ISO 13485 Lead Auditor Training
As an international standard, ISO 13485 determines the requirements for the medical devices industry. This standard was established to be used by companies during the life cycle of medical devices, from the production to post-production, including decommission and disposal. However, ISO 13485 can also be operated by other parties such as certification bodies which can assist in the certification processes. ISO 13485 serves as a tool for organizations to develop and retain their processes efficiently. Organizations that are striving for continuous improvement will benefit from this standard by being able to provide safe and competent medical devices and achieve the trust of customers.
Benefits of ISO 13485
By becoming an ISO 13485 certified professional, you will be able to:
- Increase the number of job opportunities
- Create new business connections
- Gain competitive advantage
- Increase effectiveness and lower costs
- Offer expertise on improving work processes
- Offer safer and more efficient medical devices
- Increase customer satisfaction
How do I get started with ISO 13485 Training?
If you are willing to take the challenge of obtaining an ISO 13485 certification, our experts will ensure a qualitative experience where your needs will be met, and you will become part of our global network.
ISO 13485 Lead Auditor
Why should you attend?
- During 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.
- Based 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.
- After 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.
Who should attend?
- Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits
- Managers or consultants seeking to master a Medical Devices Quality Management System audit process
- Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
- Technical experts seeking to prepare for a Medical Devices Quality Management System audit
- Expert advisors in Medical Devices Quality Management
Learning Objectives
- Understand the operations of a Medical Devices Quality Management System based on ISO 13485
- Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
- Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
- Learn how to lead an audit and audit team
- Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
- Acquire 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
Educational approach
- This training is based on both theory and best practices used in MDQMS audits
- Lecture sessions are illustrated with examples based on case studies
- Practical exercises are based on a case study which includes role playing and discussions
- Practice tests are similar to the Certification Exam
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Job Interview Question Answers
- Security Job Interview Questions
- Job Interview Checklist
- General Job Interview Questions
- What to wear for Best Job Interview Attire
- Behavioral Job Interview
- Information Technology Job Interview
International Fee: 650USD
Job Interview Preparation (Soft Skills Questions & Answers)
- Tough Open-Ended Job Interview Questions
- What to Wear for Best Job Interview Attire
- Job Interview Question- What are You Passionate About?
- How to Prepare for a Job Promotion Interview
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Flexible Class Options
- Week End Classes For Professionals SAT | SUN
- Corporate Group Trainings Available
- Online Classes – Live Virtual Class (L.V.C), Online Training
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