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Description
This BSI course, "ISO 13485:2003 Internal Quality Systems Auditor", is a competency-based 3-day course that teaches a general understanding of the concepts of the ISO 13485:2003 standard and the principles and practices of effective internal audits in accordance with ISO 19011:2002. "Guidelines for Quality and/or Environmenhtal Managementy Systems Auditing."
Experienced instructors explain the clauses of ISO 13495:2003 in detail and guide students through internal audits that are requiredfor a quality management system based on ISO 13485:2003. Students gain the necessary auditing skills through a balance of formal classroom tutorials, role playing, group workshops, and open forum discussions.
This course comprises the following two RABQSA TPECS Competency Units whose outcomes are certified by RABQSA:
MD - Medical Device Systems
AU - Management Systems Auditing
Attendees successfully completing this course receive a Certificate of Attainment for each of the RABQSA Competency Units listed above.
Learning Objective
- Understand quality management definitions, concepts, and guidelines
- Understand the purpose of the ISO 9000 series
- Understand the requirements of the ISO 13485:2003 standard
- Understand the roles and responsibilities of the auditor
Course Materials
Students receive comprehensive course manuals with reference materials.
Audience
Individuals interested in conducting, managing, or participating in first-party (internal) audits.
Prerequisite
A prior review of the ISO 13485:2003 standard is required and an understanding of auditing principles is suggested for this course. Additionally, it is highly recommended that inexperienced students take the BSI e-learning class, "Overview of ISO 13485:2003", prior to attending the classroom training. Duration
The course is taught as a three day class.
Class Logisitics
There are written tests at the end of each of the competency units on days 2 and 3. Detailed exam instructions are provided. Certificates of Attainment in each competency unit will be provided for students who are deemed "Competent" for each competency unit. Certificates of attendance are provided for those who do not pass the competency test(s), and students will be given an online opportunity to retake the test(s).
Class Hours
Day 1: 8:00 AM - 5:00 PM
Day 2: 8:00 AM - 4:00 PM
Day 3: 8:00 AM - 5:30 PM
CEUs
The student certificates display 2.4 continuing education units for the class.
Fee
The class is $1395 per student. To confirm your enrollment, pre-payment will be required.
Early Bird Discount
If you pay at least 60 days in advance, you will receive a $100 discount, reducing the fee to $1295.
Contact
If you have any questions about this course,
please call us at 770-517-7944 or send an e-mail to Larry@WhittingtonAssociates.com. |
