Applicable exclusion from standard

In view of this information you have provided to me, the following requirements do not apply:

• 7.5.3 Installation activities
• 7.5.4 Service activities
• 7.5.5 Particular requirements for sterile medical devices
• 7.5.7 Particular requirements for validation of a process for sterilization and sterile barrier systems
• 7.5.9.2 Particular requirements for implantable medical devices

All requirements that are not applicable must be stated in the Quality manual with justification why those are not applicable.

Considering the software validation, according to the requirements 4.1.6, it is necessary to validate any software that you use during your production process. If you have any software that you manage with your inventory of raw materials and finished product, the software that you use in production, needs to be validated.

Thanks for your email. In the Quality Manual I downloaded, the following clauses are not included.

• 7.5.3 Installation activities
• 7.5.4 Service activities
• 7.5.5 Particular requirements for sterile medical devices
• 7.5.7 Particular requirements for validation of a process for sterilization and sterile barrier systems
• 7.5.9.2 Particular requirements for implantable medical devices

How do I exclude the above clauses from our Quality Manual? Hope to hear from you soon.

In our documentation toolkit, in 03_Quality_Manual_Premium_EN, in section 2.1 you can state all requirements that are not applicable for your company, with proper justification.