ISO 13485 Quality Manual

This fully documented 40 page ISO 13485 Quality Manual in MS Word is efficient and easy to customize.
Price: $97.00

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Save the time and resources required to design and document an ISO 13485 Quality Management System. The 13485 Store has created most of it for you. Begin with this fully documented ISO 13485 Quality Manual that has been used for successful registrations across the globe. You will appreciate its ease of use.

This Quality Manual includes:

  • Efficient 40 page manual in MS Word format for ease of editing

  • Text to address each requirement of the ISO 13485 Standard

  • Very clear instructions in obvious Blue Text to show you where to customize your Manual

  • An example process flow chart

  • Required references to the recommended procedures for your quality management system (Procedures & Forms sold separately or as part of a package)

  • Intuitive Architecture for easy Document Control: We've numbered the sections of the Quality Manual correspond with the sections of the ISO 13485 Standard. Registrars LOVE this feature!

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.

The key to an effective Quality Management System is designing the Quality Management Processes for efficiency and ease of use. The processes must be carefully thought out, well-organized, and carefully designed to work together to lead your organization to continuous improvement.

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