The process of becoming accredited is a multi-step process:
Scope of Accreditation
Detailing the scope of an organisation’s technical activities is one of the distinguishing requirements of accreditation. To do this it is necessary to specify the range of products and services that are provided under the control of your organisation’s technical and quality systems.
Accreditation is normally granted only for work that is performed regularly and for which organisations are properly equipped and have demonstrated their competence. The scope of accreditation will, therefore, vary with the range and complexity of work carried out, the competence and experience of staff and the level of technology available in the organisation.
In granting accreditation, IANZ will specify the following details in the scope of accreditation:
- The products and services provided
- Test/inspection methods used
- For Radiology Practices, type of imaging offered
- For calibration laboratories, ranges of measurements and least uncertainties
- For testing laboratories, either measurement uncertainties or limits of detection for some types of tests.
Advice and assistance
In the first instance, please contact IANZ for advice and assistance about which accreditation programme is right for your organisation. Your contact will be referred to by one of our Accreditation Services staff or by the Programme Manager if required. You will be sent an information pack including relevant publications applicable for your accreditation, the Procedures and Conditions of Accreditation, as well as an application form and helpful information for getting started.
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You will need to write down your organisation’s technical and quality systems in a manual (or other alternative set of procedures). This manual has to meet the requirements of the relevant general criteria for accreditation for your type of activity.
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You may request an advisory visit to your premises by an IANZ accreditation assessor to review your organisation’s existing systems and procedures and/or to explain accreditation in more detail. This service is provided at the IANZ normal hourly professional fee plus expenses. From such a visit, you can get advice on your organisation’s readiness for the initial assessment and also on any aspects of the management systems that need further development. However, so as to protect the integrity of our independent, third-party assessment, IANZ cannot provide detailed advice or compliant procedures that are in the nature of consultation.
If your organisation has not had formal contact with IANZ in the past, such a visit is strongly recommended. Experience suggests that the cost of an advisory visit will be more than recovered by the savings in time at the initial assessment.
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Please complete the application form and questionnaire we provide when responding to your initial enquiry. The information requested is essential to us for selecting the appropriate technical expert(s) and to brief them prior to their visiting your organisation.
Some of the important information we need in the questionnaire is:
- The classes/types of test/inspection/radiology service for which accreditation is sought (Laboratory and Inspection Body programmes particularly). These are detailed in the IANZ Specific Criteria document for the particular technology and/or activity. These documents are available online.
- The staff members your organisation wishes to nominate as IANZ Approved Signatories or Key Technical Personnel.
- The test or inspection procedures or other work methods used within each technical area.
- Each site for which accreditation is sought.
IANZ Programme Manager
Your organisation will be allocated to the appropriate IANZ Programme Manager (PM) for the field of technology concerned. The PM will designate an IANZ Accreditation Assessor (who will be the lead assessor) who will contact your nominated person (Authorised Representative) to arrange a suitable date for the assessment and to discuss the proposed technical experts.
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A senior staff member of your organisation must be nominated to represent it in all dealings with IANZ. This person is the IANZ point of contact with your organisation and is known as the Authorised Representative. All correspondence, invoices, etc which IANZ sends to your organisation will be addressed to the Authorised Representative.
The Authorised Representative may be any senior staff member from either the technical or managerial staff. It is important that they are in a position of sufficient authority to ensure your organisation complies with the criteria for accreditation at all times. There are advantages in nominating a person who is not closely involved in the day-to-day operation but has authority over it.
The Authorised Representative is expected to be present at on-site assessment entry and exit meetings.
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Before the on-site assessment of your organisation, manuals and supporting documents making up the technical and quality systems will be comprehensively reviewed by us to ensure compliance with the relevant general criteria (the standards), the relevant specific criteria and other criteria as detailed in this section. Prior to or during on-site assessment, you will be notified of any significant changes needed to the documents.
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- The objective of IANZ assessments is to confirm that your organisation is actually doing what its manuals say it will do and that it meets good practice for that discipline. During its on-site visit, the assessment team will focus on the technical operations, the quality system, the competence of signatory applicants and key technical personnel, and on the methods used. Information gathered will include, but is not limited to, review of records, discussions with management and signatory/ technical personnel and the observation of activities within the requested scope of accreditation. The team may wish to witness tests or other work relevant to the scope.
- Most assessments take one or two working days to complete but visits to larger organisations, or those whose work extends over a range of technologies, will take longer. All sites offering the services for which accreditation is sought will need to be visited by the assessment team.
- The assessment begins with a meeting between the Assessment Team and the senior staff of your organisation. This entry meeting provides an opportunity for:
- The timetable and scope of the assessment to be finalised
- A review of the Accreditation Questionnaire
- Resolution of any immediate queries that the assessors or staff may have.
- You are asked to provide a guide(s)/escort(s) for each assessment team member for the duration of the visit. These escorts should be senior staff members of your organisation who have sufficient authority to ensure that assessors have access to all documents, personnel and activities they may wish to see.
- Observations made during the assessment will be recorded on a checklist or notebook. These will include observations of compliance as well as of any non-compliance. Following the information gathering, the assessors meet to review their notes and summarise their findings.
- The assessment ends with an exit meeting where representatives of your organisation are given the summary of findings, including details of any areas of non-compliance that have been found and guidance on correcting them. All findings will be fully discussed before the Assessment Team leaves.
- Within ten working days of the visit, your organisation will receive a comprehensive written report on the assessment findings, which were discussed at the exit meeting. The report will place the findings into two categories:
- Corrective Action Requests (CARs) are actions that your organisation must carry out before accreditation can be granted. CARs usually relate to non-compliance with the General or Specific Criteria.
- Recommendations are actions that your organisation is urged to carry out in the interests of good practice, but are not considered CARs.
- Your progress in carrying out the required actions will be monitored by the IANZ Assessment Coordinator (AC)/lead assessor. Once the AC is satisfied that all conditions for accreditation have been cleared, a report will be prepared on the assessment for consideration by the IANZ General Manager – Accreditation Services and the relevant Professional Advisory Committee (PAC). This includes the proposed scope, the assessment report and responses to it, information on the key personnel, as well as any relevant proficiency activity and follow-up action.
> Read more about Professional Advisory Committee (PAC)
- The PAC members review the assessment report. If they are satisfied that all accreditation criteria have been met, they advise the Chairman of the Accreditation Advisory Committee (AAC) who will recommend to the IANZ Director that accreditation may be awarded on behalf of the Testing Laboratories Registration Council. The recommendation includes the particular tests or types of activities for which accreditation is to be granted and, where relevant, the names of your staff that are to be awarded signatory approval or have been appointed as Key Technical Personnel. The Council will grant accreditation, issue a Certificate of Accreditation and publish the name of your organisation, together with details of the scope of accreditation, in the IANZ Directory, which can be viewed at any time in the IANZ Directory of accredited organisations.
Where major departures from accreditation criteria are found during an initial assessment, a further visit may be needed to confirm the assessment team’s requests have been carried out. Where departures are less serious but remain un-cleared for more than one year after the initial assessment, another visit will also be needed for accreditation to proceed.
Once accredited, your organisation enters the IANZ programme of scheduled reassessment visits. These visits ensure that the technical and quality systems continue to meet the criteria for accreditation and continue to work effectively.
Full technical (routine) reassessments are usually carried out at three yearly intervals, although for medical testing laboratories intervals are four years and some special accreditation programmes require annual or more frequent reassessments.
Full technical reassessments are similar to initial assessments in their scope, duration and process. Reporting procedures also resemble those at initial assessments, but once accredited there is a limit on the time organisations may take to carry out any requested changes. The time period will depend on the significance of the non-compliance and will be negotiated during the on-site exit meeting.
Surveillance visits, to confirm that the management systems are continuing to operate effectively and meeting accreditation criteria, are carried out annually between the full technical reassessments. Any Corrective Action Requests raised must also be corrected promptly.
Once compliance has been demonstrated within the agreed time interval, IANZ formally grants continued accreditation.
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Extension, Suspension and Withdrawal of Accreditation
Accredited organisations may apply to have their scope of accreditation changed at any time. An extension to the range of accredited services, or the addition of a new approved signatory, will usually require IANZ to carry out a limited assessment with a Technical Expert.
If routine reassessments, surveillance visits or special assessments reveal that an organisation’s systems no longer meet IANZ’s criteria for accreditation, or if the organisation refuses to carry out requested corrective actions either at all, or within the specified time, then accreditation may be suspended or withdrawn.
Accreditation may also be suspended when an organisation, through no fault of its own, is temporarily unable to comply with the criteria for accreditation (e.g. when all of its approved signatories or key technical personnel leave). The management of accredited organisations is expected to plan its staff resources, as far as it can, to avoid such occurrences.
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