When Recognition Matters - PECB

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When Recognition MattersEXAM PREPARATION GUIDEPECB Certified ISO 9001 Lead Auditorwww.pecb.com

PECB-820-5- ISO 9001-LA-Exam Preparation GuideThe objective of the “PECB Certified ISO 9001 Lead Auditor” examination is to ensure that thecandidate possesses the necessary expertise to perform a Quality Management System (QMS)audit and to manage an audit team by applying widely recognized audit principles, proceduresand techniques. The aim of the exam is to evaluate that the candidate possesses theknowledge and skills to proficiently plan and carry out internal and external audits in compliancewith ISO 19011 and ISO/IEC 17021-1 certification process.The target population for this examination is: Auditors seeking to perform and lead Quality Management System (QMS) certificationauditsManagers or consultants seeking to master a Quality Management System auditprocessIndividuals responsible for maintaining conformance with QMS requirementsTechnical experts seeking to prepare for a Quality Management System auditExpert advisors in Quality ManagementThe exam content covers the following competency domains: Domain 1: Fundamental principles and concepts of a Quality Management System (QMS)Domain 2: Quality Management System (QMS)Domain 3: Fundamental audit concepts and principlesDomain 4: Preparation of an ISO 9001 auditDomain 5: Conducting an ISO 9001 auditDomain 6: Closing an ISO 9001 auditDomain 7: Managing an ISO 9001 audit programPage 2 of 15

PECB-820-5- ISO 9001-LA-Exam Preparation GuideThe content of the exam is divided as follows:Domain 1: Fundamental principles and concepts of a QualityManagement System (QMS)Main objective: To ensure that the ISO 9001 Lead Auditor candidate can understand, interpretand illustrate the main Quality Management concepts related to a Quality Management System(QMS).CompetenciesKnowledge statements1. Understand and explain the operations of theISO organization and the development ofQuality Management standards.2. Ability to identify, analyze and evaluate theQuality Management compliance requirementsfor an organization.3. Understand the Quality Management tools andtechniques.4. Ability to explain and illustrate the mainconcepts in Quality Management.1. Knowledge of the application of the seven ISO2.3.4.5.management principles in Quality Management.Knowledge of the main standards in QualityManagement.Knowledge of the different sources of QualityManagement requirements for an organization,including: laws, regulations, international andindustry standards, contracts, market practices,internal policies.Knowledge of Quality Circles, Total QualityManagement, Six Sigma, Lean, Kaizen, Just-inTime, etc.Knowledge of the main Quality Managementconcepts and terminology as described in ISO9001.6. Knowledge of the concepts of process approachand risk-based thinking in Quality Management.Page 3 of 15

PECB-820-5- ISO 9001-LA-Exam Preparation GuideDomain 2: Quality Management Systems (QMS)Main objective: To ensure that the ISO 9001 Lead Auditor candidate can understand, interpret andillustrate the main concepts and components of a Quality Management System based on ISO 9001.CompetenciesKnowledge statements1. Understand and explain the components of aQuality Management System based on ISO9001 and its principal processes.2. Ability to interpret and analyze the requirementsof ISO 9001.3. Understand, explain and illustrate the mainsteps to establish, implement, operate, monitor,review, maintain and improve an organization’sQMS.1. Knowledge of the concepts, principles andterminology related to management systems andthe "Plan-Do-Check-Act" (PDCA) model.2. Knowledge of the principal characteristics of anintegrated management system.3. Knowledge of the main advantages of acertification for an organization.4. Knowledge of the ISO 9001 requirementspresented in clauses 4 to 10.5. Knowledge of the main steps to establish the QMS,policies, objectives, processes and proceduresrelevant to managing risk and improving QualityManagement to deliver results in accordance withan organization’s overall policies and objectives(awareness level).6. Knowledge of the concept of continualimprovement and its application to a QMS.Page 4 of 15

PECB-820-5- ISO 9001-LA-Exam Preparation GuideDomain 3: Fundamental audit concepts and principlesMain objective: To ensure that the ISO 9001 Lead Auditor candidate can understand, interpret andapply the main concepts and principles related to a QMS audit in the context of ISO 9001.CompetenciesKnowledge statements1. Understand, explain andillustrate theapplication of the audit principles in the contextof an ISO 9001 audit.2. Ability to identify and judge situations that woulddiscredit the professionalism of the auditor andthe PECB Code of Ethics.3. Ability to identify and evaluate ethical problemstaking into account the obligations related to theaudit client, auditee, and law enforcement andregulatory authorities.4. Ability to explain, illustrate and apply the auditevidence approach in the context of an ISO9001 audit.5. Ability to explain and compare the types andcharacteristics of evidence.6. Ability to determine and justify what type ofevidence and how much evidence will berequired in the context of a specific QMS auditmission.7. Ability to determine and evaluate the level ofmateriality and apply the risk based approachduring the different phases of an ISO 9001audit.8. Ability to judge the appropriate level ofreasonable assurance needed for a specific ISO9001 audit mission.1. Knowledge of the main audit concepts andterminology as described in ISO 19011.2. Knowledge of the differences between first party,second party and third party audits.3. Knowledge of the following audit principles:integrity, fair presentation, due professional care,professional judgment, professional skepticism,confidentiality and independence.4. Knowledge of the professional responsibility of anauditor and the PECB Code of Ethics.5. Knowledge of evidence based approach in anaudit.6. Knowledge of the different types of evidences:physical, mathematical, confirmative, technical,analytical, documentary and verbal.7. Knowledge of the quality of audit evidences(competent, appropriate, reliable and sufficient)and the factors that will influence them.8. Knowledge of the risk-based approach in an auditand the different types of risks related to auditactivities.9. Knowledge of the concept of materiality and itsapplication in an audit.10. Knowledge of the concept of reasonableassurance and its applicable in an audit.Page 5 of 15

PECB-820-5- ISO 9001-LA-Exam Preparation GuideDomain 4: Preparation of an ISO 9001 auditMain objective: To ensure that the ISO 9001 Lead Auditor candidate can prepare a QMS audit inthe context of ISO 9001 appropriately.CompetenciesKnowledge statements1. Understand and explain the steps and activitiesto prepare a QMS audit taking intoconsideration the specific context andconditions of the audit mission.2. Understand and explain the roles andresponsibilities of the audit team leader, auditteam members and technical experts.3. Ability to determine, evaluate and confirm theaudit objectives, the audit criteria and the auditscope for a specific ISO 9001 audit mission.4. Ability to conduct a feasibility study of an auditin the context of a specific ISO 9001 auditmission.5. Ability to explain, illustrate and define thecharacteristics of the audit terms of engagementand apply the best practices to establish a firstcontact with an auditee in the context of aspecific ISO 9001 audit mission.6. Ability to develop audit working papers andelaborate appropriate audit test plans in thecontext of a specific ISO 9001 audit mission.1. Knowledge of the main responsibilities of the auditteam leader and audit team members.2. Knowledge of the roles and responsibilities oftechnical experts in an audit.3. Knowledge of the definition of audit objectives,audit scope and audit criteria.4. Knowledge of the difference between the QMSscope and the audit scope.5. Knowledge of the elements to review during thefeasibility study of an audit.6. Knowledge of the cultural aspects to consider in anaudit.7. Knowledge of the characteristics of audit terms ofengagement and the best practices to establish afirst contact with an auditee.8. Knowledge of the preparation of an audit plan.9. Knowledge of the preparation and development ofaudit working papers.10. Knowledge of the advantages and disadvantagesof using audit checklists.11. Knowledge of the best practices for the creation ofaudit test plans.Page 6 of 15

PECB-820-5- ISO 9001-LA-Exam Preparation GuideDomain 5: Conducting an ISO 9001 auditMain objective: To ensure that the ISO 9001 Lead Auditor candidate can efficiently conduct aQMS audit in the context of ISO 9001.CompetenciesKnowledge statements1. Ability to organize and conduct the openingmeeting in the context of a specific ISO 9001audit mission.2. Ability to conduct a stage 1 audit in the contextof a specific ISO 9001 audit mission and takinginto account the documentation reviewconditions and criteria.3. Ability to conduct a stage 2 audit in the contextof a specific ISO 9001 audit mission by applyingthe best practices of communication to collectthe appropriate evidence and taking intoaccount the roles and responsibilities of allpeople involved.4. Ability to explain, illustrate and apply statisticaltechniques and main audit sampling methods.5. Ability to objectively gather appropriateevidence from the available information duringan audit and evaluate it objectively.1. Knowledge of the objectives and the content ofthe opening meeting of an audit.2. Knowledge of the difference between stage 1audit and stage 2 audit.3. Knowledge of stage 1 audit requirements, stepsand activities.4. Knowledge of the documentation review criteria.5. Knowledge of the documentation requirementsstated in ISO 9001.6. Knowledge of stage 2 audit requirements, stepsand activities.7. Knowledgeofthebestpracticesofcommunication during an audit.8. Knowledge of the roles and responsibilities ofguides and observers during an audit.9. Knowledge of the conflict resolution techniques.10. Knowledge of evidence collection procedures:observation, documentation review, interviews,analysis and technical verification.11. Knowledge of evidence analysis procedures:corroboration and evaluation.12. Knowledge of the main concepts, principles andstatistical techniques used in an audit.13. Knowledge of the main audit sampling methodsand their characteristics.Page 7 of 15

PECB-820-5- ISO 9001-LA-Exam Preparation GuideDomain 6: Closing an ISO 9001 auditMain objective: To ensure that the ISO 9001 Lead Auditor candidate can conclude a QMS auditand conduct follow-up activities in the context of ISO 9001.CompetenciesKnowledge statements1. Ability to explain and apply the evaluationprocess of evidences to draft audit findings andprepare audit conclusions.2. Understand, explain and illustrate the differentlevels of conformity and the concept of thebenefit of the doubt.3. Ability to report appropriate audit observationsin order to help an organization improve a QMSwith respect to audit rules and principles.4. Ability to complete audit working documents andconduct a quality review of an ISO 9001 audit.5. Ability to draft audit conclusions and presentthese to the management of the auditedorganization.6. Ability to organize and conduct an audit closingmeeting.7. Ability to write an ISO 9001 audit report andjustify a certification recommendation.8. Ability to conduct the activities following aninitial audit including the evaluation of actionplans, follow-up audits, surveillance.1. Knowledge of the evaluation process of evidencesto draft audit findings and prepare auditconclusions.2. Knowledgeofthedifferencesandthecharacteristics between the concepts of nomaly and observation.3. Knowledge of the guidelines and best practices towrite nonconformity reports.4. Knowledge of the guidelines and best practices todraft and report audit observations.5. Knowledge of the principle of the benefit of thedoubt and its application in the context of an audit.6. Knowledge of the guidelines and best practices tocomplete audit working documents and perform aquality review of an audit.7. Knowledge of the guidelines and best practices topresent audit findings and conclusions to themanagement of an audited organization.8. Knowledge of the possible recommendations thatan auditor can issue in the context of a certificationaudit and the certification decision process.9. Knowledge of the guidelines and best practices toevaluate action plans.10. Knowledge of follow-up audits, surveillance auditsand recertification audit requirements, steps andactivities.11. Knowledge of the conditions for modification,extension, suspension or withdrawal of acertification for an organization.Page 8 of 15

PECB-820-5- ISO 9001-LA-Exam Preparation GuideDomain 7: Managing an ISO 9001 audit programMain objective: To ensure that the ISO 9001 Lead Auditor understands how to establish andmanage a QMS audit program.CompetenciesKnowledge statements1. Understand and explain the establishment of anaudit program and the application of the PDCAmodel.2. Understand and explain the implementation ofan ISO 9001 audit program (first party, secondparty and third party).3. Understand and explain the responsibilities ty of audit records.4. Understand the requirements related to thecomponents of the management system of anaudit program as quality management, recordmanagement, and complaint management.5. Understand the evaluation of the efficiency ofthe audit program by monitoring theperformance of each auditor, each team and theentire certification body.6. Ability to demonstrate the application of thepersonal attributes and behaviors associatedwith professional auditors.1. Knowledge of the application of the PDCA model inthe management of an audit prog