Quality Management System Training | Consulting | Auditing

ISO 13485

Understanding and Implementing the ISO 13485 Standard

This practical two-day course will give you the knowledge, skills, and tools you'll need to design/modify and implement a quality system which meets the ISO 13485 Standards. In this course you will learn:

  • The requirements of ISO 13485
  • Valuable tips which will guarantee cost-effective and successful implementation

How to Conduct Internal Audits for ISO 13485

By attending this course, you will learn how to conduct internal audits to verify that your quality system complies with the ISO 13485 Standards, greatly improve your chances of successfully passing the ISO 13485 registration criteria on your first try, and use the internal audit system to maintain and improve your quality management system. This two-day course incorporates a variety of workshops and exercises to enhance your learning experience. We have also developed a role-playing audit in which attendees assume the roles of hypothetical company employees involved in an internal audit. Past attendees have commented that this format is very useful in learning how to conduct a thorough internal audit.

ISO 13485 Overview for Management

This course will provide management with a basic understanding of the requirements of ISO 13485, and will provide an understanding of management's specific roles and responsibilities in the ISO 13485 Quality Management System. In this course, attendees will discuss how the approach taken to implement ISO 13485 can result in either a value-added and sustainable business management system, or something undesirable.

Introduction to ISO 13485 - Awareness Training

This one-half to one day training course provides an informational setting for employees to be introduced to the ISO 13485 quality systems and the requirements of the standards. It provides an open forum for discussion, questions and answers regarding the registration process, what auditors look for, and what will be expected of employees. More importantly, the need for and value of quality systems and documentation will be addressed, along with roles and responsibilities in implementing ISO 13485.

Implementing the ISO 13485 Requirements

Attendees of this two-day course will learn how to design and implement a cost-effective ISO 13485 quality management program using existing resources, gain the competitive advantages of ISO 13485 registration, learn what the ISO 13485 standards require and how to respond, how to develop ISO 13485-compliant documentation, management's role in achieving compliance, and how to develop quality system procedures and work instructions.

Successfully Completing Documentation Requirements for ISO 13485 Registration

Documentation development is the most important task in achieving ISO 13485 registration, but can often represent 50-60% of the time and effort required to achieve registration. This one- to two-day course offers a variety of workshops and exercises to give attendees the methods, tools, and skills needed to develop and implement quality system documentation effectively and reduce the time of this task by 50%.

Using ISO 13485 as a Strategy for Continual Quality Improvement

Achieving the levels of quality improvement that provide for real cost savings and competitive advantage requires more than "quality talk". It requires the application of quality tools and methods that really add value to your operations. It is important to use the right tools and methods that really work in improving your operations and competitive position in the marketplace. With customer demands for ISO 13485 quality systems continuing to increase, learn how to implement these systems efficiently and effectively and achieve the level of quality improvement that will justify your efforts.

Root Cause Analysis

Do you find your organization in a constant state of fire-fighting or constantly dealing with the same problems over and over?  Our Root Cause Analysis course provides tools and techniques to get at the root cause of problems to ensure the problem goes away for good.