ISO 13485 standard describes requirements for a QMS where you, as a MedDev company need to show the ability to provide a safe medical device and related services that consistently meet customer and relevant regulatory requirements. However, its quality manual is here to outline the critical quality control guidelines and QMS requirements needed to keep safe users and manufacturers.
There are three sides to who is the Quality Manual important:
- To regulators and customers, because a quality manual is like the road map for getting an overview of your QMS and how it works.
- To organizations that are involved in the design, production, installation, and servicing of MedDev to maintain quality standards.
- To certification bodies for performing their basic auditing processes.
To build your Quality Manual, your organization will use ISO guidelines to meet all applicable regulatory requirements and achieve ISO certification. However, it’s not easy as it might seem. It’s found as a vulnerable zone for the company as auditors often find certain nonconformity in it.
But it does not have to be. Why?
Because there is a solution such as qmsWrapper, QMS software, that offers a Quality Manual as a template, completely free to its users? This Manual is editable and you can easily adapt it to your MedDev company. Book a demo and find out more.
The ISO contains five applicable clauses related to medical device manufacturing and quality control that should be included in your manual: (Clause 4) Quality Management System Requirements, (Clause 5) Management Responsibilities, (Clause 6) Resource Management, (Clause 7) Product Realization, and (Clause 8) Measurement, Analysis, and Improvement.
If you want to create a good quality manual, all regulatory information (laws and regulations), quality management procedures, and key structural processes must be collected in one accessible document.
The quality manual should describe your entire QMS. Don’t forget to list standard quality procedures (and consider including a flowchart). Detail your standard operating procedures (SOPs).
By google-ing, you can find a lot of expert advice on how to prepare a good quality manual, tips, and tricks, etc. so I won’t write about it. I would like to keep it short and note that whatever guideline you decide to follow, it is important that you know the following:
The ISO 13485 Quality Manual must be easy to understand, but also complex in those parts that require it to demonstrate commitment to the ISO / QMS standard.