ISO 13485:2016 Certified Lead Auditor Training
- Offered byAmerican Society for Quality (ASQ)
ISO 13485:2016 Certified Lead Auditor Training at American Society for Quality (ASQ) Overview
ISO 13485:2016 Certified Lead Auditor Training
at American Society for Quality (ASQ)
Prepare yourself for real-life ISO 13485:2016 auditing situations and learn how to manage the complete audit process
Duration | 4 days |
Total fee | ₹1.31 Lakh |
Mode of learning | Online |
Official Website | Go to Website  |
Credential | Certificate |
ISO 13485:2016 Certified Lead Auditor Training at American Society for Quality (ASQ) Highlights
ISO 13485:2016 Certified Lead Auditor Training
at American Society for Quality (ASQ)
- Earn a certification after completion
ISO 13485:2016 Certified Lead Auditor Training at American Society for Quality (ASQ) Course details
ISO 13485:2016 Certified Lead Auditor Training
at American Society for Quality (ASQ)
Skills you will learn
Who should do this course?
- Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process
What are the course deliverables?
- Fully understand and interpret the requirements of ISO 13485
- Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
- Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
More about this course
- Develop the skills you need to lead a successful medical device audit in this ISO 13485 lead auditor training course. Specifically designed to meet the needs of the medical device industry, this four-day class prepares medical device lead auditors for real-life situations via hands-on workshops
- Participants will learn how to lead the audit process and to complete reporting
- Three competency exams are included that can be submitted to Exemplar Global as part of your application for ISO 13485 Lead Auditor certification
ISO 13485:2016 Certified Lead Auditor Training at American Society for Quality (ASQ) Curriculum
ISO 13485:2016 Certified Lead Auditor Training
at American Society for Quality (ASQ)
Course Introduction
Terminology and Definitions
Background, History and Rationale of Quality Management
Introduction to Documents and Resources
Analysis of the Requirements of the Standard
Audits and Audit Findings
Exemplar Global & ANAB
Auditor Qualifications
Roles and Responsibilities During Audits
ISO 13485:2016 Certified Lead Auditor Training at American Society for Quality (ASQ) Entry Requirements
ISO 13485:2016 Certified Lead Auditor Training
at American Society for Quality (ASQ)
Eligibility criteria
- All attendees are required to have their own copy of the ISO 13485:2016: Medical devices - Quality Management Systems
Conditional Offer
- Not mentioned
Other courses offered by American Society for Quality (ASQ)
ISO 13485:2016 Certified Lead Auditor Training
at American Society for Quality (ASQ)
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