This course is intended to qualify ISO 13485:2016 auditors to conduct effective audits of an organization’s medical devices.
Understand the requirements of ISO 13485:2016 to be able to conduct a successful audit. The course includes hands-on workshops to prepare you for real-life auditing situations. You’ll learn to manage the audit process and complete reporting.
This course is being offered in cooperation with DEKRA AQS, an Exemplar Global certified provider.
- CEU Hours: 3.3
- Length: 33 Hours
- ASQ RU: 3.3
- Audience: Practitioner, Professional
- Provider: ASQ - ILT
- Describe the ISO 13485 Medical Device Quality Management System (QMS) - Requirements for Regulatory Purposes standard and development process
- Identify medical device QMS terms
- Describe the intent and requirements of IAO 13485:2016
- Determine the evidence needed to demonstrate conformity to ISO 13485:2016
- Apply the process approach and Plan-Do-Check-Act (PDCA) methodology
- Describe the relationship between ISDO 13485:2016 and applicable regulatory requirements
- Apply the principles, processes, and methods of auditing
- Demonstrate the activities involved in preparing for an audit
- Determine an effective audit in the context of the auditee’s organizational situation
- Apply effective audit skills and practice personal behaviors necessary for an effective and efficient conduct of a management system audit
- Establish and plan the activities of an audit team
- Manage the audit process
- Prepare the audit report and perform an audit follow-up
Prerequisites:All attendees are required to bring their own copy of the ISO 13485:2016 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. Copies will not be provided for you.
Who Should Attend:Those responsible for planning and scheduling an internal audit program for ISO 13485:2016 and those who must perform audits to ISO 13485:2013, medical device personnel, suppliers, managers, or anyone interested in conducting first-party, second-party, or third-party audits.
- Introduction to Quality Management Systems
- ISO 13485 family of documents
- ISO 13485 Standard
- Applying ISO 13485 Standard
- FDA Quality System Regulation General Provisions
- Medical Device Single Audit Program (MDSAP)
- Requirements for Product Realization Methods and Documentation
- Risk Management
- ISO 13485 Audit Specifics
- Types of Audits
- Audit Approaches
- Audit Objectives, Scope, and Criteria
- Auditor Competence
- Auditor Principles and Methods
- Audit Program
- Audit Roles and Responsibilities
- Audit Techniques
- Gather Information
- Audit Cycle
- Team Leader Roles and Responsibilities
- Conflict Management
- Select Audit Team
- Prepare for an Audit
- Plan the Audit
- Conduct an Audit
- Opening Meetings
- Gather Information
- Closing Meetings
- Prepare Audit report
- Audit Follow-Up
FormatThis is an instructor-led classroom course. There are written tests on each of the competency units on days 2, 3, and 4. Days 1 and 2 will cover ISO 13485:2016 along with a corresponding competency exam. Day 3 will cover management systems auditing (AU) along with a corresponding competency exam. Day 4 will cover leading management systems audit teams (TL) along with a corresponding competency exam.
- 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.
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