Description This BSI course, "ISO 9001:2000 Lead Auditor Course with Emphasis on ISO 13485:2003", begins with a review of ISO 13485:2003 and continues to teach the principles of process auditing in accordance with quality management system standards and ISO 19011:2002, "Guidelines for Quality and/or Environmental Management Systems Auditing." In addition, the concepts of ISO/TR 14971:2001, "Application of Risk Management to Medical Devices," are introduced. Through small group activities, audit role-plays, lively discussions, and instructor-led lectures, students gain a thorough understanding of the principles of auditing and how to apply the guidance of ISO 19011:2002 to implement effective audit programs for medical device manufacturing organizations.
This course is certified by the RABQSA. Students successfully completing this course (by passing the continual evaluation and the written examination) fulfill the RABQSA training requirements for QMS Auditor and QMS Lead Auditor certification.
Larry Whittington is the instructor
for all the highlighted classes.
Learning Objective
Understand Quality Management Definitions, Concepts, and Guidelines
Understand the Quality Management Principles
Interpret All Clauses of ISO 13485:2003
Apply Principles of PD ISO/TR 14969:2004 and ISO 14971:2001
Apply ISO 19011:2002 Definitions, Concepts, and Guidelines
Apply Principles of ISO 19011:2002 to the Auditing Process
Manage an Audit Program
Initiate the Audit and Conduct Opening and Closing Meetings
Conduct On-site Activities
Communicate Effectively During the Audit
Generate Audit Findings
Prepare Audit Conclusions
Report Audit Results
Conduct an Audit Follow-up
Understand the Registration Process
Course Materials Students receive comprehensive course manuals with reference materials, including copies of:
ISO 13485:2003 (with pre-course materials)
ISO 14971:2001
PD ISO/TR 14969:2004
ISO 19011:2002
Audience
Management Representatives
Quality Directors
Auditors of Medical Device Manufacturing Firms (internal and external)
Managers
Engineers
Consultants
Prerequisite A pre-course assignment must be completed before the first day of the course. A prior review of the ISO 13485:2003 standard and internal audit experience are strongly recommended for this course.
Duration The course is taught as a four and one-half day class.
Class Hours Day 1: 8:00 AM - 7:00 PM
Day 2: 8:00 AM - 7:00 PM
Day 3: 8:00 AM - 7:00 PM
Day 4: 8:00 AM - 7:00 PM
Day 5: 8:00 AM - 12:15 PM
CEUs The student certificates display 4.0 continuing education units for the class.
Fee The class is $2095 per student. To confirm your enrollment, pre-payment will be required.
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.
