Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Device

J

Jshene

#1
I have been researching ISO 13485 and planning to implement a quality managment system for the company I am working for and I'm a bit confused, or I am just think way to far into this. We are a manufacturer of medical equipment and also medical devices. My question is would all of the clauses under ISO 13485 apply to the equipment as well or just the medical devices produced? I thought the idea of a QMS was to have one unified system not just following procedures for one asspect of the company... Please help!! I'm stressing thankfully we have a long weekend :)
 
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ScottK

Not out of the crisis
Leader
Super Moderator
#2
Re: Confused

I have been researching ISO 13485 and planning to implement a quality managment system for the company I am working for and I'm a bit confused, or I am just think way to far into this. We are a manufacturer of medical equipment and also medical devices. My question is would all of the clauses under ISO 13485 apply to the equipment as well or just the medical devices produced? I thought the idea of a QMS was to have one unified system not just following procedures for one asspect of the company... Please help!! I'm stressing thankfully we have a long weekend :)

Do you ONLY make medical device products? If so there is no reason to not include all processes as required by the standard. You don't register a device to the standard... that's what the FDA is for. You register your processes to the standard and who cares how many devices you make.

That being said, I've worked at a company where there were multiple business units at one site and only one was ISO 13485 registered... but we had to make sure that everything was clearly segregated.
For example: if there is a machine used for all businesses - it had to be controlled per the QMS. If there was a machine that wasn't used for the device business then we excluded it from the QMS and we were NEVER to use if for QMS business.
Since the same ERP system was used for all business units, it had to meet QMS requirements
But there were different contract review processes, so only the device process had to meet QMS requirements.

It was not easy and there was lots of room for sloppiness.
 
J

Jshene

#3
Re: Confused about application of ISO 13485

We make suture attaching machines which are not considered a medical device. This device is used to marry needles with sutures.

But we also make needles that are a componet of an unfinished process. Pretty much we drill the needle point it and then send it off to its next operation. What I am wondering is if the machine shop and all of those operations should be included in the QMS?
 

DannyK

Trusted Information Resource
#4
Re: Confused about application of ISO 13485 - Manufacturer of Medical Equipment and D

ISO 13485:2003 is the quality management system for medical devices.
If you are making components that get assembled in medical devices, you should implement an ISO 9001:2008 quality management system.

You have to determine the scope of the certificate and that may determine whether the machine shop is part of the QMS or not.
 

Ronen E

Problem Solver
Moderator
#5
Re: Confused about application of ISO 13485

We make suture attaching machines which are not considered a medical device. This device is used to marry needles with sutures.

But we also make needles that are a componet of an unfinished process. Pretty much we drill the needle point it and then send it off to its next operation. What I am wondering is if the machine shop and all of those operations should be included in the QMS?
If you don't make finished medical devices then ISO 13485 should not be your first choice for a QMS standard. The qualifier "medical" in all other contexts is irrelevant in that respect. You are obviously in the medical industry, but that doesn't mean ISO 13485 is for you. The only exception I can see to this is an important customer (important to you in the business sense) that requires you to have an ISO 13485 certificate in order to do business with them; however, that would be a business decision, not a regulatory one, and I would still recommend trying to negotiate such requirement because implementing ISO 13485 in a non-finished-medical-device manufacturing business doesn't make a lot of sense.
 
#6
Re: Confused about application of ISO 13485

We make suture attaching machines which are not considered a medical device. This device is used to marry needles with sutures.

But we also make needles that are a componet of an unfinished process. Pretty much we drill the needle point it and then send it off to its next operation. What I am wondering is if the machine shop and all of those operations should be included in the QMS?
Have a convenient mix in your scope to direct ISO13485 to medical devices and IS09001 to other like machinery / equipment. Here the ISO13485 definition of "Medical device" will be very handy. Business requirement from your customer to qualify for ISO13485 for devices / parts of final device that you make does have a very strong bearing.
As you go about, if you are not regulatory responsible, your ISO13485 pretty much runs close to ISO9001.
Get two birds with one stone ... 9001 & 13485.
 
#7
Re: Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Dev

I have been researching ISO 13485 and planning to implement a quality managment system for the company I am working for and I'm a bit confused, or I am just think way to far into this. We are a manufacturer of medical equipment and also medical devices. My question is would all of the clauses under ISO 13485 apply to the equipment as well or just the medical devices produced? I thought the idea of a QMS was to have one unified system not just following procedures for one asspect of the company... Please help!! I'm stressing thankfully we have a long weekend :)
Looks like your organization is based in US. You may have to consider 21 CFR Part 820.
 

Ronen E

Problem Solver
Moderator
#8
Re: Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Dev

Looks like your organization is based in US. You may have to consider 21 CFR Part 820.
Only if they make finished medical devices, or accessories to such, or their customer so requires (and they dear it enough). Pretty much like ISO 13485.
 
J

Jshene

#10
Re: Confused about application of ISO 13485 - Manufacturer of Medical Equipment & Dev

Thanks everyone! I am still very new to ISO and this website/forum has been very helpful to me. I appreciate the responses :thanks:
 
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