Understand the elements that constitute a quality system, and the audit evidence necessary to comply with ISO 13485 requirements. The course includes hands-on workshops that allow you to replicate the working environment of the medical device industry. The curriculum will reinforce key topics critical to your success in this field.
This training course is an Exemplar Global-certified course and meets the training requirements for certification of individual QMS auditors, QMS senior auditors, and QMS lead auditors. Successful completion satisfies the training requirements for individual auditor certification by accrediting bodies such as IRCA and Exemplar Global. With an emphasis on hands-on training, this course features workshops tailored to the working environment of the medical device industry. You will discuss a range of topics including ISO 13485 Medical devices—Quality management systems—Requirements for regulatory purposes, as well as ISO 9001:2008. Workshops reinforce key topics including documentation of audits, opening and closing meetings, auditor interpretations, listening and questioning techniques, checklists, and nonconformance reports.
This course is offered in cooperation with AQS Management Systems, an Exemplar Global Certified course provider and meets the training requirements for individual auditor certification.
- CEU Hours: 4.4
- Length: 44 Hours
- ASQ RU: 4.4
- Audience: Professional
- Provider: ASQ - ILT
- Understand and interpret the requirements of ISO 9001:2008 in a Medical Device Environment
- Understand and interpret the requirements of ISO 13485
- Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
- Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
- Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
- Understand how to apply the requirements of ISO 9001:2008 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
- Understand the terminology of the ISO 9001:2008 and ISO 13485 and how these apply in a Medical Device Environment
- Learn how to develop an ISO 9001:2008 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
- Learn how to ask audit questions that get results
- Learn how to conduct opening and closing meetings that have impact
- Learn how to construct effective audit checklists
- Learn how to generate effective corrective actions
Prerequisites:All attendees are required to bring their own copy of the ISO 13485:2003 standard to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (item T13485).
Who Should Attend:Professionals involved in implementing and/or auditing quality management systems for medical devices, or those leading a supplier QA effort should attend this training.
- Unit 1
- Terminology and Definitions
- Background, History and Rationale for Quality Assurance
- Introduction to the ISO Family of Documents
- Analysis of the Contents of ISO 13485
- Audit of Active Medical (Audit #1)
- Unit 2
- Quality System Requirements
- Analyzing Findings
- Audit of Active Medical to ISO 13485 (Audit #2)
- Exemplar Global and U.S. Certification System
- Auditor Qualifications
- Roles and Responsibility of Auditors
- Creation of Effective Audit Checklists
- Unit 3
- Audit of Active Medical - Document Audits (Audit #3)
- Tips for the Professional Auditor
- Audit of Active Medical - Department Audit (Audit #4)
- Compiling Audit Findings
- Documentation in the Quality System
- Planning and Conducting Effective Audits
- Refining Interview and Note-Taking Skills
- Applicability of the Elements to Company Situations
- Prevention vs. Detection
- Unit 4
- Audit of Active Medical - Department and System Auditing (#5)
- Corrective Action Initiation and Closure
- Refining Audit Interview and Note-Taking Skills
- Creation of an Audit Report
- Conducting the Audit
- Preparation and Presentation of a Closing Meeting
- Unit 5
- Review and Exam
During the five days of this course, you will cover background of the ISO 9000 and ISO 13485 standards, and go through every phase of the audit—from planning to follow-up—so you will be able to lead your own audits efficiently and effectively.
This course makes extensive use of workshop and hands-on activities. The format of the course is designed to let you apply the knowledge you gain in a way that replicates the working environment of the medical device industry.
Note: All attendees are required to bring their own copy of the ISO 13485:2003 standard to this training course. These will not be provided for you. You can purchase a copy of this standard from ASQ (item #T13485).
In addition, all students will receive a course material packet on-site.
Note: Due to stringent international standards guidelines, a maximum course enrollment is strictly enforced. If you are told you are on a waiting list or have registered and not received a confirmation letter prior to the course, contact ASQ immediately to verify your status before you make travel arrangements.
- If you need to cancel, we will refund your paid registration fee as noted below.
- Requests for cancellations/transfers received at least 5 business days before the start of the course receive a full refund/transfer.
- Requests received within 5 business days of the course starting incur a $150 processing fee.
- After the course starts, there are no refunds or transfers.
- Registrants who fail to attend without advance notice are liable for the entire course fee.
- If you cannot find a substitute, we can transfer your course fees to another ASQ course of your choice.
- You must successfully complete the entire course or program before IACET CEUs and a Certificate of Completion can be awarded.
An instructor-led traditional classroom experience. Classroom-based instruction involves the highest level of instructor/student interaction. We offer classroom style training in two formats. See public and on-site.
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ON-SITE TRAINING FOR YOUR ORGANIZATION.
ASQ’s customized on-site training programs are the cost-effective way for you to train employees on your schedule. Training on-site minimizes the cost-per-student, reduces travel expenses, and ensures that the content is specific to your exact needs.
5 Benefits of On-Site Training
- Expertise to your location: Saves time and travel expenses
- Convenient scheduling: Train groups of five or more
- Customizable courses: Training tailored to your groups’ needs
- Immediate results: Employees complete courses ready to apply what they’ve learned
- Value-add support: Instructors available to answer questions after session