This one day course reviews all the ISO 13485:2016 requirements. The goal is to spend a limited amount of time on introductions and transition but to spend the full value of the course reviewing the requirements. The review will cover interpretation, application, minimum compliance, best practice, evidence, auditing, etc. as time allows. We will also attempt to answer any specific questions you may have about the standard or your situation.
You will understand the interpretation of the new requirements in ISO 13485:2016 and know how to apply them. You will appreciate everything needed to upgrade and transition to the new ISO 13485:2016
- Quality managers
- Internal auditors
- Professional ISO/AS auditors
- ISO/AS Team Members
- Organization Management
- Anyone needing to understand the new ISO 13485:2016
This course is instructor lead and driven. Participation is expected by discussion and debate. Questions and challenges are invited, especially questions related to specific situations. While this technique is harder work, it is the best approach to cover requirements more thoroughly and to get the most done. Attendees are encouraged to make their own notes. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
This course is taught by experienced instructors who are currently working in the development, implementation and auditing of quality management systems. All instructors are professional registered and certified ISO auditors and have practical, real life experience with the application and interpretation of ISO/AS to help you with specific questions and problems. These instructors have experienced thousands of good and bad management systems and can communicate practical solutions and best practices.
- The structure of the standard and “expectations” that are apparent
- Review of the standard including:
- Read and review each requirement
- Understand the spirit and letter of the requirement
- Understand the application of the requirements to processes – what might be possible and what are best practices
- Understand how it might be audited and what evidence would be appropriate.
- Review, Summary, Close
SCHEDULE AND HOURS
This course runs from 8:30am – 4:30pm with an hour for lunch and periodic short breaks. This is an intensive session designed to include as much discussion as is possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
No pre-course knowledge, activities or requirements are appropriate to this session. Attendees will benefit by reading the ISO 13485:2016 standard prior to the course.
Certificates will be provided to all attendees
In practice, it is impossible to take all your organization’s ISO/AS Team, Internal Auditors and Management out for training. By bringing the course in house to your organization, training fees are minimized, your expenses for sending personnel to public training are non-existent and management can make it! We also customize the training for you in your current situation. We use examples of your documentation for examples and exercises, we discuss your scenarios and identify best practices and solutions appropriate to you.
This is an excellent approach that will provide better, less expensive training and more specific benefits directly to your organization and your ISO program. Email for more details.
If attendees from other companies are allowed in your organization, then hosting a course can be even more cost effective. We discount your course fees for every additional attendee that you allow us to place in the course you are hosting. If you find potential attendees (e.g., among your supplier base) then we will give you an even bigger discount. We’ll handle all the administration and even help you offer the course (at discounted rates) to your suppliers. We understand that not only is ISO important to your organization, but this is a great opportunity to get more involved with your suppliers about a subject that is likely to benefit you both in the long run.
COURSE ADMINISTRATION AND PRICING
Please email with any questions and to confirm current pricing information. Course size and availability may be restricted so contact us now to guarantee your course and place.