 |
 |
Implementing and Auditing the ISO 13485:2003 Standard
|
 |
|
|
This practical two-day course will give you the knowledge, skills, and tools you'll need to implement and audit a quality management system which meets the requirements of ISO 13485:2003.
Furthermore, performing internal audits to the ISO 13485:2003 Standard demands knowledge and skills on the new requirements and process auditing techniques. Having professionally trained, competent auditors and an effective internal audit process are critical to maintaining your QMS.
To ensure learning is maximized, our course utilizes an excellent combination of lecture, examples, discussions, and hands-on workshops.
Did you know that manufacturers selling class II, III and IV devices in Canada must be registered to ISO 13485? By attending this course you'll benefit from the experience gained from the hundreds of clients we've worked with and our knowledge from keeping closely involved in the standards' revision process.
By attending you will learn:
- How to interpret and audit the ISO 13485:2003 Standard and how it will impact your system
- The key changes from ISO 13485:1996 and EN 46001
- The eight Quality Management Principles
- The restructuring of the standard to a business process model
- How to modify your documentation and implement the changes
- How to use valuable auditing techniques to help identify and correct major problems
Topics include:
- Management's Roles and Responsibilities with ISO 13485:2003
- Process Auditing Techniques
- Interpreting and Auditing the ISO 13485:2003 Standard
- Identifying Nonconformances and Writing Nonconformance Statements
- Developing and Modifying your Documentation to Meet the New Revisions
- Tips for Successful Implementation and Registration
For more information, contact us at info@hjsteudel.com or call (608) 241-8692.
|
|
|
|
|
|
