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ISO 9001:2015 MANAGEMENTSYSTEMS - REQUIREMENTSSELF-ASSESSMENT CHECKLISTCOMPASS ASSURANCE SERVICES PTY LTDNOTE: THIS IS A SIMPLIFIED SUMMARY OF THE REQUIREMENTS OF ISO 9001:2015 QUALITYMANAGEMENT SYSTEM – REQUIREMENTS FOR THE SPECIFIC PURPOSE OF HELPINGORGANISATIONS UNDERTAKE A PRELIMINARY CHECK OF THEIR READINESS FOR AN ISO9001:2015 AUDIT OR ASSESSMENT.
REQUIRED DOCUMENTED INFORMATIONDocumented information needed to be maintained by you forthe purpose of establishing the QMS(a)The scope of the QMS (clause 4.3)(b)Documented information to support the operation ofprocesses (clause 4.4)(c)The Quality Policy (clause 5)(d)The quality objectives (clause 6.2)QUALITY MANAGEMENT SYSTEM4.1UNDERSTANDING THE ORGANISATION AND ITS CONTEXT(a)(b)4.2UNDERSTANDING THEINTERESTED PARTIES(a)(b)4.3Have we determined external and internal issues relevant to the QMSachieving its aimDo we monitor and review these issuesNEEDSANDEXPECTATIONSOFHave we determined what interested parties are relevant to the QMS andwhat are their requirementsDo we monitor and review thisDETERMINING THE SCOPE OF THE QUALITY MANAGEMENTSYSTEMHave we determined the boundaries of the QMS when establishing its scope.Did we consider:(a)external and internal issues(b)the requirements of relevant interested partiesour products and/or services(c)Have we documented the scope?Have we considered this standard and have we justified any exclusion?ISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist2
4.4QUALITY MANAGEMENT SYSTEM AND ITS PROCESSESHave we determined(a)the processes for the system and how they are to be applied(b)the inputs and outputs for those processes(c)how processes interrelate(d)methods to operate and control processes(e)resources and their availability and responsibilitiesHave we evaluated risks and opportunities, processes and their implementationAs necessary, have we got documented information, that gives us confidence thatwe are carrying out activities as planned?ISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist3
5.1LEADERSHIP AND COMMITMENTCan we demonstrate top management is providing leadership and commitment to theQMS including taking accountability for:(a)the QMS(b)policy and objectives being compatible with strategy(c)integration of the QMS into business systems(d)promoting process and risk approach(e)ensuring the QMS is resourced(f)communicating the QMS(g)ensuring the QMS achieves its intended results(h)promoting improvement(i)supporting others5.1.2CUSTOMER FOCUSCan we demonstrate that top management actively providesleadership by ensuring:customer requirements and applicable statutory and(a)regulatory requirements are determined and met(b)risks and opportunities that can affect the products andservices are determined and addressed(c)customer satisfaction determined, maintained andenhanced5.2QUALITY POLICY5.3ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIESHave we ensured the Policy(a)is appropriate to the organisation(b)has a commitment to meet requirements and continually improve thesystem(c)has a framework to set objectivesis communicated and understood(d)(e)available as documented information(f)available to interested parties as appropriateHave we assigned and communicated responsibilities and authorities to ensure:(a)the QMS conforms to the standard(b)processes deliver their outputs(c)reporting on the performance of the QMS to top management(d)promotion of customer focus throughout the organizationISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist4
6 PlanningTO ADDRESS RISKS AND OPPORTUNITIES6.1 ACTIONSHave we determined the risks and opportunities that need to be addressed to:(a)(b)(c)6.26.3assure the QMS achieves its intended resultsavoid or mitigate negative effects, enhance positive effectsachieve improvementHave we planned:(a)actions to address these risks and opportunities(b)how to integrate these actions into the QMSQUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM6.2.1Have we established quality objectives at relevant functions andlevels and are they:(a)consistent with the policy(b)measurable, monitored, communicated and updated asappropriate(c)relevant to conformity of products and services and theenhancement of customer satisfaction and take into accountall applicable requirementsDo we retain documented information on the quality objectives?6.2.2In planning how to achieve our quality objectives, have wedetermined(a)what will be done(b)what resources will be required(c)who will be responsible(d)when it will be completed(e)how the results will be evaluatedPLANNING OF CHANGESWhere we need to make changes to the QMS is it planned and do we consider:(a)the purpose and potential consequences(b)the integrity of the QMS(c)the availability of resources(d)changes to responsibilities and authoritiesISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist5
7 Support7.1 RESOURCES7.1.1 GeneralHave we determined and provide the resources needed for the7.1.2QMS?Have we considered(a)the capabilities of, and constraints on existing resources(b)what needs to be obtained from external providersPeopleHave we provided the persons necessary for the QMS7.1.3Infrastructure7.1.4Environment for the operation of processes7.1.5Monitoring and Measuring ResourcesDo we provide and maintain the necessary infrastructure (such asbuildings, technology, equipment)Do we provide and maintain the environment necessary foroperations(such as temperature, humidity, ergonomics and cleanliness).Have we ensured that the resources provided:(a)are suitable for the specific type of monitoring andmeasurement activities being undertaken(b)are maintained to ensure their continued fitness for theirpurposeHave we retained appropriate documented information asevidence?Have we processes in place to(a)verify or calibrate measurement instruments against reliablestandardsidentify measurement instruments in order to determine(b)their calibration status(c)safeguarded measurement instruments from adjustments,damage or deteriorationHave corrective actions been undertaken when issues arise withmeasurement instrumentsISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist6
7.1.6ORGANIZATIONAL KNOWLEDGEHave we determined and made available the knowledgenecessary for(a)the operation of our processes and(b)achieving conformity of products and servicesDo we determine how to access additional knowledge foraddressing change in our o we(a)determine the necessary competence of person(s) that could affect theQMS(b)ensure that these person(s) are competent on the basis of appropriateeducation, training, or experience(c)take actions to access the necessary competence where applicable(d)retain appropriate documented information as evidence of competenceHave we ensured that person(s) doing work under the control of our businessare aware of(a)the quality policy and relevant quality objectives(b)their contribution to the effectiveness of the QMS, including the benefitsof improved quality performance(c)the implications of not conforming with the quality management systemrequirementsHave we determined the internal and external communications relevant to the QMSincluding:(a)what will be communicated(b)when to communicate(c)with whom to communicate(d)how to communicate(e)Who communicatesISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist7
7.5DOCUMENTED INFORMATION7.5.1GeneralDoes our QMS include(a)documented information required by the standard(b)documented information necessary for the effectivenessof the QMSCreating and updatingDo we ensure we have(a)identification and description (such as a title, date,author, or reference number)review and approval(b)7.5.2Creating and updating7.5.3Control of documented InformationDo we ensure we have(a)identification and description (such as a title, date,author, or reference number)(b)review and approvalDo we ensure documented information required by the QMSare controlled to ensure:it is available and suitable for use(a)(b)it is adequately protectedDo we take into consideration these factorsdistribution, access, retrieval and usage(a)(b)storage and preservation(c)version control(d)retention and disposition(e)external documents are identified as appropriate, andcontrolled.ISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist8
8 OperationPLANNING AND CONTROL8.1 OPERATIONALHave we planned, implemented and controlled our processesHave we(a)determined the requirements for our products and services(b)established criteria for the processes and the acceptance of products andservices(c)determined the resources needed(d)implemented controls(e)retained documented information as necessary to demonstrate processeshave been carried out effectively and product conformance(f)planned changes and reviewed issues,(g)ensured that outsourced processes are controlled8.2REQUIREMENTS FOR PRODUCTS AND SERVICES8.2.1Customer communication8.2.2Determining requirements related to products andservicesHave we established processes for communicating with customersabout:(a)our products and services(b)enquiries, contracts or orders(c)feedback including complaints(d)handling their propertycontingency processes(e)For our products and services have we determined thefollowing requirements:(a)applicable statutory and regulatory(b)those we feel are necessaryCan we meet the claims for the products and services weoffer?ISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist9
8.2.38.2.48.3Review of requirements related to products and servicesBefore committing to supply do we ensure we can meet:(a)requirements specified by the customer(b)requirements necessary for intended use(c)requirements specified by us(d)statutory and regulatory requirements(e)contract or order requirementsDo we(a)ensure that contract or order requirements differing fromthose previously defined are resolved(b)confirm requirements before acceptance of the order(c)retain documented information as applicable describingthe results of the review, including any new or changedrequirements for the products and servicesChanges to requirements for products and servicesHave we(a)ensured that documented information is amended andthat relevant personnel are made aware of the changedrequirements when requirements for products and servicesare changedDESIGN AND DEVELOPMENT OF PRODUCTS AND SERVICES8.3.1General8.3.2Design and Development planningDo we have a design and development process for productsand services that are appropriateIn determining the stages and controls for design anddevelopment, have we considered:(a)(b)(c)(d)(e)(f)(g)(h)the nature, duration and complexity of the activitiesstages including reviewverification and validationresponsibilities and authoritiesinternal and external resourcesinvolvement of customer and user groupsthe subsequent production processdocumented information requiredISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist10
8.3.38.3.48.3.5Design and development InputsHave we considered:(a)functional and performance requirements(b)similar designs(c)statutory and regulatory requirements(d)standards or codes of practice(e)potential consequences of failure due to the nature of the productsand servicesHave we ensured inputs are adequate, complete, and unambiguous andall conflicts are resolvedHave we retained documented information on design and developmentinputsDesign and development controlsDo our controls ensure(a)the results to be achieved are defined(b)reviews are conducted to ensure designs will meet requirements(c)verification is conducted to ensure that design outputs will meet thedefined inputs(d)validation ensures products and services are capable of meeting thespecified requirements or intended use(e)actions are taken on problems(f)documented information of these activities is retained.Design and development outputsHave we ensured that outputs:meet the input requirements(a)(b)are adequate for production(c)reference monitoring and measuring requirements, and acceptancecriteria, as applicable(d)specify the characteristics of the products and services that areessential for their intended purpose and their safe and proper useHas documented information of outputs been retainedISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist11
8.3.68.4Design and development changesDo we ensure there is no adverse impact on conformity when changes aremade during design and developmentDo we keep documented information on(a)design and development changes(b)results of reviews(c)authorisation of changes(d)Actions taken to prevent adverse impactsCONTROL OF EXTERNALLY PROVIDED PRODUCTS AND SERVICES8.4.1GeneralDo we ensure that externally provided processes, products, andservices conform to specified requirements and do we applyappropriate controls when:(a)products and services are provided by external providersfor incorporation into our products and services(b)products and services are provided directly to thecustomer(s) by external providers on our behalf(c)a process or part of a process is provided by an externalproviderHave we established and applied a criteria for luation of external providersDo we retain appropriate documented information8.4.2Type and extent of controlDo we(a)ensure externally provided processes are controlled withinour QMSdefine controls over the process and the output(b)(c)consider impacts to meet statutory and client requirements(d)determine verification requirementsISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist12
8.4.38.5Information for external providersHave we communicated to external providers our requirementsrelated to:(a)the processes, products or services to be provided(b)approval or release of products and services, methods,processes or equipment(c)competence of personnel, including necessaryqualifications(d)their interactions with us(e)control and monitoring we require(f)verification activities to be performed at their premisesPRODUCTION AND SERVICE PROVISION8.5.1Control of production and service provision8.5.2Identification and traceabilityIs production undertaken under controlled conditionsThis may include (as applicable)(a)documented information about the products and servicesor activities to be performed(b)monitoring and measurement activities(c)infrastructure and environment(d)the availability and use of suitable monitoring andmeasuring resources(e)competent persons(f)actions to prevent errors(g)release, delivery and post-delivery activitiesDo we identify outputs where it is necessary to ensure conformity?Do we identify the status of outputs?Do we control the unique identification of outputs wheretraceability is required?Do we retain documented information necessary to maintaintraceability?ISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist13
8.5.3Property belonging to customers or external providers8.5.4Preservation8.5.5Post-delivery activitiesDo we exercise care with property belonging to the customer orexternal providers?Have we identified, verified, protected and safeguarded thecustomer’s or external provider’s property?When property of the customer or external provider is lost ordamaged do we report to the provider and keep documentedinformation on what occurred?(includes materials, components, tools and equipment, customerpremises, intellectual property and personal data)Do we ensure preservation of process outputs during productionto maintain conformity to requirements?(can include identification, handling, packaging, storage,transmission or transportation and protection)Do we meet requirements for post-delivery activitiesassociated with the products and services(Post-delivery activities can include warranty, contractualobligations, maintenance services, recycling or final disposal)Do we consider:statutory and regulatory requirements(a)(b)the potential undesired consequences associated withour products and services(c)the nature, use and intended lifetime of our products andservices(d)customer requirements and feedback8.5.6Control of changesDo we review and control changes in production to ensurecontinuing conformity with requirementsDo we retain documented information of the review of changesto production including authorisation and any necessary actionsISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist14
8.6RELEASE OF PRODUCTS AND SERVICES8.7CONTROL OF NONCONFORMING OUTPUTSDo we have planned processes at appropriate stages of production to verify thatrequirements have been metDo we ensure product is not released until this is completedDo we retain documented information of evidence of conformity with theacceptance criteria and traceability to persons authorizing releaseDo we ensure product that does not conform to requirements are identified andcontrolled to prevent their unintended use or deliveryDo we take appropriate corrective actionDo we deal with nonconforming products in one or more of the followingways:correction(a)(b)segregation, containment, return or suspension of productioninforming the customer(c)(d)obtaining authorization for acceptance under concessionDo we re-verify when products are corrected?Do we retain documented information describing the non-conformance, actionstaken, concessions obtained and authorisationsISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist15
9 Performance Evaluation9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION9.1.19.1.2GeneralHave we determined(a)what needs to be monitored and measured(b)the methods(c)when monitoring and measurement is to be done(d)when results will be analysed and evaluatedDo we evaluate the effectiveness of the QMSDo we retain documented information of thisCustomer satisfactionDo we monitor customer perceptions(this can include customer satisfaction surveys, customerfeedback, market-share analysis, compliments, warranty claimsand dealer reports)Have we determined how we will obtain, monitor and review thisinformation9.1.3Analysis and evaluationDo we analyse and evaluate appropriate dataDo we use the results to evaluate(a)product conformity(b)customer satisfaction(c)the performance and effectiveness of the QMS and anyimprovements needed(d)if planning has been implemented effectively(e)the effectiveness of actions taken to address risks andopportunities(f)external providersISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist16
9.2INTERNAL AUDIT9.2.1Do we conduct internal audits at planned intervals to ensurethe QMS:(a)Conforms to our requirements(b)Conforms to the requirements of 9001:2015(c)Is effectively implemented and maintained9.2.2Have we:(a)planned and implemented an effective audit program(b)defined the criteria and scope for each audit(c)selected auditors to ensure objectivity and impartiality(d)ensured that the results are reported to relevantmanagement(e)taken necessary correction and corrective actions withoutundue delay(f)retained documented informationISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist17
9.3MANAGEMENT REVIEW9.3.19.3.2Does our top management review our QMS at plannedintervalsInputs(a)(b)(c)(d)(e)(f)9.3.3the status of actions from previous management reviewschanges in external and internal issues relevant to theQMSinformation on the QMS including customer satisfaction and stakeholder feedback quality objectives performance product performance and conformity nonconformance and corrective action monitoring and measurement including audits external providers process performance and conformity of productsand services;adequacy of resourcesactions taken regarding risk and opportunityimprovementOutputs(a)opportunities for improvementchanges to the QMS(b)(c)resourcesDo we retain documented information as evidence of the resultsof management reviewsISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist18
10 Improvement10.1GENERALHave we determined and selected opportunities for improvement andimplement necessary actions including:(a)improving products and services(b)correcting, preventing or reducing undesired effects;(c)improving the performance and effectiveness of the QMS10.2 NONCONFORMITY AND CORRECTIVE ACTION10.2.1When a nonconformity occurs, including complaints,do we:(a)react to the nonconformity, and as applicable: take action to control and correct it deal with the consequences(b)evaluate the need for action to eliminate thecause(s) by: reviewing and analysing determining the causes determining if similar nonconformities exist,or could potentially occur(c)implement any action needed(d)review the effectiveness of any corrective actiontaken(e)make changes to the QMS if necessary10.2.2Have we retain documented information as evidence of:(a)the nature of the nonconformities and anysubsequent actions taken(b)the results of any corrective actionISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist19
10.3CONTINUAL IMPROVEMENTDo we(a)continually improve the effectiveness of the QMS(b)consider the outputs of analysis and management reviews toidentify opportunities for continual improvement(c)encourage Compass Assurance Services to keep improving andremain a valuable partner to usISO 9001:2015 Quality Management SystemsRequirements Self-Assessment Checklist20
iso 9001:2015 management systems - requirements self-assessment checklist note: this is a simplified summary of the requirements of iso 9001:2015 quality management system – requirements for the specific purpose of helping organisations undertake a preliminary check of their readiness f
