"Anytime you need to use my name for your products and service I will give you an E for excellent on products and an A+ for outstanding service."
- Bettye Patrick, United Plating
Save the time and resources required to design and document an ISO 13485 Quality Management System. ISO 13485 Store has created most of it for you. The key to an effective Quality Management System is designing the documentation for efficiency and ease of use. Our documents, edited by professional technical writers, have been written in Microsoft Word so you can easily edit and customize them to make them your own. When you have questions, our experts are only an email away.
Begin with this fully documented 40 page ISO 13485 Quality Manual that has been used for successful registrations across the globe. You will appreciate its ease of use - simple yet thorough. Why make it complicated?
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Although our products are easy to use, we still offer World Class Support for your project - for FREE!
Our products have been proven over 10 years - longer than anyone else - and have helped companies around the world become certified. We don't flood our packages with unnecessary forms and other "fluff" to make them look complete. Ours ARE complete, and get the job done.
Experienced quality professionals are available to answer questions and help you develop and implement your QMS.
The course is approximately 30 minutes, includes audio, quizzes, and is intended for ALL of the employees in an organization so they understand the importance of ISO 13485.
There are 4 sections covering various aspects of ISO 13485:
According to the ISO 13485 Standard: the Quality Manual needs to refer to the processes which make up The Quality Management System (QMS). Our Quality Manual already references our procedures and forms, saving you much time and money. You will need to add procedures and forms to your QMS. Why create your own? Upgrade to the Quality Manual and Procedures package and use ours.
The Standard requires that you document the following:
How Much Documentation Do You Need For Your ISO 13485 process?
The ISO 13485 Standard only "requires" a Quality Manual and the six Procedures listed above.
However, you should have enough procedures to cover each section of the standard that applies to your business. Do you purchase anything? Then you'll need a Purchasing Procedure to describe section 7.4 - yet that isn't "required".
The ISO 13485 Store has designed clearly written procedures to describe each section of the standard. That is why our QMS is better than the rest - we cover the entire standard.
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