Templates for three ISO 13485:2016 SOPs

#1
Hi everyone.

I work in a small company and this is my first job in quality assurance, so I am feeling a bit lost. I am the only person in QA, despite my general manager, which is not available as he is on holidays.
They want to get the ISO certification, so I need to update all the quality documentation based on ISO 13485:2016.
I have updated almost all documents, but I can see that for this ISO, I will need to create 3 news SOP's:

QP716 - Change control;
QP811 - Statistical Process Control
QP 8212 - Device Risk Management.

This is my first time creating SOP's, perhaps do you know where I can get these templates for free? or can you give me some guidance? Many thanks.
 
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yodon

Staff member
Super Moderator
#3
I worry that you're headed for a train wreck. No doubt you'll find some good templates in the posted attachments but will you understand them to the point of adapting them to your company? Why do you think a Statistical Process Control SOP is required? I'm registered to 13485 and don't have one (of course, my circumstances are likely quite different). Do you understand the application of 14971 (risk management) for devices (do you have a copy of 14971?).

I would recommend that you seek out some help from someone (not on holiday! :) ) with experience.
 
#4
Thank you, I will take a look.
Yodon you are correct. I am wondering the same, because I believe I should get some support and understand the background better and not just trying to figure out everything by myself.
I mentioned this SOP's to my general manager and he said that if they are in the ISO, I need to do them, but I have been looking and I also do not understand why we need the statistical control as we are not manufacturing, but just distributing on behalf of other company.
No, I do not have a copy if that, so I guess I should download and read it.
As for now, I cannot get any help from someone with more experience, may I ask you what do you recommend me to do?
Thank you.
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#5
Thank you, I will take a look.
Yodon you are correct. I am wondering the same, because I believe I should get some support and understand the background better and not just trying to figure out everything by myself.
I mentioned this SOP's to my general manager and he said that if they are in the ISO, I need to do them, but I have been looking and I also do not understand why we need the statistical control as we are not manufacturing, but just distributing on behalf of other company.
No, I do not have a copy if that, so I guess I should download and read it.
As for now, I cannot get any help from someone with more experience, may I ask you what do you recommend me to do?
Thank you.
Statistical techniques are mentioned 6 times within the standard. Address them within the procedures appropriate to your operation. You may only need them for analysis of data.
 

Tagin

Trusted Information Resource
#6
...I mentioned this SOP's to my general manager and he said that if they are in the ISO, I need to do them, but I have been looking and I also do not understand why we need the statistical control as we are not manufacturing, but just distributing on behalf of other company...
As far as I can see, 13485 does not state a requirement for SPC.

The term "statistical techniques" is the closest thing used, and it appears in the following:
7.3.6 Design & Dev. verification
7.3.7 Design & Dev. validation
7.5.6 Validation of processes for production & svc provision
8.1 Measurement, analysis, improvement - general
8.4 Analysis of data

Since you are a distributor, you probably exclude D&D altogether. Likewise, 7.5.6 probably is not applicable to your company. So 8.1 and 8.4 are then the only places where "statistical techniques" is relevant. 8.1 just says you have to 'determine' (one of ISO's favorite vague terms) what statistical techniques will be used, and in 8.4 the requirements is that the procedure will include determination of statistical methods (e.g., "our company's Mgmt Team determines the KPIs and metrics to be used, including any statistical methodologies, and those determinations are recorded in _____".

If SPC were an explicit requirement, then you would expect it to appear in 8.2.5/8.2.6 (monitoring & meas. of process/product). However, the language in those clauses is instead quite general.
 
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