Mould validation

Validation documents are necessary according to the ISO 13485:2016 requirement 7.5.6 Validation of processes for production and service provision. Manufacturer need to have documented procedure for the validation and records of the result and conclusion of validation.

When it comes to product quality in injection molding, machine and tool validation is fundamental to creating a stable manufacturing process and de-risking the project. The purpose of validation is to ensure that injection molders have a stable and dimensionally centered process that consistently produces high-quality products. Validation is basically providing the scientific evidence that the machine and tool is repeatedly doing everything you expect it to do, every minute of every day.

For more information about validation please read the article on the following link: 

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/