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
No comments:
Post a Comment