Thanks for your excellent videos Rob. I’m head of medical engineering for a NHS trust and about to go for 13485 recertification after our scope dramatically changed. Just got 9001 back but as an installation &service team 13485 sets the bar high for us as it’s all about best practices
Good luck with the recertification Andy. The recert audits are always tough. If there is anything you have questions about or need help, schedule a call with me or shoot me an email.
There was no mention of digital marketing in the presentation. If you have a digital marketing business, then it would be more appropriate for your company to have ISO 9001 certification, which is a general quality system requirements.
So ISO 13485 is the very foundation of Quality Management Systems and in outlining what pieces you need for it. Is this the same foundation you created your QMS on?
I've noticed that you and many others when speaking on this topic say only "Thirteen fourty-five (1345)" rather than the full 13485. To the best of my research there isn't a 1345 standard and this is simply a way that 13485 is referenced when speaking, would I be correct in that understanding or am I missing something?
You are absolutely correct that there is no "1345" standard. We are just used to saying it so quickly that we pronounce the standard's number too quickly. Americans often poke fun at British speakers for being too formal in their diction, but this is a great example of why good diction is important. This is also how you can tell when a singer has been trained properly. My apologies for my lazy tongue, but I fear that this poor habit will not die after 20 years.
There was no slide deck for this particular video, but we do have a webinar that is available for sale (including the native slide deck): medicaldeviceacademy.com/iso-13485/
Thanks for your excellent videos Rob. I’m head of medical engineering for a NHS trust and about to go for 13485 recertification after our scope dramatically changed. Just got 9001 back but as an installation &service team 13485 sets the bar high for us as it’s all about best practices
Good luck with the recertification Andy. The recert audits are always tough. If there is anything you have questions about or need help, schedule a call with me or shoot me an email.
@@MedicalDeviceAcademy thanks Rob
What does the digital marketing business have to do with the Iso13485?
There was no mention of digital marketing in the presentation. If you have a digital marketing business, then it would be more appropriate for your company to have ISO 9001 certification, which is a general quality system requirements.
So ISO 13485 is the very foundation of Quality Management Systems and in outlining what pieces you need for it. Is this the same foundation you created your QMS on?
Yes, our turnkey quality management system is designed for compliance with ISO 13485:2016, as well as Canadian, European, and US FDA regulations.
Thank you for this video I'm moving to a company with this and this video has helped my understanding greatly
I'm glad it was helpful, and good luck with the new company.
I've noticed that you and many others when speaking on this topic say only "Thirteen fourty-five (1345)" rather than the full 13485. To the best of my research there isn't a 1345 standard and this is simply a way that 13485 is referenced when speaking, would I be correct in that understanding or am I missing something?
You are absolutely correct that there is no "1345" standard. We are just used to saying it so quickly that we pronounce the standard's number too quickly. Americans often poke fun at British speakers for being too formal in their diction, but this is a great example of why good diction is important. This is also how you can tell when a singer has been trained properly. My apologies for my lazy tongue, but I fear that this poor habit will not die after 20 years.
Hi rob. Can i get a copy of the presentation slides you made?
There was no slide deck for this particular video, but we do have a webinar that is available for sale (including the native slide deck): medicaldeviceacademy.com/iso-13485/
Very informative
Any suggestions for more content?