ISO 13485 LA study guide
ISO 13485 LA · Work through your exam, one topic at a time.
The PECB Certified ISO 13485 Lead Auditor credential is a professional certification for people who audit Medical Devices Quality Management Systems (MDQMS) against ISO 13485. PECB describes the associated training as building the expertise to perform an MDQMS audit by applying widely recognized audit principles, procedures, and techniques, and as preparing you to plan and carry out internal and external audits in line with ISO 19011 and the ISO/IEC 17021-1 certification process. The ISO 13485 LA study guide has 7 sections and about 2,415 words.
01Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
Domain 1 tests whether you can explain what ISO 13485:2016 is, who it applies to, and which of its requirements can legitimately be left out - the conceptual base the rest of the exam builds on. ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purposes , applies to any organization in the device lifecycle: design, development, production, storage, distribution, installation, servicing and disposal, plus suppliers of related services.
401 words, about 2 min02Medical Devices Quality Management System (MDQMS)
Domain 2 tests whether you know the requirement architecture of ISO 13485:2016 clause by clause - which requirements exist, what evidence satisfies them, and where auditors most often find gaps. 4 Quality management system; 5 Management responsibility; 6 Resource management; 7 Product realization; 8 Measurement, analysis and improvement.
369 words, about 2 min03Fundamental audit concepts and principles
Domain 3 covers the vocabulary and principles in ISO 19011:2018 and ISO/IEC 17021-1. These are cheap marks that candidates lose by jumping straight to clause knowledge.
352 words, about 2 min04Preparation of an ISO 13485 audit
Domain 4 tests whether you can build an audit that is proportionate, risk-based and evidence-driven before you set foot on site. Objectives, scope and criteria are fixed before planning.
326 words, about 2 min05Conducting an ISO 13485 audit
Domain 5 tests execution: how you open an audit, gather and verify evidence, follow trails, and turn what you see into defensible findings. Confirm scope, criteria, schedule, sampling approach, confidentiality, how findings will be reported, and access and safety arrangements.
316 words, about 2 min06Closing an ISO 13485 audit
Domain 6 covers the disciplined end of the audit: consolidating findings, running the closing meeting, reporting, and following up corrective action without becoming a consultant. Review the evidence against the criteria with the team, confirm wording, classify each nonconformity and remove duplicates.
327 words, about 2 min07Managing an ISO 13485 audit program
Domain 7 tests whether you can run audits as a managed programme rather than a calendar of events. Under ISO 19011 clause 5 an audit programme is a set of audits planned for a time frame to meet a specific objective.
324 words, about 2 min