ISO 13485 Training
ISO 13485 Lead Auditor Training
ISO 13485 Lead Auditor Training
ISO 13485 lead auditor training from Sync Resource will help you to develop all the necessary skills and expertise to audit an ISO 13485 based Medical Devices Quality Management System, by applying best and widely recognized audit principles, procedures and techniques, to ensure that the organization or staff is competent in managing and maintaining its Medical Devices Quality Management System.
This lead auditor training will also help you gain the knowledge and develop the skills to professionally and proficiently plan and perform not only internal but also the external audits in compliance with ISO 19011 standard, and the certification process according to ISO/IEC 17021-1 standard.
In short, this training will help you master all tools and techniques necessary for the ISO 13485 internal and external audit to competently, manage an audit program or an auditing team, communicate with customers, and conflict resolution.
Learning Objectives
- Learn to perform Medical Devices Quality Management System internal/external audit
- Learn to lead MDQMS audit or audit team
- Understand the operations of a Medical Devices Quality Management System (MDQMS) based on ISO 13485
- Understand the correlation between ISO 13485 and other ISO standards and regulatory frameworks
- Understand your role as a quality auditor to plan, lead and follow up on a management system audit according to ISO 19011
- Acquire all the necessary skills and knowledge to plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011
- Learn how to interpret the requirements of ISO 13485 in the context of an MDQMS audit
- Learn how to lead an audit and audit team
- Improve your skills to analyze the internal and external environment of an organization, and your audit decision-making in the context of an MDQMS
Who Should Attend?
- Internal Medical Devices Quality Management System auditors
- Anyone involved in performing and leading the ISO 13485 certification audit
- Members of an MDQMS audit team
- Project managers or consultants wanting to master the ISO 13485 audit process
- Any individual responsible for the Quality conformity in an organization
- MDQMS Consultants or Expert advisers
- Technical experts planning to prepare for a Quality audit function
ISO 13485 Lead Auditor Training
Course Agenda………………Duration: 5 Days
Day 1: Introduction to Medical Devices Quality management Systems (MDQMS) and ISO 13485 Standard
Day 2: Audit principles, preparation and launching of an audit
Day 3: On-site audit activities
Day 4: Closing the audit
Day 5: Certification Exam
ISO 13485 Lead Auditor Training
Examination
The Sync Resource ISO 13485 lead auditor training fully meets the requirements of the PECB Examination and Certification Programme (ECP).
The “ISO 13485 lead auditor” exam is available in different languages (the complete list of languages can be found in the examination application form)
Duration: 3 hours
The exam covers the following competency domains:
Domain 1: Fundamental Principles and Concepts in Quality Management
Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can understand, interpret and illustrate the main Quality Management concepts related to a Medical Devices Quality Management System (MDQMS)
Domain 2: Medical Devices Quality Management Systems (MDQMS)
Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can understand, interpret and illustrate the main concepts and components of an ISO 13485 based Medical Devices Quality Management System
Domain 3: Fundamental Audit Concepts and Principles
Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can understand, interpret and apply the main concepts and principles related to an MDQMS audit in the context of ISO 13485
Domain 4: Preparation of an ISO 13485 Audit
Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can prepare appropriately a MDQMS audit in the context of ISO 13485
Domain 5: Conduct of an ISO 13485 Audit
Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can conduct efficiently a MDQMS audit in the context of ISO 13485
Domain 6: Conclusion and follow-up of an ISO 13485 Audit
Main Objective: To ensure that the ISO 13485 Lead Auditor candidate can conclude a MDQMS audit, and conduct the follow-up activities in the context of ISO 13485
Domain 7: Management of an ISO 13485 Audit Program
Main Objective: To ensure that the ISO 13485 Lead Auditor understands how to establish and manage a MDQMS audit program
ISO 13485 Lead Auditor Training
Certification
After successfully passing the exam, you can apply for the credentials shown on the table below. Certification will be provided once you comply with all the requirements related to the selected credential.
The requirements for PECB Implementer Certifications are:
Credential | Exam | Professional Experience | QMS Implementation Experience | Other Requirements |
---|---|---|---|---|
PECB Certified ISO 13485 Provisional Auditor | PECB Certified ISO 13485 Lead Auditor Exam | None | None | Signing the PECB code of ethics |
PECB Certified ISO 13485 Auditor | PECB Certified ISO 13485 Lead Auditor Exam | Two years; One year of MDQMS related work experience | Medical Devices Quality Management System activities totaling 200 hours | Signing the PECB code of ethics |
PECB Certified ISO 13485 Lead Auditor | PECB Certified ISO 13485 Lead Auditor Exam | Five years; Two years of MDQMS related work experience | Medical Devices Quality Management System activities totaling 300 hours | Signing the PECB code of ethics |
PECB Certified ISO 13485 Senior Lead Auditor | PECB Certified ISO 13485 Lead Auditor Exam | Ten years; Seven years of MDQMS related work experience | Medical Devices Quality Management System activities totaling 1000 hours | Signing the PECB code of ethics |
ISO 13485 Lead Auditor Training
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