Sterilization procedure template

1. We have a procedure “Sterilization” covering below topics:
Elements of the validation process - Bioburden Method validation - Bioburden enumeration -Sterilization process validation –
Sterility testing - Validation by The Bacteriostasis/Fungistasis Test - Sterility testing - EO residue - Bacterial endotoxins (LAL) test –
Product Package Testing - Functional test - Validation records and approval - Impact on manufacturing and packing in routine –Process review – requalification – Concession.

However, we have a separate procedure on Sterility monitoring, covering below topics:
Microbial environmental monitoring - Product bioburden monitoring - Sterility testing (confirmation) -Bacterial endotoxins (LAL) test
Product Package integrity testing

In the sample we see from your documentation we only find “Sterilization”. Are the monitoring topics included in the Sterilization procedure template?

Yes, monitoring and validation topics are included in the Sterilization procedure. We wanted to simplified documentation so we prepare just one procedure for that. 

On this link you can find out how to manage the medical device sterilization process according to ISO 13485:2016

• How to manage the medical device sterilization process according to ISO 13485:2016 https://advisera.com/13485academy/blog/2017/06/28/how-to-manage-the-medical-device-sterilization-process-according-to-iso-13485/

The documents show a very adequate relationship to the ISO13485 paragraph that is the basis for the requirement.
Although most of these requirements are (then again) based on Article, annexes of the EU MDR (2017/745)
For example: For 7.3.9 (ISO) is based (now in MDR) on Annex IX, 2.2 c and Article 10.
Are there any referrals in the document point to these specific MDR article/requirements (possible?)

No, in our procedures we refer only to the MDR in general. However, this is a very good suggestion, we will think about it to implement in our documentation. Thank you for pointing it out to us.