COUNCIL OF MINISTERS REGULATION NO. 421/2017
COUNCIL OF MINISTERS
REGULATION TO PROVIDE FOR THE ESTABLISHMENT OF THE ETHIOPIAN NATIONAL
ACCREDITATION OFFICE
This Regulation is issued
by the council of Ministers pursuant to Article 5 and Article 38 of the
Definition of Powers and Duties of the Executive Organs of the Federal Democratic
Republic of Ethiopia Proclamation No. 916/2016 (as amended by Proclamation
No.942/2016).
Part one
General
1. Short Title
This Regulation may be cited as the "Ethiopian
National Accreditation Office Establishment Council of Ministers Regulation No.
421/2017”.
2. Definitions
In this Regulation, unless the context otherwise
requires:
1/ "accreditation"
means attestation related to a conformity assessment body, conveying formal
demonstration of its competence to carry out specific conformity assessment
tasks;
2/ "conformity
assessment" means demonstration that specified standards and requirements
relating to a product, process, system, person or body are fulfilled;
3/
"conformity assessment body (CAB)" means a body that performs conformity assessment services including
testing laboratory, inspection body, certification body, calibration and verification laboratory, proficiency
testing provider and reference material
producers and that can be the subject of
accreditations;
4/ "professional"
means lead assessor, technical assessor, technical expert, trainer,
accreditation committee’s member and those who make professionals contributions
to the Office activities excluding staffs of
the Office.
5/ "assessment"
means a process undertaken by the Office to assess the competence of a
conformity assessment body, based on particular standard(s) and/or other
normative documents and for a defined scope of accreditation;
6/ "surveillance"
means set of activities, except reassessment, to monitor the continued
fulfillment of requirements for accreditation by accredited conformity
assessment bodies;
7/ “accredited
body” means an organization or
facility that has been accredited by the Office or by the International
Laboratory Accreditation Co-operation institute (ILAC) or accredited by a full
member of International Accreditation Forum (IAF);
8/ "Accreditation
Certificate" means a formal document or set of documents, stating that
accreditation has been granted for the defined scope of activities;
9/ “acceptable
legal document” means a document or test report
issued by an accredited body within their approved accreditation scope
and signed by a person deemed to be competent to do so by the Office and issued
after their accreditation;
10/“accreditation symbol” means a
symbol issued by the Office to be used by the accredited conformity assessment
bodies within their scope of accreditation;
11/ "scope
of accreditation" means a scope of competence issued to specific
conformity assessment body to provide accreditation service based on standards
and requirements;
12/ "Ministry"
means the Ministry of Science and Technology;
13/ any
expression in the masculine gender includes the feminine.
Part two
Ethiopian National Accreditation Office
3. Establishment
1/ The Ethiopian National Accreditation Office
is hereby re- established by this Regulation as an autonomous Federal
Government office having its own legal personality.
2/ The Office shall be accountable to the Ministry.
3/ The Office is recognized as the sole third
party National Accreditation Body for conformity assessment bodies.
4. Head Office
The office shall have its
head office in Addis Ababa and may have branch offices elsewhere, as may be
necessary.
5. Objectives
The Office shall have the objectives to:
1/ enhance
export and inland trade of the country
by establishing and implementing internationally recognized accreditation
system and thereby causing issuance of internationally acceptable accreditation
certificate for the goods and services of the country;
2/ play
its role to ensure the public health, consumer safety, environmental safety and
fair market competition by providing competent accreditation service for CABs
by using national and international standards;
3/ contribute
its role to the efficiency and effectiveness of domestic market regulation, and
government decision to enhance acceptance and confidence in the general
public.
6. Powers and
Duties
The
Office shall have the powers and duties to:
1/ act
as sole independent body to provide accreditation service to conformity
assessment bodies based on national and international standards and requirements;
2/ promote
accreditation by providing training on accreditation standards, assessment
techniques and related requirements in an internationally acceptable manner;
3/ issue
rules on how to use National Accreditation Symbol and ensure its implementation;
promote and protect other legally granted regional and international umbrella
organization symbols in an internationally acceptable way;
4/ promote
and encourage conformity assessment bodies to obtain accreditation service;
promote the service it provides and create awareness to clients on the benefit
of accreditation;
5/ keep
register and publicize the list of accredited bodies and those whose
accreditations have been suspended and withdrawn, and notify same to the
concerned regulatory bodies;
6/ issue
and implement directives governing the accreditation process, in particular,
the assessment of applicants and the granting, suspending and withdrawing of
accreditations, and handling of grievances relating thereto;
7/ conduct
planned and surprise surveillance visit to verify continuation of scope of
competence of accredited conformity assessment bodies and fulfillment of
mandatory requirements issued by the Office;
8/conduct supervision to protect
misuse of accreditation certificate, accreditation symbol including
misrepresentation of data from an accreditation; and take administrative
measures to rectify problems identified;
9/ cause
conformity assessment bodies to purchase insurance policy to cover any damage
that they may cause on properties of
clients during their activities;
10/charge fees for the services it
renders in accordance with the rate fee approved by the Government;
11/own property, enter in to
contract, sue and be sued in its own name;
12/conduct agreements with other
bodies that do not conflict with any international agreements that the country
had entered in to.
13/carry out other related activities
necessary for the attainment of its objectives.
7. Organization of
the Office
The Office shall have:
1/ a Council of Accreditation (herein after
the "Council");
2/ a Director General and, as may be
necessary, Deputy Director Generals to
be appointed by the Government; and
3/ the necessary staff.
8. Members of Council
1/ The Council shall have 10 up to 15 members
including the Chairperson, to be drawn from the relevant government bodies,
private sectors having relevant experience and knowledge relating to the
functions and be nominated by the Minister assigned by the Government.
2/ The Director General shall participate in
meetings of the Council as member and secretary.
3/ The
term of office of the members of the Council shall be five years; provided,
however, that they may be assigned for one additional five year.
9. Powers and
Duties of the Council
The Council shall have the powers and duties to:
1/
review and approve accreditation strategies developed by the Office;
2/ advise
the Office on policy and strategic issues raised by stake holders relating to
accreditation;
3/ examine
and decide on pleadings lodged against decisions with respect to accreditation.
10. Meetings of the Council
1/ The Council shall hold its regular meet every three months;
provided, however, it may hold extraordinary meeting at any time when called by
the chairperson.
2/ There
shall be a quorum when majority of the members of the Council are present at a
meeting.
3/ Decisions
of the Council shall be passed by a majority vote; in case of a tie, the
chairperson shall have a casting vote.
4/ Without
prejudice to the provisions of this Article, the Council may adopt its own
meeting rules and procedure.
11. Powers and Duties of the Director General
1/ The
Director General shall be the chief executive officer of the Office and shall
direct and administer the activities of the Office.
2/ Without
limiting the generality of sub-article (1) of this Article, the Director
General shall:
a) exercise
the powers and duties of the Office specified under Article 6 of this Regulation;
b) employ
and administer employees in accordance with the Ministry of Federal Public
Service and Human Resource Development laws;
c) prepare
and submit to the Ministry the work program and
budgets of the office and implement same upon approval by the Government;
d) issue
accreditation certificate to the accredited institutions;
e) represent
the Office in its dealings with third parties;
f) prepare
and submit the performance and financial reports of the Office to the Ministry.
3/ The
Director General may delegate part of his powers and duties to other officers
and employees of the Office to the extent necessary for the efficient and
effective implementation of the activities of the Office.
12.
Budget
The
Office's budget shall be allocated by the Government.
13. Books of
Accounts
1/ The Office shall
keep complete and accurate books of accounts.
2/ The books of
accounts and financial documents of the Office shall be audited annually by the
Auditor General or by auditors designated by him.
Part Three
Miscellaneous
provisions
14. Admissibility of Certificates and Reports
Certificates and reports issued by an accredited body
after their accreditation as per their approved accreditation scope and signed
by a competent person authorized by the Office to do so shall be considered
legally admissible evidence.
15. Confidentiality
Any
person who is involved in the performance of any function in relation to
accreditation shall not disclose any information which he or she obtained in
the course of performance of such a function except to:
1/ the office;
2/ the concerned
party;
3/ if required by
any court of law;
4/ any competent
public authority for work, or for criminal investigation;
5/ the chairperson
of the Council.
16. Prohibitions
Professional
assessors and accreditation approval committee members shall not involve on the
consultancy activities of conformity assessment bodies.
17. Obligation to
Cooperate
1/ Any accredited
body and other concerned parties shall have the duty to cooperate with the
Office for conducting planned and surprise surveillance visit to verify
continued competence of accredited conformity assessment bodies.
2/ Regulatory
bodies, National Metrology Institution and the Ethiopian Standards Agency shall
have obligation to cooperate with the Office.
18. Utilization of
Accreditation Certificate
1/ An accreditation
certificate issued to the accredited institutions shall be signed by the
Director General or persons delegated by him to do so.
2/ A certificate of
accreditation issued in accordance with sub-article (1) of this Article shall be valid as evidence within the scope of
competence contained therein.
3/ An accreditation
certificate is the property of the Office and shall be returned by an
accredited body when requested by the Office in case of failure to maintain
requirement.
19. Repealed and Inapplicable Regulations
1/ The Ethiopian
National Accreditation Office Establishment Council of Ministers Regulation No.
279/2005 is hereby repealed.
2/ No regulations, directives or
practice shall, in so far as they are inconsistent with the provision of this
Regulation, be applicable with respect to matters provided for by this
regulation.
20. Effective Date
This
Regulation shall enter in to force on the date of its publication in the Federal Negarit Gazette.
Done
at Addis Ababa, This 22nd day of December, 2017.
Hailemarim dessalegn
Prime minster
of the federal
democraticerepublic of ethiopia
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