Technical Documentation => Responsibilities when signing documents

[Auxilium]

Dear community,
I wanted to generally ask whether there's a specific requirement in the 13485 that gives a clear guideline as to who has to sign what documents.
We have a SaMD and therefore, one of our most important company processes is software development process according to standard IEC 62304.
While releasing our QMS docs, I feel like sometimes there are entirely different people who sign the documents in comparison to actually who creates and substantially prepares certain documents.
Let's say we have to release important documents like our Software Requirements which is signed by our Tech Lead.
The documents are usually pending for a long time for this person and this person does not even create the documents.
I wonder: who else could take over? I get it that there's certain requirements as for the Risk Management File that "competent personell" with an adequate background have to sign it.
But how do you in general justify who signs which documents? Would be also really grateful for a reference the standard 13485 or the MDR which we abide by.
THX!

 

[ECHO]

I don't know if any standard/regulation will tell you who needs to approve certain documents.

When I have had to build QMS system from scratch, I have started by creating a RACI table for different documents types. Maybe you can start there.

Regarding your example of your Tech Lead, you could always try to have the Tech Lead's boss approve it. That said, before you can release your requirements, you really should have the buy-in of the people who will implement your requirements.

 

[Tidge]

As far as I know, the only place where the standards come anywhere near to identifying "who" is in 13485 5.5.1 is that it is up to MWER to establish the necessary system and guarantee that those who manage, perform, verify "work affecting quality" have "independence and authority". The Management rep is called out as an individual with specific roles, but nothing specific to "who signs what documents".

It is in the best interests of MWER (since they are the ones who, as individuals, face possible direct financial penalties and jail time) to establish policies (including having the right people in a given job) to guarantee that approved documents mean what they are supposed to mean. Folks below MWER can of course lose their jobs, but it is extremely unlikely for regulators to come after such folks.

 

[Auxilium]

I don't know if any standard/regulation will tell you who needs to approve certain documents.

When I have had to build QMS system from scratch, I have started by creating a RACI table for different documents types. Maybe you can start there.

Regarding your example of your Tech Lead, you could always try to have the Tech Lead's boss approve it. That said, before you can release your requirements, you really should have the buy-in of the people who will implement your requirements.

Hey, thank you so much for the advise!

 

[Auxilium]

As far as I know, the only place where the standards come anywhere near to identifying "who" is in 13485 5.5.1 is that it is up to MWER to establish the necessary system and guarantee that those who manage, perform, verify "work affecting quality" have "independence and authority". The Management rep is called out as an individual with specific roles, but nothing specific to "who signs what documents".

It is in the best interests of MWER (since they are the ones who, as individuals, face possible direct financial penalties and jail time) to establish policies (including having the right people in a given job) to guarantee that approved documents mean what they are supposed to mean. Folks below MWER can of course lose their jobs, but it is extremely unlikely for regulators to come after such folks.

Hey Tidge,
what does MWER mean? And thanks for the answer already!

 

[Tidge]

MWER = Management with Executive Responsibility

 

[Auxilium]

MWER = Management with Executive Responsibility

Thank you very much!

 

[somashekar]

Dear community,
I wanted to generally ask whether there's a specific requirement in the 13485 that gives a clear guideline as to who has to sign what documents.
We have a SaMD and therefore, one of our most important company processes is software development process according to standard IEC 62304.
While releasing our QMS docs, I feel like sometimes there are entirely different people who sign the documents in comparison to actually who creates and substantially prepares certain documents.
Let's say we have to release important documents like our Software Requirements which is signed by our Tech Lead.
The documents are usually pending for a long time for this person and this person does not even create the documents.
I wonder: who else could take over? I get it that there's certain requirements as for the Risk Management File that "competent personell" with an adequate background have to sign it.
But how do you in general justify who signs which documents? Would be also really grateful for a reference the standard 13485 or the MDR which we abide by.
THX!

Reflect on the Clause 5.5.1
Reflect on the word authorities here and see the meaning of the word "approve / re-approve document" as in Clause 4.2.4
This is a classic case of process interaction between Clause 4.2.4 and 5.5.1 and this also closely interacts with the Clause 6.2
Here its more about approve document than the sign on document. There can be many people signing off under various titles, but the one who signs on the 'Approved By' dotted line is of importance and therefore is accountable.