BSI’s ISO 9001:2008 Lead auditor course with emphasis on ISO 13485:2003 course begins with a review of ISO 13485 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 14971, “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.
Learning objectives
- Understand quality management definitions, concepts, and guidelines
- Understand the quality management principles
- Interpret all clauses of ISO 13485
- Apply principles of PD CEN ISO/TR 14969 and ISO 14971
- 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.
Who should attend
- Management representatives
- Quality directors
- Managers, engineers, and consultants
- Auditors of medical device manufacturing firms (internal and external)
Duration
Course times,
- 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
This course meets the time requirements set by RABQSA. Time allocated for breaks, lunch, and the written examination is excluded from this total. There are individual evening assignments. Long hours are to be expected.
Prerequisite
A pre-course assignment must be completed before the first day of the course. A prior review of the ISO 13485 standard and internal audit experience are strongly recommended for this course.
Course logistics
There is a written exam on Day 5 at 10:15 AM. Detailed exam instructions are provided during the course. Certificates of completion are provided for students who exceed a 70% on both the continual evaluation and the exam. Certificates of attendance are provided to those who do not pass. All certificates are provided within 6 weeks of course completion.
Student : Instructor ratio - 10:1
