting standards. 

A strict focus on financial accounting may lead to difficulties in those Member States 
where  the  accreditation  body  is  part  of  a  larger  governmental  structure,  as  such  a 
strict  reading  would  require  a  reform  of  the  accounts  of  the  authority  in  question 
without  contributing  proportionately  to  more  clarity  in  terms  of  demonstrating  that 
the aims of the provision are met. 

Bearing in mind that the ultimate say on matters of EU law rests with the European 
Court  of  Justice,  this  draft  paper  contains  a  proposal  for  a  common  understanding 
and pragmatic solution for this question. 

7.2. 

Background 

The Recital 14 of the Regulation states: 

“For  the  purposes  of  this  Regulation,  not-for-profit  operation  by  a  national 
accreditation  body  should  be  understood  as  an  activity  that  is  not  intended  to  add 
any  gain  to  the  resources  of  the  body's  owners  or  members.  While  national 
accreditation bodies do not have the objective of maximising or distributing profits, 
they  may  provide  services  in  return  for  payment,  or  receive  income.  Any  excess 
revenue that results from such services may be used for investment to develop their 
activities  further,  as  long  as  it  is  in  line  with  their  main  activities.  It  should 
accordingly  be  emphasised  that  the  primary  objective  of  national  accreditation 
bodies should be to support or engage actively in activities that are not intended to 
produce any gain.” 

In the same vein, Article 4(7) of the Regulation states:  

“The national accreditation body shall operate on a not-for-profit basis.” 

Article 4(9) of the Regulation stipulates: 

"Each  Member  State  shall  ensure  that  its  national  accreditation  body  has  the 
appropriate  financial  and  personnel  resources  for  the  proper  performance  of  its 
tasks,  including  the  fulfilment  of  special  tasks,  such  as  activities  for  European  and 
international  accreditation  cooperation  and  activities  that  are  required  to  support 
public policyand which are not self-financing." 

Article  8(11)  then  contains  the  provision  under  discussion,  stipulating  that  the 
national accreditation body  

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"shall  publish  audited  annual  accounts  prepared  in  accordance  with  generally 
accepted accounting principles." 

National  accreditation  bodies  operate  in  accordance  with  the  international  standard 
EN ISO/IEC 17011 which states: 

“4.5.2  The  accreditation  body  shall  have  the  financial  resources,  demonstrated  by 
records  and/or  documents,  required  for  the  operation  of  its  activities.  The 
accreditation body shall have a description of its source(s) of income.”  

7.3. 

Problem definition 

The requirement for publishing audited annual accounts does not pose a problem for 
accreditation  bodies  that  have  an  independent  private  law  status  of  some  form.  It 
may,  however,  be  more  problematic  for  accreditation  bodies  that  are,  for  example, 
part of a ministry as no separate accounts for the accreditation body may exist, the 
budgetary  and  financial  management  often  being  globalised  in  a  overall  public 
authority financial statement. 

Thus,  if  the  requirement  to  publish  accounts  is  approached  from  a  purely  financial 
perspective,  a  number of national accreditation bodies will encounter difficulties in 
demonstrating  their  compliance  during  peer  evaluations.  Considering  that  it  is 
otherwise considered to be acceptable that accreditation bodies are part of ministries 
as long as no conflict of interest exists, this requirement thus needs to be applied in a 
way that is meaningful for the purposes of the Regulation. Hence Article 8(11) needs 
to be applied in a way that allows national accreditation bodies to demonstrate that 
they are complying with the goals and provisions of the Regulation without Member 
States having to substantially reform the financial management of a ministry, which 
is otherwise controlled by public institution. 

7.4. 

Solution 

The  intentions  of  Article  8(11)  go  over  and  beyond  demonstrating  sound  financial 
management, for the purposes of peer evaluation national accreditation bodies should 
therefore  clearly  demonstrate  that  the  guiding  principles  of  non-commerciality  and 
sufficient resources for competence of the accreditation body are respected. Bearing 
in  mind  the  overall  objective  of  the  Regulation  of  establishing  accreditation  as  last 
level  of  control  in  the  conformity  assessment  system,  in  those  cases  where  the 
accreditation body is part of a larger structure, Art. 8(11) should thus be understood 
to be a tool to demonstrate compliance with these principles, rather than being used 
to create unnecessary bureaucratic burdens for Member States. Thus the accreditation 
bodies  situated  in  ministerial  departments  must  be  in  a  position  to  present  at  least 
their  overall  budgetary  and  financial  figures  covering  overall  budgetary  resources 
and  their  global  and  operational  expenses;  together  with  any  financial  policies  that 
apply to them in order to be able to demonstrate that they have sufficient resources to 
the  principle  of  non-
their 
perform 
commerciality  

tasks  adequately  whilst  safeguarding 

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