The ISO 13485 covers all phases of the medical device lifecycle and one that must be covered is also the control of nonconforming products. It’s a product or a medical device that does not fulfill its specified requirements like customer or regulatory requirements. It’s important…
The ISO 13485 Standard requires collecting data from processes and activities and analyzing them to identify trends and patterns in your processes to verify the continuing suitability and control of the effectiveness of your QMS by maintaining improvement. It’s advisable to ask a lot of…
The ISO 13485 standard in this lesson wants to suggest you a few explanatory perspectives that may serve as inputs for improvement. It also expects you to define which inputs, and sources of information may indicate the need for improvement. From your medical device company…
ISO 13485:2016 has set out requirements for a quality management system where you need to demonstrate your company’s ability to provide safe medical devices and related services that consistently meet customer and regulatory requirements. Learn more about the certification flow to certificate through this infographic.…
Perfect, now when you have learned about the ISO 13485 standard with the help of 20 lessons explained on this website, now you are ready to implement it. The first step is to perform a GAP analysis. We won’t leave you hanging at this part now, so we…
A library is an integral part of any community. They provide information and resources. So why not one in qmsWrapper, more than storage it’s a favorite place to keep important documents that need to be accessed by all. For example, standards, marketing documents, graphics used…
The main goal to conduct a management review is to allow top management from time to time to examine the quality management system. That is done usually not less than once in a year. Commonly, it’s done through the meetings. Various topics can be covered and Top…
Lecture summary: If you don’t know anything about the ISO 9001 and you want to learn and actually understand it, you are in the right place. Step by step, requirement per requirement, we will explain it to you. Implementing this standard is a mature way…
Responsibility and Authority Top management is in charge of appointing responsibilities to other staff and management to ensure that the QMS is being met. They also need to be responsible for communicating internally. One of the musts for them is to establish the pyramid of decision making to…
This part of the standard explains why is planning so influential. Because without planning it’s impossible to build quality into your medical device and company since the start. It’s necessary to plan in such a way to ensure your QMS will be and remain effective. One of the ways…
