Technical Documentation => Responsibilities when signing documents

Auxilium

Involved In Discussions
#1
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!
 
Elsmar Forum Sponsor

ECHO

Involved In Discussions
#2
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

Trusted Information Resource
#3
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

Involved In Discussions
#4
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

Involved In Discussions
#5
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!
 
#8
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.
 
Thread starter Similar threads Forum Replies Date
G Technical documentation for UKCA UK Medical Device Regulations 0
A Update of Technical Documentation EU Medical Device Regulations 3
A Updating Technical Documentation regularly => Leaner Release Advice EU Medical Device Regulations 2
P Updates to Technical Documentation EU Medical Device Regulations 7
S Documents belonging to Technical documentation to be stored in one file or spread in the QM system? EU Medical Device Regulations 9
J How many hours for a NB to review Technical Documentation? EU Medical Device Regulations 6
J Technical Documentation as per MDR / subpoint 6.1 EU Medical Device Regulations 3
B UKRP to what level should you audit Class I Technical Documentation? UK Medical Device Regulations 0
A Technical documentation ce marking pippete tips CE Marking (Conformité Européene) / CB Scheme 0
S Medical Device - Technical Documentation structure EU Medical Device Regulations 1
I "Usability" for technical documentation EU Medical Device Regulations 1
E Technical documentation for IVDD General/ other CE Marking (Conformité Européene) / CB Scheme 3
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 8
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
I MDD Class I software technical documentation sample EU Medical Device Regulations 2
M Annex II - Technical Documentation. V&V, Performance and Safety EU Medical Device Regulations 3
D MDR and Summary Technical Documentation Files EU Medical Device Regulations 18
B Gap analysis of new start-up company technical documentation CE Marking (Conformité Européene) / CB Scheme 1
A Technical Documentation - Manufacturing Specifications EU Medical Device Regulations 4
J Technical Documentation Review: Responding to a Nonconformity ISO 13485:2016 - Medical Device Quality Management Systems 14
J Software for maintaining of Technical files and medical device documentation(RA need) Medical Information Technology, Medical Software and Health Informatics 2
F Technical File - RoHS2 Technical Documentation RoHS, REACH, ELV, IMDS and Restricted Substances 2
Q Use of standard references in documentation (PRS, Technical File) Document Control Systems, Procedures, Forms and Templates 1
T Information and Structure for Technical Documentation for Firmware ISO 13485:2016 - Medical Device Quality Management Systems 1
A ISO 16016 - Technical product documentation Other ISO and International Standards and European Regulations 2
S Translation Software for Documentation with Technical Words - Recommendations wanted Quality Tools, Improvement and Analysis 5
S Medical Device Technical Files (Class IIa & IIb) ? Design Development Documentation EU Medical Device Regulations 7
M Documentation of OEM Device - Technical File for a Class IIa Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 4
Le Chiffre Health Canada to accept Summary Technical Documentation (STED) for Class III & IV ISO 13485:2016 - Medical Device Quality Management Systems 1
C Technical Documentation, DMR, ISO 13485 vs. FDA, STED Document Control Systems, Procedures, Forms and Templates 10
C Structure and Content of DMR / Technical Documentation (FDA vs. ISO 13485)? Document Control Systems, Procedures, Forms and Templates 6
A Technical Documentation Records - Customer drawing, Revision Level, PPAP, etc. Document Control Systems, Procedures, Forms and Templates 1
D Technical Documentation Package (TDP) - Listing of the types of documents contained Document Control Systems, Procedures, Forms and Templates 4
M Does anyone know of a forum that discusses Technical Documentation? Document Control Systems, Procedures, Forms and Templates 4
G Similarities between format of technical file for CE and ASEAN common submission dossier template (CSDT) CE Marking (Conformité Européene) / CB Scheme 2
V How many hrs does it take to create a Technical File (TD)? EU Medical Device Regulations 4
Q Structure Technical File for a system EU Medical Device Regulations 0
Fjalar ISO 20417:2021: Technical Data (6.6.4 c) Other Medical Device Related Standards 0
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 2
D Technical Standard aggregator company suggestions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Biggest issues when producing MDR compliant Technical Files / DD EU Medical Device Regulations 4
B MDR Technical Structure EU Medical Device Regulations 3
LostLouie Archived Specifications and Drawings for Medical Device Technical Files EU Medical Device Regulations 4
D Notified Bodies - ISO 13485 & MDR Technical Files ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom