AS/NZS ISO 9001:2000GAP ANALYSIS CHECKLISTISO 9001:2000 Gap AnalysisChecklistType:Assessor:ISO 9001 REQUIREMENTSSTATUSACTION/COMMENTS4 Quality Management System4.1 General RequirementsProcesses needed for the quality management system andtheir application throughout Company X have beendetermined.The sequence and interaction of these processes havebeen determined.Criteria and methods needed to ensure that both theoperation and control of these processes are effective havebeen determined.The availability of resources and information necessary tosupport the operation and monitoring of these processes areensured.These processes are monitored, measured and analysed.Actions necessary to achieve planned results and continualimprovement of these processes are implemented.4.2 Documentation Requirements4.2.2 Quality ManualA quality manual has been established and is maintained.The scope of the manual includes details of and justificationfor any exclusions (exclusions are limited to clause 7).The manual contains or references the documentedprocedures established for the quality management system.The manual contains a description of the interaction betweenthe processes of the quality management system.4.2.3 Control Of DocumentsAll QMS documents are controlled.A documented procedure is established to define thecontrols needed to:Approve documents for adequacy prior to issue.Review and update as necessary and re-approvedocuments.Ensure that changes and the current revision statusof documents are identified.Ensure that relevant versions of applicabledocuments are available at points of use.Ensure that documents remain legible and readilyidentifiable.Ensure that documents of external origin areidentified and their distribution controlled.Prevent the unintended use of obsolete documents,and to apply suitable identification to them if they areretained for any purpose.4.2.4 Control Of RecordsRecords are legible, readily identifiable and retrievable.A documented procedure has been established to define thecontrols needed for the identification, storage, protection,retrieval, retention time and disposition of records.
AS/NZS ISO 9001:2000GAP ANALYSIS CHECKLIST5.1 Management CommitmentTop management has communicated the importance ofmeeting customer, statutory and regulatory requirements.Quality policy is established.Quality objectives are established.5.2 Customer FocusTop management shall ensure that customer requirementsare determined and are met with the aim of enhancingcustomer satisfaction (see 7.2.1 and 8.2.1).5.3 Quality PolicyPolicy is appropriate to the purpose of Company X.Policy includes a commitment to comply with requirementsand continually improve the effectiveness of the QMS.Policy provides a framework for establishing and reviewingquality objectives.Policy is communicated and understood.Policy is reviewed for continuing suitability.5.4 Planning5.4.1 Quality ObjectivesQuality objectives, including those needed to meetrequirements for product, are established at relevantfunctions and levels within Company X.The quality objectives are measurable and consistent withthe quality policy.5.4.2 Quality Management System PlanningQMS planning is carried out in order to meet the requirementsgiven in 4.1, as well as the quality objectives.The integrity of the QMS is maintained when changes to theQMS are planned and implemented.5.5 Responsibility, Authority And Communication5.5.1 Responsibility And AuthorityResponsibilities and authorities are defined andcommunicated.5.5.2 Management RepresentativeThe Quality Systems Manager reports to top management onthe performance of the QMS and any need for improvement.The Quality Systems Manager ensures the promotion ofawareness of customer requirements throughout CompanyX.5.5.3 Internal CommunicationAppropriate communication processes are established.Communication takes place regarding the effectiveness ofthe QMS.5.6 Management Review5.6.1 GeneralTop management reviews the QMS at planned intervals, toensure its continuing suitability, adequacy & effectiveness.The review includes assessing opportunities forimprovement and the need for changes to the QMS, includingthe quality policy and quality objectives.Records from management reviews are maintained.5.6.2 Review InputIncludes results of audits.Includes customer feedback.Includes process performance and product conformity.Includes status of preventive and corrective actions.