internal quality audit part 1-2010

8/9/2019 Internal Quality Audit Part 1-2010

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Internal Quality AuditInternal Quality AuditTrainingTraining -- Part 1Part 1

By Mohd Daud Mohd SallehBy Mohd Daud Mohd Salleh

16 Aug 201016 Aug 2010


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AtAt thethe endend of of thethe session,session, thethe participantsparticipants

wouldwould havehave thethe capabilitycapability toto::

PlanPlan andand implementimplement internalinternal auditaudit

ReportReport thethe auditaudit findingsfindings

ConductConduct anan effectiveeffective followfollow -- upup onon thetheauditaudit findingsfindings

Course ObjectiveCourse Objective


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Audit DefinitionAudit Definition

Systematic,Systematic, independentindependent andand documenteddocumented

processprocess forfor obtainingobtaining auditaudit evidenceevidence andand

evaluatingevaluating itit objectivelyobjectively toto determinedetermine thethe

extentextent toto whichwhich auditaudit criteriacriteria areare fulfilledfulfilled

ISO DefinitionISO Definition


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AuditAudit CriteriaCriteria

SSet of policies, procedures or requirements usedet of policies, procedures or requirements usedas a referenceas a reference

AuditAudit EvidenceEvidence

Records, statements of fact or other informationRecords, statements of fact or other information

which are relevant to the audit criteria andwhich are relevant to the audit criteria and

verifiableverifiable

Audit evidence can be qualitative or quantitativeAudit evidence can be qualitative or quantitative

Audit DefinitionAudit Definition


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Types of AuditsTypes of Audits

Internal Audit (firstInternal Audit (first--party audit)party audit)

External Audit (secondExternal Audit (second-- or thirdor third--partypartyaudit)audit)


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Internal Audit (firstInternal Audit (first--party audit)party audit)

conducted by, or on behalf of, theconducted by, or on behalf of, theorganisation itself for internal purposesorganisation itself for internal purposes

can form the basis for an organisationscan form the basis for an organisations

selfself--declaration of conformitydeclaration of conformity


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External Audit (secondExternal Audit (second-- or thirdor third--partyparty

audit)audit)

secondsecond--party audits are conducted byparty audits are conducted byparties having an interest in theparties having an interest in the

organisation, such as customers, or byorganisation, such as customers, or by

other persons on their behalfother persons on their behalf


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External Audit (secondExternal Audit (second-- or thirdor third--partyparty

audit)audit)

thirdthird--party audits are conducted byparty audits are conducted byexternal independent organisations; suchexternal independent organisations; such

organisations provide certification ororganisations provide certification or

registration of conformity withregistration of conformity with

requirements such as those of ISO 9001requirements such as those of ISO 9001and ISO 14001and ISO 14001


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When quality and environmentalWhen quality and environmentalmanagement systems are audited together,management systems are audited together,this is termed a combined auditthis is termed a combined audit

When two or more organisations cooperateWhen two or more organisations cooperateto audit a single auditee jointly, this is termedto audit a single auditee jointly, this is termedjoint auditjoint audit


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Audit MethodAudit Method

System AuditSystem Audit

ContractContract-- related Auditrelated Audit

Process AuditProcess Audit

Product AuditProduct Audit


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Audit ObjectivesAudit Objectives

To determine that a quality program hasTo determine that a quality program has

been developed and documentedbeen developed and documented

To verify that the quality program has beenTo verify that the quality program has been

implemented by the organisationimplemented by the organisation

To evaluate the effectiveness of the qualityTo evaluate the effectiveness of the quality

program in meeting quality requirementsprogram in meeting quality requirementsand in achieving management goalsand in achieving management goals


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Audit ObjectivesAudit Objectives

To identify nonconformances andTo identify nonconformances and

program weaknessesprogram weaknesses

To ensure correction of identified orTo ensure correction of identified or

potential problemspotential problems


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Additional Functions of the AuditAdditional Functions of the Audit

ProcessProcess Providing feedback to management on howProviding feedback to management on how

regulatory requirements are being met; helpingregulatory requirements are being met; helping

to determine potential exposure of theto determine potential exposure of theorganisation to regulatory action or litigationorganisation to regulatory action or litigation

Providing unbiased evaluations centered onProviding unbiased evaluations centered on

facts rather than value judgements; correctingfacts rather than value judgements; correcting

any preany pre--conceived views management mayconceived views management may

have about the audited areahave about the audited area


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Benefits of the Internal AuditBenefits of the Internal Audit

Fulfilling the standards requirementsFulfilling the standards requirements

Continuous improvementContinuous improvement

Management confidenceManagement confidence

You know before themYou know before them


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Element 8.2.2 of ISO 9001:2008Element 8.2.2 of ISO 9001:2008

Audit procedure is documentedAudit procedure is documented

Conduct audits at planned intervalsConduct audits at planned intervals

Define audit criteria, scope, frequency andDefine audit criteria, scope, frequency and

methodsmethods

Ensure objectivity and impartiality of the auditEnsure objectivity and impartiality of the audit

processprocess

Auditors shall not audit their own workAuditors shall not audit their own work


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Element 8.2.2 of ISO 9001:2008Element 8.2.2 of ISO 9001:2008

Audit results recorded and distributedAudit results recorded and distributed

Corrective action implemented promptlyCorrective action implemented promptly

FollowFollow--up on corrective actionup on corrective action

Audit results reviewed by the ManagementAudit results reviewed by the Management


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End of Part 1End of Part 1

Thank YouThank You

internal quality audit part 1-2010

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