- Interpret and apply the requirements of ISO 13485:2016
- Apply ISO 14971
- Implement regulatory issues with minimal impact upon operations
- Identify and implement the controls necessary for ensuring the QMS consistently meets requirements
- Develop reliable and pliable systems, particularly effective for organizations where process objectives are constantly changing
- Determine and communicate the resources necessary for the system to work as planned
- Use the QMS to work proactively and not reactively, manage risk, validate software and manage suppliers
ISO 13485:2016 EXECUTIVE OVERVIEW
ISO 13485 2016 EXECUTIVE OVERVIEW
LEARN THE REQUIREMENTS OF ISO 13485:2016 AND HOW TO IMPLEMENT A MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM.
- 2 Day Training
- Taught by Industry Experts
- Onsite or Virtual (Instructor-Led)
- Course materials and exam included (standard not included)
Learn the requirements of ISO 13485 and how to relate the requirements to your business management system. This ISO 13485 Executive Overview Training addresses how management systems (MS) conforming to ISO 13485 apply to the medical device industry and how to use the system to ensure customer requirements are determined and consistently fulfilled over time.
This ISO 13485 Executive Overview Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management.
Because of our independence, you may bring your particular compliance, process and system concerns to class and the instructor will work to answer your questions as best as possible.
LEARNING OBJECTIVES
WHO NEEDS THIS COURSE?
CLASS AGENDA
CERTIFICATION
LEARNING OBJECTIVES
WHO NEEDS THIS COURSE?
CLASS AGENDA
Classes are taught in-house in half day, one day and two days version spending on client objectives and audience. Contact us to determine which version will work best for you.
CERTIFICATION
Students successfully completing QMII’s 4-day RC 14001 & RCMS Lead Auditor training and the examinations provided in conjunction with this course, receive a Certificate of successful completion.
This certificate meets the requirements dictated by the American Chemistry Council in RC206 for certification as a Responsible Care© Auditor/Lead Auditor using RCMS and RC14001:2015.
LEARNING OBJECTIVES
WHO NEEDS THIS COURSE?
CLASS SHEDULE
CERTIFICATION
LEARNING OBJECTIVES
WHO NEEDS THIS COURSE?
CLASS SHEDULE
Classes are taught in-house in half day, one day and two days version spending on client objectives and audience. Contact us to determine which version will work best for you.
CERTIFICATION
Students successfully completing QMII’s 4-day RC 14001 & RCMS Lead Auditor training and the examinations provided in conjunction with this course, receive a Certificate of successful completion.
This certificate meets the requirements dictated by the American Chemistry Council in RC206 for certification as a Responsible Care© Auditor/Lead Auditor using RCMS and RC14001:2015.
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