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The British Standards Institution,[object Object],raising standards worldwide TM,[object Object],Issue 1 December, 2008                   QMS-030-01-EN-GX           © 2008 BSI Management Systems,[object Object]
ISO Internal Auditor,[object Object],  Compliance Management,[object Object],Prepared &,[object Object],Presented by,[object Object], Yamin K Hajeej,[object Object]
1,[object Object],5,[object Object],Introduction to Auditing,[object Object],Auditor Competence and Responsibilities,[object Object],2,[object Object],3,[object Object],6,[object Object],4,[object Object],Table of Content,[object Object],The Process Approach and Process Auditing,[object Object],Managing an Audit Program,[object Object],Audit Activities,[object Object],Conclusion,[object Object]
Introduction to,[object Object],Auditing,[object Object]
Auditing,[object Object],What is an audit?,[object Object],[object Object],	        (ISO19011: 2002 clause 3.1),[object Object],Why audit?,[object Object],[object Object]
Monitor and measure the management system
Promote continuous improvement of the management system,[object Object]
Fair presentation
Due professional carePrinciples relating to audit:,[object Object],[object Object]
Evidence-based approachNote: reference to,[object Object],ISO 19011:2002,[object Object],Clause number,[object Object]
Benefits of Auditing,[object Object],Verifies conformity to requirements,[object Object],Increases awareness and understanding,[object Object],Provides a measurement of effectiveness of the management system to top management,[object Object],Reduces risk of management system failure,[object Object],Identifies improvement opportunities,[object Object],Continuous improvement if performed regularly,[object Object]
Types of Audit,[object Object],Registration / Certification,[object Object],Product,[object Object],Customer contract,[object Object],Gap assessment / Pre-assessment,[object Object],Surveillance,[object Object],Combined audit / joint audit,[object Object]
The Process Approach and Process Auditing,[object Object]
Process Approach,[object Object],The process approach emphasize the importance of:,[object Object],Understanding and meeting requirements,[object Object],Looking at processes in terms of added value,[object Object],Obtaining results of process performance,[object Object],Continual improvement of process,[object Object]
Plan,[object Object],Your,[object Object],Process,[object Object],Act,[object Object],Do,[object Object],Check,[object Object],PDCA (Plan-Do-Check-Act),[object Object],The Plan-do-Check-Act (PDCA) methodology applies to all processes,[object Object],[object Object]
Activities
Controls
Documentation
Resources
ObjectivesContinual,[object Object],Improvement,[object Object],[object Object]
Decide/change
Improve effectiveness
Measure and monitor for conformity and effectiveness,[object Object]
Applies the PDCA cycle to implementing, operating, monitoring, exercising, maintaining and improving the effectiveness of a QMSISO 19011:2002 does not explicitly mention process audits, but is written for application to all management system audits,[object Object]
Applying the Process Approach to Auditing,[object Object],Auditors can apply the process approach to auditing by ensuring the auditee:,[object Object],Can define the objectives, inputs, outputs, activities, and resources for its processes,[object Object],Analyzes, monitors, measures, and improves its processes,[object Object],Understands the sequence and interaction of its processes,[object Object]
Process Auditing Approaches,[object Object],Individual Process:,[object Object],Input / Output / Value-added Activity,[object Object],Plan-Do-Check-Act,[object Object],Resources,[object Object],Relationship with other processes:,[object Object],Flow / Sequence / Linkage / Combination,[object Object],Interaction / Communication,[object Object],Evidence,[object Object],Customer and supplier contract(s),[object Object]
Process Auditing “Turtle Diagram”,[object Object],With what?,[object Object],Resources,[object Object],With who?,[object Object],Personnel,[object Object],Inputs,[object Object],From ,[object Object],Whom/,[object Object],Where,[object Object],Outputs,[object Object],To,[object Object],Whom/,[object Object],Where,[object Object],Process,[object Object],(specific value-added ,[object Object],activities),[object Object],What results?,[object Object],Performance,[object Object],indicators,[object Object],How done?,[object Object],Methods/,[object Object],Documentation,[object Object]
Process Auditing Example,[object Object],With what?,[object Object],[object Object],With who?,[object Object],[object Object]
Competent sales and         processing staff,[object Object],Inputs,[object Object],[object Object],            requirements,[object Object],[object Object],Outputs,[object Object],Production/Service Delivery,[object Object],Contract,[object Object],Review,[object Object],What results?,[object Object],[object Object],time,[object Object],[object Object]
Value of orders
Contract accuracyHow done?,[object Object],[object Object]
Processing system
Terms and conditions
Contract review procedure,[object Object]
Managing an Audit Program Process Flow,[object Object],5.1,[object Object],PLAN,[object Object],DO,[object Object],CHECK,[object Object],ACT,[object Object],AUTHORIZE,[object Object],MONITOR &,[object Object],REVIEW,[object Object],ESTABLISH,[object Object],IMPLEMENT,[object Object],IMPROVE,[object Object],[object Object]
 EVALUATE
  AUDITORS
 SELECT TEAMS
 DIRECT ACTIVITIES
 MAINTAIN RECORDS
 OBJECTIVES
 EXTENT
 ROLES
 RESOURCES
 PROCEDURES
 MONITOR
 REVIEW
 IDENTIFY NEED  FOR CA/PA,[object Object],[object Object],  OPPORTUNITIES,[object Object],  TO IMPROVE,[object Object],AUDITOR,[object Object],COMPETENCE,[object Object],& EVALUZATION,[object Object],SPECIFIC AUDIT,[object Object],ACTIVITIES,[object Object]
Audit Activities,[object Object]
Typical Audit Activities,[object Object],6.1,[object Object],Initialing the Audit,[object Object],PLAN,[object Object],Conducting Document Review,[object Object],Preparing for On-site Activities,[object Object],Conducting for On-site Activities,[object Object],DO,[object Object],Preparing, Approving, Distributing Audit Report,[object Object],Completing the Audit,[object Object],CHECK,[object Object],Conducting Audit Follow-up,[object Object],ACT,[object Object]
Audit Program,[object Object],Top management should authorize responsibility for program management to:,[object Object],[object Object]
Identify the necessary resources and ensure they are provided
Organization should develop audit program processes
Program should be managed by a member of the organization
Keep appropriate audit records to monitor and review the audit program,[object Object]
Identify the necessary resources and ensure they are provided,[object Object]
Defining Audit Objectives, Scope, Criteria,[object Object],6.2.2,[object Object],Audit Objectives may include:,[object Object],Determining of the extent of conformity of auditee`s QMS with audit criteria,[object Object],Evaluation of capability of QMS to ensure compliance with statutory, regulatory, and contractual requirements,[object Object],Evaluation of effectiveness of the QMS to meet its objectives,[object Object],Identification of areas of improvement,[object Object]
Selecting the Audit Team,[object Object],6.2.4,[object Object],For Team size and competence, consider:,[object Object],Audit objectives, scope, criteria, and duration,[object Object],Whether audit is combined or joint,[object Object],Competence of team to meet objectives,[object Object],Statutory, regulatory, contractual and accreditation/certification requirements,[object Object],Independence of the team,[object Object]
Auditor Competence and Responsibilities,[object Object]
Auditor Competence,[object Object],7.1,[object Object],Auditor competence is based on:,[object Object],[object Object]
Application of knowledge and skillsCompetence is to be developed, maintained, and improved,[object Object]
Personal,[object Object],Attributes,[object Object],Open-minded,[object Object],Decisive,[object Object],Perceptive,[object Object],Ethical,[object Object],Observant,[object Object],Diplomatic,[object Object],Versatile,[object Object],Tenacious,[object Object],Self-reliant,[object Object],Auditor CompetencePersonal Attributes,[object Object],7.2,[object Object]
Auditor CompetenceGeneric Knowledge and skills,[object Object],7.3.1,[object Object],Auditor skills and competence could include:,[object Object],Audit principles, procedures, and techniques,[object Object],Management system and reference documents,[object Object],Organizational situations,[object Object],Laws, regulations, and other requirements ,[object Object]
Auditor CompetenceSpecific Knowledge and skills,[object Object],7.3.3,[object Object],Specific knowledge and skills for quality auditors could include:,[object Object],Quality methods and techniques,[object Object],Quality terminology,[object Object],Quality management tools and their application,[object Object],Processes and products/services specific to the sector being audited,[object Object]
Auditor Responsibilities,[object Object],Arrive on time,[object Object],Maintain confidentiality,[object Object],Be objective and ethical,[object Object],Support the audit team and team leader,[object Object],Plan and prepare work documents,[object Object],Inform auditees of the audit process,[object Object],Document and support all findings,[object Object],Keep auditee informed,[object Object],Safeguard all documents,[object Object],Prepare the audit report,[object Object]
Audit Activities,[object Object],(Continued),[object Object]
Audit Planning,[object Object],Determine the objective of the audit,[object Object],Identify specified requirements,[object Object],Determine audit duration and resources needed,[object Object],Select the team,[object Object],Contact the auditee – agree the date(s),[object Object],Draw up audit plan,[object Object],Brief the team,[object Object],Prepare work documents,[object Object]
Conducting Document Review,[object Object],6.3,[object Object],A review of documentation:,[object Object],Should be conducted prior to on-site audit activities unless deferring review is not detrimental to the effectiveness of the audit,[object Object],May include relevant QMS documents, records, and previous audit reports,[object Object],May include a preliminary site visit,[object Object]
Prepare Work Documents,[object Object],Prepare work documents,[object Object],Use as a reference and for recording audit proceedings,[object Object],Include checklists, sampling plans and forms, ISO 9001:2008 standard, etc.,[object Object],Keep checklists flexible to allow changes resulting from information collected during the audit,[object Object],Safeguard any confidential and proprietary information,[object Object],Retain work documents and records,[object Object]
Checklists Preparation,[object Object],One Approach is to:,[object Object],Identify audit scope and process(es) within scope,[object Object],Identify applicable factors (inputs, outputs, measures, resources, etc.),[object Object],Use these points and other requirements,[object Object],	(ISO 9001-2008, system documentation, etc.) to:,[object Object],[object Object]
Plan what to look for (audit evidence) Prepare checklist,[object Object]
Checklists Structure,[object Object],Audit checklist structure:,[object Object]
Conduct on-Site Audit Activities,[object Object],6.5,[object Object],Conduct opening meeting,[object Object],Communicate during the audit,[object Object],Explain roles and responsibilities of participants,[object Object],Collect and verify information,[object Object],Generate audit findings,[object Object],Prepare audit conclusions,[object Object],Conduct closing meeting,[object Object]
Opening Meeting,[object Object],6.5.1,[object Object],Hold opening meeting with auditee top management and ,[object Object],     those responsible for processes audited,[object Object],Meeting may be informal,[object Object],Chaired by team leader,[object Object],Audit team present,[object Object],Purpose is to confirm all prior arrangements,[object Object]

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