ISO 13485 Understand and Install Training
ISO 13485 Understand and Install Training is a one-day private class for the Project Manager who will be responsible for implementing an ISO 13485 quality system in a medical device company.
This private course is often selected when 1 or 2 people will do most of the work to set up the ISO 9001 quality management system.
This course focuses on the ISO 13485 requirements for documentation and records and the strategy for implementing and maintaining an ISO 13485 quality management system.
This course is held at Quality Resource Center’s office location in Sunnyvale, California, located 8 minutes from the San Jose International Airport.
Agenda:
1. Background on the ISO 13485 Standard
2. Structure of the standard – Overview of the 5 main topics
3. A review of the requirements of the ISO 13485 Standard
4. ISO 13485 is a process-based system
5. The criteria for writing a process description
6. How to evaluate existing documents
7. Identifying what new documents are needed
8. Identification and control of documents
9. Control of records
10. Documented Procedures required by the Standard
11. Develop an internal audit program and audit schedule
12. Managing corrective and preventive actions
13. Management review
14. Requirements for certification
15. Registrars and what they do
16. Maintaining the ISO 13485 system
Silicon Valley companies may request training at their office location.Course Length: 1 Day / 8 hours
Fee: $1,400.00 / lunch included (a 2nd person may attend for free)
Includes 2 hours free consulting after the course.
Additional assistance available from QRC is described below.
QRC Training Location:
Quality Resource Center, Inc.
Pacific Business Center
1250 Oakmead Parkway, Suite 210
Sunnyvale, California 94085
This is a 9 minute drive from the San Jose International Airport.
Map: Click here to see a map of our location.
A hotel list is provided below.
Additional Assistance
1. The course includes 2 hours free consulting /assistance after the course.
2. Organizations may want additional assistance after the course is completed.Additional assistance offered by QRC includes:
- consulting
- project assistance
- document writing
- document review
- internal auditor training
- internal auditing services
- pre-assessment audit (to determine readiness for certification)
Click here for a full description of support services available after the course.
Schedule a Course
To schedule a a private course for the ISO 13485 Project Manager at our Sunnyvale, CA Training Center, Contact: Jane Birkenstock
Phone: (408) 371-9995
Email: janebirk@qrccentral.com
Purchase Order Terms: Payment due upon completion of the course.
Payment by company check preferred
Make checks payable to: Quality Resource Center, Inc.
Credit cards accepted: Visa, MasterCard, American Express, Discover
Our Main Office and Course Location is:
Quality Resource Center, Inc.
1250 Oakmead Parkway, Suite 210
Sunnyvale, CA 94085
Phone/Fax: (800)244-5409
Our Accounting office – Mailing address for purchase orders and payment is:
Quality Resource Center, Inc.
Accounting Office
1448 Oak Grove Drive
Roseville, CA 95747
Accounting office contact information:
Phone/Fax: (800)244-5409
Email: KenMcCann@aol.com
HOTEL LIST: All hotels listed are 2 to 3 miles from QRC’s training center. Hotel rates below were listed on the internet on January 1, 2008 and are subject to change. Use the Web Site Reservations link to check the current rate and availability.
The following web sites offer Flight – Hotel – Car Packages:
Expedia.com
Travelosity.com
Training Center distance from Airport is 8-10 minutes.
Distance from Mineta San Jose International Airport (SJC) is 8-10 minutes.
|
Ramada Silicon Valley
1217 Wildwood Ave. Sunnyvale 94089 Shuttle from and to the Airport and within 5 mile radius of hotel. Taxis also available. Distance from hotel to training center: 1.4 miles / 4 minutes Driving Directions from Airport to Hotel Reverse Directions from Hotel to Airport |
|
| Best Western Silicon Valley Inn 600 N. Mathilda Ave. Sunnyvale 94085 Distance from hotel to training center: 3.2 miles / 7 minutes Driving Directions from Airport to Hotel Reverse Directions from Hotel to Airport |
Phone (408)735-7800
$119.00 and up |
| Holiday Inn 4200 Great America Parkway Santa Clara, CA 95054 Distance from hotel to training center: 1.9 miles 5 minutes Driving directions from Airport to Hotel Reverse directions from Hotel to Airport |
Phone (408)235-8900 $169.00 and up |
| Hilton Santa Clara 4949 Great America Parkway Santa Clara, CA 95054 Distance from hotel to training center: 2.8 miles / 6 minutes Driving directions from Airport to Hotel Reverse directions from Hotel to Airport |
Phone (408)330-0001 $229.00 and up |
|
Residence Inn by Marriott Silicon Valley
750 Lakeway Drive Sunnyvale, CA 95054 Distance from hotel to training center: 2.8 miles / 6 minutes Driving directions from Airport to Hotel Reverse directions from Hotel to Airport |
Phone (408)720-1000
$239.00 and up |
© 2010 Quality Resource Center, Inc. All Rights Reserved. Providing Services in San Jose, Los Angeles, Long Beach, Sacramento, Reno, Austin, New York, Dallas, Houston, San Francisco, San Diego, Boston, Atlanta, Chicago, London, Tokyo, Hong Kong, Beijing, Seoul, Bangkok, Munich, Istanbul, Rome, South Africa, Sidney, Manila, Mexico Designed by 