PECB certified ISO 13485:2016 Lead Auditor Training
This five-day intensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) for Medical Devices with Medical Devices Quality Management System (MDQMS) manufacturers and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this training, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with the certification process of the ISO 19011 and ISO 17021-1 standards.
Based on practical exercises, the participant will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers and conflict resolution) necessary to efficiently conduct an audit.
Who should attend?
‧ Internal auditors
‧ Auditors wanting to perform and lead Medical Devices Quality Management System (MDQMS) certification audits in the medical device industry
‧ Project managers or consultants wanting to master the Medical Devices Quality Management System audit process
‧ Persons responsible for the quality or conformity in an organization
‧ Members of a quality team
‧ Expert advisors in Medical Devices Quality Management Systems
‧ Regulatory affairs managers
‧ Technical experts wanting to prepare for Quality audit function in the medical device industry
‧ To acquire expertise to perform an ISO 13485 internal audit following ISO 19011 guidelines
‧ To acquire expertise to perform an ISO 13485 certification audit following ISO 19011 guidelines and ISO 17021 Specifications
‧ To acquire the expertise necessary to manage a MDQMS audit team
‧ To understand the operation of an ISO 13485 conformant Medical Devices Quality Management System
‧ To understand the relationship between a Medical Devices Quality Management System and compliance with customer and regulatory requirements
‧ To improve the ability to analyze the internal and external environment of an organization,and audit decision-making in the context of a MDQMS
Day 1: Introduction to Information Security Management System (ISMS) concepts as required by ISO 13485
‧ Normative frameworks and methodologies related to Quality and Medical Devices
‧ Fundamental principles of Quality and Medical Devices
‧ ISO 13485 certification process
‧ Quality Management System (QMS)
‧ Detailed presentation of the clauses 4 to 8 of ISO 13485
Day 2: Planning and Initiating an ISO 13485 audit
‧ Fundamental audit concepts and principles
‧ Audit approach based on evidence
‧ Preparation of an ISO 13485 certification audit
‧ MDQMS documentation audit
‧ Conducting an opening meeting
Day 3: Conducting an ISO 13485 audit
‧ Communication during the audit
‧ Audit procedures: observation, document review, interview, sampling techniques, technical verification, corroboration and evaluation
‧ Audit test plans
‧ Formulation of audit findings
‧ Documenting nonconformities
Day 4: Concluding and ensuring the follow-up of an ISO 13485 audit
‧ Audit documentation
‧ Quality review
‧ Conducting a closing meeting and conclusion of an ISO 13485 audit
‧ Evaluation of corrective action plans
‧ ISO 13485 Surveillance audit
‧ Internal audit management program
Day 5: Certification Exam
ISO 13485 Foundation Certification or basic knowledge of ISO 13485 is recommended
‧ This training is based on both theory and practice:
‧ Sessions of lectures illustrated with examples based on real cases
‧ Practical exercises based on a full case study including role playing and oral presentations
‧ Review exercises to assist the exam preparation
‧ Practice test similar to the certification exam
Examination and Certification
‧ The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP).
The exam covers the following competence domains:
‧ Domain 1: Fundamental principles and concepts of Quality and Medical Devices
‧ Domain 2: Medical Devices Quality Management System (QMS)
‧ Domain 3: Fundamental audit concepts and principles
‧ Domain 4: Preparation of an ISO 13485 audit
‧ Domain 5: Conducting of an ISO 13485 audit
‧ Domain 6: Closing an ISO 13485 audit
‧ Domain 7: Managing an ISO 13485 audit program
‧ The “PECB Certified ISO 13485 Lead Auditor” exam is available in English.
‧ Duration: 3 hours
‧ After successfully completing the exam, participants can apply for the credentials of ISO 13485 Provisional Auditor, Certified ISO 13485 Auditor or Certified ISO 13485 Lead Auditor depending on their level of experience. Those credentials are available for internal and external auditors
‧ A certificate will be issued to participants who successfully pass the exam and comply with all the other requirements related to the selected credential
‧ For more information about PECB Certified ISO 13485 certifications and the PECB certification process, refer to the section on ISO 13485 certifications
‧ Exam and Certification fees are included in the training price
‧ A student manual containing over 450 pages of information and practical examples will be distributed to participants
‧ A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participants
‧ In case of failure of the exam, participants are allowed to retake the exam for once.
‧ Register at the website as Student with your official name and email address before purchasing the courses.
‧ Training materials with copyright will be sent to purchaser normally within 1 to 3 working days after payment.
‧ For other payment methods, please contact us.
‧ This course is for self-study by the participants without tutor.
‧ Exam location: DQS-HK’s Office in Shatin, Hong Kong, unless otherwise agreed in writing.
‧ Professional Evaluation and Certification Board (PECB) is a Personnel Certification Body accredited by The International Accreditation Service (IAS) under ISO/IEC 17024 – Requirements for bodies operating certification of persons. Meanwhile,PECB is a full member of International Personnel Certification Association (IPC).
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