Has anyone got or know about 9001:2008 accredited business
Discussion
ks and doesn't mean fWinstonWolf said:
If you set your standards too high they'll become a millstone around your neck.
eg:
We will calibrate micrometers at the start of every day, a bugger to achieve.
We will calibrate micrometers every month, much more realistic.
Exactly. ISO9001 doesn't prescribe anything like that level of detail so don't overthink it. eg:
We will calibrate micrometers at the start of every day, a bugger to achieve.
We will calibrate micrometers every month, much more realistic.
I think maybe I am over thinking it.
The reason for me asking this is because I sell a few medial products which were designed and created by me and I am looking to start selling these to NHS customers officially where I beleive they will send me a PO, I bill NHS for it etc.
I read somewhere they have this requirement but i am not 100% sure so I will need to look into it further if it is an actual requirement or more of a just nice to have.
Overall seems to be a pain in the back side from what all of you have said haha
The reason for me asking this is because I sell a few medial products which were designed and created by me and I am looking to start selling these to NHS customers officially where I beleive they will send me a PO, I bill NHS for it etc.
I read somewhere they have this requirement but i am not 100% sure so I will need to look into it further if it is an actual requirement or more of a just nice to have.
Overall seems to be a pain in the back side from what all of you have said haha
I'm a qualified ISO9001:2008 Auditor.
Having this shows that you have a sound Quality management plan in place/followed and that everything is traceable.
Basically, we can show that every numerical result that we produce can be traced to an engineer, performing a set task, with a specific sample, on a piece of equipment.
It can then be demonstrated that the Engineer was trained to conduct that task, on that piece of equipment, by a qualified trainer, for that task/equipment and was deemed competent.
Then we can show that the equipment was the right piece to be used, and was in calibration. Calibrated by an engineer trained and deemed competent by a qualified trainer.... etc, etc, etc.
With work instructions, procedures and records all in place.It also goes some way to ensure constant upgrading and improvement of the system and procedures.
It's a hell of a lot of work to put it together, but once complete should make everything run like clockwork.....
Having this shows that you have a sound Quality management plan in place/followed and that everything is traceable.
Basically, we can show that every numerical result that we produce can be traced to an engineer, performing a set task, with a specific sample, on a piece of equipment.
It can then be demonstrated that the Engineer was trained to conduct that task, on that piece of equipment, by a qualified trainer, for that task/equipment and was deemed competent.
Then we can show that the equipment was the right piece to be used, and was in calibration. Calibrated by an engineer trained and deemed competent by a qualified trainer.... etc, etc, etc.
With work instructions, procedures and records all in place.It also goes some way to ensure constant upgrading and improvement of the system and procedures.
It's a hell of a lot of work to put it together, but once complete should make everything run like clockwork.....
oilydan said:
I'm a qualified ISO9001:2008 Auditor.
Having this shows that you have a sound Quality management plan in place/followed and that everything is traceable.
Basically, we can show that every numerical result that we produce can be traced to an engineer, performing a set task, with a specific sample, on a piece of equipment.
It can then be demonstrated that the Engineer was trained to conduct that task, on that piece of equipment, by a qualified trainer, for that task/equipment and was deemed competent.
Then we can show that the equipment was the right piece to be used, and was in calibration. Calibrated by an engineer trained and deemed competent by a qualified trainer.... etc, etc, etc.
With work instructions, procedures and records all in place.It also goes some way to ensure constant upgrading and improvement of the system and procedures.
It's a hell of a lot of work to put it together, but once complete should make everything run like clockwork.....
Having this shows that you have a sound Quality management plan in place/followed and that everything is traceable.
Basically, we can show that every numerical result that we produce can be traced to an engineer, performing a set task, with a specific sample, on a piece of equipment.
It can then be demonstrated that the Engineer was trained to conduct that task, on that piece of equipment, by a qualified trainer, for that task/equipment and was deemed competent.
Then we can show that the equipment was the right piece to be used, and was in calibration. Calibrated by an engineer trained and deemed competent by a qualified trainer.... etc, etc, etc.
With work instructions, procedures and records all in place.It also goes some way to ensure constant upgrading and improvement of the system and procedures.
It's a hell of a lot of work to put it together, but once complete should make everything run like clockwork.....
IATM said:
I think maybe I am over thinking it.
The reason for me asking this is because I sell a few medial products which were designed and created by me and I am looking to start selling these to NHS customers officially where I beleive they will send me a PO, I bill NHS for it etc.
Or maybe you're not. You may need ISO 13485, the medical devices quality standard, which fits on top of ISO9001.The reason for me asking this is because I sell a few medial products which were designed and created by me and I am looking to start selling these to NHS customers officially where I beleive they will send me a PO, I bill NHS for it etc.
That will be a pain in the proverbial.
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