Looking for some inputs for an ISO 13485 refresher training course

[keithm696 - 2008]

Hi All,
I'm looking for some inputs for a refresher training course I've been task to teach. We are moving from a quality model based on Fed-Std 368 that was written years ago to more of a model based on ISO 13485. We are a sheltered workshop that builds first aid kits and most likely never be able to afford being certified but we wish to parallel the standard as much as possible. We do work for ISO companies so we have learned to talk the talk so we can communicate with them. Any suggestions or inputs will be greatly appreciated.
Thanks,
Keith

 

[Wes Bucey]

If you are able, it would help us help you if you give us a little more information:
Do you, personally, have ANY background or training about ISO9001:2000 and/or ISO 13485? What we need to know is how basic do we have to start for YOU.

Next, regardless of your experience regarding either ISO Standard, do you have training and experience in helping your target audience learn and practice good work habits on a consistent basis?

Finally, if you don't have the budget for registration fees (outlandlish to spend money to register for an organization like yours - I think a registrar should offer to do a pro bono audit), do you have funds to purchase training materials? There are several commercial companies which have passable programs for staff familiarization of various Standards.

 

[keithm696 - 2008]

Hi Wes,
I respect the experience here and seek to learn all I can. I have worked for ISO companies in the past and I'm familiar with 9000 as we lived it at Collins Radio. I have to start with real basics here becasue of the limited experience of the staff. They are very good people but need some education as to how far they can go with their ideas. I'm thinking of starting with the definition of Qualtiy Assurance vs Quality Control and expand from there. I figured I would just post here so I can see the variety of input based on the experience across the industry. We strive for perfection and people do it every day. We soon will start processes and SOP's, they do it every day now I just have to get them to put it in writing, thus the training and a little guidance so we can do it correctly.
Regards,
Keith

 

[Al Rosen]

Keith, I'm still not clear about what you are looking for.

My understanding is that your product is not regulated. If it isn't, why would you want a system that is developed around ISO 13485 and not ISO 9001? ISO 13485 has a lot of regulatory requirements that you cannot exclude and still state that your system is compliant. This has nothing to do with registration. I believe you will be better served by applying ISO 9001 to your organization.

Are you looking for training for Management and key individuals, youself or everyone in the organization. I think, Im sure the majority of cove members will agree that it is important to first get Management to commit, then everyone will follow as long as top management supports your effort.

Since you have some background in this area, you can probably find a book for starters to tuneup your knowledge and then get management involved.

You can GOOGLE "ISO 9001 training" or "ISO 13485 training". I'm sure you'll get thousands of hits.

 

[Wes Bucey]

Hi Wes,
I respect the experience here and seek to learn all I can. I have worked for ISO companies in the past and I'm familiar with 9000 as we lived it at Collins Radio. I have to start with real basics here becasue of the limited experience of the staff. They are very good people but need some education as to how far they can go with their ideas. I'm thinking of starting with the definition of Qualtiy Assurance vs Quality Control and expand from there. I figured I would just post here so I can see the variety of input based on the experience across the industry. We strive for perfection and people do it every day. We soon will start processes and SOP's, they do it every day now I just have to get them to put it in writing, thus the training and a little guidance so we can do it correctly.
Regards,
Keith

Lots of jobs at Collins. All had "familiarity" with Standards. Some more than others. More details Please.
I sure wouldn't quibble with distinction between control and assurance. Most of us don't use EITHER term any more.

Even six sigma isn't PERFECT, but that may be a philosophical issue versus teaching, training, or (my favorite usage) "helping folks to LEARN" about Quality.

If you make and/or assemble a product, you already have a process. Depending upon how consistently each person performs that process, you also have an SOP (Standard Operating Procedure.)

One of the few things we (well, at least most of us) try to do is avoid using jargon when we aren't sure everyone is on the same page as to what it means, but most especially, we try not to use it if WE aren't sure what it means.

We haven't abandoned you, yet, but you have to help us help you by being truthful about how much you, personally, know about Quality. You may have been mislead by faulty trainers who were, themselves, not up-to-date.

 

[keithm696 - 2008]

Thanks to all!

We are a registered relabeler/repackager for first aid kits. We do comply with 820 at this time but feel we need to update our model. My Director is fully behind this effort and supports it all the way. The training that I need to conduct will be from his level on down the chain. I have written SOP's and now the rest of the company is sitting down to write what they do every day and then we will refine all SOP's to coordinate with the other areas of the workshop.
My back ground is the Air Force, Northrup Grumman, and Collins. I have dealt with ASQ 9000, ISO 9000, Mil-Std-1916. I have an EE but am fairly new to the first aid line requirements. I have filled the Quality Manager position here for 5 years and have been thru an FDA audit and we are under contract to GSA and build kits for the Forest Service. I get the GSA auditor in once a quarter and they have given us favorable ratings since I started here.

What I'm looking for is just some ideas of refresher training we can conduct internally. And I think the Cover's here would have some very good ideas. I've been here for over a year and have learned many things about this field thanks to the variety of inputs I have read.
Thanks
Keith

 

[Aaron Lupo]

Are you just looking for what the basic requirements of 13485:2003 are?