SIST-V CEN/CLC Guide 22:2018
(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 in line with the decisions of the CEN and CENELEC General Assemblies taken in June 2017 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 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 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.
Leitfaden für die organisatorische Struktur und den Prozess für die Bewertung der Mitgliedskriterien von CEN und CENELEC
Vodilo o organizacijski strukturi in postopkih za ocenjevanje kriterijev za članstvo CEN in CENELEC
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-V CEN/CLC Guide 22:2018
01-marec-2018
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Guide on the organizational structure and processes for the assessment of the
membership criteria of CEN and CENELEC
Leitfaden für die organisatorische Struktur und den Prozess für die Bewertung der
Mitgliedskriterien von CEN und CENELEC
Ta slovenski standard je istoveten z: CEN/CLC Guide 22:2018
ICS:
01.120 Standardizacija. Splošna Standardization. General
pravila rules
SIST-V CEN/CLC Guide 22:2018 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-V CEN/CLC Guide 22:2018
CEN-CENELEC
GUIDE
22
Guide on the organizational
structure and processes for the
assessment of the membership
criteria of CEN and CENELEC
Edition 4, 2018-01
(Supersedes CEN-CENELEC Guide 22:2015)
CEN and CENELEC decided to adopt this CEN-CENELEC Guide 22 through CENELEC/AG Decision
AG58/C02 and CEN/AG Resolution 30/2017 both taken by correspondence on 2017-09-05.
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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.cen.eu
www.cenelec.eu
www.cencenelec.eu
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Contents Page
1 Scope . 4
2 Governance process . 4
3 Membership Relations and Monitoring Committee (MRMC) . 4
3.1 Mandate . 4
3.2 Composition . 5
3.3 Decisions . 5
3.4 Management . 5
3.5 CCMC support . 6
4 The assessment options . 6
4.1 General . 6
4.2 Self-assessment exercise combined with EN ISO 9001 certification . 6
4.3 Peer assessment exercise . 8
5 Conformity and non-conformities . 11
5.1 Degree of conformities . 11
5.2 Escalation process in case of non-conformities . 11
6 Processing of requests from CEN and/or CENELEC Members who change legal status . 14
7 Processing of applications for membership to CEN and CENELEC . 14
Annex A Summary of the organizational model . 16
Annex B Tips for internal assessors on how to get the most from the self-assessment combined with
EN ISO 9001 certification . 17
Annex C Checklist to be used by the assessors during their assessment of the criteria for membership
. 19
Annex D Template Member’s Assessment Report (peer or self in combination with EN ISO 9001) . 44
Annex E Template MRMC Chair Assessment Report . 54
Annex F Procedure: “Members’ assessments exercise on membership criteria of CEN and CENELEC”
. 58
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1 Scope
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 in line with the decisions of the CEN and
CENELEC General Assemblies taken in June 2017 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 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 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 two approved models of “Self-assessment exercise integrated with the EN ISO 9001 certification”
and “Peer 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);
— 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 to raise
awareness of good practices;
— a standing team of peer assessors or members’ internal to support 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 or Peer assessment
reporting;
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b) ensure a smooth and effective management of a coherent self-assessment combined with
EN ISO 9001 or Peer 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 Assembly.
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 he/she devotes 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.
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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 two identified options of assessment approved by the CEN and CENELEC
General Assemblies with their distinctions underlined whenever necessary.
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, each CEN-CENELEC member organizes and conducts its self-assessment
combined with EN ISO 9001 certification and reports its findings to the MRMC. The time cycle of the
assessment Report is 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.
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.
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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.
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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 organize a peer assessment model based on independent and
competent teams of assessors coming from the staff of the members. The time cycle of the peer
assessment audit is of 3 years.
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 the criteria for membership
Clauses 7 and 8 in the CEN-CENELEC IR Part 1, 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-CENELEC
members may nominate only one candidate peer assessor.
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:
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— 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 his/her 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.
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.
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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.
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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
In case of non-conformities, the indicative process will be as follows:
Event Indicative timeframe Impact/consequence
time: T0 cumulated
time: T0
Peer assessment: in case of The member may send its separate
diverging positions between the written comments or clarifications to
member and the peer assessors the MRMC for consideration when
on the non-conformities in the assessing the related report
assessment report
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Event Indicative timeframe Impact/consequence
time: T0 cumulated
time: T0
MRMC receive a report including 0 4 weeks Following MRMC Chair report, the
one or more non-conformity with MRMC MRMC assess the possible “low”,
the criteria for membership and the Chair report “average” or “serious” impact of the
member has already indicated in non-conformity with the criteria for
+
the report how it intends to address membership and the proposed remedy
MRMC
the non-compliance. and timeframe.
meeting
The MRMC approve the remedy
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 national members are aware of a
if not satisfactory, refers the potential problem with one member of
situation to PC. CEN CENELEC.
CCMC informs the national
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
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Event Indicative timeframe Impact/consequence
time: T0 cumulated
time: T0
MRMC review of the assessors + 2 weeks 18 weeks
report
The report is positive: + 1 week 21 weeks All national 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 nominat
...
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