Hello,

Our company is being faced with a CE mark compliance issue. Our products are going from "not a medical device" to class IIa. This means that we now need to go down the ISO 13485 path and fast. I have always rolled my eyes at the "quality system in a box" idea but now that we have a short time to try to get this thing rolling and are very short on resource I'm considering it. So I was hoping I could get some recommendations. The Jack Kanholm package looks pretty good by the description and the samples but I'm afraid to spend that kind of money with out some really good testimonies. Any advice would be greatly appreciated.

Thanks
Renee

Hello,

Our company is being faced with a CE mark compliance issue. Our products are going from "not a medical device" to class IIa. This means that we now need to go down the ISO 13485 path and fast. I have always rolled my eyes at the "quality system in a box" idea but now that we have a short time to try to get this thing rolling and are very short on resource I'm considering it. So I was hoping I could get some recommendations. The Jack Kanholm package looks pretty good by the description and the samples but I'm afraid to spend that kind of money with out some really good testimonies. Any advice would be greatly appreciated.

Thanks
Renee

Renee I would get hold of a salesman or company representitive and ask if he could supply you with the names of a few customers that have used the product you are thinking of buying. (The Jack Kanholm package)Then you can get your answers from people who have tried it.:2cents::cool:

Thanks, I will give that a try.

We have at least 2 clients that purchased a packaged quality system (not from the vendor you mention). One pretty much scrapped it and started over after numerous NCs. The other is still struggling with it, replacing much of what was there with what's more reasonable for their business.

The issue I have seen is that packaged systems have to be applicable to any size company. This results in the systems I've seen as one that is rather rigid and extermely process-heavy. For example, the doc control procedures called for, in one case, more approval signatures than the company had employees! In another one, the process required routing through more committees than they had employees - every employee would have spent 100% of their time participating in meetings / sitting on committees had they actually followed the procedure.

I agree with Dean's suggestion - but be sure to evaluate companies similar to yours. For example, if you're a small company, don't think that if it worked for a large company, it will necessarily work for yours (or vice versa).

A good quality system has to both meet the regulations and fit in with your corporate culture. If you can get a package with support that includes tailoring it to your culture, you should be ok.

What, exactly, is 'pre-packaged'? Are you referring to canned procedures and such?

Yes, like this http://www.asq.org/quality-press/display-item/index.pl?item=SW1113 for example. I guess "canned" is a better word.

What, exactly, is 'pre-packaged'? Are you referring to canned procedures and such?
do you have any thought on the viability of going down a road like the OP described.

a similar thing is happening to me in regard to iso17025 and i would like to hear more about people's opinions

thanks,

GD

I'm not a fan of canned solutions, so there's not much I can contribute here. My advice is always do your own procedures. There are plenty here to look at as reference, in all forms from text to flow chart format.

Even if you do buy canned procedures, you have to look at your system and, to be nice, 'tailor' them to suit what you actually do. Since you have to do that anyway, you might as well write your own.

I'm not a fan of canned solutions, so there's not much I can contribute here. My advice is always do your own procedures. There are plenty here to look at as reference, in all forms from text to flow chart format.

Even if you do buy canned procedures, you have to look at your system and, to be nice, 'tailor' them to suit what you actually do. Since you have to do that anyway, you might as well write your own.
thanks Marc,
I'm considering all options at this point.
time is an issue for some in my company. 'get it done and do it soon' is what i'm hearing.
no need be nice, although i appreciate it. i need to hear the real deal.

i CAN handle the truth.

I totally agree. But I just thought I would check to see if it was even worth considering since we are in a pinch. So far it doesn't seem to be a popular approach. Thanks for your input.

I totally agree. But I just thought I would check to see if it was even worth considering since we are in a pinch. So far it doesn't seem to be a popular approach. Thanks for your input.

sometimes its just not practical to 're-invent the wheel'

i'm just concerned that if i buy something it will be waaaay off in left field from where i need to go

where are you looking (web site wise)?

thnaks,
GD

The one that looks like the best, at least for my need, is available through the ASQ store. It's about $900. It also considers the QSR. There are others like http://www.iso9000resources.com/ (this one has some free stuff) and www.the9000store.com (http://www.the9000store.com). Theirs is half the price.

sometimes its just not practical to 're-invent the wheel'

i'm just concerned that if i buy something it will be waaaay off in left field from where i need to go

where are you looking (web site wise)?

thnaks,
GD

Are you familiar with this site? http://www.labcompliance.com/books/default.aspx

Are you familiar with this site? http://www.labcompliance.com/books/default.aspx

thanks

i'm going down the iso17025 route and have alot of the same concerns you have

Do you have a current QMS based on the QSR in place?

I have found that canned, pre-packaged, or off the shelf QMS are so last century.

I am more of a fan of looking at what you are doing currently and blending it into your system. You will find that majority of what you do can be used for your ISO 13485. I would start with an overall system audit to develop your baseline and find any gaps that you may have.

I would also go to fda.gov and look at their guidance documents, first they are free and second risk based guidelines are set up around ISO 14971 which is your next best friend after ISO 13485.

I imagine that you have a Technical File started. Have you looked at the MDD 93/42/EEC a copy is found: http://www.mdss.com/vigilance/essential_requirements.htm

TUV use to have a technical file on their website suitable for use as a template to develop your own.

I believe that you must also be running around http://ec.europa.eu/enterprise/medical_devices/index_en.htm

I am not sure how you have determined the classification of your device. But I am accessing is the draft of the Medical Device Directive at http://ec.europa.eu/enterprise/medical_devices/consult_docs/Public_Consultation_draft.pdf
which you should review for your classification.

Remember, connecting the existing business process to a structure system can be fun.

In more of a "We already do this?" way.

Do you have a current QMS based on the QSR in place?

I have found that canned, pre-packaged, or off the shelf QMS are so last century.

I am more of a fan of looking at what you are doing currently and blending it into your system. You will find that majority of what you do can be used for your ISO 13485. I would start with an overall system audit to develop your baseline and find any gaps that you may have.

I would also go to fda.gov and look at their guidance documents, first they are free and second risk based guidelines are set up around ISO 14971 which is your next best friend after ISO 13485.

I imagine that you have a Technical File started. Have you looked at the MDD 93/42/EEC a copy is found: http://www.mdss.com/vigilance/essential_requirements.htm

TUV use to have a technical file on their website suitable for use as a template to develop your own.

I believe that you must also be running around http://ec.europa.eu/enterprise/medical_devices/index_en.htm

I am not sure how you have determined the classification of your device. But I am accessing is the draft of the Medical Device Directive at http://ec.europa.eu/enterprise/medical_devices/consult_docs/Public_Consultation_draft.pdf
which you should review for your classification.

Remember, connecting the existing business process to a structure system can be fun.

In more of a "We already do this?" way.

Yes, we do have a QMS that is compliant with the QSR. The FDA regs have our products as class II 510k exempt.

The EU classification has been a point that I have defended over the last 10 years with reference to the classification guidance and have always won the argument. I had even questioned if they were really even medical devices and found out that our competitors have been CE marking under LVD and EMC. We decided to do so under MDD as Class I, non-measuring non-sterile just to be on the safe side. After all, the FDA considers them medical products.

The classification issue came about when the "Medical Device Expert Group on Borderline Classification" issued their lasted opinion. It was very plainly stated that they are class IIa. While it is not an official law I understand that everyone goes by this groups opinion.

We should be okay on the technical file side with the exception of needing to prove compliance to IEC60601 (very expensive) and Risk Management that needs to comply with ISO 14971.

We had a preassessment done and are for the most part doing the things we need to do for compliance. It's the getting it in the format that the auditor wants to see with all the right buzz words that's the daunting part.

Ultimately, I want to have a system that provides value and can maintain registration. I was just hoping to be able to press that "EASY" button because our international sales are on the line and then come back and clean it up.

I am hiring a QE that has experience with ISO9000:2000 so maybe that will help.

Thanks for your help.

Hello,

Our company is being faced with a CE mark compliance issue. Our products are going from "not a medical device" to class IIa. This means that we now need to go down the ISO 13485 path and fast. I have always rolled my eyes at the "quality system in a box" idea but now that we have a short time to try to get this thing rolling and are very short on resource I'm considering it. So I was hoping I could get some recommendations. The Jack Kanholm package looks pretty good by the description and the samples but I'm afraid to spend that kind of money with out some really good testimonies. Any advice would be greatly appreciated.

Thanks
Renee


Renee,
Do you have copy of ISO13485? My recommendation would be to get a copy, review it, and compare it to your present quality system. I would bet that your company is already doing much of what is in the standard, it just may not be formalized. Document what you are doing, then develop action plans for the gaps in your system compared to the standard.

I hope this helps,
Phil

The Jack Kanholm package is a very good foundation, and at least gets the ball rolling. Just make sure to use it more as an example of what a documentation package should look like, feel like, and how everything is supposed to fit together. Lots of modifications to suit your business obviously, but using it as plug-and-play system really helps you get started - especially if you're starting from nothing.

Our documentation structure is based loosely on his package, and it works pretty well. I also met the man personally - first ISO audit I'd ever been subjected to. Very professional and seemed to be very knowledgable!

The Jack Kanholm package is a very good foundation, and at least gets the ball rolling. Just make sure to use it more as an example of what a documentation package should look like, feel like, and how everything is supposed to fit together. Lots of modifications to suit your business obviously, but using it as plug-and-play system really helps you get started - especially if you're starting from nothing.

Our documentation structure is based loosely on his package, and it works pretty well. I also met the man personally - first ISO audit I'd ever been subjected to. Very professional and seemed to be very knowledgable!

Thanks! What you desribe is exactly what I was hoping for. That really helped. I'm going to buy it tomorrow.

Thanks again,
Renee

Thanks! What you desribe is exactly what I was hoping for. That really helped. I'm going to buy it tomorrow.

Thanks again,
Renee

Sorry to ressurect a long-quiet thread:

Renee, assuming that you went ahead and purchased this package, with ~8 months having passed for assessment, can you offer your insights and opinions on its usefulness?

I too am seriously thinking of purchasing this same package for helping our small, spanking-new medical start-up to found a QMS that will be within spitting distance of ISO13485 and 21CFR820 compliance the first time 'round.

LOTS2LEARN basically nailed my intent and thinking regarding starting from nothing, getting the ball rolling, seeing how the entire deal fits together etc. While needing to customize for the specific organization is required, customization != writing everything from scratch and going over ground that men and women far more knowledgeable than myself have already covered.

If Kanholm's QMS package really delivers the goods for just $890, it seems a steal. Stil, I'm hoping you, Renee, can offer some feedback now that you've (hopefully) had a chance to use it for a while.

:thanx:

Hi Marc,

If you are just starting up and do not have anything in place yet you would probably get a lot out of the Kanholm package. We found that for our purposes some of the procedures were a little over the top in detail and there were a lot more than are actually necessary. Most of our key processes were very well established and meeting the intent of the standard and too much detail can be dangerous. It was good to have the Kanholm procedures as reference though.

The largest benefit to me was that it helped other deparments understand the standard better by reading and modifying the Kanholm procedures that fit their areas. We passed our certification audit with flying colors in 6 months time. Can I attribute that to the Kanholm package? Maybe partly, but I think we were further along than I gave us credit for and found that I knew more than I thought I did after it was all said and done.

Hope this helps,
Renee

Hi Marc,

If you are just starting up and do not have anything in place yet you would probably get a lot out of the Kanholm package. We found that for our purposes some of the procedures were a little over the top in detail and there were a lot more than are actually necessary.

Thanks so much for the quick reply.

This actually sounds great. I would rather have to have too much and remove what doesn't apply than to have to scramble and backfill later.

Most of our key processes were very well established and meeting the intent of the standard and too much detail can be dangerous. It was good to have the Kanholm procedures as reference though. That's my hope. I have a feeling of "not knowing what I don't know" and having a complete package on-hand from which to grow a system sounds much more realistic than trying to cobble together disparate examples -- helpful as they may be -- from the Cove or elsewhere or paying a consultant $800/day or more. I have no illusions this would be a drop-in system that I could have registered in a month's time. In the early stages, I expect to use this type of thing as a scaffold along with 14969 and 14971 to build the system and risk management from the ground up. Later on, as questions arise and specifics come into focus, a consultant would no doubt be a good thing.

But when starting from point-zero, this seems like a good idea. I appreciate your feedback. It seems like it would be a good thing to start with as it sounds like it was a worthwhile purchase for you.

The largest benefit to me was that it helped other deparments understand the standard better by reading and modifying the Kanholm procedures that fit their areas. We passed our certification audit with flying colors in 6 months time. Can I attribute that to the Kanholm package? Maybe partly, but I think we were further along than I gave us credit for and found that I knew more than I thought I did after it was all said and done.

Hope this helps,
ReneeIt does, very much so. Thanks again.

--
Mike

...you would probably get a lot out of the Kanholm package. I have some of Jack's stuff. It's OK. I've recommended Jack's stuff in the past. On the other hand, there are a lot of different books and packages out there which can help.

The bigger issue is on the end of the company and people implementing it. Which package, or whether one needs a package at all, is a side note. Some companies need a consultant, some don't. Some companies do it by 'internet self education' (such as asking questions, reading through posts, and looking through files people have shared here).

Hello,

Our company is being faced with a CE mark compliance issue. Our products are going from "not a medical device" to class IIa. This means that we now need to go down the ISO 13485 path and fast. I have always rolled my eyes at the "quality system in a box" idea but now that we have a short time to try to get this thing rolling and are very short on resource I'm considering it. So I was hoping I could get some recommendations. The Jack Kanholm package looks pretty good by the description and the samples but I'm afraid to spend that kind of money with out some really good testimonies. Any advice would be greatly appreciated.

Thanks
Renee

Hey Renee,

Canned procedures can help get you started - they can be used as templates. But, they're not going to save you any time. There's just no way to implement a QS out of a box. I'd suggest looking around here in the 13485 forums for procedure samples, and bounce ideas off of the boards. I've found this site extremely useful after just a few days.

Don't spend money on a system in a box though. You're going to have to spend time customizing and implementing those documents anyway.

The mistake people make - and the reason we all roll our eyes at these systems - is they get the impression that they can just "insert company name here" and be done with it. You already know better, so just save yourself the money and implement your own procedures!

Hope that helps.

One of the 'Canned Procedures' failure modes is when the person/company tries to tailor their systems to the templates rather than the other way around.

I very much appreciate the varied opinions and viewpoints.

One thing that is attractive to me about this package is that all of the procedures will have a single style, a commonality of "form, fit and function", if you will. Adapting a single-sourced set of procedures and forms and/or using them as a style guide or template is much more attractive to me than the samples and templates I might get lucky and find here or elsewhere as attachments or otherwise if only because the dizzying array of different schools of thought, specific application (meaning some stuff might be left out), different styles and so on. This can be a good thing but for me, with no ball in hand yet to get rolling, it's confusing.

I could easily burn through $890 worth of time searching examples and templates of up to 32 procedures and 23 forms on Elsmar (or elsewhere) or I could have the whole deal appear magically via download. You might argue then that I wouldn't need to do that many, that I could do a few, get a process interaction matrix up and then write my own from that point on. Still, the learning curve is steep and I simply am not an expert in the field of, say, purchasing (design and development is more my thing) or sterilization or building maintenance. Indeed, none of us are: we have a few developers and a few business types but none are QMS-savvy. This gets back to the "I don't know what I don't know" thing. These documents would hopefully provide me with a starting point which, along with 14969, would provide a foundation to start with. They may require vast sections to be cut, or things added, tweaked or otherwise changed to match what we do (or will be doing...) but I still believe that, for a QMS nOoBiE like myself, this would be easier done with a package like this than starting from scratch or sifting around knowledge bases like the Cove for examples, hoping someone has one. A few days of mucking about like that would cover the cost of getting this package and digging in.

Having said all that, I'm just soliciting opinions of those like Renee that actually used it. I have these preconceived notions about how I think it would go and Renee's response largely reinforced that. But the other opinions also make sense and are giving me pause too. I'll give it some more thought, dig around here a bit more and probably come to a decision tomorrow.

Again, thanks for all the help.

--
Mike

Hello again!

Just reading through some of these posts and, yes, you definitely can't do an
"insert name here", but this package is still very useful. You change the description of the operations to suit the way they happen in your company, but, they help keep you focused on the ISO 13485 requirements and also help to identify where some of the gaps might be. I compared the statements in the "canned" procedures to the requirements in the standard and easily identified where we were possibly not doing something at all, or just not doing it the right way. Then I would simply modify the procedure and/or our practices to ensure it was covered.

So far this method has passed several ISO audits, a California FDA inspection and a Federal FDA inspection....so, for us...it has worked very nicely.

Jack Kanholm also has an ISO 13485 audit checklist (online through Target, if you can imagine) and I think it's wonderful. It gives you the requirement, the corresponding ISO & QSR clause it correlates to, and various questions to ask to determine if the requirement is being met. VERY handy! Obviously, you'd still want to audit specific work instructions and the like to verify that you're not only meeting regulatory requirements, but doing what it is that you say you do, but it's a really great tool IMHO.

I agree with the time savings argument for the AQA procedures. The price was a bargain. I used the AQA template to develop a complete quality system for a start-up with a class IIb device. The resulting quality system (tailored and polished) passed an ISO13458 audit with flying colors.

The organization and the notes on what to do are very helpful. A quick read of the template procedure can help you document the existing process and spot any gaps.

Some of the procedures are by nature, not suitable for "insert name". I'd suggest the biggest issue is Document Control. Each company really needs to put some pieces together for themselves.

Instead of just working from the provided AQA files, I created a template that I liked the looks of, and that provided the sections and organization I like to see in a procedure. Where I made use of the AQA text, I copied it into the template. I've attached it, in case Mike is looking for a more stylish "Style Guide".