ISO 9001 For Dummies - Quality Austria

?ISO 9001for Dummieswww.qualityaustria.comAccredited by BMDWwww.qualityaustria.com1

?PROLOGYour trainerWhat exactly is ISO 9001?ISO 9001 is a management system standard, which is voluntarily agreed on, and applied across the industry. Thisstandard includes requirements for quality management. In order to implement ISO 9001, an organization shouldbe able to meet customer requirements and enhance customer satisfaction. Since these concerns are vital for anyorganization, ISO 9001 can be applied in all sectors or on/de/public/details/553481/DIN EN ISO 9001 2015 11Dr. Anni KoubekExecutive Vice President Innovation,Business DevelopmentCertification Quality ISOFig. 1: ISO 9001:2015 standardwww.qualityaustria.com2

?WHY IS ISO 9001IMPORTANT?Quality management systemWhat is “ISO”?Why do you need anISO certification?ISO is an abbreviation for “InternationalOrganization for Standardization”, locatedin Switzerland. (Almost) every country inthe world is represented in this organizationand is working with “ISO”. Each standardis subject to a voting process, in which allcountries have to reach consensus. ISOhas already published more than 20.000standards, whereof ISO 9001 is the mostwidely used Standard, covering certification of more than 1 million companies andorganizations. The work of preparing ISOStandards is normally carried out throughtechnical committees (TCs) and sub-committees (SCs). The committee ISO TC/176/SC2 is responsible for ISO 9001. Customer or potential customeror authority requests the certificate Internal decision - framework fororganizational development group Quality AustriaFig. 2: Responsible parties in the development of ISO standardsCEN: European Institute for StandardizationASI: Austrian Standards Internationalwww.qualityaustria.com Quality AustriaFig. 3: Benefits of a management systemA quality management system can provide manybenefits, if geared towards the goal of sustainedsuccess. In many cases, the decision on implementing ISO 9001 is taken on basis of customerrequirements. When implementing ISO 9001, organizations should establish a customizedmanagement system, which is suitable fortheir own company, in order to avoid solutions that do more harm than good.3

?WHAT IS INISO 9001?HOW DO IIMPLEMENT IT?Process managementPDCA cycleProcess approach inquality managementISO 9001:2015 is divided into 10 sections, theclauses 4 to 10 are requirements. The relationship between the individual clauses is illustratedin the figure below. Applying a process approachin a management system enables converting requirements into products and services, using acycle of planning, implementation, evaluation andimprovement. Leadership is one (or is THE) keyelement, and controls all areas of an organization.As a result, a high level of customer satisfactioncan be achieved.ActActAufBasistakeactionsAuf Basis derderErgebnissebasedon rtheErfolgErfolg derdereffectivenessofMaßnahmenMaßnahmenthe actionsprüfenprüfentaken .PlanPlanZieleestablishZiele mplementeinleiteneinleiten undundactionsumsetzenumsetzenThe process approach, illustrated below using theexample of a process flow, is another key conceptof ISO 9001. The main requirements for establishing a sound process management are stated insection 4. Requirements relating to value-addingprocesses are described further in section 8. Ifyour process management has already reacheda high level of maturity, certification according ISO9001 won’t be a big challenge for you!WorkflowWorkflowWorkflowWorkflowidentifythe demanddemandidentify the demandidentifytheforfor procurementfor procurementprocurementidentify the demandfor procurementbudgetbudgetavailable?available? Quality AustriaFig. 5: PDCA-Cyclebudgetyesavailable?yesThe PDCA (Plan-Do-Check-Act) cycle is a key eleplace the orderorderment of quality management and therefore, also ofplace theyesISO 9001. It is the basis for continual improvement,learning from mistakes and the systematic achie-place the ordervements of objectives. ISOFig. 4: ISO 9001:2015 Standard - relationships of the standard sectionswww.qualityaustria.comtaketake goodsgoods ilityResponsibilityOperatingOperating deOperating departmentdepartmentOperating departmentnonono budgetinforminform thetheavailable?departmentdepartmentnoinform theyesdepartmentplace the orderinform e goods intochargetake goods intoFig. 6: Process flow examplechargeOperating deOperatingOperating departmentdepartment Quality AustriaOperating department4

?HOW DO IIMPLEMENT IT?DocumentationPolicy, objectives,reportsThe third basic concept of ISO 9001 is risk-basedthinking (illustrated in the figure below as a risk matrix).Here, the primary objective is identifying opportunitiesand risks, and deriving actions. This can include opportunities in the field of markets, new products, orclients, and risks that affect the organization’s abilityto meet its objectives, whether at a strategical (e.g.changing political conditions), or an organizational level (e.g. the risk of incorrect operation of a machine).Addressing risks and opportunities is a central drivingforce for continual improvement.Processes,procedures, workinstructionsChecklists, templates,recordsMeasured values,indicatorsFig. 7: Documentation pyramid Quality AustriaEintrittswahrscheinlichkeitAlthough the importance of documentation has declinedwith the latest revision, it is – regardless of format or media– still a key element in structuring instructions and keepingevidence. The illustration above provides an example of apossible hierarchical structure of documentation. ISO 9001requires, for example, to maintain policy and objectives asdocumented information. For other vital elements (suchas processes, responsibilities ), the standard requires tomaintain and retain documented information as evidence(of competences, development results, approvals etc.).RisikoselektivmanagenRisikoakzeptierenRisiko nichtakzeptierenvariation11010510095901357911 13 15 17 19 21 23 25 27 29 31 33 35 37 39 Quality AustriastateFig. 9: State and variation measure Planning the provision of productsand services Requirements and customer communicationhäufig Design and developmentwahrscheinlich Procurement / outsourcinggelegentlich Production / service provisionvorstellbar Releaseunwahrscheinlich Control of nonconforming outputsunvorstellbarunwesentlichFig. 8: Risk matrixwww.qualityaustria.comKey section “Operation”Risks & opportunitiesgeringkritischkatastrophal Quality AustriaErwartetes Schadensausmaß5

?MY NEXT STEPS?International Training ProgrammeA bit of flexibility please? presence trainingWe offer a variety of certification programmes, qualificationprogrammes and online courses in different fields. All certification and qualification programmes described in the folderInternational Training Programme are offered as in-housetrainings and partly as public trainings through selected international qualityaustria partners. virtual training blended training123345Clarify objectivesPlanAnalyze thecurrent stateDerive andimplement actionsObtain certificationInformation talkInformation talkTrainingfor quality ausbildenmanagersQualitätsmanagerTraining for auditorsIn-house training for the persons responsibleCertification auditHow can we support you?Benefit from our qualityaustria services –please feel free to contact us, we are happyto help!If you have any questions concerning ourtrainings offered, please contact our Customer Service Center:Tele.: 43 732 34 23 22office@qualityaustria.comIn case of suggestions / feedback, please contact Ms. Andrea Schwarzandrea.schwarz@qualityaustria.com.Carry out a statusanalysisqualityaustria potential checkFig. 10: qualityaustria support offerwww.qualityaustria.com Quality Austria6

for Dummies. www.qualityaustria.com 2? What exactly is ISO 9001? ISO 9001 is a management system standard, which is voluntarily agreed on, and applied across the industry. This standard includes requirements for quality management. In order to implement ISO 9001, an organization should