PECB Certified ISO 13485 Lead Auditor
EXAM PREPARATION GUIDEPECB Certified ISO 13485 Lead Auditor
PECB-820-17- ISO 13485 LA Exam Preparation GuideThe objective of the “PECB Certified ISO 13485 Lead Auditor” examination is to ensure that thecandidate has the knowledge and skills to plan and perform Medical devices--QualityManagement System audit compliant with the ISO 13485:2016 standard, master widelyrecognized audit principles, procedures and techniques, and manage (or be part of) audit teamsand audit programs.The target population for this examination is: Auditors wanting to perform and lead an Medical devices--Quality Management SystemProject managers or consultants wanting to master the Medical devices--QualityManagement System audit processPersons responsible for the Medical devices--Quality Management System or conformity inan organizationMembers of a Medical devices--Quality Management System teamExpert advisors in Medical devices--Quality Management SystemTechnical experts wanting to prepare for a Medical devices--Quality Management Systemaudit functionThe exam content covers the following domains: Domain 1: Fundamental principles and concepts in Medical Devices Quality ManagementDomain 2: Medical Devices Quality Management System (MDQMS)Domain 3: Fundamental Audit Concepts and PrinciplesDomain 4: Preparation of an ISO 13485 auditDomain 5: Conduct of an ISO 13485 auditDomain 6: Conclusion and follow-up of an ISO 13485 auditDomain 7: Management of an ISO 13485 audit programPage 2 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideThe content of the exam is divided as follows:Domain 1: Fundamental principles and concepts in Medical DevicesQuality ManagementMain objective: To ensure that the ISO 13485 Lead Auditor candidate can understand,interpret and illustrate the main Medical Devices Quality Management concepts relatedto a Medical Devices Quality Management System (MDQMS)CompetenciesKnowledge statements1. Understand and explain the operations of theISO organization and the development ofMedicalDevicesQualityManagementstandards2. Ability to identify, analyze and evaluate theMedicalDevicesQualityManagementcompliance requirements for an organization3. Ability to explain and illustrate the mainconceptsinMedicalDevicesQualityManagement System4. Ability to understand relationship betweendifferent standards of ISO 9000 family1. Knowledge of the application of themanagement principles to Medical DevicesQuality Management2. Knowledge of the main standards in MedicalDevices Quality Management3. Knowledge of the different sources of MedicalDevices Quality Management requirement foran organization: laws, regulations, internationaland industry standards, contracts, marketpractices, internal policies4. Knowledge of the main Medical DevicesQualityManagementconceptsandterminology as described in ISO 13485Page 3 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideDomain 2: Medical Devices Quality Management System (MDQMS)Main objective: To ensure that the ISO 13485 Lead Auditor candidate can understand,interpret and illustrate the main concepts and components of a Medical Devices QualityManagement System based on ISO 13485CompetenciesKnowledge statements1. Understand and explain the components of aMedical Devices Quality Management Systembased on ISO 13485 and its principal processes2. Ability to interpret and analyze ISO 13485requirements3. Understand, explain and illustrate the mainsteps to establish, implement, operate, monitor,review, maintain and improve an organization'sMDQMS1. Knowledge of the concepts, principles andterminology related to management systems2. Knowledge of the principal characteristics ofan integrated management system3. Knowledge of the main advantages of acertification for an organization4. Knowledge of the ISO 13485 requirementspresented in the clauses 4 to 85. Knowledge of the main steps to establish theMDQMS , policies, objectives, processes andprocedures relevant to managing risk andimprovingMedicalDevicesQualityManagement to deliver results in accordancewith an organization’s overall policies andobjectives (Awareness level)6. Knowledge of the concept of continualimprovement and its application to a MDQMSPage 4 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideDomain 3: Fundamental Audit Concepts and PrinciplesMain objective: To ensure that the ISO 13485 Lead Auditor candidate can understand,interpret and apply the main concepts and principles related to a MDQMS audit in thecontext of ISO 13485CompetenciesKnowledge statements1. Understand, explain and illustrate the applicationof the audit principles in the context of an ISO13485 audit2. Ability to identify and judge situations that woulddiscredit the professionalism of the auditor andthe PECB code of ethics3. Ability to identify and evaluate ethical problemstaking into account the obligations related tosponsors, auditee and law enforcement orregulatory authorities4. Ability to explain, illustrate and apply the auditevidence approach in the context of an ISO13485 audit5. Ability to explain and compare the types andcharacteristics of evidence6. Ability to determine and justify what type ofevidence and how much evidence will berequired in the context of a specific MDQMSaudit mission7. Ability to determine and evaluate the level ofmateriality and apply the risk based approachduring the different phases of an ISO 13485audit8. Ability to judge the appropriate level ofreasonable assurance needed for a specific ISO13485 audit mission1. Knowledge of the main audit concepts andterminology as described in ISO 190112. Knowledge of the differences between firstparty, second party and third party audit3. Knowledge of the following audit principles:integrity, fair presentation, due professionalcare, professional judgment, professionalskepticism, confidentiality and independence4. Knowledge of professional responsibility of anauditor and the PECB code of ethics5. Knowledge of evidence based approach in anaudit6. Knowledge of the different types of ical, analytical, documentary and verbal7. Knowledge of Medical Devices Quality ofaudit evidences (competent, appropriate,reliable and sufficient) and the factors that willinfluence them.8. Knowledge of the risk based approach in anaudit and the different types of risk related toaudit activities9. Knowledge of the concept of materiality andits application in an audit10. Knowledge of the concept of reasonableassurance and its applicable in an auditPage 5 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideDomain 4: Preparation of an ISO 13485 auditMain objective: To ensure that the ISO 13485 Lead Auditor candidate can prepareappropriately a MDQMS audit in the context of ISO 13485CompetenciesKnowledge statements1. Understand and explain the steps and activitiesto do to prepare a MDQMS audit taking inconsideration the specific context andconditions of the mission2. Understand and explain the roles andresponsibilities of the audit team leader, auditteam members and technical experts3. Ability to determine, evaluate and confirm theaudit objectives, the audit criteria and the auditscope for a specific ISO 13485 audit mission4. Ability to do a feasibility study of an audit in thecontext of a specific ISO 13485 audit mission5. Ability to explain, illustrate and define thecharacteristics of the audit terms ofengagement and apply the best practices toestablish a first contact with an auditee in thecontext of a specific ISO 13485 audit mission6. Ability to develop audit working papers and toelaborate appropriate audit test plans in thecontext of a specific ISO 13485 audit mission1. Knowledge of the main responsibilities of theaudit team leader and audit team members2. Knowledge of the roles and responsibilities oftechnical experts used for an audit3. Knowledge of the definition of audit objectives,audit scope and audit criteria4. Knowledge of the difference between theMDQMS scope and the audit scope5. Knowledge of the elements to review duringthe feasibility study of an audit6. Knowledge of the cultural aspects to considerin an audit7. Knowledge of the characteristics of audit termsof engagement and the best practices toestablish a first contact with an auditee8. Knowledge of the preparation of an audit plan9. Knowledgeofthepreparationanddevelopment of audit working paper10. Knowledge of advantages and disadvantagesof using audit checklists11. Knowledge of the best practices to creationaudit test plansPage 6 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideDomain 5: Conduct of an ISO 13485 auditMain objective: To ensure that the ISO 13485 Lead Auditor candidate can conductefficiently a MDQMS audit in the context of ISO 13485CompetenciesKnowledge statements1. Ability to organize and conduct the openingmeeting in the context of a specific ISO 13485audit mission2. Ability to conduct a stage 1 audit in the contextof a specific ISO 13485 audit mission andtaking into account the documentation reviewconditions and criteria3. Ability to conduct a stage 2 audit in the contextof a specific ISO 13485 audit mission byapplying the best practices of communication tocollect the appropriate evidence and taking intoaccount the roles and responsibilities of allpeople involved4. Ability to explain, illustrate and apply statisticaltechniques and main audit sampling methods5. Ability to gather appropriate evidencesobjectively from the available information in anaudit and to evaluate them objectively1. Knowledge of the objectives and the content ofthe opening meeting of an audit2. Knowledge of the difference of the stage 1audit and the stage 2 audit3. Knowledge of stage 1 audit requirements,steps and activities4. Knowledge of the documentation reviewcriteria5. Knowledge of the documentation requirementsstated in ISO 134856. Knowledge of stage 2 audit requirements,steps and activities7. Knowledge of best practices of communicationduring an audit8. Knowledge of the roles and responsibilities ofguides and observers during an audit9. Knowledge of the conflict resolution techniques10. Knowledge of evidence collection procedures:observation, documentation review, interviews,analysis and technical verification11. Knowledge of evidence analysis procedures:corroboration and evaluation12. Knowledge of main concepts, principles andstatistical techniques used in an audit13. Knowledge of the main audit samplingmethods and their characteristicsPage 7 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideDomain 6: Conclusion and follow-up of an ISO 13485 auditMain objective: To ensure that the ISO 13485 Lead Auditor candidate can conclude aMDQMS audit and conduct follow-up activities in the context of ISO 13485CompetenciesKnowledge statements1. Ability to explain and apply the evaluationprocess of evidences to draft audit findings andprepare audit conclusions2. Understand, explain and illustrate the differentlevels of conformity and the concept of benefitsof doubt3. Ability to report appropriate audit observationsin order to help an organization to improve aMDQMSin respect of audit rules andprinciples4. Ability to complete audit working documentsand do a Medical Devices Quality review of anISO 13485 audit5. Ability to draft audit conclusions and presentthese to the management of the auditedorganization6. Ability to organize and conduct an audit closingmeeting7. Ability to write an ISO 13485 audit report andjustify a certification recommendation8. Ability to conduct the activities following aninitial audit including the evaluation of actionplans, follow up audits, surveillance audits andrecertification audits1.Knowledge of the evaluation process ofevidences to draft audit findings and prepareaudit conclusions2. Knowledge of the differences and thecharacteristics between the concepts , anomaly and observation3. Knowledge of the guidelines and best practices towrite nonconformity report4. Knowledge of the guidelines and best practices todraft and report audit observation5. Knowledge of the principle of benefits of doubtand his application in the context of an audit6. Knowledge of the guidelines and best practices tocomplete audit working documents and do aMedical Devices Quality review of an audit7. Knowledge of the guidelines and best practices topresent audit findings and conclusions tomanagement of an audited organization8. Knowledge of the possible recommendations thatan auditor can issue in the context of acertification audit and the certification decisionprocess9. Knowledge of the guidelines and best practices toevaluate action plans10. Knowledge of follow-up audit, surveillance auditsand recertification audit requirements, steps andactivities11. Knowledge of the conditions for modification,extension, suspension or withdrawal of acertification for an organizationPage 8 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideDomain 7: Management of an ISO 13485 audit programMain objective: To ensure that the ISO 13485 Lead Auditor understands how toestablish and manage a MDQMS audit programCompetenciesKnowledge statements1. Understand and explain the establishment of anaudit program2. Understand and explain the implementation ofan ISO 13485 audit program (first party, secondparty and third party)3. Understand and explain the responsibilities ty of audit records4. Understand the requirements related to thecomponents of the management system of anaudit program as Medical Devices Qualitymanagement, record management, complaintmanagement5. Understand the evaluation of the efficiency ofthe audit program by monitoring theperformance of each auditor, each team andthe entire certification body6. Understand and explain the way combinedaudits are handled in an audit program7. Ability to demonstrate the application of thepersonal attributes and behaviors associated toprofessional auditors1. Knowledge of the management of an auditprogram2. Knowledge of requirements, guidelines andbest practices regarding audit resources,procedures and policies3. Knowledge of the types of tools used byprofessional auditors4. Knowledge of requirements, guidelines andbest practices regarding the management ofaudit records5. Knowledge of the application of the concept ofcontinual improvement to the management ofan audit program6. Knowledge of the particularities to implementand manage a first, second or third party auditprogram7. Knowledge of the management of combinedaudit activities8. Knowledge of the concept of competency andits application to auditors9. Knowledge of the personal attributes andbehavior of a professional auditorPage 9 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideBased on these 7 domains and their relevance, 12 questions are included in the exam, assummarized in the following table:LeveI of Understanding(Cognitive/Taxonomy) RequiredQuestionNumberPoints perQuestionQuestions thatmeasureComprehension,Application andAnalysis351FundamentalAudit Conceptsand PrinciplesPreparation of anISO 13485 Audit2Fundamentalprinciples andconcepts inMedical ber ofQuestionspercompetencydomain% of testdevoted toeachcompetencydomainNumber ofPoints percompetencydomain% of 0.00116.671520.0018.3356.676Conduct of anISO 13485 AuditConclusion andfollow- up of anISO 13485 AuditManagement ofan ISO 13485Audit ProgramQuestionsthat measureSynthesisandEvaluationX95X115X1210105Total pointsX75Number of Questions per level of understanding% of Test Devoted to each level ofunderstanding (cognitive/taxonomy)7558.3341.67The passing score is established at 70%.After successfully passing the exam, candidates will be able to apply for the credentials ofPECB Certified ISO 13485 Lead Auditor, depending on their level of experience.TAKE A CERTIFICATION EXAMCandidates will be required to arrive at least thirty (30) minutes before the beginning of thecertification exam. Candidates arriving late will not be given additional time to compensate forthe late arrival and may be denied entry to the exam room (if they arrive more than 5 minutesafter the beginning of the exam scheduled time).Page 10 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideAll candidates will need to present a valid identity card with a picture such as a driver’s licenseor a government ID to the invigilator.The exam duration is three (3) hours.The questions are essay type questions. This type of format was chosen because the intentis to determine whether an examinee can write a clear coherent answer/argument and toassess problem solving techniques. Because of this particularity, the exam is set to be “openbook” and does not measure the recall of data or information. The examination evaluates,instead, comprehension, application, analysis, synthesis and evaluation, which mean that evenif the answer is in the course material, candidates will have to justify and give explanations, toshow they really understood the concepts. At the end of this document, you will find sampleexam questions and their possible answers.As the exams are “open book”; candidates are authorized to use the following referencematerials: A copy of the ISO 13485:2016 standard,Course notes from the Participant Handout,Any personal notes made by the student during the course andA hard copy dictionary.The use of electronic devices, such as laptops, cell phones, etc., is not allowed.All attempt to copy, collude or otherwise cheat during the exam will automatically lead to theexam’s failure.PECB exams are available in English. For availability of the exam in a language other thanEnglish, please contact examination@pecb.comPage 11 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideRECEIVE YOUR EXAM RESULTSResults will be communicated by email in a period of 6 to 8 weeks, after taking the exam. Theresults will not include the exact grade of the candidate, only a mention of pass or fail.Candidates who successfully complete the examination will be able to apply for a certifiedscheme.In the case of a failure, the results will be accompanied with the list of domains in which thecandidate had a low grade, to provide guidance for exams’ retake preparation.Candidates who disagree with the exam results may file a complaint. For more information,please refer to www.pecb.comEXAM RETAKE POLICYThere is no limitation on how many times a candidate can retake the same exam. However,there are some limitations in terms of allowed time-frame in between exams.When candidates fail the examination, they are only allowed to retake the examination oncewithin 12 months after the first attempt. If second examination is unsuccessful, candidates willbe allowed to retake the exam only after 1 year (12 months). Retake fee applies.Only candidates, who have completed a full PECB training but fail the written exam, are eligibleto retake the exam for free, under one condition:“A candidate can only retake the exam once and this retake must occur within 12 months fromthe initial exam’s date.”When candidates fail the same examination for the second time, their file is automatically closedfor 1 year.CLOSING FILESClosing a file is equivalent to rejecting a candidate’s application. As a result, when candidatesrequest that their file be reopened, PECB will no longer be bound by the conditions, standards,policies, candidate handbook or exam preparation guide that were in effect before their file wasclosed.Candidates who want to request that their file be reopened must do so in writing, and pay therequired fees.EXAMINATION SECURITYA significant component of a successful and respected professional certification credential ismaintaining the security and confidentiality of the examination. PECB relies upon the ethicalbehaviour of certificate holders and applicants to maintain the security and confidentiality ofPage 12 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuidePECB examinations. When someone who holds PECB credentials reveals information aboutPECB examination content, they violate the PECB Code of Ethics. PECB will take actionagainst individuals who violate PECB Policies and the Code of Ethics. Actions taken mayinclude permanently barring individuals from pursuing PECB credentials and revokingcertifications from those who have been awarded the credential. PECB will also pursue legalaction against individuals or organizations who infringe upon its copyrights, proprietary rights,and intellectual property.Page 13 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuideSAMPLE EXAM QUESTIONS AND POSSIBLE ANSWERS1. Evidence in an auditFor each of the following clauses of the ISO 13485 standard, please provide at least twodifferent evidences that would be acceptable to ensure conformity to the clause.-8.5.2 Corrective actions:Possible answers: Elaboration and communication of a documented procedure defining how to identifycorrective actions and how to treat them.Maintenance of an updated list of corrective actions showing the responsible person, thestatus and the deadline for each corrective action.2. Evaluation of corrective actionsYou have received a plan for corrective actions. Evaluate the adequacy of the proposedcorrective actions. If you agree with the corrective actions, explain why. If you disagree, explainwhy and propose what you think would be some adequate corrective actions.Non-conformity 2: The auditor has indicated non-conformity because the audit procedure hasnot been documented as needed.Corrective action plan 2: Do a review of the audit procedure and document it as requested.Possible answers:I agree. The audit procedures should be documented and updated after each modification.3. Writing of a test planWrite a test plan to validate the following clause identifying the different applicable auditprocedures (observation, documentation review, interview, technical verification and analysis):-Please prepare a test plan by selecting 2 different suitable, applicable and appropriateprocedures to validate clause 8.2.1 Feedback.Page 14 of 15
PECB-820-17- ISO 13485 LA Exam Preparation GuidePossible answers:-Clause 8.2.1 Feedback.ObservationObservation of the feedbacksDocumentDocuments the feedbacks for future use as an reference forimprovementsInterviewAsk questions to the managers/employees to validate thefeedbacks from the costumers.Technical verificationReview the costumers feedback and recordsAnalysisAnalysis of the sample from the feedback test.Page 15 of 15
The objective of the “PECB Certified ISO 13485 Lead Auditor” examination is to ensure that the candidate has the knowledge and skills to plan and perform Medical devices--Quality Management System audit compliant with the ISO 13485:2016 standard, master widely recognized audit principles,
The PECB Certified ISO 37001 Lead Auditor training course provides the necessary knowledge and skills that enable you to perform anti-bribery management system (ABMS) audits by applying widely recognized audit principles, procedures, and . The PECB Certified ISO 37001 Lead Auditor exam fully meets the requirements of the PECB Examination and .
The primary international version is ISO 13485:2003. The variant EN ISO 13485:2012 is the latest European harmonized version of ISO 13485; it replaces the prior harmonized version, EN ISO 13485:2003, which is now considered to be obsolete. EN ISO 13485:2012 is applicable only to manufacturers placing devices on the market in Europe.
ISO 13485 clauses 4.2.1, 5.4.1 Annex IX (Chapter I) 03 Quality Manual 9 03 Quality Manual ISO 13485 clauses 4.2.1, 4.2.2 04 Human Resources 10 04 Procedure for Human Resources ISO 13485 clause 6.2 11 04.1 Appendix 1 -Training Program ISO 13485 clause 6.2 12 04.2 Appendix 2 - Training Record ISO 13485 clause 6.2 13 04.3
ISO 13485 OPPOSED TO ISO 9001 _ As mentioned above, ISO 13485 is based on the structure of ISO 9001, even though it is a stand-alone standard. Despite that both standards are organized in the same way, ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer s
resulting in the standard now having 10 clauses, where previously there were 8. The 3rd edition of ISO 13485 will keep the current clause structure and a new Annex is proposed for ISO 13485 to provide a clause by clause correlation between the new revisions of ISO 9001 and ISO 13485. The new revisions of both ISO 9001 and ISO 13485 have anFile Size: 375KB
ISO 13485:2016 Annexes Annex A Comparison of content between ISO 13485:2003 and ISO 13485:2016 – comments on changes Annex B Correspondence between ISO 13485:2016 and ISO 9001:2015 – top level clause mapping European Annexes - ZA (AIMD), ZB (MDD) and ZC (IVD) Identifies relationship between the European StandardFile Size: 855KB
Complete the registration form and click the Submit button How to open a PECB account: 1. PECB Account. PECB ONLINE EXAM PREPARATION GUIDE 4 1. Login at your PECB account 2. Click the Examination Profile tab 3. Capture the required pictures following the guidelines set on the right side
Accounting The Accounting programme is written by Niall Lothian, formerly Professor at Edinburgh Business School, Heriot-Watt University, and John Small, Professor Emeritus at Heriot-Watt University. Both have previously occupied chairs in the University’s Department of Accountancy and Finance.
