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Policy Manual
Reviewed by: Araya Fesseha
Approved by: Mr. Mahamouda Ahmad Gaas
Position:
Position: Accreditation Council Chairman
Signature:
Director General
Signature:
CONTENTS:
1
PURPOSE AND SCOPE ........................................................................................................................................ 3
2
REFERENCES AND ACRONYMS ....................................................................................................................... 3
3
RESPONSABLITY ................................................................................................................................................. 3
4
5.
6.
7.
8.
ACCREDITATION................................................................................................................................................. 4
4.1
4.2
4.3
4.4.
4.5.
4.6.
5.1.
5.2.
5.3.
5.4.
5.5.
5.6.
5.7.
5.8.
6.1.
6.2.
6.3.
6.4.
Legal responsibility ..................................................................................................................................................... 4
Structure ......................................................................................................................................................................... 4
Impartiality .................................................................................................................................................................... 8
Confidentiality .............................................................................................................................................................. 9
Liability and Financing ........................................................................................................................................... 10
Accreditation Activity .............................................................................................................................................. 10
MANAGEMENT ............................................................................................................................................... 11
General Arrangements ............................................................................................................................................ 11
Management System ................................................................................................................................................ 11
Document Control ..................................................................................................................................................... 13
Records ......................................................................................................................................................................... 14
Non conformities and corrective action ........................................................................................................... 14
Preventive action ...................................................................................................................................................... 14
Internal Audits ........................................................................................................................................................... 14
Management Review ................................................................................................................................................ 14
HUMAN RESOURCES .................................................................................................................................... 15
Personnel associated with the accreditation body ....................................................................................... 15
ENAO Contractors- Personnel involved in the accreditation process.................................................... 15
Monitoring ................................................................................................................................................................... 16
Personnel Records.................................................................................................................................................... 16
ACCREDITATION PROCESS ........................................................................................................................ 16
7.1.
7.2.
7.3.
7.4.
7.5.
7.6.
7.7.
7.8.
7.9.
7.10.
7.11.
7.12.
7.13.
7.14.
7.15.
7.16.
8.1.
Accreditation criteria and information ............................................................................................................ 16
Application for accreditation................................................................................................................................ 17
Resource review ........................................................................................................................................................ 17
Subcontracting the assessment ........................................................................................................................... 17
Preparation for assessment .................................................................................................................................. 17
Document and record review ............................................................................................................................... 17
On-site assessment ................................................................................................................................................... 18
Analysis of findings and assessment report .................................................................................................... 18
Decision-making and granting accreditation ................................................................................................. 18
Appeals ..................................................................................................................................................................... 18
Reassessment and surveillance ....................................................................................................................... 18
Extending accreditation ..................................................................................................................................... 19
Suspending, withdrawing or reducing accreditation .............................................................................. 19
Records on CABs .................................................................................................................................................... 19
Proficiency testing and other comparisons for laboratories ................................................................ 19
Transition of revised or changed standards ............................................................................................... 19
RELATIONS BETWEEN ENAO AND THE ACCREDITED CAB............................................................. 20
Obligations of the CAB ............................................................................................................................................. 20
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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
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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.
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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 reestablished 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
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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
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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
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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: info@enao-eth.org
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.
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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:
 International standards and other normative documents relating to accreditation;
 Any other document from ILAC and IAFs;
 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:
 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;
 Have no conflict of interests, to minimize and control bias in advice and decision making;
 All personnel involved in accreditation activity shall possess the relevant competencies
required

All personnel involved in accreditation activity are declaring any actual or perceived
commercial, financial, or other pressures that could influence the accreditation process.
 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;
 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.
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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
Relationships with related bodies have the potential to compromise or create a perception of such
compromise of ENAO independence and impartiality and so that a potential damage to ENAO reputation, if
not managed properly. The management of this risk requires ENAO to have suitable “fire walls” in place.
ENAO may have various national relationships with other bodies either through common reporting or
others. ENAO shall identify these related bodies, the relation ENAO has with them, the risk raised from the
relation and the way how to mitigate such risks at least annually by involving the interested parties (the
public Wing) from different organization from both private and government sectors as specified in clause
4.2.2 of this manual by using F04.3/03 (ENAO Related Bodies Identification And Risk Analysis Form). The
effectives of the action taken for the mitigation of the risks identified will be checked through internal audit
and management review and the result will be presented for the public Wing.
4.4. Confidentiality
ENAO shall maintain a high level of confidentiality in its operations. Any person or committee involved in
any ENAO activities shall sign confidentiality agreement (i.e. Accreditation council shall sign F04.3/1
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Council Member Duties, Assessors; experts and AAC members shall sign F07/02 contractual activity
agreement and ENAO staff shall sign F06/06 ENAO staff agreement and confidentiality). Any breach of
confidentiality will be viewed in a very serious manner and ENAO will use whatever remedies are available
to deal with such breach.
4.5. Liability and Financing
4.5.1.
ENAO provides its services in a competent and professionally reliable manner. It is also
responsible for breach of professional services provided that the breach has been made while the facility
is providing services in accordance with standard, legal and ENAO’s requirements and if it is conclusively
identified to be due to negligence, error and/or omission of assessment team or AAC that leads adverse
effect on liability and/or accuracy of the result for which ENAO has ensured the risk to indemnify Up to birr
100,000 per facility according to law of insurance of the country. Therefore the affected party shall get
composition from the insurance company according to law of insurance of the country. The professional
insurance coverage covers duties of all technical staffs, assessors both internal and external and
accreditation approval committee members as specified on the accreditation agreement F08.1/01.
However ENAO is not liable for breaches resulting from failure to follow the accreditation requirements and
activities which are not in the scope of accreditation.
4.5.2. ENAO draws up on an annual basis its budgetary proposals for the operation of the accreditation
and administration which is forwarded to the Ministry of Economy and Finance. After examination of
the budgetary proposals sufficient budget will be allocated every year from the government treasury
for the operation of ENAO.
ENAO’s Finance and Property unit head is responsible for the
supervision of the ENAO finances. The other source of income of ENAO is from cooperative
partners. However the service fee for accreditation cannot be used by ENAO, it is collected by
ENAO from accredited and applicant CABs submit to government because of the law of the country.
4.6. Accreditation Activity
4.6.1. Standards and guides applicable to accreditation activities
The CAB accreditation is performed in accordance with international standards and other normative
documents as regards accreditation and any other documents from ILAC/IAF.
ENAO issues accreditation to:

Testing laboratories according to the standard ISO/IEC 17025, ILAC-P9:06/2014, ILACP10:01/2013, ILAC G9:2005, ILAC G24:2007, ILAC G17:2002, ILAC G19:08/2014, ILAC G22:2004

Calibration laboratories according to the standard ISO/IEC 17025, ILAC-P9:06/2014, ILACP10:01/2013, ILAC G9:2005, ILAC G24:2007, ILAC G17:2002, ILAC G22:2004, ILAC P 14:/2013

Medical laboratories according to the standard ISO 15189 ILAC-P9:06/2014, ILAC-P10:01/2013,
ILAC G9:2005, ILAC G24:2007, ILAC G22:2004
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Inspection bodies according to the standard ISO/IEC 17020, ILAC P15;06/2014, ILAC-P9:06/2014,
ILAC-P10:01/2013, ILAC G9:2005, ILAC G24:2007, ILAC G19:08/2014, ILAC G22:2004

Certification bodies:
 management systems according to the standard ISO/IEC 17021,
 products certification according to the standard ISO/IEC 17065,
 persons according to the standard ISO/IEC 17024.
4.6.2. Adopt application or guidance documents
When ENAO adopt application or guidance documents and/or participate in the developments of these
application or guidance documents the persons or committees involved in the adoption or development
activities shall be take awareness training on the ISO/IEC17011, international standard requirements for
accreditation of specific scopes for which the documents is applied, accreditation policy and process, and
also has skill, knowledge and experience in the relevant fields as specified on the accreditation process
P07.0. Clause 16
4.6.3. Extension to new areas of accreditation
Each extension to new areas of accreditation of ENAO is subject to a preliminary analysis, based on the
demand driven ensure through preliminary information assessment. If the extension to new areas makes
new requirements necessary (standards, applicable guides) ENAO organizes the training of its personnel
and of the members of the Accreditation Approval Committees.
Before proceeding to accreditation assessments on new areas ENAO must ensure the availability of all
necessary documents (standards, guides, etc).
ENAO may recruit assessors from other accreditation bodies in case of unavailability of specific assessors
locally.
5.
MANAGEMENT
5.1.
General Arrangements
ENAO has established and implemented a management system, as outlined in this manual. It maintains
the management system and continuality improves its effectiveness through the use of internal and
external audits, management review, corrective and preventive actions, and customer feedback.
5.2.
Management System
5.2.1. General
The executive Management of ENAO is committed to provide the resources required for implementing and
sustaining the quality system and committed to continuously improve the effectiveness of management
system.
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ENAO will provide service to the satisfaction of its customer in accordance with international standards. It
is committed to provide equal opportunity to the all applicants with the highest regard to transparency
integrity, and confidentiality.
ENAO’s top management is committed to ensure effective communication to assessors and customers
using various methods and to evaluate its effectiveness through management review.
ENAO will strive for international recognition of its accreditation schemes through international forums like
ILAC and IAF. Where relevant ENAO encourages the participation of its stakeholders representing industry,
commerce and academia.
The above said policy is pursued by complying to ISO/IEC 17011 and other relevant international standards
and applicable ILAC/IAF documents
5.2.2. Policy Statement and Objectives
Policy Statement
ENAO Top Management and all staff are committed themselves for the implementation of ISO/IEC 17011,
ILAC, IAF, AFRAC and national mandatory requirements. The implementation of the requirements will be
the basis for attaining the objectives set by top management. ENAO shall continually improve both the
quality and scope of its service to satisfy the needs of its stakeholders and customers. ENAO is also
committed to provide equal opportunity to all the applicants with highest regard to transparency, integrity,
impartiality, confidentiality, accountability and responsible for liability.
Therefore, ENAO top Management require all personnel to read, understand and implement the policy of
this organization so that all our efforts can be directed towards achieving our objectives.
Objectives
The main objectives of ENAO are: Contribute its part for acceptance and appreciation of Ethiopian products and services in the
domestic and international markets by developing appropriate infrastructure of national accreditation
system compatible with international requirements
 Establish and implement accreditation system which allows locally provided conformity assessment
service to be recognized internationally.
The specific objectives of ENAO are:
To continually improve its process of accreditation in line with international improvements
and to foster improvement in the quality Conformity Assessment Bodies

To ensure nondiscriminatory, impartial and equally accessible service delivery with the
involvement of interested parties.

To seek mutual recognition of the accreditation schemes internationally and regionally

Providing awareness to Regulatory and Customers reduce the need for multiple assessments.

To improve the number and the competence of the assessors and experts involved in
accreditation activities
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To improve the customers satisfaction
5.2.3. Responsibilities
Each person within ENAO has the responsibility for ensuring that ENAO continues to comply with the
requirements of its documented management system.
The Director General of ENAO has overall responsibility for the ENAO management system, its
implementation and maintenance.
Each person within ENAO and contracted assessors have a responsibility to read and understand the
processes and procedures of ENAO. The Quality Manager reports to Director General on the performance
of the management system within ENAO at least at monthly intervals.
5.2.4. ENAO’s documentation system
ENAO’s documented system is fully described in P05.3 Document Control process. The documentation
consists of the following categories:
a) Policy document
b) Procedure/Process
c) Requirement
d) Job description
e) Guidance document
f)
Advisory document
g) Forms
5.3.
Document Control
ENAO will develop, review, maintain and control all documentation in accordance with P05.3 (Document
control procedure). This procedure will indicate the documentation to be controlled, how and when activities
in the documentation process must be carried out and the responsibilities of the various personnel involved
in the control of the documentation.
The Quality Manager shall ensure that only current valid versions of documents are made available to all
staff internally and together with ICT service head on the ENAO website www.enao-eth.org. It shall remain
the responsibility of all staff, assessors, experts, AAC members; accredited facilities, stakeholders and
interested parties to ensure that they use only the current versions of documents, and destroy all replaced
or changed documents.
For international standards, requirements, Guidance and national mandatory requirements it will be the
responsibility of each accredited / applicant conformity assessment body (CAB) to ensure that it has the
most recent issue of the international standard/ requirements/ guide applicable to its area of accreditation
and / or the national equivalent. This will include all IAF/ILAC/AFRAC guidance and mandatory documents
on the above guides and standards where relevant. The respective team leader has the responsibility for
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follow up of the implementation. The hierarchy of ENAO documentation is addressed in P05.3 clause The
documents used by accredited/ Applicant CABs shall be released on ENAO website for specified period of
time during development and review for comment.
5.4.
Records
ENAO shall control all records in accordance with procedure P05.4 (ENAO Records Procedure), which will
define the responsibilities and procedures for the identification, collection, indexing, accessing, filling,
storage, maintenance, retention and disposal of records.
ENAO will also ensure that all records are held in a secure and confidential manner and that access is
controlled in accordance with procedure P05.4 (ENAO Records Procedure).
5.5.
Non conformities and corrective action
ENAO shall identify and manage the nonconformities occur in its own operation according to P05.5 Non
conformities and corrective action procedure. It shall be the responsibility of all staff and contracted
personnel to identify nonconformities, and report to Quality Manager who assign the nonconformities
identified to relevant personnel or function to take corrective action.
5.6.
Preventive action
ENAO shall identify and manage opportunities for improvement in its own operation and to take preventive
actions to eliminate the causes of potential non-conformities according to P05.6 Preventive Action and
Continual Improvement procedure. It shall be the responsibility of all staff and contracted personnel to
identify opportunities for improvement, and report these to the Quality Manager to allow relevant function to
implement processes that assist in preventing a potential non-conformance.
5.7.
Internal Audits
ENAO shall conduct internal audit of all its system that covers all its scopes at least once annually
according to P05.7 (internal audit procedure) to confirm continued compliance to all the requirements of
ENAO Management System, ISO/IEC 17011 and the mandatory requirements of ILAC / IAF / AFRAC, and
to ensure an effective and efficient implementation of ENAO policies and procedures. The frequency can
be increased taking into consideration the importance of the processes and areas to be audited, as well as
the results of previous audits.
Regarding to finance audit it will be conducted according to finance audit laws of the country (Ministry of
finance and economy Cooperation requirements)
5.8.
Management Review
ENAO shall conduct management review at least once annually according to P05.8 (management review
procedure) to review its management system at planned intervals to ensure its continuing adequacy and
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effectiveness in satisfying the relevant requirements, including this International Standard ILAC / IAF /
AFRAC mandatory requirements, national mandatory requirements and the stated policies and objectives
of ENAO.
5.9.
Complaints
ENAO shall receive, validate and investigate or analysis and where required take appropriate
corrective/preventative actions for compliant against its staff, Assessors/experts, AAC members, accredited
CABs according to P05.9 (Compliant handling procedure)
6. HUMAN RESOURCES
6.1.
Personnel associated with the accreditation body
ENAO has a sufficient number of competent personnel such as (internal, external, temporary or permanent,
full time or part time) having the necessary education, training, technical knowledge, skills and experience
necessary to carry out the work. The qualification experience and training required for ENAO personnel are
defined in P06.0 Human Resources and job descriptions (JDs). The lists of assessors and their scope of
competence is detailed in the F06/13 and F06/14
ENAO ensures that the staff and contracted assessors act objectively and are free from any Commercial,
financial and other pressures that could affect impartiality. These are done through the initial evaluation,
monitoring, feedback and suitable undertakings. ENAO requires all personnel to commit themselves
formally by a signature or equivalent to comply with the rules defined by ENAO and Assessor Code of
conduct as it is specified in R/06. Persons involved in ENAO accreditation activities must have a signed
conflict of interest and confidentiality statement with ENAO prior to providing service to ENAO, F07/02
Contractual Activity Agreement.
6.2.
ENAO Contractors- Personnel involved in the accreditation process
ENAO contracts on a need basis a number of qualified (competent) assessors and expertise who involved
in accreditation process for assessment, decision on accreditation and advisory.
The qualification,
experience, knowledge, personal attributes, competence, initial and ongoing training required, selecting,
formally approving assessors and experts and their responsibility is defined in P06.0 Human Resources
and job descriptions (JDs). The lists of assessors and their scope of competence is detailed in the F06/12
and F06/13
ENAO has two levels of assessors; these are lead and technical assessors. The Technical assessors are
required to be subject specialists and shall be technically qualified in the specific field or closely related
one.
ENAO also uses technical experts at times and these are qualified in the same manner as technical
assessors, except that they have not been trained as assessors and they are accompanied by qualified
ENAO assessor. The role of technical expert is to provide technical support to the technical assessor for
specific scope for which the assigned expert is registered as expert. The assessment is conducted by the
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assessor but the expert give only the technical support. Lead assessor shall have lead assessor attributes,
conducting the management system part of the CABs and managing or leading the assessment team.
ENAO ensures that the staff and contracted assessors act objectively and are free from any Commercial,
financial and other pressures that could affect impartiality. These are done through the initial evaluation,
monitoring, feedback and suitable undertakings. ENAO requires all personnel to commit themselves
formally by a signature or equivalent to comply with the rules defined by ENAO and Assessor Code of
conduct as it is specified in R/06. Persons involved in ENAO accreditation activities must have a signed
conflict of interest and confidentiality statement with ENAO prior to providing service to ENAO, F07/02
(Contractual Activity Agreement) for their commitments of fulfilling ENAO rules.
6.3.
Monitoring
Assessor’s conduct, depth of expertise and consistent interpretation and application of the
relevant
Standard/Guides used, contributes largely to the image and reputation of ENAO. In order to provide ENAO
with reasonable assurance that ENAO’s assessors fulfil the required level of professionalism, competence
and technical expertise and to allow ENAO an opportunity to identify appropriate follow-up actions to
improve performance where necessary, ENAO shall monitor of all its assessors. Feedback arising out of
any such monitoring shall be recorded, included in the assessor personal file and action shall be taken
where necessary. Responsibilities and procedures for the monitoring of assessors are defined in P06
Human Resource Procedure Personnel Records.
6.4.
Personnel Records
ENAO shall maintain the personal records for all staff members, contracted personnel and committee
members. Responsibilities and procedures for controlling the records are defined in P06 Human Resource
Procedure and P 5.4 Records procedure.
7.
ACCREDITATION PROCESS
7.1.
Accreditation criteria and information
ENAO shall provided accreditation according to GD 7.0 Accreditation Criteria for Conformity Assessment
bodies which include international standards and ILAC/IAF/AFRAC mandatory requirements, Guidance and
also National mandatory requirements.
ENAO shall make publicly available, and update at intervals detailed information about its assessment and
accreditation processes, requirements for accreditation, about fees relating to the accreditation; the rights
and obligations of CABs; the accredited CABs ,on procedures for lodging and handling complaints and
appeal, about the authority under which the accreditation program operates; description of its rights and
duties; financial support; about its activities and about the related bodies.
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Application for accreditation
ENAO shall request applicant CABs to apply for accreditation by using ENAO F07/01A… application for
accreditation. ENAO shall review the application and associated information and documentation for
adequacy the information supplied by the CAB as per to F07/18. The time line rule of ENAO for the
accreditation process starts from the completion of application requirement by CABs.
7.3.
Resource review
ENAO shall review its ability (the resource it has) to carry out the assessment of the applicant CAB, in
terms of its own policy, its competence and the availability of suitable assessors and experts including its
ability to carry out the initial assessment in a timely manner according to P07.0 (accreditation Processes
before accepting the request of the applicant CAB.
7.4.
Subcontracting the assessment
ENAO’s policy is not to sub-contract assessments to other accreditation bodies. Should this policy be
reviewed in the future based on the need to sub-contract then this document will be revised accordingly.
Note: ENAO’s business model is based on contracting individual assessors that have been trained and
registered by it or that have been trained and registered by an ILAC/IAF/AFRAC approved accreditation
body. This practice is not considered sub-contracting of assessments.
7.5.
Preparation for assessment
ENAO can be performed pre-assessment visit at the request of the CAB. This is an optional activity of the
accreditation process, which is encouraged by ENAO. The extent and length of the pre-assessment is
depend on the size and complexity of the CAB, however it shall not exceeds more than two days and the
quotation for the visit will have been included in the formal quotation issued to the CAB. ENAO shall make
the Assessors or any personnel that involved in such activities to sign F07/02 (Contractual activity
agreement form) to avoid consultancy during such activities.
ENA shall provide for the applicant CAB the opportunity to object to a member(s) of an assessment team,
however, shall only consider objection of assessors if there is a conflict of interest and economical issues
based on objective evidence and get acceptance by ENAO.
7.6.
Document and record review
ENAO shall review all relevant documents and records supplied by the CAB during application as per
F07/01… to evaluate its system, as documented, for conformity with the relevant standard(s) and other
requirements for accreditation and report to applicant CAB with recommendation to proceed or not proceed
on-site assessment according to P07.0 clause 6.
Preliminary on site visit should be done by ENAO relevant personnel to gather adequate evidence to
ensure the readiness of the applicant CAB for onsite assessment, proper planning of assessment and
resource allocation when required.
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On-site assessment
ENAO shall conduct the assessment of the conformity assessment services of the CAB at the premises of
the CAB from which one or more key activities are performed and, where relevant at other selected
locations, to gather objective evidence that the applicable scope the CAB is competent and conforms to
ENAO accreditation criteria. ENAO shall also witness the performance of a representative number of staff
of the CAB to provide assurance of the competence of the CAB across the scope of accreditation. The
initial on site assessment will be conducted according to P07.0 (ENAO accreditation processes) clause 10
and R07.0 (ENAO Timeline Rule) for the time management of corrective action to the nonconformities
identified during the assessment.
7.8.
Analysis of findings and assessment report
ENAO shall analyze all relevant information and evidence gathered during the document review and the
on-site assessment, and report to applicant CAB according to P07.0 (ENAO accreditation processes)
7.9.
Decision-making and granting accreditation
Decisions on awarding of accreditation could have an adverse effect on ENAO, its clients and their
customers. Therefore ENAO shall not subcontract any such decisions. The decision for accreditation made
by AAC (Accreditation approval committee) which consist at least three members who have no
involvements in assessment and chaired by Director General of ENAO. The final decision of accreditation
is only the decision of the Director General of ENAO. The decision for accreditation will conducted
according to P07.0 (ENAO accreditation processes procedure) clause 11 and R07.0 (ENAO Timeline Rule)
for the time management of the decision.
7.10.
Appeals
ENAO shall receive, validate and investigate or analysis and where required take appropriate
corrective/preventative actions for appeals against its adverse decision according to P07.0. clause15
(Appeals handling procedure)
7.11.
Reassessment and surveillance
ENAO shall conduct surveillance assessment at sixth month of the accreditation granting decision for the
first surveillance then every year of first surveillance for the accreditation cycle according to ENAO
accreditation process procedure (P07.0). In addition to the planned assessments, ENAO will reserve the
right to carry out extraordinary (unscheduled) visits, in order to follow up on the investigation and resolution
of a complaint against a facility, or to follow up on significant changes relevant to the accreditation of the
facility that may have an effect on their accreditation status. The cost of unscheduled surveillance shall be
borne by ENAO.
The accredited CAB shall apply for reassessment before six months of the expire date of the accreditation
certificate. ENAO shall establish new assessment team for reassessment. The reassessment will be
conducted according to P07.0 (ENAO accreditation processes procedure) clause 12 and R07.0 (ENAO
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Timeline Rule) for the time management of corrective action to the nonconformities identified during the
reassessment.
7.12.
Extending accreditation
ENAO shall response to an application for an extension of scope of an accreditation already granted by
undertaking the necessary activities to determine whether or not the extension may be granted according to
P07.0 (ENAO accreditation processes procedure) clause 13
7.13.
Suspending, withdrawing or reducing accreditation
Decisions on suspending, withdrawal, reducing and re-instating accreditation could have an adverse effect
on ENAO, its clients and their customers. Therefore ENAO shall not subcontract any such decisions. These
decisions for accreditation will be conducted according to P07.0 (ENAO accreditation processes procedure)
clause 14
7.14.
Records on CABs
ENAO shall maintain records on CABs to demonstrate that requirements for accreditation, including
competence, have been effectively fulfilled in secure confidentiality according to P05.4 ENAO records
procedure.
7.15.
Proficiency testing and other comparisons for laboratories
All Applicant and accredited laboratories, and where applicable, Inspection Bodies, shall provide ENAO
with sufficient evidence of participation in PT activities at least once every year. In cases of testing ,
calibration or Inspection(where relevant) for which suitable PT does not exist or it is not practical to
participate in PT with documented evidences the CAB can be use other alternative (such as inter-laboratory
comparison, use of CRM, use of in house prepared reference material) in place of PT participation. For
those scopes which are not possible to get PT, CRM and other laboratory performing similar activity for
inter comparison then intra comparison or other alternative can be used by the CAB with documented
evidence of the absence of the above mentioned alternatives should be verified by ENAO to consider the
intra comparison arrangements. ENAO also request applicant CABs to develop and maintain a five (5)
years Plan for PT Participation or alternatives covering all the major fields for which it intends to be, or is,
accredited. The evaluation of PT or its alternatives will be conducted according to P07.0 (ENAO
accreditation processes procedure) clause 18
7.16.
Transition of revised or changed standards
Transition period of revised standards: The transitions of revised standards preferably plan to be in line with
surveillance time considering the transition time to happen before expire date.
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8. RELATIONS BETWEEN ENAO AND THE ACCREDITED CAB
8.1.
Obligations of the CAB
ENAO shall request the applicant CABs to sign Accreditation Agreement (F08.1) to meet the obligation
set by ENAO to be accredited and so as to avoid future misunderstandings and possible litigation. The
obligations of the CAB accredited by ENAO are formalized in the following document: P 08.1 Obligations of
the CAB and F08.1 (ENAO accreditation agreement form).
8.2.
Obligations of ENAO
ENAO shall have an obligation to its stakeholders to provide accreditation services based on objective
evaluation in competent, transparent an impartial and non-discriminatory manner. ENAO shall also be
accountable and liable for its accreditation service provided to its client. The obligations of ENAO are
formalized in the following documents: P 08.2 Obligations of the Accreditation Bodies. Policy from PM08.2
8.3.
Reference to and use of ENAO accreditation Symbol
ENAO accreditation symbol and the ENAO ILAC / IAF combined marks confirms an organization’s
competence, thereby providing a level of confidence to the market. The accreditation symbols and marks
can be subject to misuse or misrepresentation and thereby could adversely impact on the integrity of ENAO
and accreditation. Therefore to protect this ENAO has established a detailed procedure for reference to
and use of ENAO accreditation Symbol in the R/8.3, ENAO ILAC, IAF and AFRAC combined
marks and
also we will take appropriate legal action in instances where there is misuse, misrepresentation or abuse of
the symbols and marks or where reference to accreditation is not in accordance with ENAO policy.
Annex A: Checklist Cross-reference Compliance to ISO/IEC17011
Clause
ISO/IEC 17011
4
4.1
4.2
4.3
4.4
4.5
4.6
5
5.1
5.2
5.3
5.4
5.5
5.6
5.7
Accreditation body
Legal responsibility
Structure
Impartiality
Confidentiality
Liability and financing
Accreditation activity
Management
General
Management system
Document control
Records
Nonconformities and corrective actions
Preventive actions
Internal audits
Policy
Clause
Manual
PM 04 Clause 4.1
PM 04 Clause 4.2
PM 04 Clause 4.3
PM 04 Clause 4.4
PM 04 Clause 4.5
PM 04 Clause 4.6
PM 04 Clause 5.1
PM 04 Clause 5.2
PM 04 Clause 5.3
PM 04 Clause 5.4
PM 04 Clause 5.5
PM 04 Clause 5.6
PM 04 Clause 5.7
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Policy Manual
5.8
5.9
6
6.1
6.2
6.3
6.4
7
Management reviews
Complaints
Human resources
Personnel associated with the accreditation body
Personnel involved in the accreditation process
Monitoring
Personnel records
Accreditation process
7.1
Accreditation criteria and information
Application for accreditation
7.2
7.3
7.4
7.5
7.6
7.7
7.8
7.9
7.10
7.11
7.12
7.13
7.14
PM 04 Clause 5.8
PM 04 Clause 5.9
PM 04 Clause 6.1
PM 04 Clause 6.2
PM 04 Clause 6.3
PM 04 Clause 6.4
PM 04 Clause 7.0
PM 04 Clause 7.1
PM 04 Clause 7.2
Resource review
PM 04 Clause 7.3
Subcontracting the assessment
PM 04 Clause 7.4
Preparation for assessment
PM 04 Clause 7.5
Document and record review
PM 04 Clause 7.6
On-site assessment
PM 04 Clause 7.7
Analysis of findings and assessment report
PM 04 Clause 7.8
Decision-making and granting accreditation
PM 04 Clause 7.9
Appeals
PM 04 Clause 7.10
Reassessment and surveillance
PM 04 Clause 7.11
Extending accreditation
PM 04 Clause 7.12
Suspending, withdrawing or reducing accreditation
PM 04 Clause 7.13
Records on CABs
PM 04 Clause 7.14
7.15
Proficiency testing
laboratories
and
other
comparisons
for PM 04 Clause 7.15
8
8.1
8.2
8.3
Responsibilities of ENAO and the CAB
Obligations of the CAB
Obligations of the accreditation body
Reference to and use of ENAO accreditation Symbol
PM 04 Clause 8.1
PM 04 Clause 8.2
PM 04 Clause 8.3
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Date approved
Revision History
2013-06-01
Amend Clause 4.1 to indicate regulation No 195/2010 was
Revision No.
1
revised and replaced by regulation No 279/2012.
Update the Organogram in Clause 4.2.1 to include the Quality
Manager.
Update the description of the two functional units in Clause 4.2.2
to include the Quality Manager.
Correct the ENAO address in Clause 4.2.3.
Change the frequency of reporting to the DG by the Accreditation
Director from quarterly to monthly in Clause 5.2.2.
Amend Clause 4.6.1 bullet five, sub-bullet 2, to replace Guide 65
by ISO/IEC 17065.
2
2013-12-20
Clause 2 and 3 were revised to indicate responsible function or
person responsible
Clause 4.5 revised to indicate that the way how ENAO liable for
its accreditation activities
Clause 4.6.2 included to indicate that the way ENAO adopt
application or guidance documents.
Clause 5.2.2 revised to indicate that the Quality Manager is
responsible to report performance of the management system to
Director General at least at monthly intervals.
Clause 6.2 was revised to include assessor code of conduct in
contractual activity agreement
Clause 6.3 and 6.4 were included to address monitoring and
Personnel records policies
Clause 8.3 was included to address Reference to and use of
ENAO accreditation symbol policy
Clause 1 was revised to
Clause 2 was revised
Clause 4.3 was revised to make more clear how ENAO
3
2015-05-19
safeguard impartiality, administrate non- discrimination in its
decision and How ENAO identifies risk of impartiality with its
related bodies and mitigates those identified risks.
Clause 4.6.1 was revised to included the ILAC documents used
to accredit CABs
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Clause 5.2.2 was revised to set policy statement of ENAO and
make more clear ENAO objectives
Clause 5.4 was revised to change responsibility of keeping CBs
file from accreditation Director to respective team leader
Clause 6.1 was revised to address how ENAO record its lists of
its staff and assessors and how ENAO ensures that all assessors
act objectively and are free from any Commercial, financial and
other pressures that could affect impartiality
Clause 6.2 was revised to include the standard requirements in
the policy manual, how ENAO record lists of assessors and their
scope of competence and role of technical expert and lead
assessor during onsite assessment.
Clause 8.3 was revised to make more clear how to use ENAO
symbols and ILAC, IAF and AFRAC combined logos.
4
2015-05-19
Clause 4.1 was revised to include mission, vision and core values
of ENAO
Clause 4.2.1 was revised to make clear the organizational
structure of ENAO Function and to include ad hoc committees in
the organizational structure.
Clause 4.2.2 was revised to define the role of public wing and
their composition
Clause 4.3.7 was revised to make clear how the related bodies
and the risk associated with them identified.
Clause 5.2.2 was revised to more clear the policy statement and
objective of ENAO
Clause 5.3 was revised to more detail policy on document control
Clause 5.4 was revised to more detail policy on record control
Clause 5.5 was revised to more detail policy on Non conformities
and corrective action
Clause 5.6 was revised to more detail policy on preventive action
Clause 5.7 was revised to more detail policy on internal audit
Clause 5.8 was revised to more detail policy on management
review
Clause 5.9 was revised to more detail policy on complain
handling
Clause 7 was revised to more detail policy on accreditation,
Proficiency testing and other comparisons for laboratories and
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transition
Clause 8.1 was revised to include ENAO shall request the
applicant CABs to sign Accreditation Agreement (F08.1) to meet
the obligation set by ENAO to be accredited and so as to avoid
future misunderstandings and possible litigation.
Clause 8.2 was revised to include ENAO shall have an obligation
to its stakeholders to provide accreditation services based on
objective evaluation in competent, transparent an impartial and
non-discriminatory manner. ENAO shall also be accountable and
liable for its accreditation service provided to its client.
Annex A was revised to include accreditation process