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ISO 9001:2015Quality Management SystemAssessment ChecklistRP-2RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
Table of ContentsIntroduction . 2Assessment Summary Sheet - Sample . .7Assessment Summary Sheet . .104 – Context of the Organization . 135 – Leadership . 146 – Planning for the Quality Management System 167—Support . 178 – Operation . 229 – Performance Evaluation . 3310 – Improvement 36RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
The Quality System Checklist is intended to help you gain a betterunderstanding of the requirements of ISO 9001:2015. ISO9001:2015 requires the adoption of the process approach whichextends to internal quality audits. This checklist follows thestructure of the standard, thus it is not process based. For thisreason it is not intended to be used as the only tool for internalquality audits.You can gain a better understanding of ISO 9001:2015 Standard asit applies to your company by reviewing these questions. You maywish to discuss them with your auditors to enhance everyone’sunderstanding of the ISO 9001:2015 requirements and theassessment process.You should be aware that although the following questions includemost of the requirements of the ISO 9001:2015 standard, they donot necessarily cover all aspects of the Standard. So, the use of thischecklist will give you only a sample of your organization’sconformance to the ISO 9001:2015 standard.RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
Assessment Summary SheetThe Assessment Summary Sheet may be used for visualizing the big picture:what areas were checked and where discrepancies were found. You’ll seefrom the sample Assessment Summary Sheet that assessment of thePurchasing Process uncovered discrepancies for clauses 4.1, 5.3, 7.1.5, 8.1,8.2, 8.3.1 and 8.5.3. This may be a sign of problems in that process, whichwarrant planning and close monitoring of corrective actions. The ProcessesAssessed column reveals that for clause 7.1.2 for Resource Requirements or8.2 for Determination of requirements for products and services,discrepancies were uncovered in all applicable areas. This may giveevidence of a system breakdown.On the sample Assessment Summary Sheet, the circled numberscorrespond to the following: The ISO 9001:2015 Assessment Standard correspond to theISO9001:2015 International Standard which your company has selected forassessment. The column Process Assessed lists the areas (i.e. process) wherecompliance to given clauses will be evaluated. These columns contain the list of clauses for the applicable ISO Standardto which compliance is being sought. NOTE: All clauses of the ISO 9001Standard must be addressed. See section 0.1. “Forward”, for furtherinformation. Use this grid to indicate where discrepancies are found by entering a “D”into the corresponding boxes. Where no discrepancies are uncovered,enter an “X” in the appropriate boxes.RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
0.2 Process ApproachISO9001:2015 promotes the adoption of a process approach. As a firststep, all processes of the organization need to be identified and theirinterrelation defined. A process is a set of activities that transform inputsinto outputs. The outputs of one process may be the input of anotherprocess, or the finished product. Although a process map is not required,it is an effective method for demonstrating process interrelation. Any othermethod will equally meet the requirements of the standard as long as theprocess interaction is somehow shown.An example of a typical process map is noted on the next page. Please notethat a process map is not a process flow diagram, but merely highlights themain processes of the organization that are needed to be effectivelymonitored to ensure “consistent and predictable results”. Also, theprocesses noted are not the names of the functions within theorganization, but value added activities within the organization that mayinvolve sub-processes that will have to be further defined.RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
Assessment Summary Sheet – SAMPLEISO t. ReviewInternal AuditsCAR/CIQualityDoc. ControlHRMaintenancePack & ShipTestProduction 2Production 1Cust. Sat.SalesEngineeringManagementQuality ManagementSystems:RequirementsPurchasingProcesses of the Organization 4.1Understanding the organizationand its contextX4.2Needs and Expectations of theInterested PartiesX X4.3Determining the scope of thequality management systemX4.4Quality Management Systemand its processesX5.1Leadership and commitmentX5.2Quality PolicyX XXX X X X X X X X X X X X X X5.3Organizational roles,responsibilities and authoritiesX XXX D X X X X X X X X X X X X6.1Actions to address risks andopportunitiesX XXX X X X X X X X X X X X X X6.2Quality objectives and planningto achieve themX XXX X X X X X X X X X X X X X6.3Planning of changesD7.1ResourcesX XXXX X X X X X X X X X X X XXXXX X X X X X X X X X X X X X7.1.1General7.1.2PeopleD D D D D D D D D D D7.1.3InfrastructureX X7.1.4Environment for the operationof processesX X7.1.5Monitoring and Measuring7.1.6Organizational KnowledgeX XXX X X X X X X X X X X X X X7.2CompetenceX XXX X X X X X X X X X X X X X7.3AwarenessX XXX X X X X X X X X X X X X X7.4CommunicationXRP-2 ISO 9001:2015DQS Inc.Discrepancy ReferenceNumberXXXX X X XXXX X X XXXD X X XX XXXIssued: 9/18/15Revised: 5/12/17
ISO 9001:2015Mgt. ReviewAccountingCAR/CIQualityHRPack & ShipTestX X X X X D X X X X X X X XDiscrepancy ReferenceNumber Documented InformationX X7.5.1GeneralX7.5.2Creating and updatingXX7.5.3Control of documentedInformationXX8.1Operational planning andcontrolX X8.2Determination of requirementsD D D D D D D D D8.2.1Customer communicationX XX8.2.2Determination of requirementsrelated to products and servicesxX8.2.3Review of requirements relatedto products and servicesX8.2.4Changes to requirementsX8.3Design and DevelopmentXX8.3.1GeneralX XX8.3.2Design and developmentplanningXX8.3.3Design and development inputsXX8.3.4Design and developmentcontrols.DX8.3.5Design and developmentOutputsXX8.3.6Design and developmentchangesXX8.4.2Type and extent of control ofexternal provisionX8.4.3Information for externalprovidersX8.5.1Control of production andServiceRP-2 ISO 9001:2015DQS Inc.Internal AuditsDoc. ControlMaintenanceProduction 2XPurchasingSalesCust. agementQuality ManagementSystems:RequirementsProduction 1Processes of the Organization XXX D X X X XXX X XX D X X X XX XIssued: 9/18/15Revised: 5/12/17
ISO t. ReviewInternal AuditsCAR/CIQualityDoc. ControlHRMaintenancePack & ShipTestProduction 2Production 1Cust. Sat.SalesEngineeringManagementQuality ManagementSystems:RequirementsPurchasingProcesses of the Organization Discrepancy ReferenceNumber 8.5.2Identification and traceability8.5.3Property belonging tocustomers or external providers8.5.4Preservation8.5.5Post-delivery activities8.5.6Control of changesXX X X XDXX X X XXX XX XXXX8.6Release of products andservicesX X8.7Control of nonconformingproductsX X X D9.1.1Monitoring, measurement,analysisX X9.1.2Customer SatisfactionX X9.1.3Analysis and evaluationX X9.2Internal AuditsX9.3Management ReviewX10.1Improvement – GeneralX X10.2Nonconformity/CorrectiveAction10.3Continual improvementXX X X X X D X X X X X X XXXX X X X X D X X X X X X XXXXX X X X X D X X X X X X XX X X DX XX XXX XX X X X X D X X X X X X X* Use an “X” to indicate that the clause was assessed in the area described.Use a “D” to indicate that a discrepancy was found.RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
Assessment Summary SheetISO 9001:2015 Quality scriptionUnderstanding the organizationand its context4.2Needs and Expectations of theInterested Parties4.3Determining the scope of thequality management system4.4Quality Management Systemand its processes5.1Leadership and commitment5.2Quality Policy5.3Organizational roles,responsibilities and authorities6.1Actions to address risks andopportunities6.2Quality objectives and planningto achieve them6.3Planning of rastructure7.1.4Environment for the operationof processes7.1.5Monitoring and Measuring7.1.6Organizational 2 ISO 9001:2015DQS Inc.Discrepancy ReferenceNumber 4.17.2Processes of the Organization Issued: 9/18/15Revised: 5/12/17
ISO 9001:2015 Quality eDescriptionProcesses of the Organization Discrepancy ReferenceNumber Documented Information7.5.1General7.5.2Creating and updating7.5.3Control of documentedInformation8.1Operational planning andcontrol8.2Determination of requirements8.2.1Customer communication8.2.2Determination of requirementsrelated to products and services8.2.3Review of requirements relatedto products and services8.2.4Changes to requirements8.3Design and Development8.3.1General8.3.2Design and developmentplanning8.3.3Design and development inputs8.3.4Design and developmentcontrols.8.3.5Design and developmentOutputs8.3.6Design and developmentchanges8.4.2Type and extent of control ofexternal provision8.4.3Information for externalproviders8.5.1Control of production andServiceRP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
ISO 9001:2015 Processes of the Organization Quality scriptionDiscrepancy ReferenceNumber 8.5.2Identification and traceability8.5.3Property belonging tocustomers or external providers8.5.4Preservation8.5.5Post-delivery activities8.5.6Control of changes8.6Release of products andservices8.7Control of nonconformingproducts9.1.1Monitoring, measurement,analysis9.1.2Customer Satisfaction9.1.3Analysis and evaluation9.2Internal Audits9.3Management Review10.1Improvement – nual improvement* Use an “X” to indicate that the clause was assessed in the area described.Use a “D” to indicate that a discrepancy was found.On the following pages,requirements.RP-2 ISO 9001:2015DQS Inc.indicates new/significantly changedIssued: 9/18/15Revised: 5/12/17
Quality Management System ChecklistQuality Management SystemRequirementsISO9001:2015Clause #44.1DocumentedInformationReferenceExplanatory Notes andCommentsContext of the organizationUnderstanding the organization and its context4.1Has the organization identified all external andinternal issues relevant to its purpose anddirection?What is the process for monitoring and review ofthe external and internal issues?4.2Understanding the needs and expectations of interested parties4.14.2Has the organization identified all relevantinterested party requirements that are relevant tothe quality management system? How is theinformation monitored?4.3Determining the scope of the Quality Management System4.3Is the scope of the quality management system,including products and services provided andjustification for any exclusion, defined?Is the scope of the quality management systemmaintained as documented information?Are the following considered when determiningthe scope? External and Internal Issues Requirements of relevant interestedparties The products and services provided.Is there assurance that all requirements of thestandard that can be applied, have been appliedby the organization and those determined nonapplicable do not affect the organization’s abilityor responsibility to ensure conformity?4.34.34.3RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
Quality Management SystemRequirementsISO9001:2015Clause anatory Notes andCommentsQuality Management System and its processesHave the processes of the organization beenidentified? Inputs and Outputs Sequence and interaction Criteria, method and performanceindicators Resources needed Defined responsibility and authority for allpersonnel. Risks and Opportunities Method for monitoring and change toensure intended results Opportunities for improvement of theprocessesHas the organization defined Needed documented information tosupport the operation of its processes? Documented information to be retained asevidence that the processes are beingcarried out as planned?LeadershipHas top management demonstrated leadership by Taking accountability of the process? Establishing the Quality Policy andObjectives? Communicating the Policy? Ensuring QMS Requirements areintegrated into the processes? Making available adequate resources? Communicating QMS effectiveness? Ensuring achievement of results? Engaging/directing/supporting processeffectiveness? Promoting continual improvement? Supporting other management roleswithin the organization to do the same?RP-2 ISO 9001:2015DQS Inc.Issued: 9/18/15Revised: 5/12/17
Quality Management SystemRequirementsISO9001:2015Clause #5.1.1 5.1.25.25.2.1Explanatory Notes andCommentsCan top management demonstrate evidence ofcommitment to the development, implementationand improvement of the effectiveness of thequality management system by: 5.1.2DocumentedInformationReferenceCommunicating to the organization theimportance of meeting customer requirements?Establishing the quality policy?Ensuring that quality objectives areestablished?Conducting management reviews?Ensuring the availability of resources?Customer FocusHas top management demonstrated leadership by Identifying customer requirements? Identifying regulatory requirements? Identifying statutory requirements? Risks and Opportunities determined andaddressed?
checklist will give you only a sample of your organization’s conformance to the ISO 9001:2015 standard. RP-2 ISO 9001:2015 Issued: 9/18/15 DQS Inc. Revised: 5/12/17 Assessment Summary Sheet The Assessment Summary Sheet may be used for visualizing the big picture: what areas were checked and where discrepancies were found. You’ll see from the sample Assessment Summary Sheet that
