ISO 9001 2008 Audit Checklist1 MSWORD

7/30/2019 ISO 9001 2008 Audit Checklist1 MSWORD

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ISO 9001:2008 AUDIT CHECKLIST

No. Question Clause/Doc. No Comments

Yes No If any?

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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?

6.

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?

7.

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?

8.

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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?

2.

5.2 Customer Focus

Has top management ensured thatcustomer requirements are determinedand met with the aim of enhancingcustomer satisfaction.

3.

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.

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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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8.

9.

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?

10.

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?

16 Are records of management reviews maintainedas quality records?

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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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Yes No If any?

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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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Yes No If any?

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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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Yes No If any?

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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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Yes No If any?

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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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Yes No If any?

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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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Yes No If any?

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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ISO 9001 2008 Audit Checklist1 MSWORD

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