The Accreditation Process
This section provides a step-by-step guide through the key steps of the accreditation process.
1. Meeting and Application
Application forms, regulations, policies and technical guides can be downloaded from this website. It is recommended to hold a meeting prior to the submission of the application form. During this meeting, the application requirements and the accreditation process will be thoroughly explained, and the laboratory may also ask for any further clarifications. It is recommended that the key personnel responsible for leading the laboratory towards accreditation, including a representative from the management, are present for this meeting.
2. Document Review
The documents submitted by the applicant are assessed by the Team Leader and, where necessary, by the Technical Assessor/s or Technical Expert/s. This desk review helps to identify whether there is the need for further documentation or the need for a preliminary visit, to highlight any deficiencies in the system and to propose the final composition of the Assessment Team. A preliminary site visit is always recommended and the final decision as to whether such a visit will be carried out will be taken by the NAB-MALTA.
3. Preliminary Visit
The preliminary visit is particularly useful for the applicant as there will be better understanding of the accreditation process. It also helps the NAB-Malta in:
- determining whether the applicant conformity assessment body appears to be sufficiently prepared for an initial assessment.
- clarifying the scope of accreditation.
- preparing properly for the initial assessment including preparation of visit plan, determination of approximate duration of assessment and type of assessors required.
4. Assessment Team
The Assessment Team is selected according to the scope of accreditation as well as on the basis of the outcome of any preliminary visit. Collectively the team will have the competence to cover every aspect of the organisation’s operations.
All assessors pass a rigorous selection exercise and any external assessors sign an agreement covering both impartiality and confidentiality, since it is vital that any information gained during any assessment activity is kept confidential and assessors act in an impartial manner.
The result of the assessment and/or witnessing activity is a detailed report on the evaluation of the organisation highlighting any areas that require attention prior to the organisation being recommended for accreditation. The main purpose of the assessment is for the assessment team to gather objective evidence that, for the applicable scope, the laboratory conforms to the relevant accreditation scheme criteria.
The assessment begins with an opening meeting between the NAB-MALTA assessment team and the conformity assessment body representatives. The Team Leader will manage the assessment team so as to ensure that the assessment plan is completed, relevant activities are assessed and provide support and advice as necessary.
Nonconformities will be based on objective evidence and will be recorded and verified before assessors/experts leave the area under assessment. Nonconformities are recorded on form NABG10 “List of Findings”. The assessment ends with a closing meeting between the assessment team and the conformity assessment body representatives, during which each assessor presents a summary of the areas assessed.
6. Accreditation Board
The Board is responsible for granting, withdrawing, suspending or reducing accreditation. This decision is based on a report which is compiled following the outcome of the assessment activity. The Board may accept the request for accreditation either conditionally or unconditionally, may request further information, or may reject it. The NAB-MALTA will inform the CAB about the decision of the Board.
7. Scope of Accreditation
The scope of accreditation is a list of specific conformity assessment activities for which accreditation has been granted. Each scope carries a unique accreditation identification, together with the effective date of accreditation. This is publicly available from this website.
8. Accreditation Cycle
An accreditation cycle begins at or after the date of the decision for granting the initial accreditation or decision after reassessment and shall not be longer than five years. The NAB-MALTA shall apply an assessment programme for assessing the laboratory’s activities during the accreditation cycle, to ensure that the laboratory activities representative of the scope of accreditation at the relevant locations are assessed during the accreditation cycle. Assessments will normally take place at intervals of 12 months not exceeding 24 months.
The first scheduled assessment will normally take place 6 months after accreditation has been granted. Before the end of the accreditation cycle, a reassessment is planned and performed taking into consideration the information gathered from the assessments performed over the accreditation cycle.