ENAO will offer accreditation services on a national basis, and international basis when needed, enabling MoST to reach globally accepted Mutual Recognition Arrangements (MRA) on the validity of certificates/reports issued by their Laboratories, Inspection Bodies, Certification Bodies and other related services.
ENAO's accreditation of CABs will be achieved through five stages:
i) Application and document review
All applications for accreditation will be accompanied by a quality manual detailing the organization's ability to meet the requirements of the relevant standard. ENAO will initially conduct a desk review of the documents submitted as part of verifying compliance. An on-site assessment will be scheduled once ENAO confirms that the applicant's quality system, as documented, addresses all the requirements of the relevant standard.
Prior to embarking on the formal accreditation process, organizations that seek accreditation, may request ENAO to conduct a pre-assessment to assess their readiness for accreditation. A pre-assessment is optional but advisable since it prepares the CAB for the Initial Assessment by identifying gaps between their current state of readiness and the relevant standard's requirements. These gaps can therefore be bridged, where relevant, prior to the initial assessment.
iii) Initial Assessment
Initial assessment is the on-site assessment of the organization's competence to perform the specific tasks for which they seek accreditation. The initial assessment covers all aspects of the organisation's relevant scope for which accreditation is sought. The ENAO approval structure will base its decision to grant or not grant accreditation, to a large extent, on the information gathered during this assessment.
iv) Surveillance assessment
After an organization has obtained accreditation, ENAO will conduct periodic surveillance assessments at intervals as set out in its policy and which conforms to ILAC and IAF requirements. The surveillance assessments are scheduled to cover a representative sample of the organizations full scope of accreditation.
A re-assessment will be conducted at the end of an assessment cycle. An assessment cycle is normally not more than 5 years and ENAO's cycle will be based on the limitations as set out in the "Combination of reassessment and surveillane as indicated in Figure 1.
Fig. 1: Assessment Cycle Options
ENAO will apply these services to accredit CABs against the following standards:
ISO/IEC 17020, General criteria for the operation of various types of bodies performing inspection
ISO/IEC 17021,Conformity assessment -- Requirements for bodies providing audit and certification of management systems
ISO/IEC 17025,General requirements for the competence of testing and calibration laboratories
ISO 15189,Medical laboratories -- Particular requirements for quality and competence
Initially, assessor training will focus on assessors for test and calibration CABs, including medical laboratories (ISO/IEC 17025 and ISO 15189), since this is the sector within which the bulk of CABs currently operate in Ethiopia. The target will be to develop a pool of at least 20 lead and technical assessors who are part-time asessors that can be contracted-in by ENAO when needed.
Suitably qualified assessors will be contracted-in for assessments of inspection and certification bodies as needed from ENAO's Twinning Partners until such time that economic conditions create a demand that justifies local training of such assessors. Such demand is estimated to reach sufficient levels in approximately three years and assessor training for inspection and certification bodies will commence prior to that time.