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#78222 09/01/25 8:11 AM
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GlynEd Offline OP
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We're just starting the process of using a quality management system (bit behind the times I know!)

Looking at other trusts the standard does appear to be ISO9001 but there are a small number using ISO13485.

Can anyone offer any advice on which one would be best to go for.

We are a Clinical Engineering department that offers a maintenance service to our trust, we don't design any kind of medical devices.

A quick look on line appears that 13485 is more suited to medical devices but leans towards the manufacturer rather than a service dept.

Timewise to achieve - what would be realistic? We're not starting from scratch, we have SOP's and procedures in place just not in the required format.

I have seen the articles by John Sandham on here, they look excellent and a great starting point.

Any advice greatly appreciated.

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Super Hero
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The bits and pieces on line make it clear that 13485 is aimed at "designers, manufacturers, and distributors of medical devices". On the other hand, unlike 9001, it specifically deals with medical equipment (devices) ... it even mentions good stuff like "risk".

If I were you I would wait a few more years to see if the two Standards settle down or even merge. But if you're under pressure to crack on, then clearly (of the two you mention) 9001 must be the one to aim for.

You say that you already have (hopefully decent) in-house procedures and so forth, so why not just make a start on re-writing any that don't already meet the "required format"?

By the way, can I ask if your Management System is not already one of Quality?

Meanwhile, did BS 70000 ever get off the ground? As I may have mentioned before, Standards are a bit like ideas, you just pick the one that suits you best.

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Master
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All the big manufactures service departments will have ISO 9001, which is also required by BS 7000. As you are not designing or constructing medical devices ISO 13485 would not be required.

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Super Hero
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It may be worth making clear that BS 7000 and BS 70000 are two different Standards.

Perhaps it's a pity that BSI and ISO et al seemingly haven't come up with a clearer (not to mention logical) naming (numbering) regime of their own!

Information on line seems to indicate that BS 70000 has been adopted by a few Medical Physics Departments (radiotherapy and so forth), rather than "clinical engineering" per se. I note also that the accreditation process (following any of these Standards) may be expected to take two years to complete.

For what it's worth (probably not a lot) my own take on all this stuff is that these processes are largely a waste of time and money; effort that would be much more usefully spent on inspecting the inventory of equipment (preferably on a rolling basis) to accurately assert the condition of the dependency - and then putting right any (probably many) of the deficiencies found.

What's the point of assessing the competency of a system, or indeed a team, that may well have completely changed in x years time?

Nice work for the accreditation authorities, though. Jobs for life!

It's all very well having a nice, tidy, Quality System (with all the boxes being ticked) ... but surely what we should be about is providing a Quality Service?

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Dreamer
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In my opinion ISO13485 is a manufacturing process quality assurance approval for medical devices same as ISO9001 for general manufacturing process control.
If you are looking at testing process control then in my opinion ISO 62353 should be the spec that you are looking at and tayloring to what you want to do.


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