CACS



Instructions for Client: Please complete the checklist below and one full internal audit against the ISO 9001:2015 requirements prior to your organization’s audit. Once the form is completed, forward it to your Auditor and admin@.au as a word document prior to the assessment. Please ensure that the completed checklist and internal audit records are available to your auditor prior to commencement of your assessment.If you are not able to complete this document, it is a strong indicator that your organization may not be ready to transition to ISO 9001:2015. In this case, please inform both your auditor and CACS admin that you need additional time and resources to prepare for the transition and they will work with you. It may be of benefit to select a mutually agreeable date for a CACS auditor to conduct a gap analysis and complete the transition checklist for you on site at a greatly reduced daily rate of $700.New Concepts & Themes: Please complete the tables below which highlight some of the new concepts and themes present in ISO 9001:2015. These concepts will bridge multiple processes, clauses and functional areas. Ensure that these new concepts have been deployed in a manner that supports the process approach and risk based thinking.IMPORTANT NOTE!Please attach and submit (together with this completed checklist) all relevant documentation and or records to support any conformity claims including reference where applicable. 1:Significant New Requirements Checklist:New ConceptsInstructionsEvidence to support ConformanceReferance & Attached documents & or RecordsAre there any requirements of ISO 9001:2015 that the organization is considering not applicable?If “Yes”, please list all non-applicable requirements and justifications of why they do not affect your organization’s ability or responsibility to ensure the conformity of your products and services and the enhancement of customer satisfaction (ref. ISO 9001:2015, 4.3)If “No”, mark response column as “N/A”and proceed to next questionIs the organization still maintaining a documented Quality Manual?If “Yes”, mark response column as “N/A”and proceed to next questionIf “No”, please detail how your organization has determined the processes needed, and their interactions in accordance with ISO 9001:2015 (ref.ISO 9001:2015, 4.4.1)Is the organization still maintaining Documented Procedures?If “Yes”, mark response column as “N/A”and proceed to next questionIf “No”, please describe on what basis your organization has determined that documented information (i.e. procedures)are not necessary for the effectiveness ofthe quality management system (ref. ISO9001:2015, 7.5.1)Has the approach changed with regard to the appointment of a Management Representative?If “Yes”, please detail how top management demonstrates leadership and commitment with respect to the quality management system (ref. ISO 9001:2015, 5.1.1)If “No”, mark response column as “N/A”and proceed to next question2:Significant Clause Requirements Change Checklist:New ThemesPhasesClausesActivityEvidence to support ConformanceReferance & Attached documents & or RecordsBusiness planning and strategic directionPlan4.14.2Has the organization identified both internal and external issues and interested parties that are relevant to and/or support the strategic direction of the organization?Do5.2.1Is the strategic direction being utilized as an input to the Quality Policy/Quality Objectives/Risk Management/Management Review processes?Check4.14.25.1.19.3.2Is the quality system being assessed and reviewed in accordance with the strategic direction?Act10.3Is the quality system being updated as necessary in response to changes in any of the above?Process RiskPlan4.4.16.16.26.38.5.6When establishing the QMS and planning for change, have risks to achieving process objectives been identified?Do8.1Have the identified process risks been addressed?Check6.1.29.1.39.3.2Is the organization analysing the effectiveness of actions taken to address process risks?Act10.2.110.3Following analysis and corrective action is there evidence that process risks have been updated?Product and Service riskPlan5.1.26.16.28.18.2.28.2.38.3.2Have risks to achieving product or service conformity been:? considered as part of the planning for operational control?? considered when determining and reviewing customer requirements?? identified and has product complexity been considered during design planning?Do8.18.2.3.18.3.3Have design and operational controls to address the identified product and service risks been implemented?Check9.1.39.3.2Is the organization analyzing the effectiveness of actions taken to address product risks?Act10.1Has the organization determined and selected opportunities for improvement on product and service?Risk associatedwith the controlof externally provided product and servicePlan6.1Have risks associated with externally provided product, process (i.e. formerly named outsourced) or service been identified?Do8.4.18.4.2Are the identified risks utilized as an input into the:potential impact of externally provided product, process or servicetype and extent of controlsselection and evaluation of external providersdegree of information provided to these resources?Check8.4.19.3.2Has the organization applied criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers?Act9.3.3Has the organization modified the controls applied to external providers based upon the results of evaluation?3:Minimum Documentation Requirements Checklist: ISO 9001:2015 enhanced emphasis: Please complete the table below to demonstrate that each of the following requirements have been addressed within the quality management system.ISO 9001:2008ISO 9001:2015Evidence to support ConformanceReference & Attached documents & or RecordsISO 9001:2008, 5.15.1 Leadership and commitment.ISO 9001:2008, 5.4.26.3 Planning of changes.ISO 9001:2008, 7.67.1.5 Monitoring and measuring resources.ISO 9001:2008, 6.2.27.3 Awareness.ISO 9001:2008, 5.5.37.4 Communication.ISO 9001:2008, 7.28.2 Determination require for products & services.ISO 9001:2008, 7.38.3 Design & development of products & services.ISO 9001:2008, 7.5.18.5.5 Control of production & service Provision.ISO 9001:2008, 5.4.28.5.6 Control of changes.ISO 9001:2008, 8.2.48.6 Release of products and services.ISO 9001:2008, 8.38.7 Control of nonconforming process outputs.ISO 9001:2008, 5.69.3 Management review.ISO 9001:2008, 8.5.210.2 Nonconformity and corrective anisation NameCompleted byContact detailsDateAdditional Client comments: OFFICE USE ONLYThis self-assessment checklist must be reviewed by a competent CACS assessor prior to attending site to conduct a certification upgrade assessment. This review must be done in combination with the review of the client’s internal audit completed against the requirements of ISO 9001:2015. If deficiencies are detected these must be validated on site before a certification upgrade is made. Both this self-assessment checklist and internal audit is to be utilised during the any upgrade assessments.Auditor/Team Evaluation SummaryHave all appropriateISO 9001:2015 Clauses been considered.Are there any deficiencies detected requiring additional time on siteSenior Management committedManagement System developmentCHOOSE OPTIONCHOOSE OPTIONCHOOSE OPTIONCHOOSE OPTIONAuditor SignoffAuditor PositionSignatureDateCommentsLead AuditorSelect Name[Date]select certification recommendationReviewer SignoffRecommendation to Upgrade to:[Select Standard]is CHOOSE OPTIONApprover PositionSignatureDateCommentsSelect Position Select Name[Date]Process as per Certification Approval CA P 40General ManagerJames Alister[Date]Checklist and supplied records and Associated Documentation Complies with CACS Req.Deficiencies Detected for review during the on-site upgrade assessment.Important Note!Areas of Concern as detailed below are to be validated on site before an upgrade recommendation is made.Standard ReferenceDetailsQuality 2015Quality 2015Quality 2015Quality 2015Additional Auditor Comments: ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download