ISO 11135:2014 and The QMS

A little more on my answer to the question posed after the EO sterilization webinar:

Ques:  I have a vendor ETO a load for me... what do i need to ensure that they let the load sit or air out between PQ runs?    ISO  11135 or FDA requirement?

Ans:  As mentioned early in the presentation, ISO 11135 presupposes the existence of a viable QMS / CGMP system, as well as adherence to the validation requirements of the standard to complete a successful validation.  Since ISO 11135 is an international standard, it specifically references ISO 13485 requirements under (page 11 of the standard) 4 Quality Management System, 4.1 Documentation, and 4.2 Management Responsibility, and 4.3 Product Realization, et al.   ISO 13485 requires, among others, that a company and its supply chain / vendors adhere to the requirements of 13485 for medical devices.  The US FDA recognizes ISO 11135 as a consensus standard, so for the US, the QSR 21 CFR 820, the CGMPs would be the device QMS in lieu of ISO 13485 (both requirements are very similar).  

So such adherence would assure that your question is addressed.  This can be reaffirmed by a Quality Agreement or Contractual Requirement, verified by Certification / Audit, and/or by other means. 

-- John E. Lincoln     jel@jelincoln.com

A vendor must follow your written requirements/specifications, in this case your validated EO cycle, which also should include a defined minimum aeration time under specified, controlled conditions, all documented, a verified copy of which should be supplied and checked by your QA as part of a sterile load release, all retained in your DHR (lot history).  Since EO gas is a carcinogen, aeration is also a safety requirement.  - JEL, 07/07/25 

The validated aeration time is confirmed by a product's EO residuals data, which have been reviewed and cleared by the FDA as part of a 510(k) clearance or PMA approval. Adherence to a validated sterilization cycle should be clearly stated in the PO, or Contract, or Quality Agreement between the company and the contract sterilizer, and cycle parameters for the lot supplied from the vendor, included with the shipment of sterilized product and checked by the receiving company's QA prior to acceptance at incoming, and prior to final release to the field, and recorded in the DHR for that sterile load, and the individual product lots' DHR's from that sterile load.  - JEL, 08/15/2025  

CRO and Client Disagreement

Here's my further response to the question from the Device Changes webinar of 03/20:

Ques:    What is a CRO's responsibility in educating the sponsor in whether or not the product is a medical device or not? Often times sponsors argue that their product is a cosmetic when it is more like a medical device.

Ans:   As I mentioned, I'm not qualified to directly answer this question.  It goes to the heart of how you as a CRO determine what potential clients you will accept as a formal client, and your legal department's and corporate policies.  As mentioned, as a consultant, I lay out the terms under which I will take on a client, and one of those is clarity of the definition of the project and its scope.  That includes agreement on applicable FDA requirements and definitions.  If the definition is subject to disagreement, then clarify what the proposal will address.

If the definition of cosmetic or device is not clear then define in your agreement just what your services cover, and the approach required by the FDA based on the definition chosen, and that the results are dependent on the chosen definition as it lays out the approaches taken.  This obviously has to be run through your legal department (as mentioned, I am not a lawyer and do not give legal advice). 

You have the right (and responsibility) to turn down clients that will not work with you, and certainly those who will not abide by FDA requirements.

Ref:  https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf

Hope that helps.

jel@jelincoln.com