How many QMS processes and procedures?

[snoopy2017]

Hi everyone,

Being the only person driving the QMS in my small company right now, and I am not the most experienced person in quality. I have a question about the ISO 13485:2016 standard. Questions are below:

1. How many QMS processes are there?

2. There are over 60 procedures in our QMS. I believe some can be consolidated though. How many of the QMS processes will need to be updated for the risk-based approach? How many procedures do we need to update? For a process like supplier control, CAPA, software validation, employee training etc, I have updated those procedures to incorporate the risk-based approach. However, for other processes like change management, a risk-based approach is not so clear to me. We do have a procedure for preventing deterioration of documents and loss etc. Does the risk-based approach require updating all procedures, even those where it is not applicable? Our QMS is aligned with FDA QSR since we market in the US, which is already risk-based.

Thanks. I would appreciate any help.

 

[AndyN]

Hi everyone,

Being the only person driving the QMS in my small company right now, and I am not the most experienced person in quality. I have a question about the ISO 13485:2016 standard. Questions are below:

1. How many QMS processes are there?

2. There are over 60 procedures in our QMS. I believe some can be consolidated though. How many of the QMS processes will need to be updated for the risk-based approach? How many procedures do we need to update? For a process like supplier control, CAPA, software validation, employee training etc, I have updated those procedures to incorporate the risk-based approach. However, for other processes like change management, a risk-based approach is not so clear to me. We do have a procedure for preventing deterioration of documents and loss etc. Does the risk-based approach require updating all procedures, even those where it is not applicable? Our QMS is aligned with FDA QSR since we market in the US, which is already risk-based.

Thanks. I would appreciate any help.

If you understand that a procedure is the "way to carry out" a process, do you have 60 processes? Probably not. Do these procedures really describe a process? This is inputs being turned into outputs? If not, you have to decide do you need it for some purpose?

We can't answer many of your questions since we have no idea what you have/had. You have to do the leg work and read the standard. Come back with concrete questions, perhaps, rather than asking very general questions such as "how many do we need to update'?

 

[QAengineer13]

Hi everyone,

Being the only person driving the QMS in my small company right now, and I am not the most experienced person in quality. I have a question about the ISO 13485:2016 standard. Questions are below:

1. How many QMS processes are there?

2. There are over 60 procedures in our QMS. I believe some can be consolidated though. How many of the QMS processes will need to be updated for the risk-based approach? How many procedures do we need to update? For a process like supplier control, CAPA, software validation, employee training etc, I have updated those procedures to incorporate the risk-based approach. However, for other processes like change management, a risk-based approach is not so clear to me. We do have a procedure for preventing deterioration of documents and loss etc. Does the risk-based approach require updating all procedures, even those where it is not applicable? Our QMS is aligned with FDA QSR since we market in the US, which is already risk-based.

Thanks. I would appreciate any help.

I agree with Andy.

My 2C's: Please do not develop/write SOP/Procedure for the sake of it or for getting ISO certificate or for regulatory agency sake, always collaborate with your internal team in a process like value stream/kaizen to understand what works for them and what doesn't and then try to improve/consolidate those process in a meaningful way so the teams can use them in a pragmatic way....its kinda "say what you do" and "do what you say in" your procedure.