Your medical device and its quality process must be measured, monitored, analyzed, reported, and reviewed. It's done by using a system of measurement-analysis-improvement that is designed to strategically manage the ‘quality’ of the Quality Management System (QMS).

The processes that ensure the effectiveness of the measurement, analysis, and improvement requirements are:

  • Performing improvement processes;
  • Monitoring and measuring quality;
  • Controlling nonconforming products;
  • Analyzing quality information;
  • Taking the required improvement actions.

It’s one of the most challenging parts of the whole QMS process. Measurement is the process to determine a value. And the measuring process is to collect, analyze, and report data that are relevant to the medical devices and realization process. 


3 Main Objectives

The analysis is here to support the processes and maintain the effectiveness of your quality management system, as well as the quality of the medical devices. These measures will collect data through a defined period of time.

With measurement and analysis, you will collect the necessary data for improvement throughout your medical device company. In other words, performing the above will generate improvement.

Remember that the ISO 13485 standard requires to maintain effectiveness rather than just implementing and measuring it.

When you want to define controls over the processes to measure analysis and improvement you have to:

  • Determine an appropriate method of control, such as statistical tools or techniques for each process or product
  • Determine the scope or extent of the control – what, when, and how many will be measured.
  • Determine the means with which the control will be implemented and utilized throughout the company



ISO 13485 Standard is telling you to plan how your medical device company will monitor, measure, and how it will use analytical processes to ensure effectiveness and conformity. It then asks you to establish feedback methods and procedures and to investigate complaints, take action, and report results. In addition to this, you are required to

  • Plan and perform internal audits
  • Find out whether processes are achieving planned results
  • Monitor and measure medical device characteristics
  • Prevent the unintended delivery or use on nonconforming products
  • Analyze data about your MedDev’s QMS for evaluation of suitability and effectiveness
  • Take corrective and preventive action
  • Make any changes necessary for product safety and performance.







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