{"product_id":"iso-13485-lead-auditor","title":"ISO 13485 Lead Auditor","description":"\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"27f839d\" class=\"elementor-element elementor-element-27f839d elementor-widget elementor-widget-text-editor\"\u003e\n\u003cp\u003eISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.\u003c\/p\u003e\n\u003ch2\u003eWhy should you attend?\u003c\/h2\u003e\n\u003cp\u003eDuring this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO\/IEC 17021-1 certification process.\u003c\/p\u003e\n\u003cp\u003eBased on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.\u003c\/p\u003e\n\u003cp\u003eAfter acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv data-widget_type=\"text-editor.default\" data-e-type=\"widget\" data-element_type=\"widget\" data-id=\"de93b7e\" class=\"elementor-element elementor-element-de93b7e elementor-widget elementor-widget-text-editor\"\u003e\n\u003ch2\u003eWho should attend?\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eAuditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits\u003c\/li\u003e\n\u003cli\u003eManagers or consultants seeking to master a Medical Devices Quality Management System audit process\u003c\/li\u003e\n\u003cli\u003eIndividuals responsible for maintaining conformance with Medical Devices Quality Management System requirements\u003c\/li\u003e\n\u003cli\u003eTechnical experts seeking to prepare for a Medical Devices Quality Management System audit\u003c\/li\u003e\n\u003cli\u003eExpert advisors in Medical Devices Quality Management\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eLearning objectives\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eUnderstand the operations of a Medical Devices Quality Management System based on ISO 13485\u003c\/li\u003e\n\u003cli\u003eAcknowledge the correlation between ISO 13485 and other standards and regulatory frameworks\u003c\/li\u003e\n\u003cli\u003eUnderstand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011\u003c\/li\u003e\n\u003cli\u003eLearn how to lead an audit and audit team\u003c\/li\u003e\n\u003cli\u003eLearn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit\u003c\/li\u003e\n\u003cli\u003eAcquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eEducational approach\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003eThis training is based on both theory and best practices used in MDQMS audits\u003c\/li\u003e\n\u003cli\u003eLecture sessions are illustrated with examples based on case studies\u003c\/li\u003e\n\u003cli\u003ePractical exercises are based on a case study which includes role playing and discussions\u003c\/li\u003e\n\u003cli\u003ePractice tests are similar to the Certification Exam\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003ePrerequisites\u003c\/h2\u003e\n\u003cdiv\u003e\n\u003cdiv id=\"480\"\u003e\n\u003cp\u003eA fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\" lang=\"EN-US\"\u003eCourse Agenda\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 1:\u003c\/strong\u003e Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 2:\u003c\/strong\u003e Audit principles, preparation and launching of an audit\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 3:\u003c\/strong\u003e On-site audit activities\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 4: \u003c\/strong\u003eClosing the audit\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDay 5:\u003c\/strong\u003e Certification Exam\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\" lang=\"EN-US\"\u003eExamination\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eThe “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency domains:\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 1:\u003c\/strong\u003e Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 2:\u003c\/strong\u003e Medical Devices Quality Management System (MDQMS)\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 3:\u003c\/strong\u003e Fundamental audit concepts and principles\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 4:\u003c\/strong\u003e Preparation of an ISO 13485 audit\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 5:\u003c\/strong\u003e Conducting an ISO 13485 audit\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 6: \u003c\/strong\u003eClosing an ISO 13485 audit\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDomain 7:\u003c\/strong\u003e Managing an ISO 13485 audit program\u003c\/p\u003e\n\u003cp\u003eFor specific information about the exam type, languages available, and other details, please visit the \u003ca href=\"https:\/\/help.pecb.com\/index.php\/list-of-pecb-exams\/\"\u003eList of PECB Exams\u003c\/a\u003e and the \u003ca href=\"https:\/\/pecb.com\/examination-rules-and-policies\"\u003eExamination Rules and Policies\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\" lang=\"EN-US\"\u003eCertificate requirements\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cp\u003eAfter successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential. For more information about ISO 13485 certifications and the PECB certification process, please refer to the \u003ca href=\"https:\/\/pecb.com\/en\/certification-rules-and-policies\"\u003eCertification Rules and Policies\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe requirements for PECB Auditor Certifications are:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv\u003e\n\u003ctable\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eCredential\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eExam\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eProfessional experience\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eMS audit\/assessment experience\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\" bgcolor=\"#ebebeb\"\u003e\u003cstrong\u003eOther requirements\u003c\/strong\u003e\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certified ISO 13485 Provisional Auditor\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Auditor Exam or equivalent\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eNone\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eNone\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certified ISO 13485 Auditor\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Auditor Exam or equivalent\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eTwo years: One year of work experience in Medical Devices Quality Management\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eAudit activities: a total of 200 hours\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certified ISO 13485 Lead Auditor\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Auditor Exam or equivalent\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eFive years: Two years of work experience in Medical Devices Quality Management\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eAudit activities: a total of 300 hours\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003e\u003cstrong\u003ePECB Certified ISO 13485 Senior Lead Auditor\u003c\/strong\u003e\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003ePECB Certified ISO 13483 Lead Auditor Exam or equivalent\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eTen years: Seven years of work experience in Medical Devices Quality Management\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eAudit activities: a total of 1,000 hours\u003c\/td\u003e\n\u003ctd align=\"center\" valign=\"middle\"\u003eSigning the PECB Code of Ethics\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/tbody\u003e\n\u003c\/table\u003e\n\u003c\/div\u003e\n\u003cp\u003e\u003cstrong\u003eTo be considered valid, these audits should follow best audit practices and include the following\u003cspan\u003e \u003c\/span\u003e\u003c\/strong\u003e\u003cstrong class=\"gr-progress\"\u003eactivities:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cdiv\u003e\n\u003col\u003e\n\u003cli\u003eAudit planning\u003c\/li\u003e\n\u003cli\u003eAudit interview\u003c\/li\u003e\n\u003cli\u003eManaging an audit program\u003c\/li\u003e\n\u003cli\u003eDrafting audit reports\u003c\/li\u003e\n\u003cli\u003eDrafting non-conformity reports\u003c\/li\u003e\n\u003cli\u003eDrafting audit working documents\u003c\/li\u003e\n\u003cli\u003eDocumentation review\u003c\/li\u003e\n\u003cli\u003eOn-site audit\u003c\/li\u003e\n\u003cli\u003eFollow-up on non-conformities\u003c\/li\u003e\n\u003cli\u003eLeading an audit team\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003c\/div\u003e\n\u003cp\u003eFor more information about the PECB certification process, please refer to \u003ca href=\"https:\/\/pecb.com\/en\/certification-rules-and-policies\"\u003eCertification Rules and Policies\u003c\/a\u003e.\u003c\/p\u003e\n\u003cp class=\"MsoNormal\"\u003e\u003cb\u003e\u003cspan style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-fareast-font-family: 'Times New Roman'; mso-hansi-theme-font: major-latin; mso-bidi-font-family: 'Times New Roman'; mso-font-kerning: 18.0pt; mso-ligatures: none; mso-ansi-language: EN-US; mso-fareast-language: EN-CA;\" lang=\"EN-US\"\u003eGeneral Information\u003c\/span\u003e\u003c\/b\u003e\u003cb\u003e\u003cspan style=\"font-size: 14.0pt; line-height: 115%; font-family: 'Aptos Display',sans-serif; mso-ascii-theme-font: major-latin; mso-hansi-theme-font: major-latin; mso-ansi-language: EN-US;\" lang=\"EN-US\"\u003e\u003c\/span\u003e\u003c\/b\u003e\u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eCertification and examination fees are included in the price of the training course\u003c\/li\u003e\n\u003cli\u003eTraining material containing over 450 pages of information and practical examples will be distributed\u003c\/li\u003e\n\u003cli\u003eAn attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.\u003c\/li\u003e\n\u003cli\u003eIn case of exam failure, you can retake the exam within 12 months for free\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003eFor additional information, please contact us at \u003ca href=\"mailto:support@pecb.com\"\u003esupport@pecb.com\u003c\/a\u003e or visit \u003ca href=\"https:\/\/pecb.com\/\"\u003ewww.pecb.com\u003c\/a\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"PECB","offers":[{"title":"Default Title","offer_id":46105312559161,"sku":null,"price":999.0,"currency_code":"CAD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0711\/4453\/8169\/files\/pecb-slogan-bottom-150x150.png?v=1740368139","url":"https:\/\/shop.martialtech.ca\/products\/iso-13485-lead-auditor","provider":"Martial Technology","version":"1.0","type":"link"}