My little ISO 9001:2008 plant is going to make a medical device...now what?

D

djbeatsent

#31
Hi Djbeatsent,

Taking a step back from the daily quality issues you contend with can I ask some questions to clarify your status in the mix.

1 - Are you a tooling manufacturing (mechanical engineering) company?
2 - or other ?
3 - Is this medical device 'your product' / did you design it?
4 - are you the Medical Device 'Manufacturer'?

If you are a tool maker for another company who are the medical device manufacturers, I'm finding that No, you dont need 13485. Your client (the medical device manufacturer) may require you to be 9001 approved more than likely, but thats it, end of.

Unless, the answers above say different.

Maybe you can clarify the above position in this scenario and that perhaps would assist you in getting clear and concise feedback and advice.

Xio
:cool:
1. We do both tool making and injection molding production- although the design/tool making process is NOT ISO certified. Design control is excluded from our certificate. To make this work, we operate almost as two separate businesses.

3. The medical product is someone's patent. This someone started his own company and went to a bunch of different manufacturers to see who could make his product. The product is basically a plastic piece with electronics in it. We are going to make the mold (excluded from ISO), make the plastic pieces, assemble the electronics (that we receive from electronic manufacturer) into the plastic pieces, and then bulk ship them to the guy who owns the patent. He will then final package it and sell it to a large, well known company to sell it on the shelves of Wal-Mart, Target, etc. Our main design guy was offered the chance to patent the plastic design that he created, but he turned it down. Now the guy with the medical device patent also owns the design of the plastic components.

4. This I am not sure of. Where could documentation of this be found?

:thanx:
 
Elsmar Forum Sponsor
X

XIO549

#32
Ok,

So from this, as I see it:
You actually undertake the manufacture a Medical Device component and assemble same to complete an actual end product (less the packaging). No two ways about it then, you are the 'medical device manufacturer'.

If this is the case then, (some one correct me if I'm wrong) you must be certified to ISO13485.
 
D

djbeatsent

#33
Ok,

So from this, as I see it:
You actually undertake the manufacture a Medical Device component and assemble same to complete an actual end product (less the packaging). No two ways about it then, you are the 'medical device manufacturer'.

If this is the case then, (some one correct me if I'm wrong) you must be certified to ISO13485.
There is one other option for us...and I am wondering if this would change us from the 'medical device manufacturer'... instead of selling to the patent owner, we have the option of selling to the electronics manufacturer who will then sell it to the patent owner. The only difference I see with this set up is that instead of the patent owner writing PO's to us, he will write PO's to the electronic manufacturer, who will then write us a PO as an outsourced job. This may make them the device manufacturer, but I am not sure.
 
X

XIO549

#34
I can only see this as trying desperately to pass the buck, but there's no getting away from the device and who makes it; You, right?

If you are in charge of the raw material coming in, process it, and the result is a device which is used to heal a person, it really makes no odds; the manufacturer is the manufacturer.

Even if an ISO 13485 company issued you work instructions and gave you the procedures to follow and records to fill in and maintain, it still would not take you out of the picture.

If you make the device, you must be 13485 certified.

Some one tell me if I'm wrong here, but its pretty black and white.

A more positive way of looking at it though is that ISO 13485:2003 can be seen as an extended ISO 9001:2008 standard as the mirror each other for most of way through, till you get to the product identification and production realization clauses. Hygiene and clean room, risk management, regs, etc come into it then.
Look at 13485 as an upgrade from 9001 - mandatory components of 9001 still apply as I see it.

Take the bull by the horns and go for both - it should stand to you in the long run.

Xio :)
 
J
#35
Ok,

So from this, as I see it:
You actually undertake the manufacture a Medical Device component and assemble same to complete an actual end product (less the packaging). No two ways about it then, you are the 'medical device manufacturer'.

If this is the case then, (some one correct me if I'm wrong) you must be certified to ISO13485.
From my background and experience, unless "medical" is your primary field of manufacture, I would take the term "medical device manufacturer" and turn it around - Like this.
I am a manufacturer of devices(commercial). I work with a number of different customers who have various special needs, and I comply with these needs so long as tehy are clearly stated inteh purchase order.
I have a single customer who wishes to have me manufacture a device that he wishes to use medically. Do I need to take on the added expense of upgrading my system to "medical" standards?
If I see a large block of business out there for medical devices - perhaps it is justified.
If I don't see this as a large part of my business - I can't really justify the expense of the new certifications....
So - I tell my customer this...I will be happy to supply commercial products to you - including any special requirements stipulated in the Purchase Order (for an appropriate upcharge) but I cannot take on the responsibility of signing off on any documentation certifying the materials for medical use. That would be their business.
In my experience (nuclear) customers can fairly easily supply the specific requirements they need for a given product, some quick training of the work-force assures the product is manufactured to the requirements of the P.O. and every one is happy....

So in short, simply explain to the customer that you are a commerical supplier but that you are more than willing to discuss and comply with any special requirements spelled out in the purchase contract.
Now you are a commerical supplier of product to your customer and what they choose to do with it is their responsibility.

Peace
James
 
M

MiaQMS

#36
Mine is going the other way (ish) from designing electronic devices (some medical) to manufacturing (non medical)

We currently comply with 9001:2008 and 13485 - for design.

Can anyone help me get started in the manufacturing end of things - what type of docs or controls do I need - not sure where to start.

Thanks in advance.

Mia
 
Thread starter Similar threads Forum Replies Date
E My little web application about ISO 9000 - Looking for suggestions, comments etc. Software Quality Assurance 8
U Dock Audits - Isn't waiting to do an audit when the product is "supposed" to ship a little late? Manufacturing and Related Processes 12
Mikey324 GR&R - Little to no part to part variation in single part number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
I Gage R&R confusion on a part that has little variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
Douglas E. Purdy Where to buy Little Red Arrow Stickers Coffee Break and Water Cooler Discussions 11
H "Too little" variation in gage R&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
T A little survey on ISMS Implementation - Need help IEC 27001 - Information Security Management Systems (ISMS) 12
optomist1 A Little Midwestern Whine - Drowning in Sea of Acronyms Inspection, Prints (Drawings), Testing, Sampling and Related Topics 14
R Is IEC 61010-1 required for my silly little device? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
somashekar Too much data, Too little analysis - Manual Stages Assembly Shop Data Collection Quality Tools, Improvement and Analysis 2
C MSA (Measurement Systems Analysis) Case - A little help? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
A Looking for a wordsmith - Little compensation - Lots of appreciation! General Auditing Discussions 8
somashekar OH&S and the little family fun Coffee Break and Water Cooler Discussions 5
M There?s a little lie within the Kano-model! Quality Tools, Improvement and Analysis 7
Claes Gefvenberg Weekly picture: The little things... Imported Legacy Blogs 1
smryan Share the Joy! Our little company just got a huge grant! Coffee Break and Water Cooler Discussions 9
R They do things a little different on Southwest Airlines! Travel - Hotels, Motels, Planes and Trains 1
BradM The family lost a little friend today Coffee Break and Water Cooler Discussions 52
M A Little Car Trouble :) The back wiper stopped working Coffee Break and Water Cooler Discussions 12
S A little weight on my mind for New Year's - Measurement Uncertainty Measurement Uncertainty (MU) 3
Wes Bucey Job hunting - the "dirty little secret" Career and Occupation Discussions 5
Jen Kirley I saw the coolest little book today. Coffee Break and Water Cooler Discussions 30
T ASQ CQE Recertification - I might be a little short on points - What to do? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
M a little Norwegian humor??.. Funny Stuff - Jokes and Humour 4
W When A Little Redneck Isn't Enough... Funny Stuff - Jokes and Humour 1
Z Their own little database empires, can anyone be impartial? Coffee Break and Water Cooler Discussions 7
BradM A little help for the bird watchers Funny Stuff - Jokes and Humour 4
I A little controversy - but is it really? Coffee Break and Water Cooler Discussions 36
Wes Bucey Thanks for giving me the opportunity to give a little bit back Philosophy, Gurus, Innovation and Evolution 20
J Choosing Samples for Gage R&R - Randomly picked samples show very little variation Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
M A little perspective... The Goodbye Letter Funny Stuff - Jokes and Humour 14
Wes Bucey Aren't we a little old to believe in fairy tales? Whirlpool to close Maytag plants World News 13
A Looking for a little insight - New to the Quality Profession - Older Company Misc. Quality Assurance and Business Systems Related Topics 19
Marc GM to place more emphasis on hybrids - Too Little Too Late World News 0
C New to 17025 and need a little help in proficiency testing ISO 17025 related Discussions 7
D Registrar's Auditors Main Interest - Football Hall of Fame - Little Work Registrars and Notified Bodies 96
D Can anyone tell me a little about AS9101? Various Other Specifications, Standards, and related Requirements 7
D A little light relief - A puzzle Coffee Break and Water Cooler Discussions 4
B How Do I Put a Little Life into the Internal Audit Report to Management? Internal Auditing 6
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom