ISO 13485 Risk Management in Simple Terms

Ronen E

Problem Solver
Staff member
Moderator
#11
One reason could be that the contract with the customer mandates it.
It can be part of the necessary level of control for component manufacturer.
Cheers!
IMHO a client requiring their production equipment manufacturer to comply with ISO 13485 don't understand what ISO 13485 is. It makes much more sense to require ISO 9001.

I believe they just want to sleep well at night, and they think ISO 13485 will provide a good blanket. :) Fact of the matter, it probably won't.

Have a nice day,
Ronen.
 
Last edited:
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somashekar

Staff member
Super Moderator
#12
We are ISO 9001:2008 and 13485:2003 certified (13485 was completed in January 12').

The company does not build medical devices, we do low to medium volume contract manufacturing and design and build jobs of a complex electro-mechanical nature. One example would be a machine which converts non-wovens into surgical dressings and packages them. In other words, we do not make any medical devices, we make the machines that make medical devices.
Your management deciding to get ISO13485 perhaps did not see the requirements and scope of the ISO13485. Even more., your CB have done next to nothing in appraising you , and that is not good on there part.
Here you can read....
This International Standard (ISO13485) specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
It can also be used by internal and external parties, including certification bodies, to assess the organization?s ability to meet customer and regulatory requirements.

As manufacturer of equipment that make fabric from non-woven, you are nowhere even near to provision of related services.

Do you also do the production of surgical dressings with your own machine ?
I doubt reading this from you ...
we do low to medium volume contract manufacturing and design and build jobs of a complex electro-mechanical nature
 

sagai

Quite Involved in Discussions
#13
I am a wee apostate about the value of the ISO13485 certification.
Literally any company can get it unless they have never looked into it, it is recently more or less an administration burden rather than a real value to gain it and I see a continuous eroding tendency in this subject.
But its another subject, that's correct.
Cheers!
 
W

WilBryan

#14
Wow, thanks to everyone for the great feedback!

Ronen E:
We currently take an exclusion on sterilization and implantable devices. Because at some point we may make an actual device (perhaps a beam therapy device or a surgical robot) I think the leaning is to not exclude at this time but it is under consideration.
We are both 9001 & 13485 certified currently.

Sagai:
It is not currently a customer mandate however within several of the fields in which we work customers will only consider us for contracts if we have the certification. It allows us to work with a broader spectrum of customers and prepares us for meeting contractual requirements like you mentioned.

Somashekar:
It is the last bit of the quote that drove us to 13485 ?design, development, and provision of related services.
It can also be used by internal and external parties, including certification bodies, to assess the organization?s ability to meet customer and regulatory requirements.? We work in many fields ranging from semiconductor and electron microscopy to machines for handling nonwovens, medical materials, medical device testing, packaging and other related fields. As a rule we do not ever make anything that would be used on a patient or by an end consumer, we make the machines that a medical (device) company would use to produce their devices, consumables and related products.

Again, thanks to everyone for their feedback! As I said, I am very new to the QMS world and have a ton to learn.


Any advice or suggestions are very welcomed!:thanks:
 

somashekar

Staff member
Super Moderator
#15
When maintaining a risk management program to meet 13485 standards is it mandatory that your process also meet 14971 standards?
Can we take an additional exclusion specific to medical devices?

I know this is a little confusing but as I said, Ive been dropped into this, am new to the QMS world and am still learning how to ask decent questions.
As you already are ISO13485 certified to your specific scope, please continue to maintain. However what has been done thus far about risk management ?
Certainly this cannot be an exclusion, but can be limited to your operational area. You need to understand specifics from medical experts what risks the patients and users face and how your operations could be a contributor to such risks and thus how you can exercise controls to eliminate / minimize.
ISO14971 is a guideline, and like any other guideline, it is not mandatory.
Your sound FMEA can be a good one. Coming to your medical products covered under your ISO13485, think patient risks and think user risks. Put a plan to eliminate or minimize them, document them and implement them.
 
W

WilBryan

#16
Somashekar:
Thank you for a great answer! As far as risk management goes, to date we have trained all project managers, engineers and QMS staff (me) on the subject by an outside source. We have drawn up a spreadsheet for doing FMEA and operator safety assessments and we have written an SOP tying it all together. We are also in the process of running a test project through our system to see how it all pans out. I have been tasked with leading a team to better refine the process. During the first meeting the question was raised of how we reconcile our process for medical devices. I gave them a similar answer to what you just said but I don?t have the experience and background to really carry enough weight to convince everyone so I wanted to follow up here (and with our management) for guidance and to make sure I wasn?t totally off base. I sincerely appreciate the assistance!
:agree:
 
I

infinitereality

#17
Hi Everyone!

I am new to this ISO 13485 standard and we are trying to weigh-in whether to have it or not. We are an independent distributor for electronic components (e.g. IC, memories, CPUs, etc.) and our list of customers ranges OEM, CEM and even other IDs. Now, some of these customers manufacture medical devices and we would want to enter into that business line (as a supplier to them); that is the reason why we are considering to be certified to ISO 13485. Reading from this forum, I have learned that this standard is not really value-adding to us since we already are certified to ISO 9001 and most probably some of the requirements of ISO 13485 will only be excluded.

Right now, I am doing a cost analysis for putting up ISO 13485, including the ROI. Do you have anything that can help me to get started with this? Any help is greatly appreciated! :)
 

Ronen E

Problem Solver
Staff member
Moderator
#18
Did you encounter any potential customers (medical devices manufacturers) who turned you down simply because you didn't have the ISO 13485 certification?
 

sagai

Quite Involved in Discussions
#19
I think if you would supply them only as a distributor of the parts they may need there is little or no value to have certified for ISO13485 (and I have doubts if you can gain such certificate without being exposed to the specialities of ISO13485 compared to ISO9001), however if this supply regards to value add activities above the level of distributing parts it is pretty much up the level of that value add.
Cheers!
 
I

infinitereality

#20
Hi Ronen - they are not really turning us down; they're not buying from us because we don't have the certificate.

Hi Sagai - I believe that they needed suppliers that are certified to ISO 13485 mostly because of the validation part; we deal with parts mostly ICs bought from China and we check these for authenticity and trap counterfeit parts.
 
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