This course shows you how to implement an ISO 13485 quality management system. You’ll examine internal auditing procedures and learn how to draft process-based documentation. This includes an overview of process validation, risk management, proper internal audits, and CAPA.
Are you new to the 2003 version of ISO 13485? In this course, you will get an understanding of the requirements, learn key steps for implementing an ISO 13485 quality management system, and examine internal auditing procedures. You’ll also learn how to draft process-based documentation. The course provides an overview of process validation, risk management, proper internal audits, and CAPA. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of Quality System Management, including direct work experience.Note: All attendees are required to have their own copy of the ISO 13485:2003 standard for this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T13485)
- CEU Hours: 0.7
- Length: 7 Hours
- ASQ RU: 0.7
- Provider: WebEx Training
- Apply ISO 13485 as a valuable business tool
- Relate common QMS and compliance issues (FDA and others)
- Describe the process approach
- Identify business drivers
- Use key steps to write effective documents
- Recognize the role of risk management
- Interpret the objective of internal auditing
Prerequisites:You must have your own copy of the ISO 13485:2003 standard for this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (Item #T13485).
Who Should Attend:This course is recommended for professionals directly involved in the development of an ISO 13485 quality management system and have a need to provide regulatory compliance. To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of an ISO 9001 quality management system, including direct work experience.
After course registration, you will receive an email with access instructions. If you do not, please check your email junk, spam, or clutter folders. If the email is not there, please contact ASQ. For virtual WebEx courses, you will receive another email 24 hours prior to the start of class containing additional access information.
- Computer – PC or Macintosh
- High-speed internet connection
- Adobe Flash Player 10.3 or later
- Windows: Internet Explorer 8 or later, Google Chrome (latest version), Firefox (latest version)
- Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)
- For instructor-led virtual WebEx courses, a speakerphone or telephone headset in a designated room or space with no distractions (preferred)
NOTE: Refer to product description for any additional system requirements.
WebEx – Virtual Course: Advance Preparation and Student Information
Join a Test Session
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If you do not have administrative privileges on the SAME computer you will be using the day of your training (i.e., your workstation within your organization) you may need the assistance of your local IT/IS help desk staff for the platform to engage correctly.
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Deactivate Pop-up Blockers
You should deactivate any pop-up blockers, spam filters, and company firewalls that could prevent the WebEx client platform or web-based course from working properly. Third-party toolbars such as Bing, Yahoo, and Google should also be disabled due to their own pop-up blocking capabilities.
- If you need to cancel, we will refund your paid registration fee as noted below.
- Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
- Requests received within 5 business days of the course starting incur a $150 processing fee.
- After the course starts, there are no refunds or transfers.
- Registrants who fail to attend without advance notice are liable for the entire course fee.
- If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
- You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
An Internet-based, instructor led course utilizing web and teleconferencing technologies to allow students to interact without traveling. Virtual courses offer interaction with instructor and students via phone and Internet capabilities. Students have access to interaction both with the instructor and other students in an Internet-based learning environment (white board, Q&A tools, application sharing, and breakout rooms). Virtual courses are classroom-like experiences offered using the latest Internet tools.
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ON-SITE TRAINING FOR YOUR ORGANIZATION.
ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.
5 Benefits of On-Site Training
- Expertise to your location: Saves time and travel expenses
- Convenient scheduling: Train groups of five or more
- Customizable courses: Training tailored to your groups’ needs
- Immediate results: Employees complete courses ready to apply what they’ve learned
- Value-add support: Instructors available to answer questions after session