Welcome to the seminar

The NewISO 9000:2000

Quality Management PrinciplesThe ISO 9001:2000 is based on the eight quality management principles concerning:

System approach to managementContinual improvementFactual approach to decision makingMutually beneficial supplier relationships

Quality Management PrinciplesCustomer focused organizationLeadershipInvolvement of peopleProcess approach

Quality Management PrinciplesThese eight principles manifest themselves through the four main clauses of:Management Responsibility cl 5.0Resource Management cl 6.0Product Realization cl 7.0Measurement, Analysis & Improvement cl 8.0Documentation of all the process 4.0 These main clauses are structures around the Plan-Do-Check-Act cycle and contain a number of individual clauses

Process ApproachWhat is a Process?Process:Any activity or group of activities that takes an input, add value to it and provides an output to an internal or external customerProcesses use organizations resources to provide definitive results

Process Approach

Process Approach

Process ApproachWhat is a Process?List of typical processes:PurchasingMarketingTrainingManufacturingQuality assurance and controlStorage Designing

0. Introduction- Model of the process -

5. Management responsibility

5.1 Management CommitmentTop management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness bya) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirementsb) establishing the quality policy c) ensuring the quality objectives are establishedd) Conducting management reviewsande) ensuring the availability of resources

5. Management responsibility

5.2 Customer focusTop management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction

5. Management responsibility- 5.2 Customer focus -Top management shall ensure that customer needs and expectations are:determined,converted into requirements andfulfilled with the aim of achieving customer satisfaction including regulatory and legal requirementsto win the confidence of the customer

5. Management responsibility- Implementation of the quality policy -

5. Management responsibility- 5.3 Quality policy -The Management shall ensure that the quality policy:

is appropriate to the purpose of the organization;includes a commitment to meeting requirements and continual improvement;provides a framework for establishing and reviewing quality objectives;is communicated and understood at appropriate levels of the organization;is reviewed for continuing suitability.

The quality policy shall be controlled

5. Management responsibility- 5.4 Quality planning -5.4.1 Quality objectives shall be:established at relevant functions and levelsmeasurable and consistent with quality policy and continual improvement5.4.2 Quality planning includes:the processes of the quality management system the resources needed to achieve the quality objectives the verification and validation activitiesthe criteria for acceptability and quality records neededcontinual improvement

5. Management responsibility- 5.5 Administration

5.5.1 Responsibility & AuthorityFunctions and their interrelations within the organization, including responsibilities and authorities shall be defined and communicated in order to facilitate effective quality management. Responsibility to initiate corrective action is to be defined

5. Management Responsibility- 5.5 Administration -

5.5.2 Management representative:member of the managementensuring that processes are established and maintained reporting of performance to top managementpromoting awareness of customer requirements

5.5 Administration- 5.5.3 Communication (1) -Management responsibilitySpecificationsresultsQMSProcessesCOMMUNICATIONCOMMUNICATION

5. Management responsibility- Communication (2) -Explanation:COMMUNICATION:e.g. announcement of quality requirements, -objectives, -results by the top management (at employees, but also, at customers and supplier)

5. Management responsibility- 5.6 Management review -5.6.2 Inputs:results of audits;customer feedback;process performance and product conformance;status of preventive and corrective actions;follow-up actions from earlier management reviews;changes that could affect the quality management system;5.6.3 Outputs:improvement of quality management system, processes and productsresource needsresults shall be recorded 5.6.1 Top management shall review the QMS to ensure its suitability, adequacy and effectiveness.

7. Product realization - Definition: Process -The Process:...is a system of activities which uses resources to transform inputs into outputs. ...is a series of actions (partial steps for reaching a work result) with a defined point of beginning and ending. (from practice)

7. Product realization - General requirements (1) -7.1 Planning of realization processes: In planning the processes for realization of product the org. shall determine: Quality objectives for the product, project or contract.The need to establish processes and documentation, and to provide resources and facilities specific to the product.Verification and validation activities, and the criteria for acceptabilityThe records that are necessary to provide confidence of conformity of the processes and resulting product.

7. Product realization - General requirements (2) -Create transparency ...

7. Product realization - General requirements (3) -... define flows fast and more economicallyProcess-oriented viewpointProcessProductProcess-managementAnalysis MeasuresResourcesCUSTOMERo.K.Not o.K.

7. Product realization - Overview -7.2Customer-related processes 7.3Design and development7.4Purchasing7.5Production and service provision7.6Control of measuring and monitoring devicesValidation of processes

7. Product realization - 7.2.1 Identification of Customer requirements -The organization shall determine customer requirements including: requirements specified by customer, including delivery and post-delivery activities (e.g. warranty / guarantee / servicing); requirements not stated by the customer but necessary for specified use or known intended use; statutory and regulatory requirements related to product; any additional requirements determined by the organization

7. Product realization - 7.2.2 Review of Product requirements -Product requirements are definedWhere the customer provides no documented statement of requirements, the customer requirements are confirmed before acceptance.Contract or order requirements differing from those previously expressed are resolvedThe organization has the ability to meet defined requirementsThe results of the review and subsequent follow-up actions shall be recorded

Prior to the commitment to supply, the organization shall ensure that:

7. Product realization - 7.2.3 Customer communication - Maintaining effective customer contactsFor the fulfillment of customer requirements, effective customer contracts are to be implemented and maintained. The following communication requirements are to be considered:

7. Product realization - 7.3 Design and/or development -Planningstagesreview and verification activitiesresponsibilitiesInputPerformance / Functional requirementStatutory requirementPast learningrequirements essential for designOutputmeet the input requirementsinformation for productionacceptance criteria for product and processesReview, verification, validationcheck fulfillment of requirementsControl of changesidentificationdocumentation

7. Product realization - 7.3 Design and/or development - 7.3.1 Design & Development plan and control

Planning means determining the design objectives and the design strategy, the design stages, timescales, costs, resources, and responsibilities needed to accomplish them.Control is a method of keeping the design on course towards its objectives. It controls the process i.e. the inputs, the outputs, the selection of components, standards, materials, processes, techniques and technologies. To control any design activity, one need to take ten primary steps.

7. Product realization - 7.3 Design and/or development - 7.3.1 Design & Development controlEstablish the customer needs.Convert the customer needs into a definitive specification of the requirement.Plan for meeting the requirements.Organize the resources and materials for meeting the requirements.Conduct a feasibility study to discover whether accomplishment of the requirements is feasible.Conduct a project definition study to discover which of the many possible solutions will be the most suitable.

7. Product realization - 7.3 Design and/or development - 7.3.1 Design & Development controlDevelop a specification which details all the features and characteristics of the product or serviceProduce a prototype or model of the proposed design.Conduct extensive trials to discover whether the product or service which has been developed meets the design requirements and customer needsFeed data back into the design and repeat the process until the product or service is proven to be fit for the task.

7. Product realization - 7.3 Design and/or development - 7.3.1a Design & Development stagesA stage is a point where a design reaches a stage of maturity.Feasibility Stage Conceptual design stageDesign definition stageDetail Design StageDevelopment Stage

7. Product realization - 7.3 Design and/or development - 7.3.1b Planning review, verification and validation At the end of each stage output needs to be verified, validated and reviewed before being passed on the next stage.Verification where design output of a stage is checked against the deign input for the stage.Validation to confirm that output is right output by comparing it with design requirement. Review results of verification and validation to confirm the design solution, recommend change, and authorize or halt further development.

7. Product realization - 7.3 Design and/or development - 7.3.1c Responsibility and Authority Responsibility needs to be defined so that there is no doubt who has the right to take actions and decisions.Authority needs to be delegated so that those responsible have the right to control their own output.Also authority responsible for the requirements at each level of the design needs defining so that there is a body to which request for change can be routed.Work package technique can be used to assign responsibility.

7. Product Realization (Contd.)7.3 Design & Development (D/D)7.3.1 Design and Development PlanningPlan and control Design and Development of the productDuring planning, determine Stages of design and developmentReview, verification and validation appropriate to each Design and Development stage Responsibilities and authorities for Design and DevelopmentManage interface between different involved groups to ensure effective communication and clear responsibilitiesUpdate planning output, as appropriate, as Design and Development progresses

7. Product Realization (Contd.)7.3 Design & Development (D/D) (Contd)7.3.2 Design & Development InputsDetermine the inputs related to product requirements and maintain recordsDesign & Development inputs to includeFunctional and performance requirementsApplicable statutory and regulatory requirementsWhere applicable, Information derived from previous similar designs Other requirements essential for Design and DevelopmentReview inputs for adequacy. Requirements to be complete, unambiguous and non-conflicting

7. Product Realization (Contd.)7.3 Design & Development (D/D) (Contd)7.3.3 Design & Development OutputsOutputs of D/D provided in a form that enables verification against D/D inputs. This shall be approved prior to release D/D Outputs shall : meet D/D input requirementsprovide appropriate information for purchasing, production and for service provisionscontain or reference product acceptance criteriaspecify product characteristics essential for safe and proper use

7. Product Realization (Contd.)7.3 Design & Development (D/D) (Contd)7.3.4 Design & Development ReviewAt suitable stages, conduct systematic D/D reviews to evaluate the ability of results of D/D to fulfill requirementsto identify any problems and proposed necessary actionsInvolve and include representatives of functions concerned with design stage(s) being reviewedRecords of results of reviews and necessary actions to be maintained7.3.5 Design & Development VerificationPerform verification to ensure that D/D outputs have satisfied D/D input requirementsRecords of results of verification & necessary actions to be maintained

7. Product Realization (Contd.)7.3 Design & Development (D/D) (Contd)7.3.6 Design & Development ValidationPerform D/D validation in accordance with planned arrangements (see 7.3.1) to ensure Resulting product is capable of fulfilling the requirements for the specified or known intended use or application Wherever practicable, validation to be completed prior to delivery or implementation of the productRecords of results of validation and necessary actions to be maintained

7. Product Realization (Contd.)7.3 Design & Development (D/D) (Contd)7.3.7 Control of ChangesChanges in D/D to be identified and records maintained The changes tobe reviewed, verified and validated, as appropriatebe approved before implementationinclude evaluation of the effect of changes on constituent parts and delivered products Records of the results of validation and necessary actions to be maintained

7. Product realization - 7.4 Purchasing -Control purchasing processes Determine the effect of purchased products on processes and their outputsEvaluation and selection of suppliersDefine criteria for selection and periodic evaluationPurchasing information (e.g. requirements for approval of product, processes, equipment and personnel)Verification of purchased products and services

7. Product realization - 7.5.1 Production and service provision -the availability of information that specifies the productthe availability of work instructions (where necessary)the use and maintenance of equipment for production and service operationsthe availability and use of measuring and monitoring devicesthe implementation of monitoring activitiesmethods for release, delivery and applicable post-delivery activitiesThe organization must control production and service provision through:

7. Product realization - Examples for product operations -Procedures, work and testing instructions, specificationsRelease proceduresMaintenance and service plansProcess ability of the machines and systems (certificate of the machine ability)safety direction, devices and meansApplication and regular control of measuring and monitoring devices (suitable measuring procedures define demands on these devices)Execution and report of necessary intermediate tests (milestones) (Use of working cards, protocols, blocking, separation)Objective evidence of final inspections (if necessary in agreement with customers: acceptance, protocols, results)

7. Product realization - 7.5.2 Validation -Validate any processes for production and service provision where resulting output can not be verified by subsequent monitoring / measurement. These include any processes where deficiencies become apparent only after the product is in use or service has been deliveredValidation to demonstrate the ability of processes to achieve planned results

7. Product realization - 7.5.2 Validation -Defined criteria for review and approval of the processesApproval of equipment and qualification of personnelUse of specific methods and procedures Requirements for recordsRevalidationThe organization must establish arrangements for these processes to include following, as applicable:

7. Product realization - 7.5.3 Identification & traceability -

The company shall:identify the product by suitable means throughout production and service operations (where appropriate)identify the status of the product with respect to measurement and monitoring requirements identify the product, where traceability is required

7. Product realization - 7.5.4 Customer Property -Customer Property - It may be hardware, software, intellectual property, tools, jigs, fixtures, packing material etc.For Customer property provided for use or incorporation, organization to ensureIdentificationVerificationProtection and Safeguard of productAny customer property lost, damaged or found unsuitable to be reported to customer and records maintained

7. Product realization - 7.5.5 Preservation of product -The company shall:preserve conformity of product during internal processing and final delivery (identification, handling, packaging, storage and protection) also apply to the constituent parts of a product.

. Product realization - 7.6 Control of monitoring & measuring devices -

Measuring and monitoring devices shall:determine the measurements to be made and the devices required to assure conformity of product and processescalibrate and adjust periodicallybe used in a manner that ensures their capabilitybe validated prior application, if software is used for measuring and monitoring requirementsExamples:self-developed software...

8. Measurement, analysis, improvement - 8.1 General -The Organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed :To demonstrate conformity of the productTo ensure conformity of the QMS,andTo continually improve the effectiveness of the QMS.

8. Measurement, analysis, improvement - Overview -8.2Measurement and monitoring - customer satisfaction - internal audit - measurement and monitoring of processes - measurement and monitoring of product8.3Control of nonconformity8.4Analysis of data8.5Improvement - planning for continual improvement - corrective action - preventive action

8. Measurement, analysis, improvement - Process-oriented viewpoint -Define, plan and implement activities to assure conformity and achieve improvement

Objective evidence, that the QM system, processes, products and/or services correspond to the requirements

8. Measurement, analysis, improvement - 8.2.1 Customer satisfaction -Measurement of the customer satisfaction:The customer satisfaction is considered as one measure of system performance.The organization shall monitor information on customer satisfaction and / or dissatisfaction. The method for obtaining and using this information shall be determined. Note: Reference to communication with customers

8. Measurement, analysis, improvement - 8.2.2 Internal audit -Internal audits are tools to evaluate the maintenance and effectiveness of the QM systemIn addition, the organization may carry out audits to identify potential opportunities for improvementThe audit scope, frequency and method shall be defined Audits shall be conducted by independent personnelThe procedure shall contain:audit targetsaudit frequencyaudit methodresponsibilitiesrequirements on realizationrecords and reports to the management

8. Measurement, analysis, improvement - 8.2.3 Measurement and monitoring of processes -The organization shall:apply suitable methods for measurement and monitoringMethods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate to ensure conformity of the product.

8. Measurement, analysis, improvement - Measurement and monitoring of processes (2) -ResultRegister Check ProveCIP Continual Improvement ProcessCustomer require-ments Degree of fulfillment customer require-ments suitable measuring methods Processes Products Servicesmake potential of improvement transparency characteristic data

8. Measurement, analysis, improvement - 8.2.4 Measurement and monitoring of product-

The organization shall:Measure and monitor the characteristics of the product to verify that requirements for the product are met.Carried out at appropriate stages of the product realization process.Evidence of conformity with the acceptance criteria shall be documented.Records shall indicate the authority responsible for release of productProduct release and service delivery shall not proceed until all the specified activities have been satisfactorily completed, unless otherwise approved by the customer.

8. Measurement, analysis, improvement - 8.3 Control of nonconformity -Identify and control nonconforming products to prevent unintended use or deliveryNonconforming products shall be corrected and verified after correction to demonstrate conformity. When nonconforming product is detected after delivery or use has started, the organization shall take appropriate action. Get concession to the customer for proposed rectification (where required)Requirements for reporting can be specified by the customer, end user, regulatory body or other relevant body.

8. Measurement, analysis, improvement - 8.4 Analysis of data -The analysis of data is a QM procedureto collect and to analyze appropriate datato determine the effectiveness of the QMS as well as to identify possible improvements Provide information on:customer satisfaction / dissatisfaction; conformance to product requirements;characteristics of processes, products and their trends;suppliers.

8. Measurement, analysis, improvement - 8.5 Improvement -improvement processcorrective actionsexisting nonconformityThe documented procedure shall define requirements for:Identifying nonconformitiesDetermining the causes of nonconformityEvaluating the need for actions to ensure that they do not re-occurDetermining and implementing the corrective action neededRecording results of action takenReviewing of corrective action takenThe organization shall facilitate the continual improvement of the quality management through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action and management review CIP Continual Improvement Process

8. Measurement, analysis, improvement - Improvement -preventive actionspotential nonconformity Identify determine the cause determine and implement actions recording results of action taken review actions

TOP MANAGEMENT RESP INCLUDE:SETTING POLICIES AND OBJ AND LEADING THE ORGANISATIONPROVISION OF ORGANISATION STRUCTURE AND RESOURCESMAINTENANCE OF CURRENT PERFORMANCE, ANDACHEIVEMENT OF CONTINUAL IMPROVEMENT

TOP MANAGEMENT SHOULD DEFINE AN APPROACH FOR MEASUREMENT OF ORG. PERFORMANCE IN ORDER TO VERIFY THAT STRATEGIC OBJ. ARE ACHIEVED. THIS APPROACH COULD INCLUDEFINANACIAL MEASURESMEASURES OF PROCESS PERFORMANCE, ANDASSESSMENT OF SATISFACTION LEVEL OF CUSTOMERS AND OTHER INTERESTED PARTIESInterested parties include: customers, endusers, employee, owners, investors, suppliers, society, community, public affectedTo meet the needs and expectations of all interested parties, org should considerIdentification of the needs and expectations of all interested partiesMaintenance of a balanced response to interested parties needs and expectationsTranslation of those needs and expectations into requirementsCommunication of those requirements to all levels of the organisation andImprovement of all processes to create value for the interested parties.

5 Verantwortung der Leitung5.1 Allgemeine ForderungenDie oberste Leitung mu ihre Verpflichtung darlegen bezglich:Schaffung und Erhaltung des Bewutseins, da die Erfllung von Kundenforderungen von wesentlicher Bedeutung ist;Festlegung der Qualittspolitik und der Qualittsziele und -planung;Festlegung eines QM-Systems;Durchfhrung von QM-Bewertungen;Sicherstellung der Verfgbarkeit von Mitteln (siehe 6).

5.2 KundenforderungenDie oberste Leitung mu sicherstellen:Erfordernisse und Erwartungen der Kunden werden ermittelt und in Forderungen umgewandelt mit dem Ziel, das Vertrauen der Kunden zu erlangen;Kundenforderungen werden vollstndig verstanden und erfllt (siehe 7.2.1).

Interested parties include: customers, endusers, employee, owners, investors, suppliers, society, community, public affectedTo meet the needs and expectations of all interested parties, org should considerIdentification of the needs and expectations of all interested partiesMaintenance of a balanced response to interested parties needs and expectationsTranslation of those needs and expectations into requirementsCommunication of those requirements to all levels of the organisation andImprovement of all processes to create value for the interested parties.

5 Verantwortung der Leitung5.1 Allgemeine ForderungenDie oberste Leitung mu ihre Verpflichtung darlegen bezglich:Schaffung und Erhaltung des Bewutseins, da die Erfllung von Kundenforderungen von wesentlicher Bedeutung ist;Festlegung der Qualittspolitik und der Qualittsziele und -planung;Festlegung eines QM-Systems;Durchfhrung von QM-Bewertungen;Sicherstellung der Verfgbarkeit von Mitteln (siehe 6).

5.2 KundenforderungenDie oberste Leitung mu sicherstellen:Erfordernisse und Erwartungen der Kunden werden ermittelt und in Forderungen umgewandelt mit dem Ziel, das Vertrauen der Kunden zu erlangen;Kundenforderungen werden vollstndig verstanden und erfllt (siehe 7.2.1).

TOP MANAGEMENT SHOULD CONSIDERTHE EXPECTED LEVEL OF CUSTOMER SATISFACTIONTHE NEEDS OF OTHER INTRESTED PARTIESOPPORTUNITIES AND NEEDS FOR CONTINUAL IMPROVEMENTRESOURCES NEEDED, AND CONTRIBUTIONS OF SUPPLIERS AND PARTNERS

An effective formulated and communicated quality policy shouldBe consistent with a vision of the organization futureMake quality objectives understood throughout the organizationDemonstrate top management commitment to quality and the provision of adequate resources for its achievementPromote a commitment to quality at all levels of the organization, with clear leadership by top management andAddress continual improvement and customer satisfactionWhile formulating objectives: mgmt should consider the current and future needs of the organization and the markets servedAlso consideration should be given to: output from mgmt. Reviews, current production and process performance, and to the levels of satisfaction of all interested parties.Objectives should be deployed throughout the org with defined resp. for their achievement and should be clearly communicated. People should be able to translate these obj to individual contributions (KRAs)Objectives should be periodically reviewed and revised as necessary Das Unternehmen mu ein Verfahren in den Ebenen des QMS zur periodischen berprfung des QMS einfhren. Die oberste Leitung mu in selbst festgelegten Zeitabstnden die Angemessenheit und Wirksamkeit des QMS berprfen. Die berprfung mu die Notwendigkeit fr nderungen im QMS eines Unternehmens beurteilen, einschlielich der Politik, Ziele und Planung.Das Management Review hat eine periodische berprfung der aktuellen Leistung und der Verbesserungsmglichkeiten im o.g. Bereich einzuschlieen.

Iso 9004 liefert weitere Ideen

bung: dazu StoffsammlungWas sollte einflieen?

Beispiel aus Umweltauditor dazu.Product realization is that sequence of processes and sub-processes required to achieve the product.Kommunikation mit den Kunden Die Organisation mu Regelungen fr die Kommunikation mit den Kunden zur Erfllung der Kundenforderungen einfhren.

Die Organisation mu Kommunikationsforderungen fr folgende Bereiche festlegen: a) Informationen ber das Produkt;b) Anfragen- und Auftragsbearbeitung einschlielich nderungen;c) Kundenbeschwerden und Manahmen bei fehlerhaften Produkten (siehe 8.3 und 8.5.2);d) Kundenreaktion auf das Leistungsvermgen des Produkts (siehe 7.3.2 und 8.2.1.1).Kommunikation mit den Kunden Die Organisation mu Regelungen fr die Kommunikation mit den Kunden zur Erfllung der Kundenforderungen einfhren.

Die Organisation mu Kommunikationsforderungen fr folgende Bereiche festlegen: a) Informationen ber das Produkt;b) Anfragen- und Auftragsbearbeitung einschlielich nderungen;c) Kundenbeschwerden und Manahmen bei fehlerhaften Produkten (siehe 8.3 und 8.5.2);d) Kundenreaktion auf das Leistungsvermgen des Produkts (siehe 7.3.2 und 8.2.1.1).Kommunikation mit den Kunden Die Organisation mu Regelungen fr die Kommunikation mit den Kunden zur Erfllung der Kundenforderungen einfhren.

Die Organisation mu Kommunikationsforderungen fr folgende Bereiche festlegen: a) Informationen ber das Produkt;b) Anfragen- und Auftragsbearbeitung einschlielich nderungen;c) Kundenbeschwerden und Manahmen bei fehlerhaften Produkten (siehe 8.3 und 8.5.2);d) Kundenreaktion auf das Leistungsvermgen des Produkts (siehe 7.3.2 und 8.2.1.1).Plan and control Design and Development of the productDuring planning, determine Stages of design and developmentReview, verification and validation appropriate to each Design and Development stage Responsibilities and authorities for Design and DevelopmentManage interface between different involved groups to ensure effective communication and clear responsibilitiesUpdate planning output, as appropriate, as Design and Development progressesKommunikation mit den Kunden Die Organisation mu Regelungen fr die Kommunikation mit den Kunden zur Erfllung der Kundenforderungen einfhren.

Die Organisation mu Kommunikationsforderungen fr folgende Bereiche festlegen: a) Informationen ber das Produkt;b) Anfragen- und Auftragsbearbeitung einschlielich nderungen;c) Kundenbeschwerden und Manahmen bei fehlerhaften Produkten (siehe 8.3 und 8.5.2);d) Kundenreaktion auf das Leistungsvermgen des Produkts (siehe 7.3.2 und 8.2.1.1).Kommunikation mit den Kunden Die Organisation mu Regelungen fr die Kommunikation mit den Kunden zur Erfllung der Kundenforderungen einfhren.

Die Organisation mu Kommunikationsforderungen fr folgende Bereiche festlegen: a) Informationen ber das Produkt;b) Anfragen- und Auftragsbearbeitung einschlielich nderungen;c) Kundenbeschwerden und Manahmen bei fehlerhaften Produkten (siehe 8.3 und 8.5.2);d) Kundenreaktion auf das Leistungsvermgen des Produkts (siehe 7.3.2 und 8.2.1.1). Feasibility stage The stage during which studies are made of a proposed objective to determine whether practical solutions can be developed within time and cost constraints. This stage usually terminates with a DESIGN BRIEF. Conceptual design stage the stage during which ideas are conceived and theories tested. This stage usually terminates with a preferred solution in the form of a DESIGN REQUIREMENT.Design definition stage the stage during which the architecture or layout takes form and the risks assessed and any uncertainty resolved. This stage usually terminates with definitive design specifications for the components comprising the product, service or process. Detail design stage the stage during which final detail characteristics are determined and method of production/delivery established. This stage usually terminates with a set of specifications for the construction of prototype.Development stage The stage during which the prototype is proven using models or simulations and refined. This stage usually terminates with a set of approved specifications for the construction, installation and operation of the product, service or process.im Rahmen der Entwicklungbei nderungen der Roh-/Einsatzstoffedazu vertragliche Vereinbarungen mit Kunden.....Allgemeine ForderungenDie Organisation mu durch Lenkung ihrer Beschaffungsprozesse sicherstellen, da das beschaffte Produkt den Forderungen der Organisation entspricht. Art und Umfang der Lenkungsmethoden fr solche Prozesse mssen vom Einflu des beschafften Produkts auf das Endprodukt abhngen.

Die Organisation mu Lieferanten aufgrund von deren Fhigkeit bewerten und auswhlen, Produkte entsprechend den Forderungen der Organisation zu liefern. Es mssen Kriterien fr die Bewertung, Neubewertung und Auswahl von Lieferanten aufgestellt werden. Die Ergebnisse von Bewertungen und Folgemanahmen mssen aufgezeichnet werden (siehe 5.6.7).

7.4.2 Beschaffungsangaben Beschaffungsdokumente mssen Angaben enthalten, die das bestellte Produkt klar beschreiben, sowie gegebenenfalls weitere Informationen ber: a) Forderungen fr die Genehmigung oder Qualifikation des Produkts, der Verfahren, Prozesse, Ausrstung und Mitarbeiter;b) Forderungen an das Managementsystem. Die Organisation mu vor der Freigabe die Angemessenheit der Beschaffungsdokumente fr die Festlegung von Forderungen sicherstellen.

7.4.3 Verifizierung von beschafften ProduktenDie Organisation mu die zur Verifizierung des beschafften Produkts erforderlichen Manahmen festlegen und durchfhren (siehe 8.2.3).Wenn die Organisation oder ihr Kunde Verifizierungsttigkeiten beim Lieferanten vorschlgt, mu die Organisation die erforderlichen Verifizierungsmanahmen und -methoden zur Freigabe des Produkts in den Beschaffungsdokumenten festlegen.

Kennzeichnung und RckverfolgbarkeitDie Organisation mu ein Erkennen des Produktstatus bezglich der geforderten Me- und Verifizierungs-ttigkeiten ermglichen und wo notwendig das Produkt in smtlichen Prozessen mit geeigneten Mitteln kennzeichnen. Dies gilt auch fr Bestandteile des Produkts, sofern deren Wechselwirkung die Konformitt mit den Forderungen beeinflut.Wenn Rckverfolgbarkeit gefordert ist, mu die Organisation die eindeutige Kennzeichnung des Produkts lenken und aufzeichnen.

Eigentum des Kunden Die Organisation mu sorgfltig mit Eigentum des Kunden umgehen, solange es sich unter der Aufsicht der Organisation befindet oder von ihr benutzt wird. Die Organisation mu die Kennzeichnung, Verifizierung, Lagerung und Instandhaltung des ihr zum Gebrauch oder zur Verwendung berlassenen Eigentums des Kunden sicherstellen. Verlorengegangenes, beschdigtes oder anderweitig fr unbrauchbar befundenes Eigentum des Kunden mu aufgezeichnet, und dem Kunden mu darber Mitteilung gemacht werden (siehe 7.2.3).ANMERKUNG: Als Eigentum des Kunden kann auch geistiges Eigentum zhlen, z. B. als vertraulich bermittelte Informationen.

Handhabung, Verpackung, Lagerung, Konservierung und Versand Die Organisation mu sicherstellen, da die Kennzeichnung, Verpackung, Lagerung, Konservierung und Handhabung des Produkts whrend der internen Verarbeitung und endgltigen Auslieferung nicht die Konformitt mit den Forderungen an das Produkt beeintrchtigen. Dies gilt auch fr Teile eines Produkts.Die Produktfreigabe darf nicht voranschreiten, bis smtliche festgelegten Ttigkeiten zufriedenstellend abgeschlossen sind und die zugehrige Dokumentation verfgbar und genehmigt ist.Kennzeichnung und RckverfolgbarkeitDie Organisation mu ein Erkennen des Produktstatus bezglich der geforderten Me- und Verifizierungs-ttigkeiten ermglichen und wo notwendig das Produkt in smtlichen Prozessen mit geeigneten Mitteln kennzeichnen. Dies gilt auch fr Bestandteile des Produkts, sofern deren Wechselwirkung die Konformitt mit den Forderungen beeinflut.Wenn Rckverfolgbarkeit gefordert ist, mu die Organisation die eindeutige Kennzeichnung des Produkts lenken und aufzeichnen.

Eigentum des Kunden Die Organisation mu sorgfltig mit Eigentum des Kunden umgehen, solange es sich unter der Aufsicht der Organisation befindet oder von ihr benutzt wird. Die Organisation mu die Kennzeichnung, Verifizierung, Lagerung und Instandhaltung des ihr zum Gebrauch oder zur Verwendung berlassenen Eigentums des Kunden sicherstellen. Verlorengegangenes, beschdigtes oder anderweitig fr unbrauchbar befundenes Eigentum des Kunden mu aufgezeichnet, und dem Kunden mu darber Mitteilung gemacht werden (siehe 7.2.3).ANMERKUNG: Als Eigentum des Kunden kann auch geistiges Eigentum zhlen, z. B. als vertraulich bermittelte Informationen.

Handhabung, Verpackung, Lagerung, Konservierung und Versand Die Organisation mu sicherstellen, da die Kennzeichnung, Verpackung, Lagerung, Konservierung und Handhabung des Produkts whrend der internen Verarbeitung und endgltigen Auslieferung nicht die Konformitt mit den Forderungen an das Produkt beeintrchtigen. Dies gilt auch fr Teile eines Produkts.Die Produktfreigabe darf nicht voranschreiten, bis smtliche festgelegten Ttigkeiten zufriedenstellend abgeschlossen sind und die zugehrige Dokumentation verfgbar und genehmigt ist.8.1 Allgemeine ForderungenDie Organisation mu die Prozesse fr die Messung, berwachung, Analyse und Verbesserung festlegen, planen und einfhren, um zu sicherzustellen, da das QM-System, die Prozesse sowie die Produkte den Forderungen entsprechen.

Art, Ort, Zeitplan und Hufigkeit von Messungen sowie die Forderungen an die Aufzeichnung mssen festgelegt werden (siehe 5.6.7).

Die Wirksamkeit der eingefhrten Manahmen mu in regelmigen Zeitabstnden bewertet werden.

Die Organisation mu geeignete statistische Hilfsmittel festlegen und anwenden.

Die Ergebnisse der Datenanalyse und Verbesserungsttigkeiten mssen eine Eingabe fr den Proze der QM-Bewertung (siehe 5.7) sein.

8.2.1.1 Messung und berwachung der KundenzufriedenheitDie Organisation mu Informationen zur Kundenzufriedenheit und/oder -unzufriedenheit auswerten. Die Verfahren fr die Beschaffung und die Nutzung solcher Informationen und Daten mssen festgelegt werden.

bung:Wer macht das?

8.2.1.2 Interne QualittsauditsDie Organisation mu objektive Audits durchfhren, um zu ermitteln, ob das QM-System wirksam eingefhrt und aufrechterhalten wurde und ob es dieser Internationalen Norm entspricht. Zustzlich darf die Organisation Audits durchfhren, um Mglichkeiten zur Verbesserung festzustellen.

Der Auditprozess sowie der Ablaufplan mssen den Status und die Bedeutung der zu auditierenden Ttigkeit und/oder Bereiche sowie die Ergebnisse frherer Audits bercksichtigen.

Das QM-Verfahren fr interne Audits mu sowohl Umfang, Hufigkeit und Methodik von Audits als auch die Verantwortungen sowie die Forderungen an die Durchfhrung von Audits, an deren Aufzeichnung und an den Bericht der Ergebnisse an die Leitung beinhalten.

Audits mssen von anderen Personen durchgefhrt werden als denen, die die zu auditierende Arbeit ausgefhrt haben.

ANMERKUNG: Eine weiterfhrende Anleitung findet sich in ISO 10011.

8.2.2 Messung und berwachung der ProzesseDie Organisation mu geeignete Verfahren anwenden, um Prozesse zu messen und zu berwachen, die zur Erfllung der Kundenforderungen notwendig sind, und um darzulegen da ein Proze weiterhin in der Lage ist, seinen Verwendungszweck zu erfllen. Die Meergebnisse mssen zur Erhaltung und Verbesserung dieser Prozesse verwendet werden.

Was sind Kennzahlen fr Prozesse?

Datenquellen:Interne Audits, Korrektur- und Vorbeugungsmanahmen, nicht anforderungsgerechte Produkte und/oder Dienstleistungen, Kundenreklamationen, Kundenzufriedenheitsuerungen.Informationen:fr das Management-Review8.5.1 Allgemeine ForderungenDie Organisation mu das QM-System stndig verbessern. Sie mu ein QM-Verfahren festlegen, das die Anwendung der Qualittspolitik, Qualittsziele, Ergebnisse interner Audits, Datenanalysen, Korrektur- und Vorbeugungsmanahmen und QM-Bewertungen beschreibt, um eine stndige Verbesserung zu ermglichen.