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.
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.