Patient Guard

A guide to ISO 13485

Implementing quality management system (QMS) iso 13485 couldn’t be easier with our step by step guide. A quality management system is necessary in medical compliance.

A QMS is simply a set of tools, processes or procedures put in place to offer high quality. The most recent version of the iso 13485 QMS dates back to 2016. There are many ways to utlise this quality system, but essentially you should keep analysing the results from your procedures. 

Here are the steps you must follow to achieve iso 13485 – 

  • Gain support from senior management.
  • Identify exactly what you need to do to meet the requirements of the QMS – including any legal requirements. 
  • Understand the scope – research into what you need to do to achieve the benefits. 
  • Define processes – procedures must be fully explained to everyone involved in the QMS. 
  • Choose the right certification body (we can help you do this).
  • Management review – this will assess the effectiveness of the QMS.
  • Action – once the review has taken place, corrective action must be taken to alter the processes to limit problems. 
  • Certificate. 

You must have a quality manual, which must describe your quality management system. You must also have a medical device file, which includes product description, packaging, instructions for use, and measurements. 

You should make sure that all of your documents are kept up to date and are frequently checked. Current QMS versions must be available at all times. Within this, a record must be kept that includes evidence that all of the required processes have been followed.

While it’s good to have a quality management system in place, it’s more important to make sure it is stable and beneficial to your company. If your system isn’t effective, results must be analysed so that the system can be altered accordingly.

There are many other ways to review quality within a system, these are – 

  • Through customer feedback. 
  • Internal and external audits. 
  • Previous corrective actions.
  • Previous preventive actions. 

Our highly experienced staff at Patient Guard can help you to put a quality system in place. We can ensure that all of the requirements of iso 13485 are met within your QMS. Contact us for more information.

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