CEN/CLC Guide 22:2021
(Main)Guide on the organizational structure and processes for the assessment of the membership criteria of CEN and CENELEC
Guide on the organizational structure and processes for the assessment of the membership criteria of CEN and CENELEC
This Guide complements, and should be read in conjunction with, the membership criteria of CEN and CENELEC included in CEN-CENELEC Internal Regulations Part 1 (IR1), Part 1D.
This Guide supersedes CEN-CENELEC Guide 22:2015 and Guide 22:2018, in line with the decisions of the CEN and CENELEC General Assemblies taken in June 2021 to review the organizational structure and processes for the assessment of the membership criteria of CEN and CENELEC.
This Guide aims to illustrate the organizational model implementing the management of the exercises of peer assessment, external assessment or self-assessment combined with EN ISO 9001 certification of the membership criteria laid down in IR1, Part 1D, as well as their reports and follow-up of actions.
The agreed organizational model aims at building trust and accountability of the CEN-CENELEC system, while ensuring efficient and effective management. Indeed, the implementation of such an assessment system replies to the ambitious goal of “excellence” embedded in the provisions of the membership criteria.
The assessment exercises are handled under the supervision of a recognized super partes body, and independent Chair and by competent assessors, be they independent from the Member assessed (e.g. in case of peer or external assessment) or within the same Member (self-assessment combined with EN ISO 9001 certification).
The blend of competence and independence of judgment of the Chair and assessors and the effective and efficient processes of follow-up actions will ensure the integrity of the CEN-CENELEC assessment system and the recognition of those CEN and CENELEC stakeholders closely linked to, and benefiting from, standardization.
Vodilo o organizacijski strukturi in postopkih za ocenjevanje kriterijev za članstvo CEN in CENELEC
To vodilo dopolnjuje kriterije za članstvo CEN in CENELEC, vključene v notranjih predpisih CEN-CENELEC, 1. del (IR1), del 1D, in naj bi se ga bralo skupaj z njimi.
To vodilo nadomešča vodilo CEN-CENELEC 22:2015 in vodilo 22:2018, v skladu z odločitvami generalnih skupščin CEN in CENELEC, ki so bile sprejete junija 2021 za pregled organizacijske strukture ter postopkov za oceno kriterijev za članstvo CEN in CENELEC.
Namen tega vodila je prikaz organizacijskega modela za vodenje dejavnosti medsebojnega ocenjevanja, zunanjega ocenjevanja ali samoocenjevanja v kombinaciji s certifikatom EN ISO 9001 glede kriterijev za članstvo, določenih v dokumentu IR1, del 1D, ter njihovih poročil in nadaljnjih ukrepov.
Cilj dogovorjenega organizacijskega modela je vzpostavitev zaupanja in odgovornosti v sistemu CEN-CENELEC ter zagotavljanje učinkovitega in uspešnega vodenja. Izvajanje takšnega sistema ocenjevanja je odgovor na ambiciozen cilj »odličnosti«, kot ga predvidevajo določbe kriterijev za članstvo.
Dejavnosti ocenjevanja se izvajajo pod nadzorom pristojnega organa super partes, neodvisnega predsedujočega in pristojnih ocenjevalcev, ne glede na to, ali so neodvisni od člana (npr. v primeru medsebojnega ali zunanjega ocenjevanja), ki se ga ocenjuje, ali delujejo znotraj istega člana (samoocenjevanje v kombinaciji s certifikatom EN ISO 9001).
S kombinacijo usposobljenosti in neodvisne presoje predsedujočega in ocenjevalcev ter učinkovitih in uspešnih nadaljnjih ukrepov bosta zagotovljena celovitost sistema ocenjevanja CEN-CENELEC ter priznavanje deležnikov CEN in CENELEC, ki so tesno povezani s standardizacijo in imajo od nje korist.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2022
Nadomešča:
SIST-V CEN/CLC Guide 22:2018
Vodilo o organizacijski strukturi in postopkih za ocenjevanje kriterijev za članstvo
CEN in CENELEC
Guide on the organizational structure and processes for the assessment of the
membership criteria of CEN and CENELEC
Ta slovenski standard je istoveten z: CEN/CLC Guide 22:2021
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN-CENELEC
GUIDE
Guide on the organizational
structure and processes for the
assessment of the membership
criteria of CEN and CENELEC
Edition 5, 2021-12
(Supersedes CEN-CENELEC Guide 22:2018)
CEN and CENELEC decided to adopt this CEN-CENELEC Guide 22 through CENELEC/AG Decision
AG62/05 and CEN/AG Decision 31/2021 on 2021/11/25.
European Committee for Standardization
Tel: +32 2 550 08 11
Fax: +32 2 550 08 19
European Committee for Electrotechnical Standardization
Tel: +32 2 550 08 11
Fax: +32 2 550 08 19
Rue de la Science 23
1040 Brussels – Belgium
www.cencenelec.eu
CEN-CENELEC Guide 22:2021(E)
Contents Page
1 Scope . 5
2 Governance process . 5
3 Membership Relations and Monitoring Committee (MRMC) . 5
3.1 Mandate . 5
3.2 Composition . 6
3.3 Decisions . 7
3.4 Management . 7
3.5 CCMC support . 7
4 The assessment options . 7
4.1 General . 7
4.2 Self-assessment exercise combined with EN ISO 9001 certification . 7
4.2.1 General and time cycle of the assessment report . ………………………………………………7
4.2.2 Certification EN ISO 9001……. . ……………………………………………………………………….7
4.2.3 Internal assessors' team……. . …………………………………………………………………………8
4.2.4 Membership Relations and Monitoring Committee . ………………………………………………8
4.2.5 Main implementation steps of the self-assessment exercise combined with EN ISO 9001
certification and follow up . …………………………………………………………………………………….8
4.2.6 Working language . ………………………………………………………………………………………9
4.3 Peer assessment exercise . .9
4.3.1 General and time cycle of the peer assessment report . …………………………………………9
4.3.2 Membership Relations and Monitoring Committee . ……………………………………………….9
4.3.3 Chair of the Membership Relations and Monitoring Committee . ………………………………9
4.3.4 The peer assessors . …………………………………………….……………………………………10
4.3.5 Criteria for nomination and selection of peer assessors and remuneration . ………………10
4.3.6 Establishment of the peer assessors’ team for the Member assessment . …………………10
4.3.7 Main implementation steps of the peer assessment and follow-up ……………………………….11
4.3.8 Working language . ……………………………………………………………………………………11
4.3.9 Other complaints on peer assessors . ………………………………………………………………12
4.4 External assessment exercise . 11
4.4.1 General and time cycle of the external assessment report . .………………………12
4.4.2 Membership Relations and Monitoring Committee . ……………………………………………12
4.4.3 The external assessors . ………………………………………………………….12
4.4.4 Establishment of the external assessors’ team and remuneration . …………………………12
4.4.5 Main implementation steps of the external assessment and follow-up …………………….12
4.4.6 Working language …………………………………………………………………………………….14
5 Conformity and non-conformities . 14
5.1 Degree of conformities . 14
5.2 Escalation process in case of non-conformities (peer asessment) . 14
6 Processing of requests from CEN and/or CENELEC Members who change legal status . 17
7 Processing of applications for membership to CEN and CENELEC . 17
CEN-CENELEC Guide 22:2021(E)
Annex A Summary of the organizational model . 19
Annex B Tips for internal assessors on how to get the most from the self-assessment combined with
EN ISO 9001 certification . 20
Annex C Checklist to be used by the assessors during their assessment of the criteria for membership . 22
Annex D Template Member’s Assessment Report (peer, external or self in combination with EN ISO
9001) . 52
Annex E Template MRMC Chair Assessment Report . 66
Annex F Procedure: “Members’ assessments exercise on membership criteria of CEN and CENELEC” . 67
CEN-CENELEC Guide 22:2021(E)
1 Scope
This Guide complements, and is intended to be read in conjunction with, the membership criteria of CEN
and CENELEC included in the CEN-CENELEC Internal Regulations Part 1 (IR1), Part 1D.
This Guide supersedes CEN-CENELEC Guide 22:2015 and Guide 22:2018, in line with the decisions of
the CEN and CENELEC General Assemblies taken in June 2021 to review the organizational structure
and processes for the assessment of the membership criteria of CEN and CENELEC.
This Guide aims to illustrate the organizational model implementing the management of the exercises of
peer assessment, external assessment or self-assessment combined with EN ISO 9001 certification of the
membership criteria laid down in IR1, Part 1D, as well as their reports and follow-up of actions.
The agreed organizational model aims at building trust and accountability of the CEN-CENELEC system,
while ensuring efficient and effective management. Indeed, the implementation of such an assessment
system replies to the ambitious goal of “excellence” embedded in the provisions of the membership criteria.
The assessment exercises are handled under the supervision of a recognized super partes body, and
independent Chair and by competent assessors, be they independent from the Member assessed (e.g. in
case of peer or external assessment) or within the same Member (self-assessment combined with
EN ISO 9001 certification).
The blend of competence and independence of judgment of the Chair and assessors and the effective and
efficient processes of follow-up actions will ensure the integrity of the CEN-CENELEC assessment system
and the recognition of those CEN and CENELEC stakeholders closely linked to, and benefiting from,
standardization.
2 Governance process
The three approved assessment models of “Self-assessment exercise integrated with the EN ISO 9001
certification”, “Peer assessment exercise” and “External assessment exercise” are built around the
following organizational principles:
— the Presidential Committee leads the process, in full collaboration with the CEN and CENELEC
General Assemblies (AGs) and the CEN and CENELEC Board (CAs) in the case of External
assessment exercise;
— the Membership Relations and Monitoring Committee (MRMC) manages the process including
assessment activities, reporting and follow-up actions with the Members;
— a channel of reporting from the MRMC to the AGs through the Presidential Committee raises
awareness of good practices;
— the CEN and CENELEC Boards identify external assessors in case of External assessment;
— a standing team of peer assessors or Members’ internal assessors supports the assessment process.
3 Membership Relations and Monitoring Committee (MRMC)
3.1 Mandate
The MRMC is the core of the system.
The MRMC is mandated by the CEN and CENELEC General Assemblies to:
a) manage the CEN-CENELEC assessment system and ensure the overall quality, coherence and
fairness of the Self-assessment combined with EN ISO 9001 certification, Peer assessment or
External assessment reporting;
CEN-CENELEC Guide 22:2021(E)
b) ensure a smooth and effective management of a coherent self-assessment combined with
EN ISO 9001, Peer assessment or External assessment approach through appropriate processes,
preparation and maintenance of the necessary documents and templates, as well as selection and
training of qualified assessors;
c) seek continuous improvement on the definitions of the criteria for membership based on the
experience acquired;
d) ensure the effective follow-up of the outcomes of the reports on the assessments made and coordinate
and disseminate good practices to the CEN-CENELEC members with a view to facilitating the
exchange of information among the Members through appropriate mechanisms;
e) coordinate the assessment process of those organizations applying for membership in CEN and
CENELEC;
f) coordinate the assessment process in case of change of legal status of a Member of CEN and/or
CENELEC.
The MRMC reports to the Presidential Committee and, at least once a year, to the General Assemblies.
The MRMC’s main tasks, in accordance with the above mandate, are further detailed in its Terms of
Reference (ToR) as approved by the CEN and CENELEC General Assemblies in October 2012 (CEN/AG
Resolutions 31 and 32/2012 and CLC/AG53_CCMC_12_211/2012_RV).
3.2 Composition
The composition of MRMC is as follows:
— the Chair;
— two members appointed by CEN;
— two members appointed by CENELEC;
— the CEN-CENELEC Director General.
The Chair, who is an impartial person trusted by the whole community, is appointed by the CEN and
CENELEC General Assemblies for a 4-year term and receives some financial compensation for the time
they devote to this activity.
The other members of the Committee are appointed by the respective CEN and CENELEC Governing
Bodies following a call for nomination. They are appointed for a 3-year term and re-eligible for an additional
term of 3 years. They divest themselves from any representation of specific interests of the organization
that nominated them.
The Director General attends the Committee meetings as an observer with an advisory role.
3.3 Decisions
The Committee decides by consensus. The Chair, the CEN and the CENELEC nominated members take
decisions. The ToR specifies those cases of abstention from voting when, for instance, the MRMC’s
decisions concern the national organization from which the representative comes from.
3.4 Management
The MRMC works mainly by electronic means, holding online meetings as appropriate, but at least once a
year holds a physical meeting.
CEN-CENELEC Guide 22:2021(E)
The working language of the Committee is English.
The MRMC Chair and members shall abide to specific confidentiality rules in order to ensure that the
information in the assessment reports of CEN and CENELEC Members is managed with due care within
the MRMC.
3.5 CCMC support
CCMC appoints a member of its staff to be in charge of ensuring the secretariat and the administration of
the MRMC’s work (meetings and flow of information) and assisting the Chair in specifically identified tasks
related to the preparation and follow-up of MRMC meetings.
4 The assessment options
4.1 General
This clause describes the three identified options of assessment approved by the CEN and CENELEC
General Assemblies with their distinctions underlined whenever necessary for the different types of CEN
and CENELEC Members (Article 7.1 of the CEN Statutes and Article 7.2 of the CENELEC Statutes):
o Blue-type Members: NSB/NC from a European Economic Area State
o Red-Type Members: NSB/NC from an EFTA state (not Blue-type Members), or from States that are
officially identified as candidate countries for accession to the EU
o Yellow-Type Members: NSB/NC from a State having an agreement with the EU and demonstrating
regulatory convergence or compatibility with the essential regulations that support the Single Market in
areas that are relevant to CEN and CENELEC activities.
4.2 Self-assessment exercise combined with EN ISO 9001 certification
4.2.1 General and time cycle of the assessment report
Under this option, CEN and CENELEC Members of Blue and Red types organize and conduct their self-
assessment combined with EN ISO 9001 certification and report the findings to the MRMC. The time cycle
of the assessment Report is every 3 years.
The following specific elements should be taken into account.
4.2.2 Certification EN ISO 9001
Members having chosen this option shall have a quality management system in place, which is
EN ISO 9001 certified at their own cost, in addition, the following applies:
— Membership requirements shall be covered by the QMS system of the Member;
— The Member shall provide information to the external auditor about the scope and membership
requirements as outlined in the relevant documents before completing the EN ISO 9001 audit;
— The assessment report and action plan for dealing with non-conformities to the membership criteria
shall be agreed between the management and the external auditor before it is sent to MRMC;
— An annual monitoring during the internal audits within the exercise of EN ISO 9001 certification should
be carried out by the internal assessor to ensure ongoing compliance.
It is the Member’s responsibility to decide the most convenient organizational modalities regarding the
involvement of the external auditor in the assessment of the membership criteria.
CEN-CENELEC Guide 22:2021(E)
4.2.3 Internal assessors' team
The Members nominate their own internal team of assessors in line with the practices of the quality
management system in place. Please also refer to Annexes B and F.
4.2.4 Membership Relations and Monitoring Committee
The MRMC is called to:
— agree on the yearly calendar of self-assessment combined with EN ISO 9001 certification exercises to
be held by the concerned Members;
— monitor the execution of the scheduled self-assessment combined with EN ISO 9001 certification;
— receive, accept and handle the reports produced by the Members;
— benchmark the result of reports with a view to defining some good practices.
4.2.5 Main implementation steps of the self-assessment exercise combined with EN ISO 9001
certification and follow-up
a) Review and assessment by the CEN or CENELEC Member’s internal assessors
The CEN or CENELEC Member’s internal assessor(s) are expected to fully understand the relevant
documents. If needed, they can request at any time additional information and clarification from the
MRMC on matters related to the handling of the self-assessment and on the organization of this
exercise.
b) Final Report and feedback
The Member sends the final report produced by its internal assessors to the MRMC, which will accept
it following the review and recommendation of the Chair. The Committee handles the report with due
confidentiality.
Where relevant in case of non-conformities, the MRMC provides specific recommendations and
feedback to the Member on possible improvements (see Clause 5) and may also indicate good
practices from other Members. The MRMC may also facilitate the exchange of information on good
practices by inviting the Member to contact other relevant members on specific matters.
c) Review of the relevant parts of EN ISO 9001 certification by the internal assessors
In order to allow the MRMC to be able to compare the reports received from the Members, the
assessors of each Member shall ensure that all relevant information of the EN ISO 9001 auditors’
report is properly included in their self-assessment report respecting the given template. It is also
important to underline two important aspects:
— not all parts of EN ISO 9001 audit reports are relevant for the membership criteria; and
— the assessment of the membership criteria is not entirely covered by the EN ISO 9001 audit.
In order to make sure that the MRMC only receives the relevant part of the Member’s EN ISO 9001
report produced by the auditors, the Members' internal assessors should define:
— what information within their EN ISO 9001 exercise is relevant for the self-assessment reporting
on the basis of the membership criteria;
— what are the additional specific assessment activities that are needed to fulfil the self-assessment
reporting.
CEN-CENELEC Guide 22:2021(E)
4.2.6 Working language
The working language in this option will be the language of the country of the Member. However, the report
will be drafted in English.
4.3 Peer assessment exercise
4.3.1 General and time cycle of the peer assessment report
Under this option, CEN and CENELEC Members of the Blue, Red and Yellow types organize a peer
assessment model based on independent and competent teams of assessors coming from the staff of the
Members. For Blue and Red type Members, the time cycle of the peer assessment audit is 3 years. For
Yellow-type Members, a peer assessment exercise must be delivered in the first two years after becoming
a Member as well as an external assessment while applying for membership and then every following third
year.
It should be noted that peer assessment exercises may be requested by the MRMC at any time in case of
change of legal status of an existing CEN and/or CENELEC Member and in case of a new application for
membership in CEN and CENELEC, as laid down in clause 3.2 of the CEN-CENELEC IR Part 1D.
4.3.2 Membership Relations and Monitoring Committee
In addition to the responsibilities of the MRMC already outlined, in the case of peer assessment the
Committee will also be in charge of:
a) the organization of the peer assessment processes;
b) the selection, appointment and coordination of the peer assessors.
4.3.3 Chair of the Membership Relations and Monitoring Committee
The Chair is expected to ensure:
a) the most appropriate composition of the peer assessment teams, taking into account the size and
other specificities of each Member, including (if possible) the national language;
b) the efficient management of the assessment visits held by the peer assessors.
The Chair will not act as a peer assessor in order to avoid a conflict of interests between the two positions.
4.3.4 The peer assessors
The assessments on the membership criteria under this option are made by individual peer assessors or
teams of peer assessors, depending on the size of the Member.
The peer assessors are competent persons appointed to handle the assessment exercises and to report
accordingly to the Membership Relations and Monitoring Committee. They commit to be independent in
their judgment and behaviour.
The names of the peer assessors enabled to run peer assessments are included in a list that is made
available to all Members.
4.3.5 Criteria for nomination and selection of peer assessors and remuneration
Each Member may nominate a candidate peer assessor. However, common CEN and CENELEC Members
may nominate only one candidate peer assessor.
CEN-CENELEC Guide 22:2021(E)
The call for nomination of the peer assessors is made through an open process based on objective criteria
to be laid down in a separate document. Members are expected to nominate their own staff as candidates
to become peer assessors. Candidates should demonstrate, at least:
— a good knowledge of English and, possibly, of other national language(s) spoken in the Member's
country(ies);
— previous knowledge/work experience with quality audit exercises;
— knowledge on standardization development.
Following the deadline of the call, the MRMC evaluates the proposed curricula according to the agreed
criteria and establishes a list of maximum 15 appointed assessors.
The peer assessors are expected to remain available in the shortlist for a period of 4 years.
Calls for peer assessors are normally handled once every 4 years.
Each time a peer assessor is called to handle an assessment exercise, the Member in which this assessor
is employed receives a financial compensation for the time its employee spends on the assessment
exercise. This is calculated for an amount of € 600 per day/assessor plus travel costs (reimbursed upon
real flight expenses) and accommodation costs (reimbursed upon fixed daily allowance based on the EC
official rates for European projects).
The same financial compensation and reimbursement of cost is applied to the CEN and/or CENELEC
Member that changes its legal status requiring an assessment of compliance with the membership criteria.
In case of the assessment following a new application for membership in CEN and CENELEC, the same
financial conditions as above will apply, and the related cost will be charged directly to CEN and CENELEC
and invoiced to CCMC.
4.3.6 Establishment of the peer assessors’ team for the Member assessment
The Chair of the MRMC appoints the peer assessors to handle the assessment visits.
Confidence in the process is key to the relevance of the peer assessment process. Therefore, the Chair
appoints the peer assessors in a dialogue with the Member to be assessed. A contact person in the
Member’s organization is to be nominated to this end.
Depending on the size of the Member to be assessed, the MRMC can agree to allow just one peer
assessor to handle the exercise or to have a team of peer assessors composed of a lead assessor and one
assessor.
The Chair appoints the peer assessors who have the qualifications required for the specific assessment,
bearing in mind the profile of, and their independency from, the Member to be assessed.
The Member to be assessed has the right to reject a peer assessor, providing reasons for their non-
acceptance.
In all cases, the team is appointed in agreement with the Member to be assessed.
4.3.7 Main implementation steps of the peer assessment and follow-up
a) Desk review and preparation of the visit on location
Relevant documents are sent by the Member to the assessors’ team in advance. The need for specific
translations is discussed on a case-by-case basis.
The assessors’ team studies the documents, requests additional information (if needed) and clarifies
items as much as possible before the assessment on location.
CEN-CENELEC Guide 22:2021(E)
In order to ease the assessment visit, a preliminary short report and a proposed assessment schedule
(topics, persons, documents, and timetable) are sent to the Member for comments and agreement.
b) Visit by the Assessors to the Member
The visit and assessment are organized on the basis of good audit practices. At the end, a first oral
summary of findings, results and recommendations will be given to the Member’s management by the
assessors’ team.
c) Draft report
The draft report is sent to the Member for comments within a given timeframe. If the Member does not
agree with the findings in the assessors’ report, further clarifications to find consensus are possible.
The Chair of the MRMC may intervene to facilitate the exchange of information between the assessors
and the Member.
If consensus is not possible, the Member sends its written comments or clarifications to the MRMC.
The diverging positions between the assessors and the Member are quoted in the final Report (see
also Clause 5).
d) Final report and feedback
The assessors’ final report is sent to the Member concerned and to CCMC for processing to the
MRMC, which handles it with due confidentiality. The MRMC may also provide specific feedback to the
assessed Member on possible remedies and improvements. It also indicates good practices of other
Members and facilitates the exchange of information on these by inviting contact to be made with other
relevant Members on specific matters.
e) Non-conformities
Should non-conformities be revealed, a reasonable timeframe for reaching compliance is agreed with
the Member concerned. In case of persistent failure of compliance, MRMC will engage in an escalation
process as defined under Clause 5.
4.3.8 Working language
The choice of the assessors will also take into account their language skills, so as to facilitate the reading
and use of the Member's documents. However, it may be required that at least the main documents are
translated into English. The peer assessment report will be drafted in English.
4.3.9 Other complaints on peer assessors
The Member may put forward formal complaints to the MRMC about the assessors’ work and/or behaviour.
Any complaint must be accompanied by the relevant evidence.
4.4 External assessment exercise
4.4.1 General and time cycle of the external assessment report
CEN and CENELEC Yellow-type Members shall undergo an external assessment focusing on regulatory
compatibility when applying for membership and then every third year after becoming a Member. The
external assessment model is based on a team of independent and competent assessors appointed by
the CEN and CENELEC Administrative Boards upon recommendation of the Presidential Committee.
CEN-CENELEC Guide 22:2021(E)
In particular, the external assessment shall include all agreements with the EU and documents that certify
compliance with regulatory convergence or compatibility with the essential regulations that support the
Single market in the areas that are relevant to CEN and/or CENELEC.
4.4.2 Membership Relations and Monitoring Committee
In addition to its above-mentioned responsibilities, in the case of an external assessment the MRMC is in
charge of:
a) the organization of the external assessment process;
b) advising the Presidential Committee on the identification and composition of the teams of external
assessors.
4.4.3 The external assessors
The external assessors are competent persons appointed to handle the assessment exercises and to
report accordingly to the Membership Relations and Monitoring Committee. They commit to be
independent in their judgment and behaviour.
4.4.4 Establishment of the external assessors’ team and remuneration
The composition and the size of the team are decided by the Administrative Boards upon
recommendation of the Presidential Committee. The Presidential Committee shall consult the MRMC for
the identification of the assessors.
The Administrative Boards appoint external assessors who have the qualifications required for the specific
assessment, bearing in mind the profile of, and their independency from, the Member to be assessed.
The Administrative Boards, upon recommendation of the Presidential Committee, appoints a leader
among the external assessors responsible for assigning specific roles and tasks, for the coordination of
the team and for the final drafting and delivery of the assessment report.
The assessment costs shall be covered by the assessed organization. The overall calculated costs for
work and accommodation are the same as those indicated for the peer assessment exercise under clause
4.3.5. The assessed Member does not have the right to reject an assessor appointed by the Boards.
4.4.5 Main implementation steps of the external assessment and follow-up
a) Desk review and preparation of the visit on location
Relevant documentation, including extensive legal evidence establishing compliance with the
membership criteria for Yellow type Members are sent by the Member to the external assessors’ team
in advance. The need for specific translations is discussed on a case-by-case basis.
The assessors review the documents, request additional information (if needed) and clarify items as
much as possible before the assessment on location.
In order to facilitate the assessment visit, a short preliminary report and a proposed assessment
schedule (listing topics, persons to meet with, documents to access and timetable) are sent to the
Member for comments and agreement. Additional meetings to define the needs and objectives of the
assessment exercise may also be proposed.
b) Visit by the Assessors to the Member
The visit and assessment are organized on the basis of good audit practices. At the end, a first oral
summary of findings, results and recommendations will be given to the Member’s management by the
assessors’ team.
CEN-CENELEC Guide 22:2021(E)
c) Draft report
The draft report is sent to the Member for comments within a given timeframe. If the Member does not
agree with the findings in the assessors’ report, further clarifications to find consensus are possible.
The Member does not have the right to object the findings and recommendations provided in the draft
report.
The Chair of the MRMC may intervene to facilitate the exchange of information between the assessors
and the Member.
If consensus is not possible, the Member sends its written comments or clarifications to the MRMC.
The diverging positions between the assessors and the Member are quoted in the final Report
d) Final report and feedback
The external assessors’ final report is sent to the Member concerned and to CCMC for processing to
the MRMC, which handles it with due confidentiality.
The MRMC may provide specific feedback to the assessed Member on possible remedies and
improvements. It also indicates goals and practises of other Members and facilitates the exchange of
information on these by inviting contacts to be made with other relevant Members on specific matters.
Based on the final report, the MRMC provides a detailed recommendation to the Presidential
Committee, which may contain specific feedback on possible remedies to non-conformities and
possible improvements. It also underlines good practices and other supporting evidence and
information.
e) Non-conformities
Should non-conformities be revealed, the PC asks the MRMC to manage the follow-up process. A
reasonable timeframe for reaching compliance is agreed with the Member concerned. In case of
persistent failure of compliance, MRMC provides the PC with a negative feedback on the Member’s
Membership status.
f) Recommendations of the Presidential Committee
Based on the feedback of the MRMC, the Presidential Committee provides further recommendation to
the Administrative Boards.
g) Recommendations of the Administrative Boards
The Administrative Boards analyse the recommendations provided by the PC and deliver final
recommendations on Membership status to the General Assemblies.
h) Final Decision of the General Assemblies
The General Assemblies decide on the Membership status of the assessed Member during their
common session.
4.4.6 Working language
The criteria established under clause 4.3.8 applies.
CEN-CENELEC Guide 22:2021(E)
5 Conformity and non-conformities
5.1 Degree of conformities
The degrees from Full Conformity to Serious Non-Conformity are described as follows:
GRADE DEFINITION
Full conformity The Member meets all obligations in full. Flawless in terms of attention
to specifics and showing original insight.
Conformity with comments The Member meets all obligations but lacks specific evidence.
Attention to specific requirements with room for improvement is
needed. The evaluated Member is encouraged to respond to
comments and an Action Plan for further development near flawless is
needed.
Conformity with concern The Member meets all obligations at present, but attention to specific
requirements is needed as the Member’s practice may develop into a
non-conformity. The evaluated Member is expected to respond to a
Concern by providing the MRMC with an appropriate Action Plan and
time schedule for implementation. The response shall include an
analysis of the root cause and extent and include a corrective action
plan.
Low The Member does not meet a membership requirement under one or
more criteria. An immediate corrective action is needed and evidence
Non-Conformity
of its implementation is provided to the MRMC.
The assessed Member is expected to respond to a Low Non-
Conformity by taking immediate corrective action.
The response shall include, within an appropriate Action Plan, an
analysis of root cause and extent and explanation of corrective and
preventative actions and objective evidence of implementation.
Medium or Serious Non- The Member does not meet a membership requirement under one or
Conformity more criteria. However, the MRMC can decide that several low rated
non-conformities may amount to a “Medium” or “Serious” non-
conformity as it may indicate a systemic problem.
5.2 Escalation process in case of non-conformities (peer assessment)
In case of non-conformities, the indicative process will be as follows:
Event Indicative timeframe Impact/consequence
time: T0 cumulated
time: T0
Peer and external assessment: in The Member may send its separate
case of diverging positions written comments or clarifications to
between the Member and the peer the MRMC for consideration when
assessors on the non-conformities assessing the related report
in the assessment report
CEN-CENELEC Guide 22:2021(E)
Event Indicative timeframe Impact/consequence
time: T0 cumulated
time: T0
MRMC receive a report including 0 4 weeks The MRMC assess the possible “low”,
one or more non-conformity with MRMC “average” or “serious” impact of the
the criteria for membership and the Chair report non-conformity with the criteria for
Member has already indicated in membership and the proposed remedy
+
the report how it intends to address
and timeframe.
MRMC
the non-compliance.
The MRMC approve the remedy
meeting
actions and timeframe.
Comment deadline 1 week Member to explain the reason of the
delay and to indicate a new deadline.
At the agreed deadline, the
Member has not taken the remedy
action
CCMC to inform the MRMC at the 1 week MRMC MRMC possible formal reminder
next meeting meeting
Concern deadline 1 week Member to explain the reason of the
delay and to indicate a new deadline.
At the agreed deadline, the
Member has not taken the remedy
action
CCMC Review with the Member 2 weeks 3 weeks MRMC possible formal warning
and CCMC to inform the MRMC
Non-Conformity deadline 1 week Member to explain the reason of the
delay and to indicate a new deadline.
At the agreed deadline, the
Member has not taken the remedy
action
MRMC Chair to have preliminary + 2 weeks 3 weeks Chair to decide if to call for an ad hoc
discussion with the Member (with meeting + possible formal warning
support CCMC) and inform the
MRMC
MRMC to send written questions to + 1 weeks 4 weeks -
the Member.
Answers from the Member + 2 weeks -
MRMC consider the answers and, + 2 weeks 8 weeks All Members are aware of a potential
if not satisfactory, refers the problem with one Member of CEN
situation to PC. CENELEC.
CCMC informs the Members
accordingly.
PC considers the situation and + 4 weeks 12 weeks -
decides sending a peer assessor
to the Member to investigate on
site and any other support action
(including further legal advice) to
be handled by MRMC and CCMC
Visit of the assessor on site and + 4 weeks 16 weeks -
preparation of an assessment
report
CEN-CENELEC Guide 22:2021(E)
Event Indicative timeframe Impact/consequence
time: T0 cumulated
time: T0
MRMC review of the assessor’s + 2 weeks 18 weeks
report
The report is positive: + 1 week 21 weeks All Members are informed of the
positive outcome of the process
MRMC inform the PC
CCMC inform all Members
The report is negative: + 1 week 21 weeks -
MRMC inform the PC
The President calls for the General
Assembly meeting to decide on
further actions including a possible
site visit
Upon consideration of the report of + 4 weeks 23 weeks Ad hoc suspension of certain
the assessor, the General membership rights and obligations
Assembly(ies) require urgent
ie: the Member no longer enjoys full
remedy actions and reduce the
rights, for instance its nominated CA
rights of the Member
member would be suspended, if
applicable, and AG or BT voting rights
are suspended…)
Experts nominated by the NSB/NCs in
working groups are suspended.
TC secretariats held by NSB/NC are
considered by the BT(s) for
reassignment.
In the absence of effective and + 12 35 weeks -
demonstrated remedy actions weeks
(within 3 months), the CA
recommend the AG to exclude the
Member
By resolution of the AG(s) by + 4 weeks 39 weeks Loss of the status of Member with CEN
correspondence, the Member is CENELEC.
excluded (qualified majority vote
National votes are rejected.
according to the relevant statutory
National delegations in TCs are no
provisions)
longer accepted.
Experts nominated by the NSB/NCs in
working groups are excluded.
TC secretariats held by NSB/NC are
offered by the BT(s) for reassignment.
CEN and/or CENELEC 0 -
communicate the situation to the
European Commission under art.
24–1 e) of Regulation 1025/2012
The situation is referred to in the + 3 1 year -
agenda of the Committee of months
Standards under art. 23 of
Regulation 1025/2012
CEN-CENELEC Guide 22:2021(E)
Event Indicative timeframe Impact/consequence
time: T0 cumulated
time: T0
Possible notification of another - - Possible loss of the status of Member
body by the Member State under of the NSB/NC with its Member state
art. 27 of Regulation 1025/2012 and with the European Union.
Consideration by CEN and - - -
CENELEC of the candidature of a
replacement body as the new
Member
6 Processing of requests from CEN and/or CENELEC Members who change legal
status
The fulfilment of the CEN-CENELEC Membership Criteria is to be considered as a requirement that all
CEN and CENELEC Members, present and future, have to respect at all times. A current CEN and/or
CENELEC Member may decide - or be requested by its national Public Authorities - to change its legal
status or, alternatively, be replaced by a new legal entity in the domain of standardization at national level.
All those cases may lead de jure and de facto to a new legal entity. Consequently, an assessment made by
independent assessors under the coordination of the MRMC may be needed. In this case, the process of
assessment of compliance with the membership criteria is as follows:
— the Member notifies CEN and/or CENELEC with official letter the new situation at national level,
including the relevant evidence (such as: new Statutes, organizational chart, administrative acts and
national law translated in English).
— On receipt of the letter, the Director General, in consultation with the CEN and/or CENELEC President
and Vice-Presidents, informs the Chair of the MRMC.
— The MRMC assess whether the change of legal status is such to require the organization of the
assessment of the criteria for membership by independent assessors. If so, CCMC assists the MRMC
on the organizational aspects.
— If the new legal status further entails a change in the Membership type, a new assessment of the
necessary requirements for membership will be needed.
7 Processing of applications for membership to CEN and CENELEC
The acceptance of a new Member by the CEN and/or CENELEC General Assemblies has to be based on
the evidence of the ability by the applicant organization to abide to the membership criteria, as a result of
the assessment made by independent experts under the coordination of the MRMC.
The process for application for membership in CEN and CENELEC is as follows:
— An official letter of application is to be addressed to CEN and/or CENELEC. This letter must provide
evidence, and a supporting file regarding the items developed in this document is to be annexed
(notably demonstrating compliance with the above criteria).
— On receipt of the letter, the Director General, in consultation with the CEN and/or CENELEC President
and Vice-Presidents, informs the Chair of the MRMC.
Please also refer to CEN-CENELEC IR Part 1, Part D, Clause 7.
Please also refer to CEN-CENELEC IR Part 1, Part D, Clause 8.
CEN-CENELEC Guide 22:2021(E)
— The MRMC organizes the assessment of the criteria for membership set by the Internal Regulations
Part 1D, by independent assessors. If the applicant is applying for a Yellow-type membership, an
external assessment process as defined under clause 4.4 is organized and CCMC assists the
assessors on the organizational aspects.
— The assessment is handled following the same organizational rules and costs as of the peer
assessment exercises.
— A consultation with the European Commission and EFTA Secretariat is arranged.
— A consultation with the other ESOs is arranged (notably on the weighted voting).
— On the basis of the outcome of the above steps, negotiations start between CCMC on behalf of CEN
and CENELEC and the candidate organization on the terms of accession to membership and, in
particular, with respect to the calendar and the weighted vote to be granted.
— The completed file, including the MRMC Report on the outcome of the assessment, is transmitted to
CEN and/or CENELEC Board for recommendation and from this to the CEN and/or CENELEC
General Assembly for decision.
— The General Assembly of CEN votes in accordance with Article 12 of the CEN Statutes.
— The General Assembly of CENELEC votes in accordance with Article 12 of the CENELEC Statutes.
Annex A
Summary of the organizational model
Membership Relations and Monitoring
Co mmitte e
Presidential Committee
Mandated by CEN & CENELEC AGs to
- Cases of non-compliance
To report
handle:
- Annual reporting to
...








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