More resources to acquaint you with ISO and the certification process.
Both ISO 9001 and ISO 13485 emphasize a process approach. This process is the conversion of inputs into outputs to create something of value. As an example, every worker in an assembly line follows a process and each output becomes an input for the next worker. Other inputs may include materials, instructions, resources, tools, etc.
At the end of the day, an ISO 9001 or ISO 13485 quality management system should implement processes for the following capabilities:
For information or help building an ISO certified QMS, feel free to contact us with your questions. DoMETRIQ is committed to driving ISO approved quality projects to put our clients ahead of the curve.
A documented procedure describes a process using text, images or flowcharts. Both QMS standards (ISO 9001 & ISO 13485) require documented procedures* for the following elements of your QMS:
*ISO 13485 expands this list to include documenting, implementing and maintaining:
Turtle Diagrams are popular tools for dissecting a process. They are commonly used by ISO auditors to visualize the procedures in an operation during an audit. Components of the model include:
To get a better understanding of your QMS, try mapping each process using this simple diagram. It's a great tool demystifying your system.