Yes, at the beginning it is hard and it is a trial and error process with lots of assumptions, nevertheless it is better than doing nothing. With experience we make better assumptions, we become more proactive and we get better at smelling a rat a mile away. This is also a team effort where each member covers other members blind spots. The risk analysis needs also to be reviewed periodically because things change.
Is it at all possible to show us an example of risk-based thinking for blast cleaning, powder coating, and wet paint systems. I have done one but not entirely sure that I am on the right track. Love the videos. They are all very helpful. Keep up the good work.
Are you doing one of these tables per process (marketing, sales, operation, finance, dispatch)? I have created a risk register, with a column defining the process the risk is associated with. Is that something that is sufficient?
ISO 13485 is specific to Med devices, its QMS for Med devices. ISO 9001 is non-specific, can be applied to any service !! So ISO 9001 is mother, ISO 13485 can be called as its derivatives
Hi, do you have a video on change management?
Thanks a lot! This part was the most difficult to me to understand and visualaize it!
Liana Latipova you’re welcome I’m glad it helped! Let me know if you have more questions. We’re trying to do a live Q&A every Friday cheers Kobi
risk is sometime hard to quantify and even qualify them. We making a lot of assumptions on the processes and likelihood of risk may encountered.
Yes, at the beginning it is hard and it is a trial and error process with lots of assumptions, nevertheless it is better than doing nothing. With experience we make better assumptions, we become more proactive and we get better at smelling a rat a mile away. This is also a team effort where each member covers other members blind spots. The risk analysis needs also to be reviewed periodically because things change.
Hi, how do you document the risk assessments as showing in this clip within the companies QMS??
Great
ISO 9001:2015 Free Gap Analysis Checklist - ISO 9001:2015 bit.ly/2EIFAHf
Is it at all possible to show us an example of risk-based thinking for blast cleaning, powder coating, and wet paint systems. I have done one but not entirely sure that I am on the right track. Love the videos. They are all very helpful. Keep up the good work.
Stuart Lemon have you checked out our online course?
www.bestpracticeeducation.com.au/p/iso-9001-essentials-sales-page-new
Are you doing one of these tables per process (marketing, sales, operation, finance, dispatch)? I have created a risk register, with a column defining the process the risk is associated with. Is that something that is sufficient?
Thank you so much for the reply!
Hi kobi,
what is ISO 13485 standard, is there any relation between 9001 QMS & ISO 13485.
Please explain?
ISO 13485 is specific to Med devices, its QMS for Med devices. ISO 9001 is non-specific, can be applied to any service !! So ISO 9001 is mother, ISO 13485 can be called as its derivatives
wo0o0o0ow the way you ilastrat in