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Part of this approach includes a common high-level clause structure. This common approach will apply to all certification standards, and therefore includes the ISO 9001 Quality standard. Note that FDA 21 CFR Part 820 does not explicitly define risk-based requirements for a quality system in the regulations. Clauses of the new ISO 9001:2015 standard ISO (the International Standards Organisation) has a strategy to create a common approach to management system standards.
Iso 9001:2015 vs iso 13485:2016 matrix manual#
It even has an inbuilt quality manual that you configure to your companies needs. The biggest change of these clauses against ISO 13485:2003 is the 2016 version requires application of a risk based approach in establishing and maintaining a QMS. The processes explain what you need to do, step by step, giving you templates to download, populate, and upload back into the system.Īuditors don't just want to see that you have said you are going to do something, they want proof that you have done it - using QmsWrapper to do your project management, host your meetings, and have conversations in its inbuilt chat program, provide you with just that - proof. Their support reflects this, as they understand your needs and go above and beyond helping you. This was clearly made by people who have not only been through the process, but recognised how hard it was and the need for a system to help guide one through it. QmsWrapper is not only a QMS system and a Project Management tool, but it actually has the processes and templates required to get you through ISO 13485 and an FDA510k build directly into it. For a long time we have to run project management separately in Asana, increasing our workload and, even after expensive MasterControl training, leaving us wondering what to do to get our medical device through the certification process.
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Pros: My company came from MasterControl we found it hard to use, expensive, and essentially a giant version control system that was quite dated.