ISO 9001 - 2008 Awareness Presentation

ISO 9001:2008 Awareness Presentation
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Ismail Latiff, Principal Consultant at Nuri Consulting & Services (Malaysia) @ Let's connect for ISO training and system development
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Published on Nov 01, 2012
Published in: Business, Technology

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Faisal Al Daoudi
could you please share with me the presentation? faisal.aldaoudi@ehcoman.com
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Gerard Joseph Francisco , MBA, ALMI, ACS at Gothong Southern Shipping Lines
Great Material! May I get a copy? here's my email: franciscogherard@gmail.com thanks in advance.
3 weeks ago Reply
Rebbecca Holmes , Senior Quality Engineer at Roche NimbleGen Inc. at Roche NimbleGen Inc.
I would like a copy of your presentation, if you could share? Rebbecca.Holmes@roche.com
1 month ago Reply
Adsells Advertising at Adsells Advertising

Great Presentation, Please email a copy so we could train our team here as well...Wil be thankful "Adwiser.saad@gmail.com"
1 month ago Reply
Syed Shakeel Ahmed , Planning Manager at GASCO Engineering Pvt Ltd at GASCO Engineering Pvt Ltd
Hi, Great presentation, can I have the presentation plz. engr.shakeel@hotmail.com.
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1. 1. ISO 9001:2008Awareness Presentationwww.iso9001consultant.org
2. 2. Suitable for allkinds ofinterestedaudiences
3. 3. Empty your cup andenjoy the presentation Facts about ISO 90011. ISO 9001 is beingimplemented in 175countries around theworld2. Over 1.2
millioncertificates issuedworldwide3. ISO has 163 membercountries
4. 4. Bachelors degree in Business Diploma in internationaltrade Certificate in civil engineering Member of Institute Qualityof Malaysia Trained in
ISO 9001, ISO14001, OHSAS 18001Presenter: Leo
5. 5. What is ISO 9001? Its a quality managementsystem that can beadopted by any kind oforganization The system is focusedtowards the meeting
ofcustomer requirementsand enhancing ofcustomer satisfactionKeywords:1. Quality2. Management system3. Customer requirements4. Customer
satisfaction
6. 6. What is ISO 9001? This system has 4 components or elements andthey are applied within your businessmanagement:a) Management responsibilityb)
Resource managementc) Product realizationd) Measurement, analysis and improvement Before we explore these elements, why is ISO9001 necessary
for your organization?
7. 7. Why do we need ISO 9001? To be effective in whatever we do, we need asystem of doing things to be consistent. Just likecraftsmen, managers need a
good managementtool to get the job done. There are too many activities in any organization.Easy to lose track of things and focus. Easy to getdistracted.
Managers need a good system to keepthings in order. Systemizing of activities is a naturalphenomenon. We do it all the time privately,publicly or
commercially
8. 8. Why do we need ISO 9001? A business faces great risks biginvestments, customer expectations, jobs,credibility, etc. The business owner mustdo all
he can to ensure success, or he/shewill fail. Every major economy in the world adoptsit! Governments give recognition to it.Because it works.
9. 9. Global Issuance ofISO 9001 Certificates0200,000400,000600,000800,0001,000,0001,200,000No of ISO 9001
certificates2000200120022003200420052006200720082009
10. 10. ISO Survey 2010ISO 9001 Certificates issued by region
11. 11. You already have a system of doingthings too! But is it effective? If you keep doing what youalways do, you will always get the same result. ISO
9001 is an option, a good one. It requiresyour organization to document your businessprocesses (QMS), monitor, measure, analyzeand improve it.
Business owners and top management needto make a strategic decision on whether toimplement the ISO 9001 QMS.
12. 12. Biggest benefit The ISO 9001:2008 Standardprovides managers with atool that is designed tocontinually improve theirbusiness performance. ISO
9001 requires you to: Plan what you want to do, Follow that plan, Monitor, measure andanalyze your execution ofthe plan, and Improve the
plan.Planningis the keyP D C A
13. 13. A well-designed and well-implemented qualitymanagement system can and should eliminate
14. 14. What is ISO 9001? ISO = InternationalOrganization forStandardization isos = Greek = equal 9001 = unique IDnumber 2008 = Year it
waspublishedFormation 23 February 1947Type NGOPurpose Intl standardizationHQ GenevaMembership 63 countriesWebsite www.iso.orgNo. of stds
over 18,000
15. 15. ISO 9000 Familya) ISO 9001:2008 Quality Management Systems Requirementsb) ISO 9000:2005 Fundamentals and vocabularyc) ISO 19011:2011
Guidelines for auditing managementsystemsd) ISO 9004:2009 Managing for the sustained success ofan organization A quality management
approach The term ISO 9000 is frequently used to refer to theISO 9001 standard Only ISO 9001 is auditable. The rest serves asreferences only.
16. 16. ISO 9001 HistoryIt all started when the US Military were getting sub-par products from their suppliers.Then it caught on.YEAR STANDARDS
TITLE1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS1974
BS 5179 GUIDELINES FOR QUALITY ASSURANCE1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT,
PRODUCTION,INSTALLATION AND SERVICING1987 ISO 9001:1987 Model for quality assurance in design, development,production, installation,
and servicingISO 9002:1987 Model for quality assurance in production, installation, andservicingISO 9003:1987 Model for quality assurance in final
inspection and test1994 ISO 9001:1994 QUALITY SYSTEMS MODEL FOR QUALITY ASSURANCE2000 ISO 9001:2000 QUALITY
MANAGEMENT SYSTEMS - REQUIREMENTS2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS
17. 17. What is ISO 9001:2008 QualityManagement Systems - Requirements? Quality = degree to which customer requirements havebeen met
Management = coordinated activities to direct andcontrol an organization System = set of interrelated or interacting elements Quality management
system = a system to direct andcontrol an organization with regard to quality Requirements = a set of management parameters yourQMS
18. 18. More about quality How do you know requirements have been met? Review = confirm that requirements are accurate Verify = measure accuracy
of output against requirements Validate = Get feedback from customer/end-user Nonconformance = failure to fulfill requirements Nonconformance =
error All forms of nonconformances require corrections andcorrective action to prevent recurrences Correction = Elimination of error Corrective
action = Elimination of the root causes ofthe error (Ask WHY 5 times)
19. 19. Root cause analysisRoot cause Effect 1 Effect 2 Effect 3 Direct cause Nonconformity1. Why did the nonconformity occur?2. Why did the direct
cause occur?3. Why did effect 3 occur?4. Why did effect 2 occur?5. Why did effect 1 occur?
20. 20. 8 Quality Management PrinciplesThe ISO 9001Standard is basedon these principles1. Customer focus2. Leadership3. Involvement of people4.
Process approach5. System approach tomanagement6. Continual improvement7. Factual approach to decisionmaking8. Mutually beneficial
supplierrelationships
21. 21. System approach Quality must be managed by a system to beeffective This system is done for you, as represented bythe ISO 9001:2008 standard
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Recall: A system is a set of interrelated orinteracting elements System approach is described in Clause 4.1 The description of Clause 4.1 matches the
PDCAapproach to process management -Plan, Do, Check, Act
22. 22. System and process approach Quality must be managed by a system The system must be managed using theprocess approach because the system is
madeup of processes These processes are linked to each other A process has inputs, resources, activities, outputs and customers.Manage them all.
23. 23. ISO Lingo Product = Any output- physical product orservices Output = product Product = result of a process Process = a set of inter-relating
activities focusedtowards producing the output Input = requirementsinput process output
24. 24. Process approachinput Your process outputCan be applied to anyother process that youmanage
25. 25. Process approach Every process require specificinputs, resources, activities, outputs and customers What you can do now is: Define and document
the inputs Define and document the kinds of resources that yourprocess use Define and document the activities and their interactions Define and
document the responsibilities Define and document the outputs You can name this document as Department ControlPlan Then execute this plan, and
monitor, measure, analyzeand improve its performance (KPI) Thus, Plan Do - Check Act (Edward Demmings)
26. 26. Anatomy of aprocessProcessInputsActivitiesOutputsResourcesEvery processhas an owner
27. 27. Process management
28. 28. ISO 9001:2008 ELEMENTSinput Your QMS output
29. 29. ISO 9001:2008 Structure Clause 1 Scope Clause 2 Normative references Clause 3 Terms and definitions Clause 4 Quality management system
Clause 5 Management responsibility Clause 6 Resource management Clause 7 Product realization Clause 8 Measurement, analysis and improvement
30. 30. Your QMSQuality managementsystemGeneral requirementsDocumentationrequirementsResource managementProduct realizationMeasurement,
analysisand improvement
31. 31. Clause 1 Scope Your organization should consider to adoptthe ISO 9001 standard if it needs to demonstrate its ability to consistentlyprovide
Emptyproduct
your cup
andenjoy
the presentation
Factsstatutory
about ISO
90011.
ISO 9001 is beingimplemented
175countries
around
thewor...throughthe effective
that
meets customer
andapplicable
and
regulatoryrequirements,
and aims toinenhance
customer
satisfaction
application of the system, includingprocesses for continual improvement of thesystem and the assurance of conformity tocustomer and applicable
statutory and regulatoryrequirements.
32. 32. In this International Standard, the termproduct only applies toa) product intended for, or required by, a customer,b) any intended output resulting
from the productrealization processes. All requirements of this International Standardare generic and are intended to be applicableto all organizations,
regardless of type, sizeand product provided.
33. 33. Clause 1.2 Application Where anyrequirement(s) of thisInternational Standardcannot be applied due tothe nature of anorganization and itsproduct,
this can beconsidered for exclusion. Where exclusions aremade, claims of conformity tothis International Standard arenot acceptable unless
theseexclusions are limited torequirements within Clause 7. And such exclusions do notaffect the organizationsability, or responsibility, toprovide
product that meetscustomer and applicablestatutory and regulatoryrequirements.
34. 34. Clause 2 Normative references This document is indispensable in theapplication of the ISO 9001 standard: ISO 9000 Fundamentals and
vocabulary
35. 35. Clause 3 Terms and definitions Wherever the term product occurs, it canalso mean service.
36. 36. 4.1 QMS General Requirements1. Determine the QMS processes2. Determine the sequence and interactions3. Determine the methods of operations
andcontrol4. Provide resources to ensure effective operations(Clause 6)5. Monitor, measure and analyze processes (Clause8.2 to 8.4)6. Improve the
effectiveness of the processes(Clause 8.5)
37. 37. QMS processes are in the circle
38. 38. Clause 4.2 Documentation requirementsa) Quality Policyb) Quality Manual todescribe the systemc) Quality ObjectivesRegister to documentyour
quality objectivesd) Control of DocumentsProceduree) Control of RecordsProceduref) Internal Audit Procedure Note: Templates areavailable. g)
Control of NonconformingProducth) Corrective ActionProcedurei) Preventive ActionProcedurej) Quality Plank) Control plansl) Other documents,
asnecessarym) Records (to showevidence of workperformed in all QMSprocesses)
39. 39. Control of documentsCreatedocumentGetapprovalRegisterdocumentDistributedocumentReviewdocumentAmenddocumentGet
re-approvalUpdateregisterIdentifyexternaldocumentsRegisterexternaldocumentsCheck forupdatesUpdateregisterDispose obsoletedocumentStamp
obsoletedocument if retained
40. 40. Clause 4.2.4 Control of records Records established to provide evidence ofconformity to requirements and of the effectiveoperation of the quality
management systemshall be controlled. Process owners must identify, classify andmaintain all process records in good and secureconditions throughout
retention period. Records shall remain legible, readily identifiableand retrievable.
41. 41. Good records management Enables you toa) conduct business in an orderly, efficient andaccountable mannerb) support and document decision
makingc) provide continuity in the event of a disasterd) meet legislative and regulatory requirementse) protect the interests of customers, employeesand
stakeholders
42. 42. Types of records to maintain Go through the ISO 9001 standard or your Quality Manual Identify the following phrases where they appear:
Records shall be maintained (see 4.2.4) Most of the records requirements are readily available, such asproduct planning records, product design
records, purchasingrecords, production records, monitoring records, analysis records,employee performance appraisal and training records,
jobdescriptions, organization chart, infra maintenance records,contract/sales records, marketing records, customer complaintsrecords, etc. Records
pertaining to the mandatory SOPs and quality objectivesshall be created.
43. 43. Clause 5 Management Responsibility Top management musta) Be committed to the QMSb) Be customer focusedc) Establish a quality policyd) Plan
for the QMS in terms of establishing qualityobjectives and management of changee) Assign responsibility, authority and providesuitable communication
channelsf) Review the QMS performance
44. 44. What to do Read the ISO 9001:2008 Standard Establish a Quality Policy Appoint a Management Representative (from mgt rank) Establish a
QMS Committee Establish your Quality Manual Establish the 6 mandatory procedures (Clause 4.2) Establish your Quality Plan Establish your
Department/Process Control Plans Establish and document your quality objectives Establish your KPIs and start collecting data Implement all the
procedures
45. 45. Key Performance Indicators Ask this question whendetermining KPIs: As the CEO/Manager ofthis organization, whatdata will instantly give
methe ability to assess overallperformance at any givenpoint of time? Then list all them downand select your
desiredKPIs.BalancedscorecardFinancialsProcessesCustomersHumancapital
46. 46. Can be used to benchmarkperformance based on inputrequirements (customer wants 100units per month, so give them 100units per month) Can be
used to improve KPIperformance levels decision mustbe based on past performance dataand existing capacity to be realistic You can use existing
performancelevels to establish your qualityobjectives Use quality objectives to improve onproductivity levels, decreaseerrors, improve speed,
reducecosts, reduce complaints, etc.Qualityobjectives
47. 47. Employee responsibility Know the Quality Policy Aware of the relevance and importanceof their activities and how theycontribute to the
achievement of thequality objectives Comply with the requirements of theQMS, as stated in the QualityManual, procedures, Quality Plan, etc. Provide
feedbacks or ideas about theQMS Report any nonconformities
48. 48. Clause 6 Resource management Clause 6.1 Provision of resources The organization shall determine and providethe resources neededa) to
implement and maintain the qualitymanagement system and continually improve itseffectiveness, andb) to enhance customer satisfaction by
meetingcustomer requirements.
49. 49. Types of resources Determine , provide and manage the following:a) Clause 6.2 Competent human resources(competency assessment, training needs
analysis)b) Clause 6.3 Suitable and well-maintainedinfrastructures (maintenance ofbuildings, hardware, software, transportation, utilities)c) Clause 6.4
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Suitable and well-maintained workenvironment (5S program)d) Consider including financial management in yourQMS to ensure product conformity
50. 50. Clause 6.2.1 Personnel performing work affectingconformity to product requirements shall becompetent on the basis of appropriateeducation,
training, skills and experience.Establish JobDescriptionHireemployeeAppraiseperformanceIdentifytrainingneedsConducttrainingAssesseffectivenessof
trainingPLAN DO CHECK ACT
51. 51. Create a survey form which contains thesecolumns:1. Employees name2. Job position3. List of routine activities4. List of non-routine activities5.
Key performance indicators6. Skills required7. Competency assessment per skill (use scoreratings)8. Recommendation for training Employees fill in
columns 1 to 4 Manager fills in columns 5 to 8 Benefits: Manager can identify workredundancies, activity gaps, competencygaps, need for training and
maybe the need tore-engineer the work processes Output: ?Sometimes, workactivities are notdefined. So theresa lot of confusionDefining staffduties
andresponsibilitiesand analyzingtraining needs toensurecompetence isessential
52. 52. 5S Program for work environmentmanagementSEIRI SEITON SEISO SEIKETSU SHITSUKESORT SET IN ORDER SHINE STANDARDIZE
SUSTAIN
53. 53. Product realization processes
54. 54. Clause 7.1 Planning of product realization The organization shall plan and develop the processesneeded for product realization, in terms ofa) quality
objectives and requirements for the productb) the need to establish processes and documents,c) providing resources specific to the productd) required
verification, validation, monitoring,measurement, inspection and test activities specific tothe product and the criteria for product acceptancee) records
needed to provide evidence that the realizationprocesses and resulting product meet requirements
55. 55. Clause 7.1 Create a Quality Plan With the following contents:a) Assigned responsibilities (whos doing what)b) Quality objectives
(productivity/quality targets)c) Customer requirements/Productcharacteristics, features, etc.d) References to procedures to controlproduction/creation,
storage, release, delivery, etc.e) Required resources- HR, materials, equipment, etc.f) Requiredverification, validation, monitoring, measurement,
inspection and test activities specific to the product and thecriteria for product acceptanceg) Types of records needed to provide evidence that
therealization processes and resulting product meetrequirements
56. 56. Whats a Plan?PLANDuties andresponsibilitiesKPI &QualityobjectivesFlow
ofactivitiesQualitycontrolactivitiesOutputdescriptionRequiredphysicalresourcesDescriptionof activitiesSOPs andrecords
57. 57. Clause 7.2Customer relatedprocessDetermination ofcustomerrequirementsReview of customerrequirementsCustomercommunication
58. 58. Design & developmentPlanningInputOutputReviewVerifyValidateControl of changesClause 7.3Create a Design Plan This clause can beexcluded
from your QMSif you dont design theyour products
59. 59. Design & development Review activity undertaken todetermine thesuitability, adequacy andeffectiveness of thesubject matter to achieveestablished
objectives Verificationconfirmation, through theprovision of objectiveevidence, that specifiedrequirements have beenfulfilled Validation confirmation,
through theprovision of objectiveevidence, that therequirements for a specificintended use orapplication have beenfulfilled
60. 60. Design & development Review activity undertaken todetermine thesuitability, adequacy andeffectiveness of thesubject matter to achieveestablished
objectives Verificationconfirmation, through theprovision of objectiveevidence, that specifiedrequirements have beenfulfilled Validation confirmation,
through theprovision of objectiveevidence, that therequirements for a specificintended use orapplication have beenfulfilled
61. 61. PURCHASINGPurchasing processPurchasing informationVerification of purchasedproductClause 7.4
62. 62. Keep records of your purchase orders, suppliersquotations & delivery orders and inspectionforms for purchased products. Monitor, measureand
analyze their performance (only those whosupply materials/equipment/services used withinthe product creation
processDeterminepurchaserequirementsIssue RFQEvaluatequotesIssue PO Inspect DOAssesssuppliersperformancePLAN DO CHECK ACT
63. 63. Production & serviceprovisionControl of production andservice provisionValidation of processes forproduction and serviceprovisionIdentification
andtraceabilityCustomer propertyPreservation of productClause 7.5 - Create aProduction/ServicePlan
64. 64. Clause 7.6 Control of monitoring andmeasuring equipment The organization shall determine the monitoring andmeasurement to be undertaken and
the monitoringand measuring equipment needed to provide evidenceof conformity of product to determined requirements. Calibrate the monitoring and
measuring equipment atsuitable intervals. Verify the monitoring and measuring equipment atsuitable intervals. Segregate those equipment which are
not calibratedyet or not used within the process. Tag or cage them. This clause can be excluded from your QMS if you dont use suchequipment in your
product creation process.
65. 65. Product realization process controlsa) Quality Plan to document how you intendto meet your customers requirementsb) Customer & Legal
Requirementsc) Customer complaints handling procedured) Design Plane) Purchasing Proceduref) Production/Service Plang) Monitoring & Measuring
Equipment Plan(can be included in Production/Service Plan)
66. 66. Clause 8 Measurement, analysis and improvement The organization shall plan and implement the monitoring,measurement, analysis and
improvement processesneededa) to demonstrate conformity to product requirements,b) to ensure conformity of the quality management system, andc) to
continually improve the effectiveness of the qualitymanagement system. This shall include determination of applicable methods,including statistical
techniques, and the extent of their use.
67. 67. Why monitor and measure? If you cannot measure it, youcannot improve it. Lord Kelvin Measurements provide youwith a baseline to
improveupon.
68. 68. What do you measure?1. Customer satisfaction (Survey, returnsrate, complaints, lost business, etc)2. Process conformance and effectiveness(internal
audit)3. Process performance (Key PerformanceIndicators and quality objectives)4. Product characteristics (QC inspection beforerelease to customer)
where nonconformingproducts must be controlled
69. 69. Clause 8.3 Control of nonconforming productsWhere applicable, the organization shall deal withnonconforming product by one or more of the
following ways:a) by taking action to eliminate the detected nonconformity;b) by authorizing its use, release or acceptance underconcession by a relevant
authority and, whereapplicable, by the customer;c) by taking action to preclude its original intended use orapplication;d) by taking action appropriate to
the effects, or potentialeffects, of the nonconformity when nonconforming productis detected after delivery or use has started.
70. 70. Internal audit process Purpose is to verify whether your QMSa) Conforms to your Quality Plan,b) Conforms to ISO 9001 requirements,c) Conforms
to your QMS requirements, andd) is effectively implemented and maintained.EstablishannualauditscheduleDistributeAudit
PlanPerformauditReportfindingsFollow-upactions
71. 71. Audit defined Audit is a systematic and documented process forgathering audit evidence and evaluating it against theaudit criteria to determine
whether it has been fulfilled Audit criteria is a set of policies, procedures orrequirements Audit evidence is records, statements of fact or
otherinformation which are relevant to the audit criteriaand verifiable Audit conclusion is the outcome of an audit providedby the audit team after
consideration of the auditobjectives and all audit findings
72. 72. What to ask? What records to inspect? What activities to observe?1. Remember your purpose is to verifyconformance and effectiveness against
aspecific requirement.2. That requirement may come from the ISO9001 Standard, your QualityManual, SOP, etc.3. So the answer depends on what
auditcriteria you want to verify4. Remember, your job as an auditor is tolook for the audit evidence, thats all 5. So use the ISO 9001 Audit Checklist
andstart auditing.Audit methodologya) Interviewing the auditeeb) Inspection of documentsand records, etc.c) Observation of ongoingactivities
73. 73. What do you analyze? Analyze what you measured:a) Customer satisfaction levelsb) Internal audit resultsc) Product QC inspection resultsd) KPI
resultse) Suppliers performance.
74. 74. How do you analyze? Line Chart/Trend Chart/Control Chart - used to detect trends andunusual activities within the data set, Pareto Chart Analysis used to analyze the different componentsthat make up the data value in a descending order, complete withthe cumulative percentage line superimposed
on it, SWOT Analysis - used to analyze process strengths, weaknesses,opportunities and threats based on the characteristics of the dataset - whether
internal or external, Arithmetic average or mean - used to identify the averageperformance value of the process, Median - used to identify the actual
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middle value of the data set, Mode - used to identify the most frequent value occurring withinthe data set, Range - used to identify the difference
between the lowest andhighest values , Standard deviation used to identify the SD from the mean Cause and Effect Analysis - used to analyze the
causes and effectsof a given data set, Risk Analysis - used to identify potential risks given the data set
75. 75. 024681012Errors What causedthis spike?Trend chartUse it to identify potential problems
76. 76. Pareto Principle20% of the causes contributes to 80% of the effects Identify and classifyall problems Calculate cumulativeoccurrences up to80%
Focus on solvingthose problems Continually improvethe management ofthose causes Analyze your salesfigures and identifythe contributors Focus
your efforts oncustomers whocontribute 80% ofthose sales Focus your efforts onthe sales personnelwho are managingthose customersJoseph M. Juran
suggested the principle and named it after Italian economist VilfredoPareto, who observed in 1906 that 80% of the land in Italy was owned by 20% of
thepopulation; he developed the principle by observing that 20% of the pea pods in hisgarden contained 80% of the peas.
77. 77. What to improve? The organization shall continually improve theeffectiveness of the quality management systemthrough the use of the quality
policy, qualityobjectives, audit results, analysis ofdata, corrective and preventive actions andmanagement review. All nonconformities require corrective
actions All potential nonconformities require preventiveactions.
78. 78. Corrective action processDetectnonconformityReportnonconformityReviewnonconformityagainst criteriaIssue CARPerform rootcause
analysisEvaluate needfor correctiveactionImplementcorrectiveactionRecord theresults ofactions takenVerifyeffectiveness ofactions taken
79. 79. Preventive action processDetectpotentialnonconformityReportpotentialnonconformityReview againstcriteriaIssue PARPerform rootcause
analysisEvaluate needfor preventiveactionImplementpreventiveactionRecord theresults ofactions takenVerifyeffectiveness ofactions taken
80. 80. Risk analysisPerforming a risk analysis on yourbusiness processes can help youdetect potential nonconformities Describe the risk Describe the
potential effects Quantify likelihood of occurrence(consider frequency) Quantify severity of consequence(consider harm or damage) Assign risk rating
(likelihood xseverity) Risk rating > 4 shall be controlled(ALARP = as low as reasonablypracticable)Score ratings1 = very low2 = low3 moderate4 =
high5 = very high
81. 81. Root cause analysisRoot cause Effect Effect Direct cause Nonconformitycauses effectSources of direct causes:1. Human error,2. Material defect,3.
Equipment malfunction,4. Ineffective methods of operation or control, or5. Flawed management policies.
82. 82. Nonconformities Dont fear them becauseWe detect and report them because wedont want them to recurWe report and record them because
wewant to document the improvements madeto the QMS
83. 83. ISO 9001 Certification Performed by independent CertificationBody, such as SIRIM QAS, BVQI, LRQA, SGS Client gets a renewable 3-year
certificate Phase 1 audit = Adequacy audit =Documentation audit Phase 2 audit = Conformance audit = Physicalaudit of personnel, records and
processes
84. 84. ISO 9001 Certification First year = Certification audit 2nd year = Surveillance audit 3rd year = Surveillance audit and/or re-certification audit If
after 3 months, nonconformities were notcorrected (via the corrective action procedure)by the client, the ISO 9001 certificate will berevoked by the CB.
85. 85. Decide if ISO 9001 is for you Purchase the standard online Purchase a Quality Manualtemplate Appoint a ManagementRepresentative Appoint
a QMS Committee Read the ISO 9001 Standardand the Quality Manual Plan your QMS by customizingthe Quality Manual Plan and implement
everyclause within the QualityManualPlan of action
86. 86. Hope youbenefited fromthat presentation
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Solving Business Problems
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You already have a system of doingthings too! But is it effective? If you keep doing what youalways do, you will always g...
14/12/2015 12:23
14 of 91
Biggest benefit The ISO 9001:2008 Standardprovides managers with atool that is designed tocontinually improve theirbusine...
14/12/2015 12:23
15 of 91
A well-designed and well-implemented qualitymanagement system can and should eliminate
14/12/2015 12:23
16 of 91
What is ISO 9001? ISO = InternationalOrganization forStandardization isos = Greek = equal 9001 = unique IDnumber 2008 ...
14/12/2015 12:23
17 of 91
ISO 9000 Familya) ISO 9001:2008 Quality Management Systems Requirementsb) ISO 9000:2005 Fundamentals and vocabularyc) ISO...
14/12/2015 12:23
18 of 91
ISO 9001 HistoryIt all started when the US Military were getting sub-par products from their suppliers.Then it caught on.Y...
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What is ISO 9001:2008 QualityManagement Systems - Requirements? Quality = degree to which customer requirements havebeen ...
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More about quality How do you know requirements have been met? Review = confirm that requirements are accurate Verify =...
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Root cause analysisRoot cause Effect 1 Effect 2 Effect 3 Direct cause Nonconformity1. Why did the nonconformity occur?2. W...
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8 Quality Management PrinciplesThe ISO 9001Standard is basedon these principles1. Customer focus2. Leadership3. Involvemen...
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System approach Quality must be managed by a system to beeffective This system is done for you, as represented bythe ISO...
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System and process approach Quality must be managed by a system The system must be managed using theprocess approach bec...
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ISO Lingo Product = Any output- physical product orservices Output = product Product = result of a process Process = a...
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Process approachinput Your process outputCan be applied to anyother process that youmanage
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Process approach Every process require specificinputs, resources, activities, outputs and customers What you can do now ...
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Anatomy of aprocessProcessInputsActivitiesOutputsResourcesEvery processhas an owner
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Process management
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ISO 9001:2008 ELEMENTSinput Your QMS output
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ISO 9001:2008 Structure Clause 1 Scope Clause 2 Normative references Clause 3 Terms and definitions Clause 4 Quality m...
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Your QMSQuality managementsystemGeneral requirementsDocumentationrequirementsResource managementProduct realizationMeasure...
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Clause 1 Scope Your organization should consider to adoptthe ISO 9001 standard if it needs to demonstrate its ability to...
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In this International Standard, the termproduct only applies toa) product intended for, or required by, a customer,b) ...
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Clause 1.2 Application Where anyrequirement(s) of thisInternational Standardcannot be applied due tothe nature of anorgan...
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Clause 2 Normative references This document is indispensable in theapplication of the ISO 9001 standard: ISO 9000 Fund...
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Clause 3 Terms and definitions Wherever the term product occurs, it canalso mean service.
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4.1 QMS General Requirements1. Determine the QMS processes2. Determine the sequence and interactions3. Determine the metho...
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QMS processes are in the circle
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Clause 4.2 Documentation requirementsa) Quality Policyb) Quality Manual todescribe the systemc) Quality ObjectivesRegist...
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Control of documentsCreatedocumentGetapprovalRegisterdocumentDistributedocumentReviewdocumentAmenddocumentGet re-approvalU...
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Clause 4.2.4 Control of records Records established to provide evidence ofconformity to requirements and of the effective...
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Good records management Enables you toa) conduct business in an orderly, efficient andaccountable mannerb) support and do...
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Types of records to maintain Go through the ISO 9001 standard or your Quality Manual Identify the following phrases wher...
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Clause 5 Management Responsibility Top management musta) Be committed to the QMSb) Be customer focusedc) Establish a qual...
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What to do Read the ISO 9001:2008 Standard Establish a Quality Policy Appoint a Management Representative (from mgt ran...
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Key Performance Indicators Ask this question whendetermining KPIs: As the CEO/Manager ofthis organization, whatdata wil...
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Can be used to benchmarkperformance based on inputrequirements (customer wants 100units per month, so give them 100units...
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Employee responsibility Know the Quality Policy Aware of the relevance and importanceof their activities and how theycon...
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Clause 6 Resource management Clause 6.1 Provision of resources The organization shall determine and providethe resources...
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Types of resources Determine , provide and manage the following:a) Clause 6.2 Competent human resources(competency assess...
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Clause 6.2.1 Personnel performing work affectingconformity to product requirements shall becompetent on the basis of ap...
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Create a survey form which contains thesecolumns:1. Employees name2. Job position3. List of routine activities4. List o...
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5S Program for work environmentmanagementSEIRI SEITON SEISO SEIKETSU SHITSUKESORT SET IN ORDER SHINE STANDARDIZE SUSTAIN
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Product realization processes
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Clause 7.1 Planning of product realization The organization shall plan and develop the processesneeded for product realiz...
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Clause 7.1 Create a Quality Plan With the following contents:a) Assigned responsibilities (whos doing what)b) Quality ob...
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Whats a Plan?PLANDuties andresponsibilitiesKPI &QualityobjectivesFlow ofactivitiesQualitycontrolactivitiesOutputdescripti...
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Clause 7.2Customer relatedprocessDetermination ofcustomerrequirementsReview of customerrequirementsCustomercommunication
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Design & developmentPlanningInputOutputReviewVerifyValidateControl of changesClause 7.3Create a Design Plan This clause c...
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Design & development Review activity undertaken todetermine thesuitability, adequacy andeffectiveness of thesubject matt...
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Design & development Review activity undertaken todetermine thesuitability, adequacy andeffectiveness of thesubject matt...
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PURCHASINGPurchasing processPurchasing informationVerification of purchasedproductClause 7.4
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Keep records of your purchase orders, suppliersquotations & delivery orders and inspectionforms for purchased products....
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Production & serviceprovisionControl of production andservice provisionValidation of processes forproduction and servicepr...
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Clause 7.6 Control of monitoring andmeasuring equipment The organization shall determine the monitoring andmeasurement to...
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Product realization process controlsa) Quality Plan to document how you intendto meet your customers requirementsb) Cus...
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Clause 8 Measurement, analysis and improvement The organization shall plan and implement the monitoring,measurement, anal...
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Why monitor and measure? If you cannot measure it, youcannot improve it. Lord Kelvin Measurements provide youwith a base...
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What do you measure?1. Customer satisfaction (Survey, returnsrate, complaints, lost business, etc)2. Process conformance a...
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Clause 8.3 Control of nonconforming productsWhere applicable, the organization shall deal withnonconforming product by one...
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Internal audit process Purpose is to verify whether your QMSa) Conforms to your Quality Plan,b) Conforms to ISO 9001 requ...
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Audit defined Audit is a systematic and documented process forgathering audit evidence and evaluating it against theaudit...
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What to ask? What records to inspect? What activities to observe?1. Remember your purpose is to verifyconformance and ...
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What do you analyze? Analyze what you measured:a) Customer satisfaction levelsb) Internal audit resultsc) Product QC insp...
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How do you analyze? Line Chart/Trend Chart/Control Chart - used to detect trends andunusual activities within the data se...
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024681012Errors What causedthis spike?Trend chartUse it to identify potential problems
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Pareto Principle20% of the causes contributes to 80% of the effects Identify and classifyall problems Calculate cumulati...
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What to improve? The organization shall continually improve theeffectiveness of the quality management systemthrough the ...
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Corrective action processDetectnonconformityReportnonconformityReviewnonconformityagainst criteriaIssue CARPerform rootcau...
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Preventive action processDetectpotentialnonconformityReportpotentialnonconformityReview againstcriteriaIssue PARPerform ro...
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Risk analysisPerforming a risk analysis on yourbusiness processes can help youdetect potential nonconformities Describe t...
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Root cause analysisRoot cause Effect Effect Direct cause Nonconformitycauses effectSources of direct causes:1. Human error...
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Nonconformities Dont fear them becauseWe detect and report them because wedont want them to recurWe report and record...
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ISO 9001 Certification Performed by independent CertificationBody, such as SIRIM QAS, BVQI, LRQA, SGS Client gets a rene...
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ISO 9001 Certification First year = Certification audit 2nd year = Surveillance audit 3rd year = Surveillance audit and...
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Decide if ISO 9001 is for you Purchase the standard online Purchase a Quality Manualtemplate Appoint a ManagementRepr...
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Hope youbenefited fromthat presentation
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ISO 9001 - 2008 Awareness Presentation

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