Performing validation of process/activity

According to requirement 7.5.6 Validation of processes for production and service provision, validation must be done for processes in which the resulting output cannot be verified by subsequent monitoring or measurement. It means that, for example, validation is not necessary when the mass of the medical device is in question, because you can weigh each product and check is the mass according to the specification. However, if you have a sterile product, it is not easy to check the sterility of the product. In that case, you need to dexterous the product and make an analysis of sterility. This is not convenient because you will destroy all your products and have a lot of costs. For such processes, validation must be performed. 

Therefore, validation is documented evidence that declares a process or system will consistently meet a predetermined specification. It is a series of documented tests and gathered information that proves a system will produce a product that meets all specifications and standards. 

Very often, there are standards that guide you on what has to be done to validate certain processes. Some of the most used standards for validations for medical devices are the following:

• ISO 11737-2:2019(en) - Sterilization of health care products — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation, and maintenance of a sterilization process
• ISO 11135:2014 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation, and routine control of a sterilization process for medical devices
• ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing, and assembly processes
• ISO 14644-2:2015(en)
• Cleanrooms and associated controlled environments — Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

For more information about this topic, please see the following articles:

• Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
• How to establish process validation in the QMS https://advisera.com/9001academy/blog/2017/01/31/how-to-establish-process-validation-in-the-qms/