Differences - ISO 13485 - Requirements in Addition to ISO 9001:2000

J

Jimmy Olson

#1
Differences - 13485 - Requirements in Addition to ISO 9001:2000

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:
 
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J

Jimmy Olson

#3
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:
 
V

Vincnet

#4
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
 
V

Vincnet

#5
more questions on 13485:2003 and 14969

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
 
A

Aero-Dutch - 2004

#7
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:
 

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#8
Aero-Dutch said:
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?
 
W

wrodnigg

#9
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.

HTH.
 
A

Aero-Dutch - 2004

#10
Dear Al,

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

Andre
 
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