Accreditation process


7.1. Accreditation Requirements

7.1.1. General Requirements for Accreditation

UNIVAB aims to achieve and maintain international recognition of all the accreditation schemes it operates. UNIVAB policy is therefore to accredit conformity assessment bodies that fully meet the requirements of the relevant international standard and/or normative documents and the appropriate ILAC/IAF guidance or interpretations thereof.

7.1.2. Accreditation Criteria

7.1.2.1. Testing/Calibration laboratories

The criteria which laboratories must comply with to obtain accreditation are contained in ISO/IEC 17025 and the appropriate UNIVAB requirement documents which include the appropriate ILAC criteria. Laboratories have to fully comply with all the requirements of the relevant standard for which accreditation is sought.

7.1.2.2. Medical laboratories

The criteria which laboratories must comply with to obtain accreditation are contained in ISO 15189. Medical laboratories that perform only medical testing shall be accredited to this standard. Medical laboratories can also be accredited to ISO/IEC 17025. Medical laboratories may decide on which standard to be accredited to, based on guidance from UNIVAB.

7.1.2.3. Certification bodies

UNIVAB accredits management systems/product/personnel certification bodies.

a) Management systems certification bodies
UNIVAB accredits quality/environmental/occupational health and safety/food safety management systems. The criteria which quality/environmental/occupational health and safety management systems certification body must comply with to obtain accreditation are contained in ISO/IEC 17021-1 and the IAF guidance or interpretations thereof.
The criteria which food safety management systems certification bodies must comply with to obtain accreditation are contained in ISO/TS 22003 and the relevant IAF guidance or interpretations thereof.
b) Product certification bodies
The criteria which product certification bodies must comply with to obtain accreditation are contained in ISO/IEC 17065 and the IAF guidance or interpretations thereof.
c) Personnel Certification Bodies
The criteria which personnel certification bodies must comply with to obtain accreditation are contained in ISO/IEC 17024 and the relevant IAF guidance or interpretations thereof.

7.1.2.4. Inspection bodies

The criteria which inspection bodies must comply with to obtain accreditation are contained in ISO/IEC 17020 and the relevant ILAC guidance or interpretations thereof.

Fields and scopes of accreditation are available.


7.2. Application for Accreditation

The applicant conformity assessment body submits directly to UNIVAB duly completed and signed application form together with the conformity assessment body quality manual detailing the organization’s ability to meet the requirements of the relevant international standard, and duly completed application for approval of personnel i.e. nominated representative and technical signatory as relevant and duly signed accreditation Agreement. The respective Scheme Coordinator shall undertake a completeness check or file review of the submitted applicant’s documents to ensure completeness.

Prior to or after embarking on the formal accreditation process, organizations that seek accreditation may voluntarily request UNIVAB to conduct a pre-assessment to assess their readiness for accreditation. Pre-assessments may however be compulsory for new organizations seeking accreditation depending on the regulator’s condition of acceptance. Pre-assessments are carried on site by the Team Leader/Assessor and shall be undertaken after the document review.

At any point in the application, or assessment, if there is evidence of fraudulent behavior, if the conformity assessment body intentionally provides false information or if the conformity assessment body conceals information, UNIVAB shall reject the application or terminate the assessment process.

7.3. Resource Review

In undertaking a file review, UNIVAB also undertakes resource review which takes into account the availability of personnel throughout the accreditation process including decision making. UNIVAB also takes into account its ability its ability to carry out the assessment in a timely manner.

Where the initial assessment cannot be undertaken in a timely manner UNIVAB shall communicate this to the conformity assessment body.

7.4. Preparation for assessment

7.4.1. A competent assessment team is identified to evaluate the applicants documented system, and to conduct the assessment on behalf of UNIVAB. Technical Experts, where required also form part of the assessment team.
7.4.2. An assessment team is set up and presented to the conformity assessment body sufficiently in advance, for approval. In case of objection raised by the applicant regarding impartiality, this shall be explained in writing within seven (7 days) of receipt of the notification and UNIVAB shall evaluate if the reasons are acceptable, then changes are made to the assessment team.
7.4.3. The assignment given to the assessment team is clearly defined right from setting up the team when assurance is sought for the assessor/technical expert’s ability to assess the assigned technical scope. Selection as a Technical Assessor/Technical Expert is in accordance with the specific expertise. The Technical Assessor/Technical Expert will still need to advise UNIVAB should there be anything in the scope that have been assigned that Technical Assessor/Technical Expert are not able to or uncomfortable to assess.
7.4.4. UNIVAB has documented procedures which outline the process and assessment techniques used in the accreditation of conformity assessment bodies in accordance with the relevant international standard, UNIVAB requirements as well as the ILAC /IAF requirements.
7.4.5. All locations must be working to the same requirements and will be subject to an on-site assessment on a sampling basis as part of the accreditation process to provide evidence of the operation and effectiveness of the system.
7.4.6. Selection of activities to be assessed is on a sampling basis which takes into account the risk associated with the activities, locations and personnel covered by the scope of accreditation.
7.4.7. An assessment plan shall be prepared. The time required for assessment will be dependent on the complexity of the conformity assessment body, the geographical spread of its activities, the structure of the quality system, the proposed scope(s) of accreditation and where relevant, the combination of multi-standards for accreditation.
7.4.8. The assessment plan and a quotation will be forwarded to the laboratory in advance of the assessment for which a written acceptance of the quotation will be required before an on-site assessment can be undertaken.
7.4.9. The Team Leader shall provide the assessment team the assessment plan and information about the assessment and the conformity assessment body at least 2 weeks before an assessment.

7.5. Review of Documented Information
The appointed assessment team shall conduct a desk review of all relevant documented information provided by the applicant in order to evaluate its system for conformity with the relevant standard(s) and other requirements for accreditation. The assessment team shall use the appropriate checklist as a guide in reviewing the quality documentation.
On completion of the document review, a report on the relevant document review report shall be issued and the report shall contain comments on any nonconformity, areas which are not addressed, areas where actions are needed, areas where there are concerns or weaknesses and a recommendation on the way forward.

Once the applicant’s documented quality management system has been confirmed to address all the requirements of the relevant standards, an assessment will be scheduled. UNIVAB can decide not to proceed with the on site assessment based on the review of the documented information.

7.6. Assessment
7.6.1. UNIVAB has documented procedures which describe the assessment techniques used, the timescales for the accreditation process and reporting to the conformity assessment body on the findings raised from the assessment.
7.6.2. Assessments are undertaken on-site at the applicant organization’s premises or remotely and involve an opening meeting.
7.6.3. The assessment team conducts the assessment based on the assessment plan.

7.6.4. The assessment of the organization’s competence to perform specific tasks for which accreditation is sought, witnessing of select technical activities are conducted. The initial assessment covers all aspects of the organization’s scope of application.
7.6.5. The assessment team can ask for support from UNIVAB when it cannot reach conclusion on a finding.
7.6.6. The assessment ends with a closing meeting during which a summary of the assessment report is presented to the conformity assessment body.
7.6.7. UNIVAB is responsible for the content of the assessment reports.
7.6.8. The findings from the assessment are recorded as nonconformities where the conformity assessment body needs to institute corrective action. Where corrective action by the conformity assessment body is required the applicant organization shall be invited to identify and propose corrective actions to address the raised nonconformities within one (1) month after the assessment and have corrective action cleared within three (3) months after the assessment. For periodic on-site assessments and re-assessments conformity assessment bodies shall address the nonconformity and have the corrective action cleared within two (2) months after the assessment.

UNIVAB requires the conformity assessment body to provide an analysis of the extent and cause (e.g. root cause analysis) of the nonconformities.

7.6.9. UNIVAB reviews the responses of the conformity assessment body to determine if the actions are considered sufficient and appropriate. Where the conformity assessment body’s response is found to be insufficient, further information shall be requested. Evidence of effective implementation may be requested or a follow up assessment may be carried out to verify effective implementation.

7.7. Accreditation Decision-making
Accreditation decisions relate to granting, maintaining, extending, reducing, suspending or withdrawing accreditation.

UNIVAB maintains two (2) approaches to accreditation decision making process as follows:
a) Decisions arising from initial assessments, reassessments and extensions to new scopes shall be made by the Accreditation Approvals Committee (AAC) consisting of not less than 2 competent members, one of whom shall be either the UNIVAB Chief Executive Officer (CEO) or Technical Manager; and
b) Decisions arising from periodic on-site assessments, extension of existing scopes and additional signatories to existing accredited facilities shall be made by the AAC consisting of at least one competent member.

Any other specialized technical expert shall be invited to serve on the AAC as deemed necessary. Personnel who have carried out the assessment shall not participate in the decision-making process.

UNIVAB shall, without undue delay, make the decision on whether to grant, maintain, extend, reduce, suspend or withdraw accreditation and notify the conformity assessment body in writing of the decision including justification where relevant.

All accreditation decisions shall be made based on the information gathered and the recommendations made by the respective assessment team. The recommendation together with supporting documentation shall be forwarded to the Accreditation Approvals Committee for decision.

The supporting documentation shall include the following, as minimum:

a) Unique identification of the conformity assessment body;
b) Date(s) and type (s) of assessment;
c) Name(s) of the assessor(s) and where applicable, technical experts involved in the assessment;
d) Unique identification of all premises assessed;
e) Scope of accreditation that was assessed;
f) The assessment report(s);
g) A statement on the adequacy of the internal organization and procedures adopted by Conformity Assessment Bodies to give confidence in its competence, as determined through its fulfillment on the requirements for accreditation;
h) Sufficient information on the resolution of all nonconformities;
i) Where relevant, any further information that may assist in determining the competence of the Conformity Assessment Bodies as determined through conformity with requirements; and
j) Where appropriate, a recommendation as to the accreditation decision for the proposed scope.

Prior to making the decision UNIVAB shall be satisfied that the information is adequate to decide that the requirements for accreditation have been fulfilled.

7.8. Accreditation Information
An accredited facility may only issue a UNIVAB certificate for the type and range of activities for which accreditation has been granted and which is listed on the accompanying schedule of accreditation.
The certificate shall include the following information:
a) The UNIVAB name and logo;
b) Name of accredited conformity assessment body and name of the legal entity if different;
c) Details of the scope of accreditation:
 For certification bodies to include:
o Type of certification (e.g. management systems, products, processes, services or persons.
o Certification scheme.
o The standards, normative documents, and /or regulatory requirements to which management systems, products, processes and services, or persons are certified, as applicable.
o Industry sectors where relevant.
o Product, processes, service and persons categories where relevant.
 For inspection bodies to include:
o Type of inspection body as defined in ISO/IEC 17020.
o Inspection schemes, where relevant.
o Field and range for which accreditation has been granted.
o Regulations, inspection methods, standards and/or specifications containing the requirements against which the inspection is to be performed, as applicable.
 For calibration laboratories to include:
o The calibration and measurement capability (CMC) expressed in terms of
 Measurand or reference material
 Calibration or measurement method or procedure and type of instrument or materials to be calibrated or measured
 Measurement range and additional parameters where applicable e.g. frequency of applied voltage
 Measurement uncertainty
 For testing laboratories including medical laboratories to include:
o Materials or products tested.
o Component, parameter or characteristic tested.
o Tests or types of tests performed and, where appropriate, the techniques, methods and/or equipment used.

d) Locations from which key activities are performed and which are covered by the accreditation;
e) Unique accreditation number;
f) Effective date of granting accreditation i.e. the date of issue of certificate and date of expiry of certificate;
g) Statement of conformity and reference to the standards/ other normative documents including issue or revision used for assessment of the conformity assessment body;
h) Contact details of the accredited facility.
i) Personnel approved.
j) The certificate shall be signed by the authorized signatory.
UNIVAB does not use flexible scopes of accreditation.
7.9. Accreditation Cycle
The UNIVAB accreditation cycle shall be a period of 5 years for all the accreditation schemes. The accreditation cycle shall begin on the date of the decision to grant accreditation and shall be valid for five (5) years from that date.
During the accreditation cycle, UNIVAB shall conduct periodic on-site assessments or remote assessments, where applicable to verify that the accredited conformity assessment body continues to comply with the accreditation requirements.

The first periodic on-site assessment shall be undertaken not more than twelve (12) months after the date of accreditation. Thereafter periodic on-site assessments are scheduled at a frequency such that the time between consecutive periodic on-site assessments does not exceed two years. However, if UNIVAB determines that an on-site assessment is not possible or feasible, another assessment technique (e.g. remote assessment) shall be used to achieve the same objective as the on-site assessment being replaced.

In developing the assessment programme for assessing throughout the accreditation cycle, UNIVAB shall take into account UNIVAB’ knowledge of the accredited organization’s activities, management system and performance obtained from previous assessments and the possible risks thereof. The assessment programme shall ensure coverage of a representative sample of the organization’s full scope of accreditation at the relevant locations.

Reassessments will be conducted at least six (6) months before the end of an assessment cycle. The reassessment shall be planned and performed taking into account the information gathered from the assessments performed over the accreditation cycle. The re-assessment shall be a complete assessment covering the organization’s scope of accreditation and including all elements of the relevant standard. An accreditation decision shall be made after the reassessment.

UNIVAB may decide that at any time extraordinary assessments be undertaken as a result of complaints or changes in the accredited conformity assessment body where such assessments are deemed necessary. UNIVAB shall advice the conformity assessment body accordingly and of the scope and reasons for the extraordinary assessment.

 

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