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Elements and Performance Criteria

1. Plan the document review
   • Determine the objective(s), scope and criteria of the document review
   • Identify relevant and current regulatory and commercial requirements
   • Define audit client and reporting processes
   • Select an audit team with appropriate technical expertise against the scope
2. Develop document review checklist
   • Develop checklist against criteria
   • Ensure the checklist covers all applicable regulations and/or commercial requirements as defined by the scope
3. Conduct document review
   • Identify and retrieve required enterprise documents for review
   • Review documents against the prepared checklist and determine compliance with each element on the checklist
   • Identify and raise non-conformances against nominated criteria
4. Report on outcomes of document review
   • Collate and report on findings according to workplace requirements
   • Consult with relevant personnel and raise corrective actions where required according to workplace requirements
   • Close out audit
5. Confirm and close out corrective actions
   • Evaluate and report the effectiveness of the corrective action after an agreed time interval
   • Close out Corrective Actions according to workplace requirements
6. Plan the document review
   • Determine the objective(s), scope and criteria of the document review
   • Identify relevant and current regulatory and commercial requirements
   • Define audit client and reporting processes
   • Select an audit team with appropriate technical expertise against the scope
7. Develop document review checklist
   • Develop checklist against criteria
   • Ensure the checklist covers all applicable regulations and/or commercial requirements as defined by the scope
8. Conduct document review
   • Identify and retrieve required enterprise documents for review
   • Review documents against the prepared checklist and determine compliance with each element on the checklist
   • Identify and raise non-conformances against nominated criteria
9. Report on outcomes of document review
   • Collate and report on findings according to workplace requirements
   • Consult with relevant personnel and raise corrective actions where required according to workplace requirements
   • Close out audit
10. Confirm and close out corrective actions
    • Evaluate and report the effectiveness of the corrective action after an agreed time interval
    • Close out Corrective Actions according to workplace requirements

Range Statement

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Performance Evidence

The candidates must conduct a document review.

The candidate must:

complete at least one document review of a section of the Approved Arrangement or Quality System within area of technical expertise

establish the authenticity of the documents being audited

identify and assemble documents for a minimum of one audit of an Approved Arrangement or Quality System

develop and validate a checklist for the audit

verify compliance with regulatory systems and/or commercial requirements

explain the process of audit and the reasons for the findings made

be able to reference the specific requirement that has not been met when a non-conformity is issued

plan and organise audit activities to conduct the audit effectively

use information systems, technologies and software, where applicable, to manage security, authorisation and distribution of audit data and records

interpret evidence and make a judgment on the level of compliance

prepare well-balanced, factual and objective written audit reports

use communication methods relevant to different groups and audience

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Knowledge Evidence

The candidate must demonstrate a broad factual, technical and theoretical knowledge of:

the specified regulatory and commercial requirements and their impact on the nominated enterprise

audit management to develop an audit plan and audit processes

legislation, regulations, orders, codes and standards applicable to the areas being audited

the structure, authority levels and lines of reporting within the organisation

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