13485 and Signed Documents

I work at a software company and our work is for other companies. We are 13485 certified.

When we are hired by a company to write software for a medical device we say we will create not only the software but a series of documents to support that code from simple things like code and design review meeting minutes to software requirements to hazard analysis, and the list goes on.

Many times, the customer is not eager to sign a document, even after explaining this is the first draft, not the final thing. Some customers want to wait until the very end. Some just never seem to want to sign at all. They know in the back of their head they need this stuff in their DHF for an eventual FDA consideration but try as we might, no signature happens.

The sticky part comes when we ourselves are audited against 13485 by our 3rd party auditor. We get dinged for not having signed documents. Our process says we'll create documents and sign them and if the customer won't sign them, shame on us. Essentially, "if you have a requirements doc and have signed it and they have not, why have you moved forward?" Well, because the customer doesn't want to sign right now and the customer has asked us to continue with work. Ding.

Over the years and especially the last 5 years, this has become more common.

So we say we'll code and write documents, per 13485, but the customer has little concern about the documents. Is the answer to say we can't do your work for you or do we need to change our SOPs to reflect the attitude of the customer? Can you be 13485 compliant while doing work for a customer and not supplying them with the documentation you think they need?

Thanks.

 

Hi James, I can understand your customer's reluctance to sign the documents, they were not involved in the work and probably do noty have the expertise to critically review them. I would suggest changing your procedures so that they customer does not need to sign the documentation. However I carefully look at how you transfer the work to the customer, so they recieve acknowledge receipt (not nescessarily approve) of a package of documentation.

 

Agree with Vintage Goose. Your contract with your customer should define what the deliverables are, including who approves them. With the contract in place, you can point the auditor there to show who is required to approve. In some cases, you may not even retain the final, approved copy so be sure your internal procedures clarify whatever approach you ultimately take.

They also need to be aware that just because they defer approval to you, they are ultimately responsible for the content.

 

Hello again, [Vintage Goose]. Just put Hella horns on my Bassa yesterday.

Good point, [yodon]. And this now leads the discussion in the directions of terms and conditions review. Read yours first (conditions of sale) and then read an example of the customers document.

You may be amazed at all the arcane requirements that are not being met, are not applicable to the product/service/use, or worse. Make certain your own are in order, and look closely at theirs for Easter eggs you did not expect. Then sort this all out in advance before accepting orders in the future. Over on Elsmar I have a thread " Interesting Purchase Order for it's Terms and Conditions " or some such - hold on, I'll be right back ... Yeah, there you go:

https://elsmar.com/Forums/showthread.php?t=65128

Have a great weekend all, and thank you for all your help here - I would have cracked long ago without your support.

 

Hi, I know it is a few months since you posted but I have only recently joined this forum. We are a company similar to yours in that we supply software to a medical device manufacturer. We have a slightly different problem in that our customer requires more controls round our documentation than we state in our QMS. We have a Project Quality Plan per project that defines what processes and procedures a project will follow. On medical projects there is also a Software Development Plan that further documents the additional steps the project team need to follow. So you could document in the quality plan that customers will not sign a document until the end of the project.
We also have customers that are not medical and like your customer are not keen to sign but insist on reviewing and having their names as approver's in the document. We get round the need for their signature with an email that they send us showing that they are happy to approve the document. There is no actual signature on the document but we can show an auditor the email to show that it is an approved version.
I hope you have found a solution to your problem.