TGA Standards & Principles vs. ISO9001:2000 - Summary of the Similarities

[Red4165]

Hi All

I need to create a summary of the similarities of the TGA and ISO standards/principals. I don't know where to start???

I currently work in the soft drink / brewing industry as the QA Manager and have had a offer to work in a organic growing and producing industry as their QA Manager who operate under the TGA and GMP compliance standards. I do not have a background in TGA and the employer is unsure of my ability to understand their standards. I have advised that my understanding is that they standards are similar in principals and now they have asked for me to provide a bullet point summary of the differences or similarities. They are not familiar with iso9001;2000 - iso22000 standards therefore need for me to justify the ease of transition in the industry change for myself. Can anyone help me with a bullet point comparison of the differences and similarities??? I only have about 1 hour to complete this task!!!!!

Many thanks in advance folks!!!

Janice

 

[harry]

Re: TGA Standards vs ISO9001;2000

I don't know anything about Australian TGA standard but believe that most of these standards are based on FDA's.

Attached is a copy of comparison between 21CFR and ISO13485. 13485 is structured along the lines of 9001. Hope it can be of use.

Regards.

 

[Red4165]

Thank you so much Harry.........you are a life saver. I am sure that I can use this information.

Thanks once again, you have been most helpful!!!!

:

 

[Al Rosen]

How does a standard for Medical Devices, ISO 13485, relate to a standard, ISO 22000, for HACCP in the food industry?

Bad advice is worse than no advice.

 

[Red4165]

AL

My question is how do they compare in their principles not how they relate to each other. Obviously it is a different industry to the one I am currently working in therefore I am wanting to show the employer that I understand that they are different industries but there are so many similarities in the principles of the standards that the transition from one industry to the other should be easy for me to follow their systems and standards. Have i interpreted the similarities incorrect?

JJFoyster

 

[Al Rosen]

AL

My question is how do they compare in their principles not how they relate to each other. Obviously it is a different industry to the one I am currently working in therefore I am wanting to show the employer that I understand that they are different industries but there are so many similarities in the principles of the standards that the transition from one industry to the other should be easy for me to follow their systems and standards. Have i interpreted the similarities incorrect?

JJFoyster

There may be many common principles, but the comparison that was posted by harry is a comparison of two medical device quality systems. I'm not sure that would help your argument. Maybe I'm confused as I understood TGA to mean Therapeutic Goods Administration, which as far as I can tell does not regulate food. Which standard or system is applicable to organic food growing and which is the one you are familiar with?

 

[harry]

My simple mind tells me that Janice is looking for a template to carry out a comparison and I cautioned that the document I attached is 21CFR vs 13485. My guess is TGA is drafted along the lines of FDA requirement. Seems that I read her requirements correctly.

Did I give any advice? No, I did not. I would not have posted if it wasn't an SOS situation.

 

[cheahga]

There may be many common principles, but the comparison that was posted by harry is a comparison of two medical device quality systems. I'm not sure that would help your argument. Maybe I'm confused as I understood TGA to mean Therapeutic Goods Administration, which as far as I can tell does not regulate food. Which standard or system is applicable to organic food growing and which is the one you are familiar with?

Hi Al,

You're right on the TGA which is part of the Australia regulation.

Here's the attachment which I forgot where I got it from.....

Hope that it will help Janice...

Have no experience in this field, just to learn from you all I guess.....:truce:

 

[Al Rosen]

My simple mind tells me that Janice is looking for a template to carry out a comparison and I cautioned that the document I attached is 21CFR vs 13485. My guess is TGA is drafted along the lines of FDA requirement. Seems that I read her requirements correctly.

Did I give any advice? No, I did not. I would not have posted if it wasn't an SOS situation.

harry, she needs a comparison for food. Your comparison is for med devs. As far as an SOS situation, it's like throwing a concrete life preserver to a drowning person .

 

[harry]

Hi Al,

As I guess, you were aiming at me. I still think that what she want is an example of how to do a comparison. She should have TGA details and as QA manger, she must be able to recognise the layout of the clauses. As for 13485, isn't it very similar to 9001. And you are wrong all the while, she doesn't need comparison for food - thats her forte. As the title clearly suggest, she needs TGA comparison with ISO 9001. If I am not mistaken, its health supplements.

If you assume that she will be blindly copying 21CFR requirements in her assigment, I think you greatly underestimated her intelligence - just ask her!

JJ - we would appreciate if you let us know if I had thrown a concrete block at you.