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Internal Audit Checklistfor ISO 9001:2015 based Implementation Gap Analysis2016
ISO 9001:2015 Quality Management System Audit ChecklistPro QC International ISO 9001:2015 Gap Analysis Audit Tool Disclaimer§ This audit is intended for use within one organization. The audit may be customized to suit your needs and preferences.§ THE AUDIT IS DISTRIBUTED ON AN "AS IS" BASIS WITHOUT WARRANTIES OF ANY KIND, EITHER EXPRESSED ORIMPLIED. Copyright§ This tool is created and copyrighted by PRO QC INTERNATIONAL & ART OF QUALITY CONSULTING§ Copyrights of all the questions used in this presentation are held by their respective owners.Current contact information can be found at proqc.com.Page 2 of 49
ISO 9001:2015 Quality Management System Audit ChecklistAUDIT PLANName of our organization audited:Audit Number:Date and Time of Audit:Functional Area covered:All ISO 9001:2015 QMS related process areasName(s) of Auditor(s):(Internal Auditor Team names)Name(s) of Auditees/QMS Process Owners(s):(QMS Process owners)ISO 9001:2015 Quality Management SystemClause OverviewNr45678910309 309CLAUSEContext of our ormance EvaluationImprovementPage 3 of 49PDCA CYCLEPlanPlan, Do, Check, ActPlanDoDoCheckActRequirement #242627431284318
ISO 9001:2015 Quality Management System Audit ChecklistGAP ANALYSIS EVALUATIONAudit Result SummaryAffected QMSProcessGap Analysis ResultsOpportunity for Improvement(OFI) RecommendationResponsibility(Who?)Due Date(Untilwhen?)Name the affectedQMS Process(Existing/New)(Write all justification artifacts like.Levels of current implementation at organization,Nonconformity to ISO 9001:2015 facts, Easy toimplement or accomplish, potential remedy orsolution to become compliant, etc.Who will take care ofthat particular QMSupgrade?Calculate duedates for theImplementationProject Plan(Clausewise)Name the ClauseSignature of Lead Auditor : Date: Page 4 of 49Reviewed and Approved - Signature of CEO : . .Date: .
ISO 9001:2015 Quality Management System Audit ChecklistClause 4: CONTEXT OF OUR ORGANIZATION4.1 Understanding our organization and its contextSl. SI.#Au Audit Question11122Au Audit ResultAu Describe the GapHas our organization determined the external and internal issues that are relevant to itspurpose and its strategic direction andthat affect our ability to achieve the intended result(s) of our quality management system?(Are documents available like Business Plans, SWOT Analysis, Stakeholder Analysis, etc )Is our organization monitoring and reviewing information about these external and internalissues? How is it done?4.2 Understanding the needs and expectations of interested partiesSI.#Audit Question1Due to their effect or potential effect on our organization’s ability to consistently provideproducts and services that meet our customer and applicable statutory and regulatoryrequirements, has our organization determined in documented format .a) the interested parties that are relevant to our quality management system?b) the requirements of these interested parties that are relevant to our quality managementsystem? (Any documentation available as evidence for that?)2Whether and how our organization monitors and reviews information about these interestedparties and their relevant requirements?Page 5 of 49Audit ResultDescribe the Gap
ISO 9001:2015 Quality Management System Audit Checklist4.3 Determining the scope of our quality management systemSl. #Audit Question1Has our organization determined the boundaries and applicability of our qualitymanagement system to establish its scope? (Scope Statement available?)2When determining this scope, did our organization consider:a) the external and internal issues referred to in 4.1?b) the requirements of relevant interested parties referred to in 4.2?c) the products and services of our organization.3Did our organization apply all the requirements of the ISO 9001:2015 standard if theywere applicable within the determined scope of our QMS?4Is the scope of our organization’s quality management system visually available andmaintained as documented information somewhere?5Does the scope state the types of our products and services covered, and providejustification for any requirement of the ISO 9001:2015 standard that our organizationdetermines as not applicable to the scope of our quality management system?6Are we aware that conformity to the ISO 9001:2015 standard may only be claimed if therequirements determined as not applicable do not affect our organization’s ability orresponsibility to ensure the conformity of our products and services and the enhancementof customer satisfaction?Page 6 of 49Audit ResultDescribe the Gap
ISO 9001:2015 Quality Management System Audit Checklist4.4 Quality management system and its core processesSl. #12Audit Question(4.4.1)Has our organization determined the main QMS related processes needed for our qualitymanagement system and their application throughout our organization?(4.4.1)Has our organization .a) determined the inputs required and the outputs expected from these processes?b) determined the sequence and interaction of these processes? (Flow charts?)c) determined and applied the criteria and methods (including monitoring, measurementsand related performance indicators) needed to ensure the effective operation andcontrol of these processes?d) determined the resources needed for these processes and ensured their availability?e) assigned the responsibilities and authorities for these processes?f) addressed the risks and opportunities as determined in accordance with therequirements of 6.1 (planning)?g) evaluated these processes and implemented any changes needed to ensure thatthese processes achieve their intended results?h) tried to improve these processes and also our entire quality management system?(4.4.2)3To the extent necessary, does our organization .a) maintain documented information to support the operation of our QMS relatedprocesses? Please cite some examples like Core Process Map, Quality Manual, etc.b) retain documented information to have confidence that all QMS related processes arebeing carried out as planned? Records keeping? Please cite some examples.Page 7 of 49Audit ResultDescribe the Gap
ISO 9001:2015 Quality Management System Audit ChecklistClause 5: LEADERSHIP5.1 Leadership and commitmentSl. # Audit Question1(5.1.1 - General)In order to demonstrate its leadership and commitment with respect to our qualitymanagement system, is our top management “Hands on”.a) taking accountability for the effectiveness of our quality management system? Pleasecite some examples.b) ensuring that our quality policy and quality objectives are established for our qualitymanagement system and are compatible with the context and strategic direction of ourorganization? Please cite some examples (Quality Policy signed, etc ?).c) ensuring the integration of our quality management system requirements into ourorganization’s business processes? Please cite some examples.d) promoting the use of the process approach and risk-based thinking? Please cite someexamples. (Quality training, E-newsletter, any other documented evidence, etc )e) ensuring that the resources needed for our quality management system are available?Please cite some examples. Is there are Employee Handbook available?f) communicating the importance of effective quality management and of conforming toour quality management system requirements? Please cite some examples.g) ensuring that our quality management system achieves its intended results? Pleasecite some examples. Is there a List of Authorities/Responsibilities, Org-Chart available?h) engaging, directing and supporting persons to contribute to the effectiveness of ourquality management system? Please cite some examples.i) promoting improvement? Please cite some examples. Improvement plans, etc j) supporting other relevant management roles to demonstrate their leadership as itapplies to their areas of responsibility? Please cite some examples. QMS Processowner plan, Master-list of approved SOP’s, Records, Job descriptions, advancedquality training evidence records (Lean, Six Sigma, etc )Page 8 of 49Audit ResultDescribe the Gap
ISO 9001:2015 Quality Management System Audit Checklist2(5.1.2 - Customer focus)In order to demonstrate its leadership and commitment with respect to customer focus, isour top management ensuring that .a) customer and applicable statutory and regulatory requirements are determined,understood, monitored and consistently met?b) the risks and opportunities that can affect conformity of products and services and theability to enhance customer satisfaction are determined and addressed? (Risk plan?)c) the focus on enhancing customer satisfaction is maintained?NOTES:Page 9 of 49
ISO 9001:2015 Quality Management System Audit Checklist5.2 PolicySl.#Audit Question(5.2.1 - Establishing the quality policy)1Has our top management established, implemented and maintaining a quality policy that .a) is appropriate to the purpose and context of our organization and supports its strategicdirection?b) provides a framework for setting our quality objectives?c) includes a commitment to satisfy applicable requirements?d) includes a commitment to continual improvement of the quality management system?(5.2.2 - Communicating the quality policy)2Whether the quality policy .a) is available and is maintained as documented information?b) is communicated, understood and applied within our organization? Posters, e-newsletter?c) is available to relevant interested parties, as appropriate?Page 10 of 49Audit ResultDescribe the Gap
ISO 9001:2015 Quality Management System Audit Checklist5.3 Organizational roles, responsibilities and authoritiesSl. #Audit Question1Does our top management ensure that the responsibilities and authorities for relevant QMSrelated process roles are assigned, communicated and understood within our organization?(Responsibility Charts, Org-Chart, etc )2Has our top management assigned the responsibility and authority for .a) ensuring that our quality management system conforms to the requirements of the ISO9001:2015 standard?b) ensuring that all QMS related processes are delivering their intended outputs?c) reporting on the performance of our quality management system and on opportunities forimprovement, in particular to our top management?d) ensuring the promotion of customer focus throughout our organization?e) ensuring that the integrity of our quality management system is maintained when changesto our quality management system are planned and implemented?Page 11 of 49Audit ResultDescribe the Gap
ISO 9001:2015 Quality Management System Audit ChecklistClause 6: PLANNING6.1 Actions to address risks and opportunitiesSl. #Audit Question(6.1.1)1When planning for our quality management system, did our organization consider theissues referred to in 4.1 and the requirements referred to in 4.2 and determine allrisks and relevant new opportunities that need to be addressed to:a) give assurance that our quality management system can achieve its intendedresult(s)? Global Risk plan if needed? Inclusive Supplier risk evaluation?b) enhance desirable effects?c) prevent, or reduce, undesired effects? (FMEA, or any other Risk planning tool?)d) achieve improvement?(6.1.2)2Has our organization planned .a) actions to address these risks and opportunities? (Continuity/Contingency plan?)b) how to:1) integrate and implement the actions into its quality management systemprocesses (see 4.4)? Do we have a Risk and/or Safety Committee?2) evaluate the effectiveness of these actions? Regular Risk status meetings?(6.1.2)3Whether the actions taken to address risks and opportunities shall be proportionateto the potential impact on the conformity of products and services? Global and local?Page 12 of 49Audit ResultDescribe the Gap
ISO 9001:2015 Quality Management System Audit Checklist(6.1.2)4Do the options to address all to our organization relevant risks include avoiding risk,taking risk in order to pursue an opportunity, eliminating the risk source, changing thelikelihood or consequences, sharing the risk, or retaining risk by informed decision?(6.1.2)5Has any opportunity led to the adoption of new practices, launching new products,opening new markets, addressing new customers, building partnerships, using newtechnology and other desirable and viable possibilities to address our organization’sor its customers’ needs? Please cite some instances.NOTES:Page 13 of 49
ISO 9001:2015 Quality Management System Audit Checklist6.2 Quality objectives and planning to achieve themSl. #Audit Question(6.2.1)1Has our organization established and connected our quality objectives with relevant functions,levels and processes needed to achieve our quality management system objectives?(6.2.1)2Whether the chosen quality objectives .a)b)c)d)are consistent with our quality policy? Any SOP for QMS planning?are measurable and broken down visible in our QMS processes?take into account applicable requirements? Key Performance Indicator (KPI) Plan?are relevant to conformity of our products and services and focus on enhancement ofcustomer satisfaction?e) are monitored? Do we have a Records keeping plan?f) are communicated throughout our organization?g) are updated, as appropriate?(6.2.1)3Does our organization maintain documented information on the QMS quality objectives?(6.2.2)4When planning how to achieve our quality objectives, does our organization determine .a)b)c)d)e)what will be done? Do we collect and track monthly KPI Records for status update?what resources will be required?who will be responsible? Process owners responsible for tracking process interruptions?when it will be completed? Quarterly, Monthly, weekly?how the results will be evaluated? Is the Quality team
ISO 9001:2015 Quality Management System Audit Checklist Page 6 of 49 4.3 Determining the scope of our quality management system Sl. # Audit Question Audit Result Describe the Gap 1 Has our organization determined the boundaries and applicability of our quality management system to establish its scope? (Scope Statement available?) 2File Size: 903KBPage Count: 49
