iso 9001 (2000) checklist

Page 1 of 20ISO 9001 (2000) QUALITY MANAGEMENT SYSTEM ASSESSMENT REPORTSUPPLIER/ SUBCONTRACTORSUPPLIER/ SUBCONTRACTOR NAME:ADDRESS:CITY AND STATE:ZIP CODE:SUPPLIER/MANUFACTURER NOPHONE:DIVISION:REQUESTED BY:EVALUATOR:EVALUATION DATE:CHECKLIST INSTRUCTIONS1. All checklist line items within each element must be answered in sufficient detail to permitevaluation of compliance.2. Enter an “X” in the appropriate spaces. (Refer to the COM, MIN and MJR definitions on page oneof the checklist). List procedure numbers and paragraph numbers in the comments column.4. A separate comment sheet may be used to supplement the checklist comments column. (Entercorresponding reference comment numbers).5. When supplemental data is required, reference it in the in the comments column.6. Submittal of an incomplete checklist will be cause for delay in completing the evaluation.

RefParRequirementISO 9001-2000 Audit Checklist4.1 General RequirementsA quality management system has been established,documented, implemented, maintained, and continuallyimproved?Does the quality management system include:a. Identification of the processes needed for the qualitymanagement system and their application?ComplianceStatusCOM MIN MJRPage 2 of 20Commentsb. Determination of the sequence and interaction of theseprocesses?c. Determined criteria and methods required ensuring theeffective operation and control of these processes?d. The availability of information necessary to supportthe operation and monitoring of these processes?e. Methods to measure monitor and analyze theseprocesses?f. Implemented action necessary to achieve plannedresults and continual improvement?Are processes that are outsourced that may affectproduct or service conformity identified anddocumented?4.2.1 General Documentation RequirementsDoes the quality management system documentationinclude documented procedures and records requiredensuring effective operation and control of its processes?Is the extent of the quality management systemdocumentation appropriate to:a. Size and type of the organization?b. Complexity and interaction of the processes?c. Competence of personnel?Does the quality system documentation include:COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParISO 9001-2000 Audit ChecklistRequirementComplianceStatusCOM MIN MJRa. A documented quality policy and quality objectivesPage 3 of 20Commentsb. A quality manual?c. Documented procedures required by ISO 9001:2000?d. Documents required by the organization?e. Quality records required by ISO 9001:2000?4.2.2 Quality ManualHas a quality manual been established which includes:a. Scope of quality system, including details andjustifications for exclusions?b. Procedures or references to procedures?c. Sequence and interaction of QMS processes orreference to them?4.2.3 Control of DocumentsAre documents required for the quality managementsystem controlled?Is there a documented procedure for:a. The approval of documents for adequacy priorto issue?b. The review, updating as necessary and re-approval ofdocuments?c. The identification of the current revision status ofdocuments?d. Ensuring that relevant versions of applicabledocuments are available at points of use?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementf. For ensuring that documents of external origin areidentified and their distribution is controlled?e. For ensuring that documents remain legible, readilyidentifiable and retrievable?ISO 9001-2000 Audit ChecklistComplianceStatusCOM MIN MJRPage 4 of 20Commentsg. Preventing the unintended use of obsolete documents,and to apply suitable identification to them if they areretained for any purpose?4.2.4 Control of RecordsAre quality records for resources and systemplanning available?Do these records provide evidence of conformance torequirements and of effective operation of the qualitymanagement system?Are records legible, readily identifiable and retrievable?Is there a documented procedure that defines the controlsneeded for identification, storage, retrieval, protection,retention time and disposition of records.5.1 Management CommitmentHow has top management demonstrated commitment tothe development and improvement of the qualitymanagement system?a. Communicating to the organization the importance ofmeeting customer as well as regulatory & legalrequirements?b. Establishing the quality policy?c. Ensuring that quality objectives are established?d. Conducting management reviews?e. Ensuring the availability of resources?5.2 Customer FocusDoes top management ensure that customer requirementsare determined and fulfilled with the aim of achievingcustomer satisfaction?5.3 Quality PolicyCOM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParISO 9001-2000 Audit ChecklistRequirementComplianceStatusCOM MIN MJRHas as top management ensured that the quality policy:Is appropriate to the purpose of the organization?Page 5 of 20Commentsb. Includes a commitment to meeting requirements andto continual improvement?c. Provides a framework for establishing and reviewingquality objectives?d. Is communicated and understood at within theorganization?e. Is reviewed for continuing suitability?5.4 Planning5.4.1 Quality ObjectivesWhat are the quality objectives that have beenestablished at relevant functions and levels within theorganization?Are the quality objectives measurable and consistentwith the quality policy?Do quality objectives include those needed to meetrequirements for product/service?5.4.2 Quality Management System PlanningHow has Top Management ensured that:a. Processes of the quality management system arecarried out in order to meet the requirements?b. Is the output of quality planning documented?How?c. A changes conducted in a controlled manner and is theintegrity of the QMS maintained during changes?d. How and what method is used when planning changesthat may affect the quality management system?5.5 Responsibility, authority and Communication5.5.1 Responsibility and authorityCOM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementISO 9001-2000 Audit ChecklistHow are the functions and their interrelations within theorganization, including responsibilities and authorities,defined and communicated?How is responsibility and authority defined?ComplianceStatusCOM MIN MJRPage 6 of 20Comments5.5.2 Management representativeHas top management appointed a member of management that has the responsibility andauthority that includes:a. ensuring that processes needed for the QMS areestablished, implemented and maintained?b. reporting to top management on the performance ofthe QMS and any need for changes.c. ensuring the promotion of awareness of customerrequirements throughout the organization.5.5.3 Internal CommunicationsWhat communication channels have been establishedwithin the organization relating to quality managementsystem effectiveness?5.6 General - Management ReviewDoes top management review the quality managementsystem, at planned intervals, to ensure its continuingSuitability, adequacy, and effectiveness?What is the interval?Does the review evaluate the need for changes to thequality management system, including quality policy andquality objectives?How are opportunities for improvement and changesneeded within the quality system evaluated anddocumented?5.6.2 Review InputDo inputs to management review include current performance and improvement opportunitiesrelated to the following:a. Results of audits?b. Customer feedback?c. Process performance and product conformance?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParISO 9001-2000 Audit ChecklistRequirementComplianceStatusCOM MIN MJRd. Status of preventive and corrective actions?Page 7 of 20Commentse. Follow-up actions from earlier management reviews?f. Planned changes that could affect the qualitymanagement system?g. Recommendations for improvement?5.6.3 Review OutputDo outputs to management review include currentperformance and improvement opportunitiesrelated to the following:a. Improvements of the effectiveness of the QMSand its processes?b. Improvement of product or service related tocustomer requirements?c. Resource needs?6 Resource Management6.1 Provision of resourcesHow have resources needed to implement andimprove quality management system processesbeen provided?Are there adequate resources available toimplement and maintain the QMS and tocontinually improve its effectiveness?Are resources available to ensure that customersatisfaction is enhanced?Are there defined responsibilities and authorities of allpersonnel who can affect quality?6.2.2 Competence, Awareness and TrainingAre personnel assigned responsibilities in thequality management systems qualified anddeemed competent based on skills, experience,and education & training requirements ?How has the organization:COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParISO 9001-2000 Audit ChecklistRequirementComplianceStatusCOM MIN MJRa. Determined the necessary competency for personnel?b. Provided training to satisfy competency needs?Page 8 of 20Commentsc. Evaluated the effectiveness of actions taken?d. Ensured that its personnel are aware of their part in theQMS?e. Maintained appropriate records of education, training,skills, and experience?6.3 InfrastructureIs the infrastructure of the organization such that:a. Buildings, workspace, and associated utilitiesare determined, provided, and maintained?b. Process equipment, hardware, and softwareare determined, provided, and maintained?c. Supporting services such as transportation orcommunication are determined, provided, andmaintained?6.4 Work EnvironmentDoes the organization identify and manage thehuman and physical factors of the workenvironment needed to achieve conformity ofproduct/service?7.1 Planning of Product (Service) RealizationIs planning of the realization processes consistentwith the other requirements of the organization’squality management system?Are realization processes documented in a formsuitable for the organization’s method of servicedeliver and/or operation?In planning product realization, has the organization determined:a. That quality objectives and requirements for theproduct, service?b. The need to establish processes and documents, andprovide resources specific to the product/service?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

ISO 9001-2000 Audit ChecklistRefRequirementComplianceParStatusCOM MIN MJRc. That verification, validation, monitoring, inspectionand test activities, and the criteria for product/serviceacceptability?d. The records that are necessary to provide evidence ofconformity of the processes and resulting product/servicefulfill customer requirements?7.2 Customer Related Process7.2.1 Determination of Requirements Related to the Product/ServiceHas the organization determined customer requirements including:a. Product/service delivery requirements specified by thecustomer (including post delivery activities if any)?b. Product/service delivery requirements not specified bythe customer but necessary for intended or specified use?c. Obligations related to product, including regulatoryand legal requirements?Page 9 of 20Commentsd. Additional requirements determined by theorganization?7.2.2 Review of Requirements Related to the Product (Service)Does the organization review the identifiedrequirements together with additional requirementsdetermined by the organization prior to acceptance?Is this review conducted prior to the commitment tosupply a product to the customer?Does the review ensure that:a. Product/service delivery requirements aredefined?b. Where the customer provides no documentedstatement of requirement, the customerrequirements are confirmed before acceptance?c. Contract or order requirements differing fromthose previously expressed are resolved?d. The organization has the ability to meet definedrequirements?Are the results of the review, actions, andsubsequent follow up actions recorded (see ISOElement 4.2.4)?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementISO 9001-2000 Audit ChecklistWhere product/service requirements are changed, doesthe organization ensure that relevant documentation isamended?How are verbal orders handled, addressed, anddocumented?Does the organization ensure that relevant personnel aremade aware of the changed requirement?How are customer requirements reviewed beforeservices are provided?ComplianceStatusCOM MIN MJRPage 10 of 20CommentsHow are the results of the review of agreements and anyfollow-up actions recorded?7.2.3 Customer CommunicationHow does the organization identify and implement arrangements for communication withCustomers relating to:a. Product information?b. Inquiries, contracts, or order handling, includingamendments?c. Customer feedback, including customer complaints?7.3.1&7.3.2Design and Development Planning and Design and Development InputsWhat is the design and development planningmethodology described in the design procedure?How are the design and development stagesplanned and organized?Who is responsible to review, verify and validateeach design and development stage?How are the interfaces between different groupsinvolved in design identified and managed?Are design and development inputs relating toproduct requirements defined and documented?Do these inputs include:a. functional and performance requirements?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementb. Applicable statutory and regulatoryrequirements?c. Where applicable, information derived fromprevious similar designs?d. Other requirements essential for design anddevelopment?ISO 9001-2000 Audit ChecklistComplianceStatusCOM MIN MJRPage 11 of 20Comments7.3.3 Design and Development OutputsAre the outputs of the design and/or developmentprocess documented in a manner that enablesverification against the design and/or developmentinputs?Does design and/or development output:a. Meet the design and/or development inputrequirements?b. Provide appropriate information for productionand service operations?c. Contain or reference product acceptancecriteria?d. Define the characteristics of the product thatare essential to its safe and proper use?Are design and/or development output documentsapproved prior to release?Documentation of design outputs is maintainedand easily accessible?A review of design outputs, change notices,customer complaints, and internal audit reportsindicate consistent adherence to organizationalstandards for design output plans, etc.?7.3.4 Design and Development ReviewAre systematic reviews of design and/ordevelopment conducted at suitable stages?Do these reviews:a. evaluate the ability to fulfill requirements?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementb. identify problems and propose follow-upactions?Do participants in such reviews includerepresentatives of functions concerned with thedesign and/or development stage(s) beingreviewed?Are the results of the reviews and subsequentfollow-up actions recorded?At what stages of the design are plans or otherdesign documented?Where are records of design reviews maintained?ISO 9001-2000 Audit ChecklistComplianceStatusCOM MIN MJRPage 12 of 20Comments7.3.5 Design and/or Development VerificationIs design and/or development verification performed toensure the output meets the design and/or developmentinputs?Are the results of the verification and subsequent followupactions recorded?7.3.6 Design and/or Development ValidationIs design and/or development validation performedto confirm that resulting product is capable ofmeeting the requirements for the intended use?Wherever applicable, is validation completed prior to thedelivery or implementation of the product?If full validation is impractical prior to delivery orimplementation, is partial validation performed to theextent applicable?Are the results of the validation and subsequent followupactions recorded?7.3.7 Control of Design and Development ChangesAre design and/or development changes identified,documented, and controlled?Does this process include evaluation of the effectof the changes on constituent parts and deliveredproducts?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementAre changes verified and validated, as appropriate,and approved before implementation?Are the results of the review of changes andsubsequent follow up actions documented?ISO 9001-2000 Audit ChecklistComplianceStatusCOM MIN MJRPage 13 of 20Comments7.4.1 Purchasing ProcessDoes the organization control its purchasingprocesses to ensure purchased product conformsto requirements?Is the type and extent of control dependent upon theeffect of subsequent realization processes andtheir output?Does the organization evaluate and selectsuppliers based on their ability to supply product inaccordance with the organization’s requirements?Are criteria for selection and periodic evaluationdefined?Are the results of evaluations and subsequentfollow up actions recorded?7.4.2 Purchasing InformationDo purchasing documents contain informationdescribing the product to be purchased?Do these documents include where appropriate:a. requirements for approval or qualification ofproduct, procedures, processes, equipment,and personnel?b. quality management system requirements?Is the adequacy of specified requirementscontained in the purchasing documents reviewed prior totheir release?When purchasing good/services, does thepurchaser provide subcontractors/suppliers withprecise details of the order to ensure item/servicesare purchased correctly in the first place?NOTE: Sample purchase requisitions to determine the above.7.4.3 Verification of Purchased ProductCOM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

ISO 9001-2000 Audit ChecklistRefParRequirementComplianceStatusCOM MIN MJRHave activities necessary for the verification ofpurchased product been identified andimplemented?7.5.1 Control of Production and Service ProvisionDoes the organization control production and service operations through:a. the availability of information that specifies thecharacteristics of the product?Page 14 of 20Commentsb. where necessary, the availability of workinstructions?c. the use and maintenance of suitableequipment for production and serviceoperations?d. the availability and use of measuring andmonitoring devices?e. the implementation of monitoring activities?f. the implementation of defined processes forrelease, delivery, and applicable post-deliveryactivities?7.5.2 Validation of Processes for Production and Service ProvisionDoes the organization validate any production andservice processes where the resulting outputcannot be verified by subsequent measurement ormonitoring?Are any processes included where deficienciesmay become apparent only after the product is inuse or the service has been delivered?Does validation demonstrate the ability of theprocesses to achieve planned results?Do defined arrangements for validation include as applicable:a. approval/qualification of processes?b. approval/qualification of equipment and personnel?c. use of defined methodologies and procedures?d. requirements for records?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefPare. re-validation?ISO 9001-2000 Audit ChecklistRequirementComplianceStatusCOM MIN MJRPage 15 of 20Comments7.5.3 Identification and traceabilityIs product identified by suitable means throughoutproduction and service operations whereappropriate?Is the status of the product with respect to measurementand monitoring requirements clearlyidentified?Where traceability is a requirement, is the uniqueidentification of product controlled and recorded?7.5.4 Customer PropertyHow does the organization exercise care withcustomer property while it is under theorganization’s control or being used by theorganization?How is customer property provided for use or incorporation in product:a. Identified?b. Verified?c. Protected?d. Maintained?If any customer property is lost, damaged, orotherwise found to be unsuitable for use is itrecorded and reported to the customer?7.5.5 Preservation of ProductIs product preserved to ensure that conformity withcustomer requirements is maintained duringinternal processing and delivery to the intendeddestination?Does this include identification, handling,packaging, storage, and protection?Do these controls also apply to the constituentparts of a product?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementISO 9001-2000 Audit Checklist7.6 Control of Measuring and Monitoring DevicesHow does the organization identify themeasurements to be made and the measuring andmonitoring devices required to assure conformity ofproduct to specified requirements?ComplianceStatusCOM MIN MJRPage 16 of 20CommentsAre measuring and monitoring devices used andcontrolled to ensure that measurement capability isconsistent with the measurement requirements?Where applicable, measuring and monitoring devices shall:a. be calibrated and adjusted periodically or prior touse, against devices traceable to Internationalor national standards?a.1 Where no such standards exist, is the basis used forcalibration recorded?b. be safeguarded from adjustments that wouldinvalidate the calibration?c. be protected from damage and deteriorationduring handling, maintenance, and storage?d. have the results of their calibration recorded?e. have the validity of previous resultsreassessed if they are subsequently found outof calibration and corrective action taken?NOTE: Investigate methods in which measurement and monitoring devices are controlled to ensurefitness for use (i.e. identification of calibration status, traceability of device to calibration record, methodin which frequency of calibration is determined).Is software used for measuring and monitoring ofspecified requirements validated prior to use?Measurement, analysis and improvement8.1 GeneralThe organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to:a. demonstrate conformity of the productb. ensure of the quality management systemCOM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementc. continually improve the effectiveness of the qualitymanagement systemISO 9001-2000 Audit ChecklistComplianceStatusCOM MIN MJRPage 17 of 20Comments8.2.1 Customer SatisfactionAre measurement and monitoring activities neededto assure conformity and achieve improvementbeen identified and included in the product qualityplan?Does this process include the determination of theneed for, and use of, applicable methodologiesincluding statistical techniques?8.2.2 Internal AuditAre periodic internal quality audits conducted todetermine whether the quality management systemhas been effectively implemented and maintained?Are internal quality audits planned, includingconsideration of the status and importance of theactivities and areas to be audited as well as the results ofprevious audits?Is the audit scope, frequency, and methodologiesdefined?Are audits conducted by personnel other thanthose who performed the activity being audited?Are there documented procedures that includethe responsibilities and requirements forconducting audits, ensuring their independence,recording results, and reporting to management?Have personnel conducting internal audits beentrained?Are records of internal auditor training maintainedand available?Does management take timely corrective action ondeficiencies found during the audit?Do follow-up actions include the verification of theimplementation of corrective action and thereporting of verification results?8.2.3 Measuring and Monitoring of ProcessesAre product realization processes measured andmonitored by suitable methods to ensure customerrequirements are met?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementDo these methods confirm the continuing ability ofeach process to satisfy its intended purpose?ISO 9001-2000 Audit ChecklistComplianceStatusCOM MIN MJRPage 18 of 20Comments8.2.4 Measuring and Monitoring of Product (Service)Are product characteristics measured andmonitored to verify that requirements for theproduct are met?Is this carried out at appropriate stages of theproduct realization process?Is evidence of conformity with the acceptancecriteria documented?8.3 Control of NonconformityIs product, which does not conform torequirements, clearly identified and controlled toprevent unintended use or delivery?Are these activities defined in a documentedprocedure?Does the organization deal with nonconforming productby one or more of the following:a. taking action to eliminate the nonconformityb. authorizing it’s use, release or acceptance byrelevant authority or when applicable by thecustomerc. taking action to preclude it’s use or applicationRecords of nonconformities and subsequent actionstaken shall be developed and maintained.Is nonconforming product corrected and subjectedto re-verification after correction to demonstrateconformity?When nonconforming product is detected afterdelivery or use has started, is appropriate actiontaken regarding the consequences of thenonconformity?8.4 Analysis of DataHow is appropriate data collected and analyzed todetermine the suitability and effectiveness of thequality management system and to identifyimprovements that can be made?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParISO 9001-2000 Audit ChecklistRequirementComplianceStatusCOM MIN MJRDoes this include data generated by measuringand monitoring activities and other relevantsources?How is this data analyzed to provide information on:a. customer satisfaction and/or dissatisfaction?Page 19 of 20Commentsb. conformance to customer requirements?c. characteristics of processes, product, and theirtrends?d. suppliers?8.5.1 Continual ImprovementAre processes necessary for the continualImprovement of the quality management systemplanned and managed?How is continual improvement of the quality management system facilitated through the use of:a. quality policy?b. quality objectives?c. audit results?d. analysis of data?e. corrective and preventive action ?f. management review?8.5.2 Corrective ActionHow is corrective action taken to eliminate thecause of nonconformities in order to preventrecurrence?Is corrective action appropriate to the impactof the Problems encountered?Is there a documented procedure for corrective action which defines requirements for:COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract

RefParRequirementa. identifying nonconformities (including customercomplaints)?b. determining the causes of nonconformity?ISO 9001-2000 Audit ChecklistComplianceStatusCOM MIN MJRPage 20 of 20Commentsc. evaluating the need for actions to ensure thatnonconformities do not recur?d. determining and implementing the correctiveaction needed?e. recording results of action taken?f. reviewing corrective action taken?8.5.3 Preventive ActionDoes the organization identify preventive action toeliminate the causes of potential nonconformitiesto prevent occurrence?Are preventive actions taken appropriate to theimpact of the potential problems?Is there a documented procedure for preventive action which defines requirements for:a. identifying potential nonconformities and theircauses?b. determining and ensuring the implementationof preventive action needed?c. recording results of action taken?d. reviewing preventive action taken?Do the procedures ensure relevant information onactions taken is submitted for management review?COM - Compliance with requirement.MIN - Minor noncompliance (administrative in nature). Requires a corrective action plan and estimated completion date prior toawarding a purchase order or subcontract.MJR - Major noncompliance (directly effects the product). Requires corrective action implemented and validation prior to awarding apurchase order or subcontract