Presentation on theme: "ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS"— Presentation transcript:
1 ISO 9001:2000 QUALITY MANAGEMENT SYSTEM REQUIREMENTS 1.0 SCOPEISO 9001:2000 – Clause 1.1 “General”This clause includes also the requirement to address customer satisfaction “through the effective application of the system, including processes for continual improvement and prevention of non-conformity.ISO 9001:2000 – Clause 1.2 “Application”This clause is a general description of the use of the term “Application”
2 INTENT: All requirements of this international standard are generic and are intended to be applied to all organizationsRegardless ofTYPE, SIZE AND PRODUCT provided:WHY: Where any requirement of this international standard cannot be applied due to the nature of the organization or product, THIS CAN BE CONSIDERED FOR EXCUSION.
3 WHAT: Where exclusions are made,claims of conformity of this international standard are are not acceptable unless:Exclusions are limited to requirements within CLAUSE 7WHEN:…And such exclusions do not affect the organization’s ability and responsibility to provide product that fulfills customer and applicable regulatory requirements
4 The following diagram applies: TERMS AND DEFINITIONSThis clause states that the terms and definitions given in ISO 9000:2000 QMS fundermentals and vocabulary apply to ISO 9001:2000The following diagram applies:SUPPLIER ORGANIZATION CUSTOMER
5 REQUIREMENTS4.1 General RequirementsMore emphasis has been put on the need for continuous improvementClarification on the necessary steps to implement the QMS is given
6 Steps;- Identify the processes needed for QMS- Determine the sequence and interaction of these processes-Determine criteria and methods required to ensure the effective operation and control of these processes- Ensure the availability of information necessary to support the operation and monitoring of these processes I.e.provide necessary information to the right personnel.
7 4.2 Documentation requirements 4.2.1 General The QMS documentation shall include:Documented statement of QUALITY POLICY and QUALITY OBJECTIVESQuality ManualDocumented procedures required by the standardDocuments needed by the organization to ensure effective planning, operation and control of its processesQuality records required by the international standard.
8 The documented procedures required by the standard are: CONTROL OF DOCUMENTS (4.2.3)CONTROL OF QUALITY RECORDS (4.2.4)INTERNAL AUDIT (8.2.2)CONTROL OF NON-CONFORMING PRODUCT (8.3)CORRECTIVE ACTION (8.5.2)PREVENTIVE ACTION (8.5.3)
9 4.2.2 QUALITY MANUALThe term “Quality Manual” is defined as “a document specifying the QMS of an organization”There are no requirements here for the inclusion of the following in this sort of quality manual:Quality PolicyQuality objectivesNOTE: Although it is not required here, nothing prevents the organization from doing so.
10 5.0 MANAGEMENT RESPONSIBILITY All the sub clauses of the main clauses start with “Top management shall…”Provide - see clause 5.1Ensure – see clause 5.2, 5.3, 5.4.1, 5.4.2, 5.5.1, 5.5.3Appoint – see clause 5.5.2Review – see clause 5.6.1
11 5.1 “MANAGEMENT COMMITMENT” Requires that Top Management shall provide evidence of its commitment of theDevelopment of the QMSImplementation of the QMSContinually improving its effectiveness
12 By:Communicating to the organization the importance of meeting customer as well us statutory and regulatory requirementsEstablishing the quality policyProviding a frame work for establishing and reviewing quality objectivesRequires that the quality policy is communicated and understood within the organization.
13 5.1 QUALITY OBJECTIVESQUALITY OBJECTIVES shall be measurable and consistent with the Quality PolicyUnder 5.4.1, requirement for quality objectives at relevant functions and levels within the organization has been stressed.QMS PLANNINGTop management shall ensure that:-Planning of the QMS is carried out in order to meet the requirements given in 4.1; as well as quality objectives andThe integrity of the QMS is maintained when changes to the QMS are planned and implemented
14 .5.2 MANAGEMENT REPRESENTATIVE (MR) Management shall appoint a member of management who irrespective of other responsibilities shall have responsibility and authority that includes: -(C) Ensuring the promotion and awareness of customer requirements throughout the organization.
15 5.5.3 – INTERNAL COMMUNICATION Top management has been made responsible for the establishment of appropriate communication process” within the organization.Communication has been focused on the“EFFECTIVENESS of the QMS” and not the processes of the QMS.
16 5.6 “MANAGEMENT REVIEW”GeneralThe following requirements have been included here:“This review shall include assessing opportunities for improvement of the QMS…
17 5.62 REVIEW INPUTAttention should be given to input and output related sub-clauses:-INPUT RELATED SUB-CLAUSES:Focus on very specific “information”Customer feedbackProcess performance and product conformity; andStatus of preventive and corrective actionsPlanned changes that could affect the QMS.The inputs to management review shall include information on recommendations for improvement.
18 Improvement of the effectiveness of QMS and its processes .5.3 REVIEW OUTPUT RELATED SUB-CLAUSES: -Improvement of the effectiveness of QMS and its processesImprovement of product related customer requirements, andResource needs“Decisions” also needs to result as outputs from the review process
19 6 – RESOURCE MANAGEMENT6.1 “PROVISION OF RESOURCES”The requirement for an organization to determine and provide resources needed:-
20 To implement and maintain the QMS and continually improve its effectiveness and, Enhance customer satisfaction.GENERALHUMAN RESOURCESThe focus of this clause is on “personnel performing work affecting product quality”.
21 Provide training or take other actions to satisfy these needs 6.2.2 “COMPETENCY, AWARENESS AND TRAININGThe organization shall: -Determine the necessary competence for personnel performing work affecting qualityProvide training or take other actions to satisfy these needsEvaluate the effectiveness of the actions takenEnsure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, andMaintain appropriate records of education, training, skills and experience (see 4.2.4)
22 6.3 – “INFRASTRUCTURE”The organization to determine, provide and maintain the infrastructure needed to achieve conformity to product requirements.Infrastructure includes: -Building, workshops and associated utilitiesProcess equipment both hardware and softwareSupporting services such as transport or communication.The primary requirements is to ensure processes are carried out under controlled conditions.
23 6.4 “WORK ENVIRONMENT”The organization to determine and manage the conditions of the work environment needed to achieve conformity to product requirements.The terms “conditions” provides flexibility to the organization in deciding WHICH “Work place conditions” they need to “determine and manage” here.
24 PRODUCT REALIZATION7.1 PLANNINGOrganization to plan and develop processes (documented procedures) by determining:Quality objectivesRequirements of the product.ProcessesDocumentsResources specific to the process.
25 PRODUCT REALIZATION7.1 PLANNINGOrganization to plan and develop processes (documented procedures) by determining:Quality objectivesRequirements of the product.ProcessesDocumentsResources specific to the process.Verification
26 ValidationMonitoringInspection and test activitiesCriteria for product acceptanceAppropriate records(evidence of planning and product meeting requirements)
27 7.2 CUSTOMER RELATED PROCESSES Organization to determineCustomer requirements (related to the product)stated (delivery and post Delivery)not stated (necessary for intended use)Statutory and regulatory requirementsrecords to be maintained
28 REVIEWFor adequacy of the requirementsRecords of review to be maintainedCUSTOMER COMMUNICATIONOrganization to determine and effect effective arrangements for communicating with customers in relation toProduct informationEnquiriesCustomer feedback including complaintsThe arrangements should be formal.
29 DESIGN AND DEVELOPMENT PLANNINGPlan and control design and development of the product by determiningDesign and development stagesReview, verification and validation appropriate at each stageResponsibilities and authorities
30 INPUTSDetermined and recordedFunctional and performance requirementsApplicable statutory and regulatory requirementsInformation derived from previous similar designs.
31 OUTPUTSTo be provided in a form that enables verification against inputsApproved prior to releaseSHALLMeet input requirementsProvide information for purchasing, production and service provisionContain/reference product acceptance criteriaSpecify characteristics essential for safe and proper use.
32 REVIEWBe systematic and at suitable stagesIdentify any problemsPropose all necessary actions.VERIFICATIONaccording to planned arrangementsENSURE: OUTPUTS meets input requirements.
33 7.3.6 VALIDATIONAccording to planned arrangementsENSURE: Product is capable of meeting specified application requirements(prior to delivery or implementation of the product.)CONTROL OF (CHANGES)Changes be identifiedRecords maintainedReviewedEffective of changes on constituent parts be evaluated(if already delivered)
34 7.4 PURCHASINGPROCESSEnsure a system of ensuring purchasing products conforms to specified purchase requirementsEstablish criteria for selection, evaluation (re-evaluation) of suppliersEvaluate, and select suppliers
35 INFORMATIONDescribe product to be purchasedIndicate requirements for approval of productState QMS requirements(Ensure adequacy of specified purchase requirements prior to communicating to the supplier)VERIFICATION OF PURCHASED PRODUCTSEstablish & implement inspection activitiesEnsure purchased product meets specified purchase requirements
36 7.5 PRODUCTION & SERVICE PROVISION 7.5.1 CONTROL Plan and carry out activities under controlled conditions by ensuringAvailability of information (describe product characteristics)Availability of work instructionsUse of suitable equipmentAvailability/use of Monitoring and Measurement devicesImplement Monitoring and MeasurementImplement release, delivering/post delivery activities
37 7.5.2 VALIDATION OF PROCESSES: (VALIDATE SPECIAL PROCESSES – Process where resulting output cannot be verified by subsequent Monitoring and Measurement or where deficiencies become apparent only after the product is in use).Establish arrangements for these processes by.Define criteria for review/approvalApproval of Equipment and Qualification of personnelUse of specified methods, proceduresRe-validation
38 7.5.3 IDENTIFICATION & TRACEABILITY ShallIdentify product by suitable means throughout product realizationIdentify product status with respect to Monitoring/Measuring requirements.FOR TRACEABILITYRecord and control the unique identification
39 CUSTOMER PROPERTYShallExercise care with customer propertyIdentify, verify, protect and safeguardRecord any loss, damage, unsuitability for useReport to the customerRecords maintained
40 PRESERVATIONShallPreserve conformity (of product)ThroughoutInternal processingDelivery to intended destinationShall includeIdentificationHandlingPackagingStorageProtection(Apply to constituent parts of the product)
41 7.6 CONTROL OF MONITORING/MEASUREMENT DEVICES Shall determine:-Monitoring/measurement to be undertakenMonitoring/measurement devices neededShall establish
42 Process to ensure monitoring/measurement is carried out in Constituent with monitoring/measuring requirements.Measuring equipment shallBe calibrated (or verified at specified intervals) prior to use.Traceability to international or national standardsBe adjusted/re-adjusted as necessaryBe identified to enable calibration status to be determinedBe protected from damage
43 Demonstrate conformity of product 8. MEASURING, ANALYSIS AND IMPROVEMENT8.1 GeneralPlan, implement monitoring, measurement analysis and improvement processesTO:Demonstrate conformity of productEnsure conformity and continued improvement of QMSBy applicable methods(e.g. statistical technique)
44 8.2.1 (Customer Satisfaction) Top management to ensure 8.2 MEASUREMENT AND MONITORING(Customer Satisfaction)Top management to ensureEffective, Efficient methods are used to identify areas of improvement.Information relating to customer perception.e.g. satisfaction surveys for customer and other interested parties
45 Conduct Internal Audit at Planned intervals ShallConduct Internal Audit at Planned intervalsPlan audit programDefine audit criteria, scope, frequencyClarify auditors impartiallyDefine responsibilities for various audit activities
46 OF PROCESSShall apply suitable methods for monitoring (and where possible) measurements of QMS processesWhen planned results not achievedCorrection & corrective action to be taken
47 Product characteristics OF PRODUCTMonitor & MeasureProduct characteristicsMaintain evidence of conformity with acceptance criteriaIndicate authority for release and service deliveryConditionNo proceeding until planned arrangements have been satisfactorily completedOrApproved by relevant authority (or by customer)
48 8.3 CONTROL OF NON-CONFORMING PRODUCTS Establish a documented procedure for specific activities.Take action to eliminated detected nature of non-conformityAuthorize use, release/acceptance under concession (relevant authority/or customerTake action of preclude original intended useRecord nature of non-conformity subsequent actions takenMaintain the records
49 Detection after delivery/use Take action appropriate to the effects, potential effects, of the non-conformity
51 Areas of continual improvement (within QMS) Appropriate data (Data to include results of monitoring/measurement)EvaluateAreas of continual improvement (within QMS)Analysis to provide information aboutCustomers satisfactionConformity to product requirementsSuppliersTrends/characteristics of process/product
52 8.5 IMPROVEMENTCONTINUALShall continually improve the effectiveness of QMS through use ofQuality policyQuality ObjectivesAudit resultsAnalysis of dataCorrective actionManagement reviews.
53 CORRECTIVE ACTIONEstablish a documented procedureDefine requirements forReview non-conformitiesCustomer complaintsDetermine the causesEvaluate need for corrective actionDetermine and implement actionRecord results of actionsReview correction action takenEliminate the cause (of nature) of non-conformance in order to prevent recurrence
54 PREVENTIVE ACTIONEstablish a documented procedureDetermine action to eliminated causes of potential non-conformities in order to prevent their occurrences.Define requirements forDetermine potential non-conformance and their causesEvaluate the need for preventive action to prevent occurrenceDetermine/improvement preventive actionKeep record of preventive action takenReview preventive action taken.