Plan-Do-Check-Act in the ISO 13485 standard
Waqas Imam
We know that one of the main goals of an ISO 13485 Quality Management System (QMS) is continual improvement. But,...
We know that one of the main goals of an ISO 13485 Quality Management System (QMS) is continual improvement. But, does that mean improvement of our individual processes? Or, should we focus on overall improvement...
How to conduct an internal audit in ISO 13485
Updated: November 27, 2023. Like many companies, you may view the internal audit process as one more necessary evil required...
Updated: November 27, 2023. Like many companies, you may view the internal audit process as one more necessary evil required for ISO 13485:2016 certification and maintenance. Some think of it as a waste of time,...
Can determining the context of the organization be beneficial for ISO 13485 implementation?
Although determining the context of the organization is not a requirement in ISO 13485, it is an explicit requirement in ISO...
Although determining the context of the organization is not a requirement in ISO 13485, it is an explicit requirement in ISO 9001:2015. This standard specifies that an organization must identify both the internal and external factors...
How to structure Quality Management System documentation according to ISO 13485
When you think about Quality Management System (QMS) documentation, do you picture piles of documents? Maybe bureaucratic red tape and...
When you think about Quality Management System (QMS) documentation, do you picture piles of documents? Maybe bureaucratic red tape and unnecessary procedures? For some companies, this is the unfortunate reality, because they mistakenly believe that...
First-, Second- & Third-Party Audits for medical device manufacturers & suppliers
In the quality management domain, there exists a number of names for various types of audits. In fact, there are...
In the quality management domain, there exists a number of names for various types of audits. In fact, there are so many audit names and types that it’s quite easy to become confused. Further complicating...
How to create a checklist for an ISO 13485 internal audit for your QMS
One of the most important checking tools in a Quality Management System (QMS) for medical devices, or any management system,...
One of the most important checking tools in a Quality Management System (QMS) for medical devices, or any management system, is the internal audit. The ISO 13485:2016 requirements are very clear that this is a critical...
