ISO 13485 Documentation Package

K

kvrad

#1
I am in need of a ISO 13485 documentation template package. We are developing a Class II device and need to build a system quickly and efficiently. Any suggestions would be greatly appreciated.
 
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Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
I am in need of a ISO 13485 documentation template package. We are developing a Class II device and need to build a system quickly and efficiently. Any suggestions would be greatly appreciated.
In my opinion, your first mistake is to rush it. You need to look at the entire Business from beginning to end. Why are you in such a hurry?
 
K

kvrad

#3
We are not in a rush, but the company previously had consultants in that developed 'plans' and not procedures. There was a great deal of $$$ and time (18+ months) wasted. Parts of the system they implemented are salvagable, but not enough to encompass a whole system. Our device is software only so it is unique.

A good example is that the consultants had been training personnel and had DCO released a training form, but there is no training procedure (even a draft).
 

Wes Bucey

Quite Involved in Discussions
#4
I am in need of a ISO 13485 documentation template package. We are developing a Class II device and need to build a system quickly and efficiently. Any suggestions would be greatly appreciated.
We are not in a rush, but the company previously had consultants in that developed 'plans' and not procedures. There was a great deal of $$$ and time (18+ months) wasted. Parts of the system they implemented are salvagable, but not enough to encompass a whole system. Our device is software only so it is unique.

A good example is that the consultants had been training personnel and had DCO released a training form, but there is no training procedure (even a draft).
OK. We can help!
Just answer a few questions and we can narrow down what you need.


  1. Do you know WHY your company needs the ISO 13485 documentation template package? (I get the sense you are asking for "plug and play" documents which just need a few blanks filled in.)
  2. I presume your company wants to get ISO 13485 registration to take advantage of the "harmonization" rules laid down by regulatory authorities in various countries which allow a registrant to easily sell medical device products in their counties. Is this true?
  3. Has the company decided on a registrar to provide registration?
  4. Where does your company stand with the USA FDA regarding the medical device software?
  5. About how many employees are involved in the development of the device? How many employees in the entire company?
  6. Has the company been in business long or was it created primarily to develop this product?
  7. Does the company have any other products in production or development (regardless whether they are medical devices) or is this a single product company?
  8. Would your company be amenable to engaging in a no-obligation interview with an experienced, qualified (really qualified) consultant who would, if hired, be able to lead them through FDA and ISO 13485 registration?
  9. You write "need to build a system quickly and efficiently" - what do you mean in terms of time? days? weeks? a month or two?
The point of these questions is there is no "one size fits all" documentation package available anywhere that will adequately prepare an organization for the rigors of FDA and ISO 13485 registration. If the organization has not reached the point of running a business without the documentation, adding generic documentation at this point would set them back, not advance them toward registration.

If a previous "consultant" (probably doesn't fit MY description of "consultant" see: Consulting – Is it in YOUR Career Future?) had been training personnel and had DCO released a training form, but there is no training procedure (even a draft). A "DCO" normally means a "Document Change Order" - if this is what you are referencing, how could you possibly have change orders BEFORE you had adequate documents:confused:
Based on your brief description, it seems there was a major mismatch between the person calling himself a "consultant" and your company and its management.

:topic:Maybe, just maybe, you and your company bosses should also read through this thread Wes Bucey offers service as "Strategy Advisor" - Seeking Case Studies for Book - maybe you could be a chapter in my book!:)
 
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M

MIREGMGR

#5
Whatever else your business does, obviously it's already got operations in the area of product design and development.

If somehow you actually got to a 13485 certificate after adopting a canned 13485 system, and auditors began to expect your design control actions to be consistent with your procedures, I'll bet you'd regret the adoption of that canned package.

Big time.

So, we're trying to warn you: don't go that way. You need a system that, in every sentence, describes the actions and operations that your team actually does, or will be happy being required to do.
 

DannyK

Trusted Information Resource
#6
As an ISO 13485 lead auditor, I have seen many canned procedures which were adopted by companies and they basically had to go back to the drawing board since the procedures led to bureaucratic processes and were not able to be maintained.

I would recommend you obtain a copy of ISO 14969, which provides guidelines to all the requirements and start writing your procedures.

There is no requirement for a training procedure in ISO 13485, although it would be better to have one if your process is complex.

Danny
 

Stijloor

Staff member
Super Moderator
#7
As an ISO 13485 lead auditor, I have seen many canned procedures which were adopted by companies and they basically had to go back to the drawing board since the procedures led to bureaucratic processes and were not able to be maintained.

I would recommend you obtain a copy of ISO 14969, which provides guidelines to all the requirements and start writing your procedures.

There is no requirement for a training procedure in ISO 13485, although it would be better to have one if your process is complex.

Danny
ISO/TR 14969:2004.

Stijloor.
 
K

kvrad

#8
We have a well developed Design and Development Processes, a CAPA process, Complaint process, Change Management and Document Control.

I have been brought in to clean up the mess the contractors made. The developed plans instead of procedures. That has been changed. But the system structure is not in place. All of the document titles and cross references they have put in place don't make any sense. "Regulatory Affairs" covers complaint handling, field actions and training. I need a basis system structure that I can modify.

With the economy $$ are closely watched so it's just me working on this for now and I'm afraid if I start from scratch it will take much longer than management is expecting.
 
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