When you think of an ISO 13485 Consultants position you most likely have no clue what they do. Unless you are a person who works in the medical device industry than you may actually know what they do. This is an implementation that was placed in 2003, to make sure that medical devices were produced following standards. These requirements have been set in place for quality and reliability of these devices for consumers.
With this upgrade the past documents were superseded. Though it is a document that is meant to stand alone, it does go hand in hand with that of AS9100. The biggest difference between the two is that 13485 is only making sure that an organization demonstrates they have maintained the quality system.But that's not all that it deals with there are other things that are set up in this ISO. For one the management of that organization is the one who will be responsible to make sure that the ISO is in place and being followed.Ensure that work environment keeps the product safe and keeps track of the safety of the environment in general. Works on the risk management of a project, and also with any type of design transfer that may need to take place during the development of a specific product.While devices that are intended to be implanted into a body are required to meet more requirements. Including the inspection to make sure they are safe. There are even more steps that are put in place for those medical devices that need to be kept sterile. Documentation needs to be kept on both of these things.If there was any reason for something to be correct on a device it should be noted how it was handled and whether it was fixed. That includes any kind of preventative process that may have happened too.With the compliance being met for the ISO 13485, it will be the first step a company will take in getting it approved for sales in Europe. They will need to go through and conform to the other standards that have been set up in Europe before they will be allowed to be sold though.When those are all conformed to the organization will receive a certificate that will prove they have passed all the requirements needed. With that certificate they will then have opened up a whole new area where they can sell medical devices.It's easy to see why so many different standards and regulations are in place when it comes to medical devices. After all with an ISO it is the main objective to protect the customers. To make sure that products that are manufactured are of the highest and best quality.Once they have audited the steps to make sure the company is doing them correctly, they will be approving them as a quality product.It has become very popular in the medical device industry that the certification process for the ISO 13485 is of great importance. Showing that they are intending to meet all those requirements that have been set forth and to keep consumers safe. The ISOs that are out there are in place for very good reasons.Learn more about ISO 13485. Stop by Quality Resource Center