Howdy everyone.

After reading through the draft of 13485 I have a few questions about some of the things that are in addition to 9001:2000.


4.2.1 f mentions national regulations. I'm assuming this means FDA regulations. Are there other regulations that apply to medical devices? How can I find out which regulations apply to my company? (we are a contract manufacturer and don't produce any end products)

4.2.2 states that the quality manual shall outline the structure of the documentation. Does this just mean identifying documents as level, level 2, etc.?

5.5.1 states "Top management shall establish the interrelation of all personnel who manage, perform and assess work affecting
quality, and provide the independence and authority necessary to perform these tasks." Is this still satisifed by an org chart, or are they looking for something more specific?

7.1 mentions risk management activities. Where can I find information about this?

7.2.3 d mentions advisory notices. Does this apply to advisory notices from us, or from external sources, or something totally different?

I apologize for asking so many questions and overwhelming anyone, but I have no idea what I'm doing in this field :confused:

Thank you in advance for your assitance :bigwave:

Richard the attachment should clear things up for you. Let me know what you think.

That looks great. I will definately have to look at closer later today. Thank you so much for all of your help so far. :bigwave:

Thanks for this PPT presentation ISO GUY

I am new to the ISO world and there is something that I don't understand. I've red both ISO 9000:2000 and ISO FDIS 13485
And nowhere I saw anything saying that you just need 6 procedure to comply with 9K and that you need 19 to comply with 13485! Did I missed something in my readings ?


V

One more dumb question

In the very valuable asq 13485 ppt on slide 29 a list of the 19 mandatory procedures is given for

7.5.1.2 Installation activities (if applicable)
7.5.1.3 Servicing activities (when required)

I do not have the same header in my ISO FDIS version

im my case
7.5.1.2 is General (record keeping from 7.5.1 Control of prod and serv provision)
and
7.5.1.3 is Control of prod and serv provision -specific requirements

I am lost
:(

This makes me think : is there a way to get a draft of ISO/TS 14969 ?

Thanks in advance for your help guys
V

Vincnet

I have used the following site for many documents. I haven't looked for ISO/TS 14969 specifically, but it can't hurt if you want to check it out.

http://global.ihs.com/

Bill

Dear everyone,
I'm also new in the field of ISO and been asked to set up a QS 9001:2000 and 13485:2003. I'm facing some diffilculties regarding Microbiological requirements. Are there specific requirements concerning class I products ??
Thanks in advance.

Joop

:frust:

Dear everyone,
I'm also new in the field of ISO and been asked to set up a QS 9001:2000 and 13485:2003. I'm facing some diffilculties regarding Microbiological requirements. Are there specific requirements concerning class I products ??
Thanks in advance.

Joop

:frust:
Hi Joop:

A bandage or scalpel are examples of class I devices that require sterility. I think this is addressed in the particular standard for the device and indirectly by the Quality standard (REF: ISO 13485, 7.5.2.2). What type of device do you have?

Hello Joop,

if you have sterile products, the Class will be at least "1s" and therefore you have to deal with one of the Annexes IV, V or VI.

In this case you should also read the Standards

EN 556 (Sterilization of medical devices - requirements for medical devices to be labelled sterile) and EN 550/552/554 (Sterilisation of medical devices by different methods)

An official List of the harmonized standards can be found here (http://europa.eu.int/comm/enterprise/newapproach/standardization/harmstds/reflist/meddevic.html).

HTH.

Dear Al,

We want to produce a product that comes in contact with the skin (Aerosol)

Andre

Dear Al,

We want to produce a product that comes in contact with the skin (Aerosol)

Andre
Andre, wouldn't that be considered a pharmaceutical? I'm not familiar with that. Can someone else provide some insight?

Al,

a medical device is defined as:

any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
— investigation, replacement or modification of the anatomy or of a physiological process,
— control of conception,

which does not achieve its principal intended action in or on
the human body by pharmacological, immunological or metabolic
means, but which may be assisted in its function by such means

And the important thing is, that it does not act by pharmacological, immunological or metabolic means.

Yes, the number of borderline products is growing. But it is possible to find solutions in most cases. And it is pirmarily the decision of the manufacturer whether he claims a product to be a medical device or not.

I recently had a product on my desk which has been sold as medicinal product and now it is sold as medical product (since the CE-approval is valid for the whole European Community).

Andre,

it depends if your product is intended to come into contact with injured skin or not, if it is a wound which has breached the dermis, if the product acts as a wound dressing or if it is intended to manage the micro-environment of a wound.

The range varies from Class I to Class IIb (plus 's' if it is a sterile product).

So for a Class Is product you have to follow Annex V (QM-System for production and therefore you should fulfil the harmonized standards (for sterilization) I mentioned before).

wrodnigg, thanks for the information.

Here in the US the device Andre described, I think, would be considered a "combination product" and would be evaluated as such. I am involved with diagnostic devices (MRI scanners), strictly "Medical Devices".

One more dumb question

In the very valuable asq 13485 ppt on slide 29 a list of the 19 mandatory procedures is given for

7.5.1.2 Installation activities (if applicable)
7.5.1.3 Servicing activities (when required)

I do not have the same header in my ISO FDIS version

im my case
7.5.1.2 is General (record keeping from 7.5.1 Control of prod and serv provision)
and
7.5.1.3 is Control of prod and serv provision -specific requirements

I am lost
:(

This makes me think : is there a way to get a draft of ISO/TS 14969 ?

Thanks in advance for your help guys
V

Vincnet,

In the latest ISO 13485 2003 (E)

7.5.2 is Control of prod and service provision
7.5.1.1 - General Requirements

7.5.1.2 - Control of prod and service provision - Specifica requirements
7.5.1.2.1 - Cleanliness of product and contamination control
7.5.1.2.2 - INstallation activities
7.5.1.2.3 - Servicing activities

Richard the attachment should clear things up for you. Let me know what you think.

Aaron,
This is a lovely presentation :applause: . There are many aspects, though, that I'm sure you have updated. Do you have an updated version you care to share? I found it very educational.

I am tasked with writing a presentation that shows the differences between the old and new (2003) ISO 13485. Within this presentation, I am suppsoed to convince upper management why the measurements of effectiveness and management responsibility are agood things. This is a tought sell in my organization. They have often used the bully approach to get people to be involved, so it is as little as humanly possible, (and enforceable by the regs). Has anyone done a presentation like this, and if so, can you share it? I'm working on ours, but it's falling on deaf and uninterested ears. Maybe you more experienced (or more creative) folks have tackled this before and have found a way to sell it to your organization (other than "you have to do it because that's what the regulations say"). :frust:

Hello everyone,

After reading lots and lots of doc's concerning ISO13485 and ISO9001, I'm still puzzled what is mandatory for our company :bonk: (located in Netherlands and operating mainly in Europe)....
We mainly build (standard) products for industrial use but lately we also make the same or partially different products for hospitals and medical use (nuclear medicine). We are ISO9001 certified, but do we need ISO13485 as well??
Or can we fill in the blanks our selves and have some form of upgraded ISO9001 for medical devices. It might sound stupid but I just don't know if ISO13485 is mandatory :o .
We do have PMS and vigilance procedures in place and I'm working on a Risk Management procedure.

Can anyone help me or redirect me on this matter?

Thanx,

Jerome

ISO 13485 is the International standard for medical devices - Quality Management Systems. This is a specific set of regulations for manufacturers of medical devices.

ISO 9001:2000 is Quality Management Systems - Requirements. This is not specific to any type of manufacture, it is just what it says - Quality Management Systems.

I hope this helps.

In answer to your earlier Q on FDA regulation/finished medical devices - If the end product displays your company name, then you do in fact manufacture a finished medical device and will therefore have to be regulated by the FDA. (If you supply to the USA that is)

Hello everyone,

After reading lots and lots of doc's concerning ISO13485 and ISO9001, I'm still puzzled what is mandatory for our company :bonk: (located in Netherlands and operating mainly in Europe)....
We mainly build (standard) products for industrial use but lately we also make the same or partially different products for hospitals and medical use (nuclear medicine). We are ISO9001 certified, but do we need ISO13485 as well??
Or can we fill in the blanks our selves and have some form of upgraded ISO9001 for medical devices. It might sound stupid but I just don't know if ISO13485 is mandatory :o .
We do have PMS and vigilance procedures in place and I'm working on a Risk Management procedure.

Can anyone help me or redirect me on this matter?

Thanx,

JeromeAs I understand, you need to:


Determine if you are manufacturing a Medical Device and the classification of the device from Annex IX of the MDD (http://elsmar.com/Forums/attachment.php?attachmentid=3000).
Determine which route to CE marking you will take (Annex II through Annex VII.
Find a Notified Body if other than class I.
Your Notified Body will then require assessment to ISO 13485.

Thanx Al,

But I know we make MD's in Classes I and IIa (acc. MDD).
I was just wondering if ISO13485 is mandatory then. (when selling in EU)
Or if ISO9001 is enough plus PMS, Vigilance system, Risk management (acc.14971).
We have ISO9001 and with all the extra procedures for MD's in place I was hoping I could leave out the ISO13485.

Anyway thanx for your help.

Greetingz,
Jerome

Thanx Al,

But I know we make MD's in Classes I and IIa (acc. MDD).
I was just wondering if ISO13485 is mandatory then. (when selling in EU)
Or if ISO9001 is enough plus PMS, Vigilance system, Risk management (acc.14971).
We have ISO9001 and with all the extra procedures for MD's in place I was hoping I could leave out the ISO13485.

Anyway thanx for your help.

Greetingz,
JeromeWhen you add all the additional requirements of the MDD, you will have met ISO 13485. There is a difference though regarding Customer satisfaction(ref 5.2 & 8.2.1). ISO 13485 is convenient for the Notified Body to use for assessment. Look at the discussion in the thread, CE Mark & Harmonized Standards - Article 5.1, MDD - Has anyone challanged this? (http://elsmar.com/Forums/showthread.php?t=9771)