I would like to bring some simple assembly procedures in house. Is it ok to manufacture and implement ISO at the same time? It is very difficult for me to develope the quality system without having the actual assembly procedures in action to facilitate the thought process. To me setting up a quality system w/o the manufacturing line is not practicle. The product is already approved by the FDA.

Thx

You mean ISO 13485 implementation? I haven't seen a company stop production whilst a system was being implemented.

I would like to bring some simple assembly procedures in house. Is it ok to manufacture and implement ISO at the same time? It is very difficult for me to develope the quality system without having the actual assembly procedures in action to facilitate the thought process. To me setting up a quality system w/o the manufacturing line is not practicle. The product is already approved by the FDA.

Thx

Hi sailorboy,

I am sure it will be difficult at the beginning.
But the systems & procedures will really help you
in getting the work done in the right manner & in right time.
& also with best results....
try to catch hold of people from all areas of the product o/p and
get it done

cordination.........cordination..............cordination is what is required

with follow upsssssssssssssssssss.

shesha

I would like to bring some simple assembly procedures in house. Is it ok to manufacture and implement ISO at the same time? It is very difficult for me to develope the quality system without having the actual assembly procedures in action to facilitate the thought process. To me setting up a quality system w/o the manufacturing line is not practicle. The product is already approved by the FDA.

ThxAre you planning to do some operations or a complete device? If it is a complete device, you will have to register with FDA and they just may want to inspect your facility.:eek:

You mean ISO 13485 implementation? I haven't seen a company stop production whilst a system was being implemented.You can't put the CE mark on your finished medical device unless you're registered.

Hello to everyone and I thank you for responding. I am planning to start with some in house assembly operations at the beginning. I have several years of process validations experience at a previous company and will validate all operations as a start and will work towards ISO certification. The catch is that the company would like to take advantage of some labor reductions as soon as possible and most importantly use the knowledge to eventually bring more manufacturing in house. However they are a bit nervous and want to know if it is mandatory that certification be in place prior to starting.

Hello to everyone and I thank you for responding. I am planning to start with some in house assembly operations at the beginning. I have several years of process validations experience at a previous company and will validate all operations as a start and will work towards ISO certification. The catch is that the company would like to take advantage of some labor reductions as soon as possible and most importantly use the knowledge to eventually bring more manufacturing in house. However they are a bit nervous and want to know if it is mandatory that certification be in place prior to starting.What type of business? Are you marketing or manufacturing a medical device?

The device measures cardiac values and is noninvasive. I think it falls under Type 1? We currently own the technology but have the manufacturing done offsite and want to bring the final assembly in house.

The device measures cardiac values and is noninvasive. I think it falls under Type 1? We currently own the technology but have the manufacturing done offsite and want to bring the final assembly in house.If it is an electrocardiagraph, I believe it is class 2. Regardless, you must register with FDA (http://www.fda.gov/cdrh/devadvice/341.html#link_2). Actually, I think as the developer of the design, you are required to register. What is your operation like now?

Hi AL, thank you very much for the valuable information. I really appreciate your prompt advice. We currently are registered with the FDA as the developer of the design so I think we are good there. I guess I am a bit confused with the requirements to bring manufacturing in house. I have experience working at medical device companies and working in an established quality system but have never implemented a quality system. I am really excited to have the opportunity at my new employment to implement a quality system based on ISO 13485 but was not sure if it was immediately mandatory to have it in place before manufacturing begins.

Can you describe your system as it is now? In order to market your product now, you need to meet the FDA regulations (http://www.fda.gov/cdrh/devadvice/overview.html). Much of the QSR (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820) and ISO13485 are similar and in some cases the QSR is more proscriptive. If you are going to start mfg in-house, you will need to change your registration status from specifier to manufacturer and more than likely need to revise your procedures to meet FDA regulations. You can sell your device in the US if you meet all the requirements of the FDA, but you can't apply the CE mark and sell it in the European Union or sell it in many other markets before registering to ISO 13485. Speak to a few registrars about your plans.

We currently market our device. It has been approved by the FDA and so we do meet all of the regulations. SO if we bring mfg in house then I guess we have to revise our procedures. I guess I am asking what the next steps should be?

Thank you very much for the links. They have been very helpful. ANything else you think I may need other than revising my procedures?