Thursday, August 27, 2020

Ethiopian National Accreditation Office Establishment Council of Ministers Regulation No. 421-2017

 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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