Startup Company - Implementation of ISO 13485

[Mr_medtech]

I have taken a look at the other threads which are very useful but i don't feel like anyone has explicitly asked and answered this question.

We are building a pure software medical device and need to implement iso 13485. Is it feasible to implement this standard on our own without prior experience in ISO standards / implementing a QMS. There are literally two of us in the company and will need to undertake other business related activities. One of us can take the lead on the design and implementation.

I have read through the standards clause by clause and read about each clause, although i would say that claiming i "understand" or have internalised each clause would be a leap. It feels like this process is very much something that is learned by doing. Would attending a BSI training course on implementing the standard be useful? We have a very limited budget and i don't want to waste money on something that won't add value.

Furthermore, there seem's to be a plethora of eQMS systems online. Are there any that anyone could vouch for in terms of cost & quality for a smaller team?

Is it an issue that there are only two of us in the company and we are both new to ISO standards? For example, training is part of the standard. I assuming if i undertook an implementation course i can then train my co-founder on the importance of working to this standard and what it means for us as an organisation and all the processes we use/follow.

Finally, in terms of quality manual, quality policy and SOPs. I'm wondering if there is some sort of ISO specific way this stuff should be laid out - i understand the content but i'm wondering if we don't create these documents in a certain way will it look like we are complete amateurs if we have an external audit / once we go for the certificate.

I will add that i actually really do see the value in doing this from a product realisation perspective and a lot of the things the standard asks for we are already doing, we just need to formalise the processes and start to document things. I'm slightly worried that the "continuous improvement" side of things could be a pain, but i'm thinking we could start to include potential QM/S improvements in our weekly retrospective.

Thanks

 

[AndyN]

Many questions! A lot have been answered in other threads (see below). Simply, it doesn't matter how you and your colleague go about this. There's no ISO format for any kind of documentation. In fact the K.I.S.S principle is the best format. I would guard against attending training offered by a CB. It can be a bit like learning product design from the perspective of the QC inspector (only how to screw it up). There are many sources of help and a course may not answer a lot of your questions, because you'll be one voice in a class of 10 - 15 all wanting a different answer.

As far as software/eQMS - I've yet to see one which does all things even remotely well. Many do a few things, like document control, corrective actions well, because those are well known to software engineering folks.

As far as improvements go, doing anything weekly is overkill. You improve only when and what you decide you need to. As you implement 13485 you will naturally discover improvements.

If you are located in the USA, there may be Federal/State grant money available to assist you. PM me and I'll send details. I have no commercial interest - just FYI (which is why the Cove exists)

 

[Marc]

PM me

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[Mr_medtech]

ok thanks @AndyN - great feedback. Reading the documentation to me it seems like the QMS system should be serving us and not the other way around and I'm hoping we can keep it this way.

I'm surprised that training from a CB may not be the best way ahead and this is great feedback as it is not cheap (at least on the budget we are working with now).

Unfortunately, we are not based in the USA - we are split between the UK and Asia for the time being.

In terms of eQMS then, my original inclination was to use a separate g suite / drive specifically for QMS and restrict access as it would seem drive / suite has the capacity for a lot of things that are required and would be a good base for us for the size of the company now.

If we have SOPs that are documented in a specific G-suite that has access control and we work to those processes, I'm hoping that's a good starting point that we can improve from as we hopefully raise some capital and hire a couple of additional people.

 

[Mr_medtech]

Also, i would just add in that thought that getting training from a CB would give some evidence of competence in terms of being able to implement the system and train my co-founder on QMS.

 

[AndyN]

getting training from a CB

Not to seem too blunt, but it's not their core competency! Organizations like Bywater in the UK are a training org. and have more expertise, if you're looking for a comparison.

 

[Mr_medtech]

Again, this is great feedback and thank you. I will see if Bywater or someone like that has an office where we are or i can make it to one of their UK sessions. Much appreciated @AndyN

 

[AndyN]

Always happy to help a fellow Brit!

 

[Ed Panek]

We are a start up of 15 employees. We used a consultant to give us the ISO 13485 skeleton which I modified to suit our needs. From there we had audits based upon our scope and made corrections.

 

[Mr_medtech]

@Ed Panek we have someone who will give us a friendly ear and point us in the right direction but actually paying a consultant is beyond our means now. It's a frustrating position because we are on a see-saw where we are on the point of imminent destruction if we do not manage our cash over the next few months very efficiently. We are committed to the quality process but the main resources we are going to be able to dedicate at the moment is time over outward spend. A good example of this is instead of actually buying the ISO standards we went to the library to study them and saved cash in the process. The more things we can do like this the better until we get a first sale and hopefully use that to raise some investment.