iso 9001 2008 audit checklist1 msword
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ISO 9001:2008 AUDIT CHECKLIST
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4. QUALITY MANAGEMENT SYSTEM4.1 General Requirement
Has the organization established, documented,implemented and maintained a qualitymanagement system in accordance with therequirements of ISO 9001?
Is the effectiveness of the quality managementsystem continually improved?
Has the organization ;
a. Identified the processes needed forthe quality management system
including their applications throughoutthe organization.
b. Determined the sequence andinteraction of these processes.
c. Determine the criteria and methodsneeded to ensure that both theoperation and control of theseprocesses are effective.
d. Ensure the availabili ty of resourcesand information is necessary tosupport the operation and monitoringof these processes.
e. Measured, monitored and analyzed
these processesf. Implemented actions needed to
achieve planned results andcontinual improvement?
Does the organization manage the processes inarcordance with the requirement of ISO 9001?
Where processes that affect productconformity with requirements areoutsourced, are the controls for theseprocesses identified within the qualitymanagement system?
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4.2 Documentation Requirements
4.2.1 General
Does the quality management systemdocumentation include ;
a. documented statements of qualitypolicy and quality objectives?
b. Quality Manual?c. Documented procedures and
records required by ISO 9001?
d. Documents and records needed by theorganization to ensure the effectiveplanning, operation and control of its
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processes?
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4.2.2 Quality Manual
Has a quality manual been established and
maintained that includes ;
a. the scope of the quality managementsystem including details of andjustification for any exclusions?
b. Documented procedures establishedfor the quality management systemsystem, or reference to them?
c. Description of the interactionbetween the processes of thequality management system?
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4.2.3 Control of documents
Are documents required for the qualitymanagement system controlled?
Has documented procedure been establishidentifying the following controls needed?
a. Approval of documents for a adequacyprior to issue?
b. Review, update as necessary and re-approval of documents?
c. Ensure that changes and the currentrevision status of documents are
identified?d. Ensure that relevant version of
applicable documents are available atpoints of use?
e. Ensure that documents remainlegible and readily identifiable?
f. Ensure that documents of externalorigin are identified and theirdistribution controlled?
g. Preventing the unintended use ofobsolete documents, and to applysuitable identification to them if theyare retained?
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4.2.4 Control of Records
Have records been establish and maintained toprovide evidence of conformity to requirementsand of the effective operation of the qualitymanagement system?
Has a documented procedure been establishedto define the following controls needed?
a. Identification?b. Storage?
c. Retrieval?d. Protection?e. Retention Time?f. Disposition?
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5. MANAGEMENT RESPONSIBILITY
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5.1 Management Commitment
Has top management provide evidence of itscommitments to the development andimplementation of the quality managementsystem and for the continual improvement of itseffectiveness by ;
a. Communicating to the organizationthe importance of meeting customeras well as regularly and legalrequirements?
b. Establishing the quality policy?c. Ensuring that quality objectives are
established?
d. Conducting management reviews?e. Ensuring the availability of
resources?
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5.2 Customer Focus
Has top management ensured thatcustomer requirements are determinedand met with the aim of enhancingcustomer satisfaction.
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5.3 Quality Policy
Has top management ensured that thequality policy :
a. is appropriate to the purpose of theorganization.
b. Includes a commitment to comply withrequirements and to continuallyimprove the effectiveness of thequality management system.
c. Provides a framework for establishingand reviewing quality objectives.
d. Is communicated and understoodwithin the organization?
e. Is reviewed for continuingsuitability?
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5.4 Planning5.4.1 Quality Objectives
Has top management ensured that qualityobjectives are established at relevant functionsand levels within the organization.
Have quality objectives needed to meet therequirements of the product been established?
Are quality objectives measurable and consistentwith the quality policy?
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5.4.2 Quality Management System Planning
Has top management ensured that theresources needed to achieve the qualityobjectives are identified and planned?
Is the output of the planning documented? (e.g :quality manual, procedures, works instructions,quality plans, etc.)
Does top management ensure that theintegrity of the quality management systemis maintained when changes are planned andimplemented?
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5.5 Responsibility, Authority andCommunication
5.5.1 Responsibility and Authority
Has top management ensured thatresponsibilities, authorities are defined andcommunicated within the organization?
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5.5.2 Management Representative
Has top management appointed member(s) ofmanagement who have responsibility andauthority for :
a. Ensuring that processes are
established, implemented andmaintained?
b. Reporting to top management on theperformance of the qualitymanagement system, including needsfor improvement?
c. Promoting awareness of customerrequirements throughout theorganization.
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5.5.3 Internal CommunicationHas top management ensured that appropriatecommunication processes have been
established within the organization?
Does communication take place regarding theeffectiveness of the quality managementsystem?
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5.6 Management Review5.6.1 General
Does the top management review the qualitymanagement system, at planned intervals, toensure its continuing suitability, adequacy andeffectiveness?
Are opportunities for improvement and the needfor changes to the quality management system,including quality policy and objectives, reviewed
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during the review?
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5.6.2 Review Input
Do the inputs to management review includeinformation on:a. Results of audits?b. Customer feedback?c. Process performance and product
conformity?d. Status of preventive and correct ive
actions?e. Follow-up actions from previous
managements reviews?f. Planned changes that could affect the
quality management system?g. Recommendations for improvement?
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5.6.3 Review Output
Do the outputs from management review includethe decisions and actions related to:a. Improvement of the effectiveness of the
quality management system and itsprocesses?
b. Improvement of the product related tocustomer requirements?
c. Resources needed?
6 Resource Management
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6. Resource Management6.1 Provision of Resources
Have the resources been determined andprovided for:a. Implementing and maintaining quality
management system and continuallyimproving its effectiveness?
b. Enhancing customer satisfaction bymeeting customer requirements?
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6.2 Human Resources6.2.1 General
Is competency for personnel who perform workaffecting product quality based on appropriateeducation, training, skills, and experience?
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6.2.2 Competency, awareness and training
Has the organization :a. Determined the necessary competency
for personnel performing work affectingproduct quality?
b. Provided training or take other actions tosatisfy these needs?
c. Evaluated the effectiveness of the actionstaken?
d. Ensured that employees are aware of therelevance and importance of theiractivities and how they contribute to the
achievement of the quality objectivese. Maintained appropriate records of
education, training, skills and experience.
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6.3 Infrastructure
To achieve conformity of product, does theorganization identity, provide, and maintain thefacilities including :
a. Building, workshops and associatedutilities?
b. Process equipment, hardware andsoftware?
c. Supporting services?
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6.4 Work Environment
Has the environment needed to achieveconformity of product requirements beendetermined and managed?
7. Product Realization
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7. Product Realization7.1 Planning of Realization Process
Is planning of the organizations productrealization consistent with the requirements ofthe other processes of the quality managementsystem?
Are the following being determined whenplanning the product realization:
a. Quality objectives and requirementsfor the product?
b. The need to establish processes,documents, and provide resourcesspecific to the product?
c. Required verification, validation,monitoring, inspection and testactivities specific to the product andcriteria for product acceptance?
d. Records needed to provide evidencethat the realization processes andresulting product fulfil requirements?
Is the planning output in a form that is suitablefor the organizations method of operation?
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7.2. Customer-Related Processes
7.2.1 Determination of Requirements Relatedto the Product
Has the organization determined :a. Requirements specified by the
customer, including the requirementsfor delivery and post deliveryactivities?
b. Requirements not stated by thecustomer but necessary for specifiedor intended use, where known?
c. Statutory and regulatory requirementsrelated to the product?
d. Any additional requirements
determined by the organization?
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7.2.2 Review of Requirements Related to theProduct
Prior to the commitment to the customer (e.g.submission of tenders, acceptance of contractsor orders or acceptance of change orders) are
requirements reviewed to ensure that:
a. Product requirements are defined?b. Contract or order requirements differing
from those previously expressed orresolved?
c. The organization has the abili ty to meetdefined requirements?
Are the results of reviews and actions arisingfrom these reviews recorded and maintained asrecords?
Where the customer has not provided a
documented statement of requirements, arecustomer requirements confirmed by theorganization before acceptance?
Where product requirements are changed, doesthe organization ensure that relevantdocumentation is amended and relevantpersonnel are made aware of the changedrequirements?
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7.2.3 Customer Communication
Has the organization determined andimplemented effective arrangements for
communicating with customers relating to:a. Product information?b. Inquiries, contracts, amendments or
order handling?c. Customer feedback, including
customer complaints?
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7.3 Design and Development7.3.1 Design and Development Planning
Are product design and development activitiesplanned and controlled?
During design and development planning hasthe organization determined:
a. Stages of design and development?b. Review, verification and validation that
are appropriate to each design anddevelopment stage?
c. Responsibilities and authorities fordesign and development?
Are interfaces between different groups involvedin design and development managed to ensureeffective communication and clear assignment ofresponsibilities?
Is planning output updated as the design anddevelopment progresses?
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7.3.2 Design and Development Inputs
Are inputs relating to product requirementsdefined, documented and maintained as arecord?
Does design and development input include:a. Functional and performance
requirements?b. Applicable statutory and regulatory
requirements?c. Applicable information derived from
previous similar designs?d. Other requirements essentials for
designs and development?Are design and development inputs reviewed foradequacy?
Are incomplete, unambiguous or conflictingrequirements resolved?
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7.3.3 Design and Development Outputs
Are outputs of the design and developmentprovided in a form that enables verificationagainst the design and development inputs?
Are design outputs approved prior release?
Does the design and development output:
a. Meet the design and development
input requirements?b. Provide appropriate information for
purchasing, production and for serviceprovision?
c. Contain or reference productacceptance criteria?
d. Specify the product characteristics thatare essential to its safe and properuse?
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7.3.4 Design and Development Review
Are systematic reviews performed in accordancewith planned arrangements at suitable stages of
the design and development?
Do design and developments review:a. Evaluate the ability of the results of
design and development to meetrequirements?
b. Identify problems and proposenecessary actions?
Do review participants include representatives offunctions concerned with the design anddevelopment stage(s) being reviewed?
Are results of reviews and any actions necessary
maintained as records?
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7.3.5 Design and development Verification
Is design and development verificationperformed in accordance with plannedarrangements to ensure that the design outputs
have met the design and development inputrequirements?
Are results of the verification and actionsmaintained as records?
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7.3.6 Design and Development Validation
Is design and development validation performedin accordance with planned arrangements?
Is design and development validation performedto confirm that the product is capable of meetingthe requirements for the specified application or
intended use, where known?
Is validation completed prior to delivery orimplementation of the product whereverapplicable?
Are results of the validation and actionsmaintained as records?
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7.3.7 Control of Design and DevelopmentChanges
Are design and/ or development changesidentified and recorded?
Do reviews of design and development changesinclude evaluation of the effect of the changeson constituent parts and product alreadydelivered?
Are design and development changes reviewed,verified, validated as appropriate and approvedbefore implementation?
Are results of the review of changes andnecessary actions maintained as records?
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7.4 Purchasing
7.4.1 Purchasing control
Are the purchasing processes controlled toensure purchased product (or service) conformsto requirements?
Is the type and extent of control applied to thesupplier and purchased product dependent uponthe effect of the purchased product onsubsequent product realization or the finalproduct.
Are supplies selected and evaluated based on
their ability to supply product in accordance withthe organizations requirements?
Has the organization established criteria for
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selection evaluation and re-evaluation ofsuppliers?
Are results of the evaluations and any necessaryactions maintained as records?
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7.4.2 Purchasing Information
Does purchasing information describe theproduct to be purchased? Including areappropriate:
a. Requirements for approval of product,procedures, processes andequipment?
b. Requirements for qualification ofpersonnel?
c. Quality management systemrequirements?
Is the adequacy of specified purchased
requirements ensured prior to theircommunication to the supplier?
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7.4.3 Verification of Purchased Product
Have the inspection or other activities necessaryfor ensuring that purchased product meetsspecified purchase requirements beenestablished and implemented?
Are verification arrangements and method ofproduct release specified in the purchasinginformation where the organization or itscustomer intends to perform verification at
suppliers premises?
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7.5 Product and Service Provision7.5.1 Control of Production and Service
Provision
Are the production and service provision plannedand carried out under controlled conditionsincluding :
a. Availability of information thatdescribes the product characteristics?
b. Availability of work instructions, asnecessary?
c. Use of suitable equipment?d. Availability and use of monitoring and
measuring devices?e. Implementation of monitoring and
measurement?f. Implementation of release, delivery
and post delivery activities?
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7.5.2 Validation of Processes for Productionand Service Provision
Have processes where deficiencies may becomeapparent only after the product is in use or the
service has been delivered been validated?
Do the results of validation demonstrate theability of the processes to achieve planned
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results?
Where applicable, have the arrangements beenestablished for:
a. Defining criteria for review andapproval of processes?b. Approval of equipment and
qualification of personnel?c. Use of specific methods and
procedures?d. Requirements for records?e. Re- validation?
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7.5.3 Identification and Traceability
Is the product identified by suitable meansthroughout product realization?
Is the product status identified with respect tomonitoring and measurement requirements?
When traceability is a requirement, is the productuniquely identified and controlled?
Is the unique identification maintained as arecord?
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7.5.4 Customer Property
Does the organization exercise care withcustomer property while it is under theorganizations control or being used by the
organization?
Is customer property identified, verified,protected, and safeguard?
If lost, damaged or otherwise found to beunsuitable for use, is condition recorded,reported to the customer and maintained as arecord?
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7.5.5 Preservation of Product
Is conformity of product preserved duringinternal processing and delivery to the intended
destination?
Does preservation activities include:a. Identification?b. Handling?c. Packaging?d. Storage?e. Protection?
Are preservation activities applied to constituentparts of a product?
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7.6 Control of Measuring and MonitoringDevices
Has the organization determined the monitoringand measurement to be undertaken and themonitoring and measurement devices needed to
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provide evidence of conformity of product todetermined requirements?
Have processes been established to ensure thatmonitoring and measurement can be carried out
in a manner consistent with the monitoring andmeasurement requirements?
Where necessary to ensure valid results, aremeasuring equipment:
a. Calibrated or verified at specifiedintervals, or prior to use, againstmeasurements standards traceable tointernational or national measurementsstandards; where no such standardsexist, is the basis used for calibrationor verification recorded?
b. Adjusted or re-adjusted as necessary?
c. Identified to enable the calibrationstatus to be determined?
d. Safeguarded from adjustments thatwould invalidate the measurementresult?
e. Protected from damage anddeterioration during handling,maintenance and storage?
Has the organization assessed and recorded thevalidity of the previous measuring results whenthe equipment is found not to conform torequirements?, and taken the appropriate actionon the equipment and any product affected?
Are records of the calibration and verificationresults maintained?
Where computer software is used in themonitoring and measurement of specifiedrequirements is the ability of the computersoftware to satisfy the intended applicationconfirmed prior to initial use?
Is the ability of computer software to satisfy theintended application reconfirmed as necessary?
8 Measurement, Analysis and Improvement
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8 Measurement, analysis and improvement
8.1 General
Have the monitoring, measurement, analysisand improvement processes been planned, andimplement to:
a. Demonstrate conformity of theproduct?
b. Ensure conformity of the qualitymanagement system?
c. Continually improve the effectiveness
of the quality management system?
Have the applicable methods including statisticaltechniques and their extent to use been
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determined?
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8.2 Monitoring and Measurement
8.2.1 Customer satisfaction
Is information relating to customer perceptionmonitored by the organization as to whethercustomer requirements have been met?
Have the methodologies for obtaining and usinginformation related to customer perception beendetermined?
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8.2.2 Internal Audit
Are internal audits conducted at plannedintervals to determine whether the quality
management system:a. Conforms to planned arrangements,
requirements of ISO 9001 and thequality management system?
b. Is effectively implemented andmaintained?
Are the audit programs planned taking intoconsideration the status and importance of theprocesses and areas to be audited, as well asthe results of previous audits?
Is the audit criteria, scope, frequency and
method defined?
Do auditor selection and conduct of auditsensure objectivity and impartiality of the auditprocess?
Is it ensured that auditors do not audit their ownwork?
Has a documented procedure been establishedto define responsibilities and requirements forplanning and conducting audits, reportingresults, and maintaining records?
Have management responsibilities for the areabeing audited ensured that actions have beentaken without undue delay to eliminate detectednonconformities and their causes?
Do follow-up activities include the verification ofthe actions taken, and the reporting of theverification results?
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8.2.3 Monitoring and Measurement ofProcesses
Are suitable methods applied for monitoring andwhere applicable, measurement of the qualitymanagement system processes necessary tomeet customer requirements?
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Do these methods demonstrate the ability of theprocesses to achieve planned results?
Are correction and corrective actions taken whenplanned results are not achieved?
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8.2.4 Monitoring and Measurement ofProduct
Are the product characteristics monitored andmeasured to verify that product requirements aremet?
Is monitoring and measurement of productcharacteristics carried out at appropriate stages
of the product realization process in accordancewith the planned arrangements?
Is evidence of conformity with the acceptancecriteria documented and maintained?
Are records maintained to indicate the person(s)authorizing release of product?
Unless otherwise approved by a relevantauthority or where applicable, the customer, areall planned arrangements satisfactory completedprior to proceeding with release?
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8.3 Control of Nonconforming Product
Is nonconforming product identified andcontrolled to prevent unintended use or delivery?
Has a documented procedure been establishedto define controls and related responsibilities andauthorities for dealing with nonconformingproduct?
Are nonconforming product dealt with by one ormore of the following ways:
a. Action taken to eliminate the detectednonconformity?
b. Authorized use, release or acceptanceunder concession by a relevantauthority and, where applicable, by thecustomer.
c. Action taken to preclude its originalintended use or application.
Are records maintained identifying the nature ofnonconformities and any subsequent actionstaken, including any concessions?
When nonconforming product is corrected, is itsubject to re-verification to demonstrateconformity to the requirements?
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26 When nonconforming product is detected afterdelivery, or use has started, is appropriate actiontaken by the organization to the effect orpotential effect?
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8.4 Analysis of Data
Is appropriate data determined, collected andanalyzed to demonstrate the suitability andeffectiveness of the quality management systemand to evaluate where continual improvement ofthe effectiveness of the quality managementsystem can be made?
Does this data included data generated frommonitoring, measurement and other relevantsources?
Does the analysis of this data provideinformation related to:
a. Customer satisfaction?b. Conformance to product requirement?c. Characteristics and trends of
processes and product including,opportunities for preventive action?
d. Suppliers?
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8.5 Improvement8.5.1 Continual Improvement
Does the organization continually improve theeffectiveness of the quality managementssystem?
Are results of audits, analysis of data, correctiveand preventive actions, management reviews,quality Policy and quality objectives used forcontinual improvement?
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8.5.2 Corrective Action
Are corrective actions taken to eliminate thecause of nonconformities and to prevent
recurrence?
Are corrective actions appropriate to the effectsof the nonconformities encountered?
Has documented procedure been established todefine the requirements for:
a. Reviewing nonconformities, includingcustomer complaints?
b. Determining the causes ofnonconformity?
c. Evaluating the need for action toensure that nonconformities do not
recur?d. Determining and implementing action
needed?e. Recording and maintaining the results
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of action taken?f. Reviewing corrective action taken?
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8.5.3 Preventive Action
Has the organization determined actions toeliminate the causes of potential nonconformitiesin order to prevent occurrence?
Are preventive actions appropriate to the effectsof the potential problems?
Has documented procedure been established todefine the requirements for:
a. Determining potential nonconformitiesand their causes?
b. Evaluating the need for action toprevent occurrence of
nonconformities?c. Determining and implementing actions
needed?d. Recording and maintain the results of
action taken?e. Reviewing of preventive action?
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