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Document No. PM.04
Rev No.5
Effective date: 2016-05-23
Reviewed by: Araya Fesseha / Approved by: Mr. Mahamouda Ahmad Gaas
Position: Director General / Position: Accreditation Council Chairman
Signature: / Signature:
CONTENTS:
1 PURPOSE AND SCOPE 3
2 REFERENCES AND ACRONYMS 3
3 RESPONSABLITY 3
4 ACCREDITATION 4
4.1 Legal responsibility 4
4.2 Structure 4
4.3 Impartiality 8
4.4. Confidentiality 9
4.5. Liability and Financing 10
4.6. Accreditation Activity 10
5. MANAGEMENT 11
5.1. General Arrangements 11
5.2. Management System 11
5.3. Document Control 13
5.4. Records 14
5.5. Non conformities and corrective action 14
5.6. Preventive action 14
5.7. Internal Audits 14
5.8. Management Review 14
6. HUMAN RESOURCES 15
6.1. Personnel associated with the accreditation body 15
6.2. ENAO Contractors- Personnel involved in the accreditation process 15
6.3. Monitoring 16
6.4. Personnel Records 16
7. ACCREDITATION PROCESS 16
7.1. Accreditation criteria and information 16
7.2. Application for accreditation 17
7.3. Resource review 17
7.4. Subcontracting the assessment 17
7.5. Preparation for assessment 17
7.6. Document and record review 17
7.7. On-site assessment 18
7.8. Analysis of findings and assessment report 18
7.9. Decision-making and granting accreditation 18
7.10. Appeals 18
7.11. Reassessment and surveillance 18
7.12. Extending accreditation 19
7.13. Suspending, withdrawing or reducing accreditation 19
7.14. Records on CABs 19
7.15. Proficiency testing and other comparisons for laboratories 19
7.16. Transition of revised or changed standards 19
8. RELATIONS BETWEEN ENAO AND THE ACCREDITED CAB 20
8.1. Obligations of the CAB 20
8.2. Obligations of ENAO 20
8.3. Reference to and use of ENAO accreditation Symbol 20
Annex A: Checklist Cross-reference Compliance to ISO/IEC17011 20
1 PURPOSE AND SCOPE
The purpose of this Policy manual is to establish and outline General policies which give direction for ENAO Management System, and describes Quality Management system established, implemented and maintained for the operation of Accreditation activities of Ethiopian National Accreditation Office according to the requirements of ISO/IEC 17011,ILAC/IAF/AFRAC and national laws.
This Policy manual is applicable to all ENAO Management system, staff, accredited/ applicant CABs, stakeholders and to any person or committee who involved in accreditation activities.
This manual, along with the procedures and instructions therein mentioned, forms the basis for the participation of ENAO in multilateral agreement with analogous accreditation bodies.
2 REFERENCES AND ACRONYMS
The following documents are referenced:
ISO/IEC 17011, Conformity Assessment – General requirements for accreditation bodies accrediting conformity assessment bodies;
ILAC/IAF A2: Requirements and Procedures for Evaluation of a Single Accreditation Body
IAF/ILAC-A5:11/2013 IAF/ILAC Multi-Lateral Mutual Recognition Arrangements (Arrangements):
Regulation No. 195/2010, Council of Ministers Regulation to provide for the establishment of the Ethiopian National Accreditation Office
Regulation No. 279/2012, Council of Ministers Regulation to Provide for Re-establishment of the Ethiopian National Accreditation Office
CAB: Conformity assessment body.
ENAO: Ethiopian National Accreditation Office
IAF: International Accreditation Forum
ILAC: International Laboratory Accreditation Cooperation
AFRAC: African Accreditation Cooperation
PR: Public Relation
HRD: Human Resource Development
3 RESPONSABLITY
It is the responsibility of top management or top management representative to establish, communicate, implement and managing this policy. All staffs of ENAO are also responsible for the implementation of this policy manual in their daily accreditation activities.
4 ACCREDITATION
4.1 Legal responsibility
The Ethiopian National Accreditation Office (ENAO) is a Federal accreditation body of CABs in Ethiopia with legal entity established by the Council of Ministers Regulation No. 195/2010 and later revised and re-established by Regulation No. 279/2012.
Mission Vision and Core value of ENAO
Mission:
To provide credible accreditation service for conformity assessment bodies
Vision:
To become an internationally recognized accreditation centre by 2012 E.C
ENAO’s Core values are:
Competence
Impartiality
Transparency
Non discrimination
Accountability
Liability
4.2 Structure
4.2.1. ENAO is structured and organized in order to ensure its operations safeguard the objectivity, confidentiality and impartiality of its activities hence providing confidence in its accreditation services. See the organ gram below:
Ethiopian National Accreditation Office organizational structure
Note: Accreditation team in ENAO operational structure and responsible for all accreditation activities in respective team is different from assessment team responsible for the assessment of specific CABs. And also Accreditation team leader is responsible for all accreditation activities in respective accreditation team where as Assessment team leader is a registered lead assessor responsible for managing and controlling the assessment of specific CABs only during assessment dates.
4.2.2. ENAO is established as a Government entity. The office has a Council of Accreditation. The Council has members not more than 13 in number, including the Chairperson, to be drawn from the relevant government bodies, private sector and associations and will be appointed by the Government. To avoid domination, the members of council have to be selected from different organizations or secretors. The council of Accreditation was selected from the following organizations Ministry of Science and Technology (chair man), Trade association, Ethiopia industry association, Drug & health administrative and control, Higher Education Relevance and quality agency, Ministry of Agriculture, Trade Competition and Consumer Protection Authority of Ethiopia, Ministry of Industry, Ministry City infrastructure & construction, and Ethiopian National Accreditation Office Director General (secretary).
The Council has powers and duties to:
· Review and approve accreditation policies, and strategies developed by ENAO.
· Consider policy and strategic issues raised by stakeholders relating to accreditation and advise the Director General accordingly.
· Ensure the maintenance of good governance in the office of ENAO by:
- Acting as the last resort for appeals from ENAO clients;
- Protecting the principles of impartiality and non-discrimination by ensuring a balanced representation of interested parties on the Council, with no single part dominating,
· Where necessary, provide support in attaining resources for fulfillment of ENAO’s mandate and to lobby support for accreditation as a means to facilitating trade.
· Submit for approval of the government the rate of fees to be charged for the services of the ENAO.
In addition to the accreditation Council ENAO has a public Wing forum in which the interested parties involved in accreditation activities with members Private Health Sector Association, Ethiopian Testing Laboratory Association, Inspection Body Association, National Metrology Institute (NMI), Ethiopia industry association, Food, Medicine and Health Care Administration and Control Authority (FMHACA), Higher Education Relevance and Quality Agency, Ministry of Agriculture, Ethiopian Institute for Agricultural Research, Trade Competition and Consumer Protection Authority of Ethiopia, Ethiopian Commodity Exchange (ECX), Ministry of Industry, Ministry of construction, Ministry of Environment & Climate Change, chambers of Commerce, Ministry of Education, Ministry of Labor and Social Affairs, Ministry of Water, Electric and Irrigation, Ministry of Energy, Mines& Fuel, Ministry of science and Technology, Ministry of Justice, Ministry of Livestock and Fishery Development, and Ethiopian Public Health Institute, to have saying on the accreditation strategic plan, and annual plan and risk associated among ENAO and related bodies to ensure the plan accommodates their accreditation needs, provide feedback for the implementation of the plan, ensure risks are identified and mitigated on annual bases.
The risk analyzer committee consists of five members three from ENAO staff (Accreditation Director, Quality Manager and one of the team leaders), and two from interested parties (one from Private organization and one from government) will be established for the identification of draft related bodies, risks from those related bodies and action shall be taken for the mitigation of these risks and presenting this draft to the public wing for effective participation these interested bodies.
ENAO is composed of two (2) functional units.
The first functional unit is the core or the technical function which comprises the Accreditation Directorate which is responsible to deliver the accreditation service as per the accreditation process (P07.0) and the Quality Manager responsible for establishment of system based on ISO/IEC 17011 and relevant ILAC/ IAF/AFRAC requirements the maintenance and implementation of the system and audit the effectiveness of the system against ISO/IEC 17011, relevant ILAC/ IAF/AFRAC requirements and ENAO systems. Both Accreditation Directorate Director and Quality Manager Report to Director General.
The second functional unit consists of five support sub-units responsible for Information and Communication Technology, Human Resource Development and Administration, Public Relation and Communication, Internal Audit service (Finance Audit), and Finance and Supply Administration . These units also report directly to the Director General.
4.2.3. According to the regulation, ENAO is established as a Federal Government entity and recognized as a national accreditation body. ENAO accredits laboratories, certification bodies, inspection bodies and verification bodies to relevant International standards.
ENAO is also responsible to provide recognition service to foreign conformity assessment bodies that wish to operate in the country. ENAO operates accreditation schemes in both the conformity and regulatory sector. Accreditation is open to any organization that carries out any function for which ENAO accredits regardless of size of the applicant organizations, its membership or the number of organizations already accredited.
ENAO is located in Addis Ababa, with the following address:
Ethiopian National Accreditation office (ENAO)
P.O. Box 3898
Gulf Aziz Building,
Bole sub city, Addis Ababa
Ethiopia
Tel. (251 - 118) 302469,
E-mail:
Website: www.enao-eth.org
4.2.4. ENAO documents the duties, responsibility and authorities of top management and other personnel associated with ENAO who could affect the quality of the accreditation. Refer Job Descriptions.
4.2.5. ENAO has identified the top management having overall authority and responsibility for each of the following:
4.2.5.1. Formulation of policy relating to the operation of the accreditation schemes including the procedures of ENAO and ensuring that the services offered by ENAO are independent, impartial and free from any bias.
4.2.5.2. Review the financial status to ensure financial independence of the office. Review includes proposing the fee structure and financial statements of the office.
4.2.5.3. The Accreditation Council shall formulate an Ad-hoc appeal committee which haven’t been involved in the activity under consideration and have the knowledge on that particular issue where adverse decisions taken by the Office and the council gives final decision.
4.2.6. ENAO has a procedure for appointment, terms of reference and operation of committees that are involved in the accreditation process.
4.3 Impartiality
4.3.1. ENAO has organized and operated in the way safeguard objectivity and impartiality. The objectivity and impartiality of accreditation programs defined and updated by ENAO is preserved because they are based on:
Ø International standards and other normative documents relating to accreditation;
Ø Any other document from ILAC and IAFs;
Ø Requirements for ENAO staff (qualification and experience, duty and responsibility considering the administrative code, to exercise any action or any activity that could jeopardize their independence and integrity) had developed and endorsed within Ministry of Civil Service, ENAO shall ensure that the principles of impartiality and non-discrimination are upheld within its Committees (Accreditation decision, Advisory etc.) to protect the integrity of the system. These principles shall as a minimum include:
Ø ENAO shall select members of committee different organizations without compromising their experience, skill and educational qualification ENAO formulated to ensure that no one interest dominates the committee;
Ø Have no conflict of interests, to minimize and control bias in advice and decision making;
Ø All personnel involved in accreditation activity shall possess the relevant competencies required
Ø All personnel involved in accreditation activity are declaring any actual or perceived commercial, financial, or other pressures that could influence the accreditation process.
Ø ENAO has not provided consultancy, nor suggest the use of consultants, nor participate in or offer any activities that it accredits other organizations to perform;
Ø ENAO has complaints and appeals procedure in case objectivity and impartiality problem existed and identified.
4.3.2. ENAO shall ensure the equitable representativeness of the Council, Technical Advisory Committee, Accreditation Approval Committee and others without any predominance of interest within the committees.
The assessors’ objectivity is defined in the code of ethics. The assessors will be independent of the bodies they assess. All Assessors, AAC members, technical advisory committee members shall sign contractual activity agreement (F07/02) and all council members shall sign F04.3/01 for impartiality, conflicts of interest, non discrimination and confidentiality.
4.3.3. ENAO puts its services at the disposal of all bodies which application meets the activities and the limits defined in the policy and other documents. The access to accreditation is not influenced by the size of the CAB or by the link to an association or a group. Accreditation doesn’t depend on the number of laboratories or organizations already accredited by ENAO. Policy document PM8.2 Obligations of ENAO elaborates further on impartiality and non-discriminatory mechanisms that have been established within ENAO to ensure that these principles become institutionalized. The discrimination in the assessors, expertise and AAC members managed as specified in section 4.3.1 and by singing of the agreement of non-discrimination (F07/02 Contractual Activity Agreement) with any personnel involved in accreditation activities.
4.3.4. As shown by the organizational chart of ENAO (see clause 4.2.1), ENAO is operating independently. It has its proper management system based on the standard ISO/IEC 17011, its own staff, its own logo and it administers its own expenses and incomes.
All ENAO personnel and committees that involved and could influence the accreditation process (such as assessment, accreditation decision etc.) shall act objectively and shall be free from any undue commercial, financial and other pressures that could compromise impartiality and also such personnel and committees members shall sign F07/02 Contractual Activity Agreement.
4.3.5. The person(s) or committee(s) involved in accreditation decision shall be competent and shall be different from those who carried out the assessment or involved in assessment activities
4.3.6. Apart from the general information concerning accreditation, the criteria and procedures concerning the accreditation system, ENAO prohibits itself to give consultancy and to offer conformity assessment services.
4.3.7. ENAO Related bodies