Iso 13485 quality manual requirements

The objective of this requirement within your quality manual is to describe how your various processes interact with one another. One of the simplest ways to depict this is by including a process flowchart that shows the dependencies and interactions of your processes. Whichever method you choose, it needs to show the inputs and outputs of each corresponding process. This flowchart is bigger than your design and production processes.

You can visualize the quality manual as sitting at the top of the pyramid, with your SOPs and work instructions in the middle and your document records such as records of internal audits at the bottom of the pyramid, as shown in the figure below. The Quality Policy, since your Quality Manual is your users guide, it makes sense for your Quality Policy to showcased here. A list of the regulations and standards you are following especially if your products are sold in multiple markets. Get your free demo today!

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Subscribe See the Demo. Search Results for:. What are ISO quality manual requirements? It creates, develops and markets innovative medical devices on the market of your industry. Within the framework of the applicable regulatory requirements, the company assumes the role of :. This quality manual contains the activities undertaken by your company name to fulfil our commitments to our customers and the applicable regulations.

It has been written so that all parties involved e. Example: The QMS scope includes the activities of design, production, distribution, installation, maintenance, eliminationof the reference or family of your devices. The following table identifies the requirements of ISO that are not applicable to our company and justifies these non-applicabilities :.

Our Quality Management System has been defined to comply with the applicable regulatory requirements for medical devices:. Our policy is to serve the patient, to propose innovative devices using the latest advances in your technical branch to be able to summary of intended use and thus bring summary of patient benefits to the patient.

The company applies a risk-based approach to the control of its activities. The resources implemented are proportionate to the level of risk assessed according to appropriate criteria. You must be logged in to post a comment. What is quality manual? So, what do you want them to see? A large document that takes two people to carry, and a month to read? Or colorful, easy-to-scan informational brochure that sets your organization apart from the competition?

For a graphical representation of the implementation process, check out this free Diagram of ISO Implementation Process. Download now. You may unsubscribe at any time. For more information, please see our privacy notice. For full functionality of this site it is necessary to enable JavaScript.

Here are the instructions how to enable JavaScript in your web browser. Waqas Imam. What does ISO require from the quality manual? Upcoming free webinar. Presenter Kristina Zvonar Brkic.