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Description
This BSI course, "ISO 13485:2003 Lead Auditor", is a competency-based 4-day course that teaches a general understanding of the concepts of the ISO 13485:2003 standard and the principles and practices of leading management system and process 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 the entire audit process, from managing an audit program to reporting on audit results. 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 three RABQSA TPECS Competency Units whose outcomes are certified by RABQSA:
MD - Medical Device Systems
AU - Management Systems Auditing
TL - Leading Management Systems Audit Teams
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
- Apply ISO 19011:2002 definitions, concepts, and guidelines
- Recognize the principles, practices, and types of audits
- Conduct all phases of an internal audit
- Prepare and present effective reports
- Understand the RABQSA auditor certification scheme
- Understand the role of objectives, scope, and criteria in the audit process
- How to plan audits
- Conduct audit team selection
- Initiate the audit and conduct opening and closing meetings
- Understand audit team leader responsibilities
- Communicate effectively during the audit
- Conduct onsite activities
- Prepare audit conclusions
- Report audit results
Course Materials
Students receive comprehensive course manuals with reference materials.
Audience
- Individuals interested in conducting first-party, second-party, and third-party audits
- Management Representatives
- Quality Directors in Medical Device sector
- Managers
- Engineers
- Consultants
Prerequisite
A prior review of the ISO 13485:2003 standard is required and internal audit experience 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 four day class.
Class Logistics
There are written tests at the end of each of the competency units on days 2, 3, and 4. 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
Day 4: 8:00 AM - 3:30 PM
CEUs
The student certificates display 3.2 continuing education units for the class.
Fee
The class is $2095 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 $1995.
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.
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