Subject: Quality Management System Clause 9 & 10 .

Subject: Quality Management SystemClause 9 & 10 – Performance Evaluation &Improvement

ContentsISO 9001:2015LeadershipContext of theorganizationSupportPlanningOperationPerformance evaluationImprovement

CLAUSE 9 – Performance EvaluationRequirements

CLAUSE 9 – Performance EvaluationThe organization shall determine:What needs to bemonitored andmeasuredThe methods formonitoring,measurement,analysis andevaluationWhen themonitoring andmeasuring shall beperformedWhen the resultsfrom monitoringand measurementshall be analyzedand evaluated

CLAUSE 9 – Performance Evaluationthe performance and theeffectiveness of the qualitymanagement systemappropriate documentedinformation as evidence of theresults

Customer satisfactionThe organization shall monitorthe customers‘ perception ofthe degree to which theirneeds and expectations havebeen fulfilled.The organization shall determinethe methods for obtaining,monitoring and reviewing thisinformation

Customer satisfactionExamplesCustomer surveys, customer feedback (praise, complaints )Meetings with customersMarket-share analysisCompliments, warranty claimsDealer reports

[Short Client Name]Customer Satisfaction Survey Rev. [Rev Number]Instructions: Please fill out the form below and fax it back to [Fax] or email to [General Company EmailAddress].Customer Name:Customer Fax:Contact Name:Date:RatingSurvey Question1 Are you satisfied with our services?2 How would you rate our level of quality?How would you rate our level of customerservice?Do you feel we adequately respond to4 and correct any problems or issues thatmay arise?How would you rate our provement

An organization - wide program that integrates allfunctions and processes of the business so that design,planning, production, distribution and services arefocused on maximizing customer satisfaction throughcontinued improvement.Gary Dessler (Author in Human Resource Management)

DETERMINANTS OF SERVICE QUALITY (SERVQUAL)A system approach of the customer satisfaction through the different attributes of service qualityINPUT bility/ AccessAssuranceCourtesy/ FriendlinessCredibilityReliabilityAssurance/ esUnderstanding CustomersOUTPUTCUSTOMERSATISFACTION

ANALYSIS AND EVALUATIONThe results of analysis shall be used to evaluate:a.Conformity of products and servicesb.the degree of customer satisfactionc.the performance and effectiveness of the quality management systemd.if planning has been implemented effectivelye.effectiveness of actions taken to address risks and opportunitiesf.the performance of external providersg.the need for improvements to the quality management system

FAILURE MODE EFFECT ANALYSIS (FMEA)FAILURE MODE & EFFECTS ANALYSIS (FMEA)PROCESS NAMEDate:PROCESS NUMBERA) SeverityFailure ModeRevision:B) Probability ofOccurrenceC) Probability ofDetectionRate 1-10Rate 1-10Rate 1-1010 Most Severe10 Highest Probability10 Lowest ProbabilityRisk PreferenceNumber (RPN)AxBxC1. Select wrong color seat belt543602. Seat belt bolt not fully tightened9281443. Trim cover clip misaligned23424

FIVE WHY ANALYSISThe 5 Whys is a question-asking method used to explore the cause of a particular problem and tounderstand cause-and-effect relationshipsWHY?Root Cause*REASONWhy was our customer unhappy?The service has been delivered to late. The customer was unsatisfied.Why was the service not prepared on time?We did not prepare the service on time because it took much longer than we expected.Why did it take so long?Because we did not receive all approvals on time and underestimated theduration of the project.Why did we underestimate the projectduration?Because we forgot to prepare a detailed list of all tasks.Why did we forget it?Because we were running behind on other projects and failed to review ourtask list and time estimation during the project.We did not have checklists to track our tasks and to estimate the duration of the project. For future projects, these factors shall be considered.* Note the root cause(s) of the problem here. Only the one who experienced the problem is qualified to perform the analysis.There is usually more than one root cause.

INTERNAL AUDITThe organization shall conduct internal audits at planned intervalsto provide information on whether the quality managementsystem conforms to the organization‘s own requirements for its qualitymanagement system and the requirements of this International Standard

INTERNAL AUDITThe organization shall plan establish implement and maintain one or more audit program(s)

INTERNAL AUDITIn doing so, it shall be considered : frequency of audits methods responsibilities planning requirements and reportingwhich is dependent on: importance of the processes concerned changes affecting the organization and the results of previous audits

INTERNAL AUDITThe organization shall: define the audit criteria and scope for each auditselect auditors and conduct audits to ensure objectivity and the impartiality of the audit process.

INTERNAL AUDITIt shall be ensured that the results of the audits are reported torelevant management.If correction and corrective actions are necessary,they shall be implemented without undue delay.[Short Client Name]Internal Audit Report Rev. [Rev Number]STEP ONE: Audit PlanProcess to Audit (Audit Scope):Audit Date(s):Lead Auditor:Audit #:Auditor(s):Site(s) to Audit:Applicable Clauses of [ISO 9001 or AS9100] Standard:Applicable Documents to AuditRev.[Quality Manual Doc Title]STEP TWO: Compare Documentation vs. RequirementsCompare the [Short Client Name] documentation with the applicable clauses of [ISO 9001 or AS9100].QuestionIn general, does the [Short Client Name] documentation meet the requirementsof [ISO 9001 or AS9100]?Review any customer requirements that may be applicable to this process. (Ifthere are none, enter “N/A” in the middle column.) In general, does the [ShortClient Name] documentation meet these requirements?Review any statutory or regulatory requirements that may be applicable to thisprocess. (If there are none, enter “N/A” in the middle column.) In general, doesthe [Short Client Name] documentation meet these requirements?Example – Internal audit reportIndicate any suggestions for improvement related to the documentation:Y/N(or N/A)Evidence or NotesSheet Ref. #

MANAGEMENT REVIEWTop management shall review the organization‘s quality management system at planned intervals to ensure its continuing suitability adequacy and effectiveness and alignment with the strategic directionof the organization.

MANAGEMENT REVIEWThe management review shall be planned and carried out, takinginto consideration the following aspects (inputs): Status of the actions from previous management reviews changes in external and internal issues that are relevenat to thequality management system information on the performance and effectiveness of the qualitymanagement system the adequacy of resources the effectiveness of actions taken to address risks andopportunities opportunities for improvement

MANAGEMENT REVIEWThe outputs of the management review shall include decisions and actions related to: opportunities for improvement any need for changes to the quality management system resource needs[Short Client Name]Management Review Meeting Minutes Rev. [Rev Number]This template is intended as a tool to prepare records of Management Review Meetings. Please completeeach section; this form may be used as the final report, or used as a template to type and publish moreformal Management Review Meeting records. At all stages, management must consider proper, proactivemeasures to take to improve the company, and where it is necessary to apply preventive action. Record[CAR Form Name] ([CAR Form Abbreviation]s) filed in last section of this template.Date of Review:Recorded by:In attendance:NAMETITLEAbsent:NAMEExample – Management Review Meeting MinutesTITLEFor absent members, the minutes of this meeting must be sent to them afterwards, and opportunity forreview and comment given. Any comments, changes, or additional inputs from these individuals must beincorporated into the final minutes or issued as an addendum.

ContentsISO 9001:2015LeadershipContext of theorganizationSupportPlanningOperationPerformance evaluationImprovement

CLAUSE 10 – ImprovementRequirements

GeneralThe organization shall determine and select opportunitiesfor improvement and implement any necessary actions to meet customer requirements and enhance customer satisfactionProduction capacityInventory levelsOrder lead timeCarrier performanceINTERNAL PROCESS MATRIXPrimary relationshipSecondary relationshipMinor relationship

GeneralThese shall include: Improving products and services to meet requirements as well as to address future needs andexpectations Correcting, preventing or reducing undesired effects Improving the performance and effectiveness of the quality management system

GeneralExamples of improvements can include:Customer Focus corrections corrective actions continual improvementTotalInvolvementPlanningProcess breakthrough change innovation and re-organizationProcessImprovementProcessManagement

NONCONFORMITY AND CORRECTIVE ACTIONWhen a nonconformity occurs (whether determined internally or externally), theorganization shalla.react to the nonconformits and, as applicable, take action to control andcorrect it to deal with the consequencesb.evaluate the need for action to eliminate the cause(s) of the nonconformity,in order that it does not recur or occur elsewherec.implement any action neededd.review the effectiveness of any corrective action takene.update risks and opportunities determined during planning, if necessaryf.make changes to the quality management system, if necessary

CONTINUAL IMPROVEMENTSuitabilityAdequacyEffectiveness

CONTINUAL IMPROVEMENTThe organization shall consider: The results of analysis and evaluation The outputs from management reviewto determine if there are needs oropportunities that shall be addressed as apart of continual improvement.

Strategy is a style of thinking, a conscious anddeliberate process, an intensiveimplementation system, the science of insuringfuture success.Peter Johnson (American pianist)

INTERNAL AUDIT Example –Internal audit report [Short Client Name] Internal Audit Report Rev. [Rev Number] STEP ONE: Audit Plan Process to Audit (Audit Scope): Audit Date(s): Lead Auditor: Audit #: Auditor(s): Site(s) to Audit: Applicable Clauses of [ISO 9001 or AS9100] S