The assessment of facilities is carried out in a helpful, constructive manner. The process is designed to assist facilities in complying with the criteria for accreditation. Organisations can have all or part of their testing, measurement, inspection or calibration activities accredited by NATA.
The following is a summary of the accreditation process. It should be noted that there are some differences between NATA's various fields and programs in relation to the order in which the steps detailed below are followed. There may also be a need to vary these steps in the case of applications from overseas laboratories.
Click here to download more general information, and here for information regarding fees. For information on the various accreditation fields and programs NATA offers, see Types of Accreditation or Apply for accreditation in Medical Testing.
When seeking accreditation with NATA, staff should familiarise themselves with the NATA Accreditation Criteria (NAC) for the field of testing or program relevant to their application. These can be downloaded free of charge from this website.
Application for Accreditation
Applications for accreditation with NATA can be made by any legally identifiable organisation providing testing, inspection, calibration or related services. The application must be made on a prescribed application form and accompanied by the current application fee. Application forms are provided by NATA technical staff after discussion with the applicant facility.
Each applicant will be required to provide a copy of its quality manual and other management system and technical documentation as advised by NATA.
An advisory visit is an informal review of facilities undertaken by a NATA lead assessor to examine the major non-technical elements of the system and identify any significant gaps in relation to the requirements. Advisory visits may be conducted either prior to or after an application has been made. An initial visit by NATA staff can help prepare a facility for accreditation, and provides an opportunity for the facility to ask questions about the process or NATA.
The Authorised Representative
The authorised representative is the facility's recognised official contact with NATA. The rights and legal obligations of the authorised representative are detailed in the NATA Rules. At a practical level, the authorised representative is normally a senior staff member who is in a position to make decisions regarding the facility's accreditation and to effectively communicate with colleagues. The authorised representative may also choose to direct NATA to other staff with whom relevant issues may be discussed. The authorised representative is required to notify
NATA within 14 days if:
* the name or ownership of the facility changes
* changes in duties or departures of senior key staff occur; or
* significant changes occur to the functions or accommodation of the facility.
To download a Nomination of New Authorised Representative form, click here.
When the facility considers itself ready for evaluation, a mutually convenient time is arranged for the assessment and NATA organises a team of technical assessors in consultation with the facility.
The assessment team consists of:
at least one NATA lead assessor who reviews the management system
one or more specialist volunteer technical assessors. Technical assessors are chosen according to their specialist knowledge and are matched as closely to the activities of the facility as possible.
Consideration is given to possible concerns about conflicts of interest in selecting technical assessors. The size of the assessment team is dependent upon the areas that must be covered in the course of the assessment.
Compliance of an applicant facility with accreditation criteria is determined primarily by an on-site assessment of its resources, procedures and documentation. The objective is to establish whether the facility can competently perform the activities for which accreditation is sought. The assessment team investigates the operation of the facility against the relevant NATA Accreditation Criteria and reports its findings to the facility seeking accreditation.
The assessment involves a thorough evaluation of all the elements of the facility's operation that contribute to the production of accurate and reliable data. These elements include:
staffing, including training and supervision
methods, including validation/verification
equipment, including calibration
recording and reporting of results
the physical environment in which the activities are performed.
Assessments will take at least one full working day and may extend over a number of days. They involve discussions with management and technical staff, a review of documented procedures and associated records, and witnessing of activities where practicable.
An exit meeting is held at the conclusion of the assessment. In this the assessment findings are detailed by the NATA lead assessor to the authorised representative and other members of staff at the discretion of the authorised representative. The purpose of the exit meeting is to allow frank and open discussion about the assessment findings. Facilities are strongly encouraged to clarify issues they consider may have been misunderstood by the assessment team and to seek clarification about assessment findings where this is necessary.
The findings of the assessment team are subsequently confirmed in a formal report after they have been reviewed by senior NATA staff. Specific technical issues may be referred to the relevant NATA Accreditation Advisory Committee for resolution. Where necessary, the report will detail any non-conformities needing to be addressed by the facility which were identified at the assessment. In these cases, the facility will provide NATA with the necessary information to demonstrate that these deficiencies have been rectified. In some cases, a further visit by a NATA lead assessor either alone or accompanied by one or more assessors will be necessary. Charges will be levied for such visits.
Scope of Accreditation
Accreditation is described by of classes and subclasses of test or activity. The extent of a facility's accreditation is known as its 'scope of accreditation'.
Applications for accreditation may be made for one or more classes of test or for one or more subclasses within any class.
NATA's Chief Executive grants accreditation following a recommendation by the relevant Accreditation Advisory Committee (AAC). This recommendation is made when the facility has met all the requirements for accreditation. The authorised representative is formally advised of the granting of the accreditation and issued with a certificate and the scope of accreditation.
Having achieved NATA accreditation, facilities are entitled to apply the NATA endorsement to their reports. This is widely recognised in Australia and overseas as a symbol of competence and reliability.
NATA publishes the facility's contact details and scope of accreditation in the NATA website directory. This information is also supplied to enquirers who are seeking accredited facilities.
Variations to Scopes of Accreditation
Accredited facilities may request variations to their scope of accreditation. Significant additions to the scope of accreditation will require an assessment. NATA technical staff will provide direction on the information required, the process that will be followed and the charges that will be levied.
In order to ensure continued compliance with accreditation requirements, facilities are placed on a routine surveillance program comprising 18-monthly visits. 'Surveillance visits' are conducted by a lead assessor only and concentrate on a review of the management system. Some technical elements of the relevant standard are also reviewed. These visits alternate with reassessments.
'Reassessments' follow the same processes and have the same broad objectives as initial assessments, although the review of the management system is limited to a few key elements. Shorter intervals or a change to the visit type may be specified, for example when significant changes to staffing or procedures occur, where significant non-conformities are identified at a visit, or to investigate a complaint.
A new surveillance model for Medical Testing was introduced on the 1st of July 2013. The new surveillance model involves three types of assessment activities over a four year period.
Online assessment activity: This involves an online activity by a NATA lead assessor at 12 and 36 months.
Surveillance visit: This involves an on-site visit by a NATA lead assessor at 24 months. Selected technical areas and the management system are reviewed.
Reassessment visit: This involves an on-site visit by the NATA lead assessor and the relevant number of technical assessors every four years.
For further information please refer to Policy Circular 46.
Participation in proficiency testing activities (either inter-laboratory comparisons or measurement audits) is mandatory.
You can get more information from the documents in the relevant NAC.
All information provided by a facility in connection with an enquiry or an application for accreditation and all information obtained in connection with an assessment, is treated as confidential by NATA staff, technical assessors, and Committee and Board members. All such personnel are made aware of this requirement and have signed confidentiality agreements.
What Do I Do Next?
To discuss your interest in applying for accreditation or to clarify any of the above information, please contact any NATA office. The relevant information and forms will then be sent to you by NATA technical staff.
To download NATA's fee schedules click here.