Validation Procedure

No, our pack does not include a Validation procedure. It is covered in the procedure 11_Procedure_for_Production_and_Service_Provision_Premium_EN, under section 3.2.3.

Since processes that need validation are very different it is not possible to make a uniform procedure for them all. Also, some processes have their own rules and standards on how validation must be performed (eg. each type of the sterilization has its own standard for the validation:

• 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 11137-1:2006(en) - Sterilization of health care products — Radiation — Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

For more information on validation, you can 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/
• Production and service provision process in ISO 13485 - https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/