Dear all,

I would like to get some views here :)

My company plans to fabricate precision metal parts for medical industry. We have already obtained ISO9001:2000, is it compulsory to have ISO 13485:2003 as well?

Looking forward for your input! Thanks in advanced. ;)

Dear all,

I would like to get some views here :)

My company plans to fabricate precision metal parts for medical industry. We have already obtained ISO9001:2000, is it compulsory to have ISO 13485:2003 as well?

Looking forward for your input! Thanks in advanced. ;)

It is not required theoretically :)

Dear all,

I would like to get some views here :)

My company plans to fabricate precision metal parts for medical industry. We have already obtained ISO9001:2000, is it compulsory to have ISO 13485:2003 as well?

Looking forward for your input! Thanks in advanced. ;)
ISO 9001 is good enough if you have addressed all the processes in the right perspective. Is your customer demanding it ? If so then perhaps he is pushing from the CMDCAS point of view. ISO 13485 is not necessary if you are capable of meeting your customer's outsourced process control requirements.

Esthyl,

Please see yhis and if you follow it thien you can say ISO9000/2008 is acceptable.

It is not required theoretically :)

All right, it means we still can do it without ISO 13485:2003, but it will be an added advantage with having it.

ISO 9001 is good enough if you have addressed all the processes in the right perspective. Is your customer demanding it ? If so then perhaps he is pushing from the CMDCAS point of view. ISO 13485 is not necessary if you are capable of meeting your customer's outsourced process control requirements.

We are now just at the stage of planning to develope business into medical industry, hence wish to gather more relevant information for preparation. :agree1: with you that customers will request for ISO when they are suggested by auditors to get all their vendors ISO certified, , as a step of continuous improvement to ensure incomings more reliable. So, I would have to strengthen the outsourcing process for products dealing with medical industry.

Thanks guys for your input... :thanx:

All right, it means we still can do it without ISO 13485:2003, but it will be an added advantage with having it...............

Absolutely - you got it right :agree1:

There's nothing to stop you from complying with the requirements first or gradually complying with the requirements and go for certification when the need arises.

Your inputs has triggered me to another thought: anyone has experience in expanding company product range from other industry (eg. semicon, food) to medical industry? What are the changes that you have made to previous ISO 9001?

As I am very new to medical industry, my assumption is medical equipments need to be well handled as it is health concerned. Perhaps need stringent control at inspection, proof of sterilization on the equipments by vendors.

It will be appreciated if you could suggest guidance for relevant website or reading material. :)

There's nothing to stop you from complying with the requirements first or gradually complying with the requirements and go for certification when the need arises.

Thanks for telling me the truth, it makes sense :agree1: Having ISO 13485 will be the competitive edge as days pass. Your info had made a point that I have to ever prepare for it, that the day will come finally, if our company wants to survive and grow in the industry.

:thanks:

New/revised SOPs shall cover,
1. compliance with regulations, such as QSR 21 CFR820, MDD etc (particularly design control, change control, SW validation, process validation)
2. complaint handling
3. assissing adverse event investigation if you are a parts supplier
4. allowing regulatory inspection, such FDA, a notified body etc.
5. document, records retention time complying with regulation
6. DMF, DHR, DHF, TF shall be established
7. 21CFR part 11 compliance if you have SW in your production, process control, quality records handling
8. (any more formthe cove?)

Absolutely - you got it right :agree1:


Actually I would go further than that. No it's not compulsory (from a regulatory standpoint), yes it would be a marketing advantage.


However you might simply not get business from some potential customers without it, without having ISO13485 you simply won't appear on their radar, they only want to deal with companies that hold it.


Beyond that, there are elements within ISO13485 that would be of value to you.

For example, the requirement for risk management. You may be required to present evidence of the risk controls within your process (i.e. your submission would feed into your customer's overall risk management documentation).
The fact that these devices are going to end up in people can have a different impact on how you operate. Remember that while your customer will have greater experience on how the product is used clinically, your company will likely be more expert in the fabrication side of things.

The bottom line - having ISO13485 will help you and your company "think medical".


Finally - and this is far from a universal truth - you might find that your ISO13485 auditors have higher expectations in general, which could help you improve your business.

It will be appreciated if you could suggest guidance for relevant website or reading material. :)

ISO13485 may tell you to utilize statistical methods, but does not tell you the correct ones. If you are precision machining, your auditor may not know the correct methodology, either. So, you need to do you homework to make it work for you. I recommend reviewing Statistical process control for precision machining (http://elsmar.com/Forums/blog.php?b=79) for starters.

New/revised SOPs shall cover,
1. compliance with regulations, such as QSR 21 CFR820, MDD etc (particularly design control, change control, SW validation, process validation)
2. complaint handling
3. assissing adverse event investigation if you are a parts supplier
4. allowing regulatory inspection, such FDA, a notified body etc.
5. document, records retention time complying with regulation
6. DMF, DHR, DHF, TF shall be established
7. 21CFR part 11 compliance if you have SW in your production, process control, quality records handling
8. (any more formthe cove?)

Thanks for the list of revision to be made for the changes.

If we are still fabricating parts for semicon industry, should we amend or add in few more procedures to the SOPs?

Besides, can u pls clarify what do SW, DMF, DHR, DHF & TF means?

ISO13485 may tell you to utilize statistical methods, but does not tell you the correct ones.

What if our quantity is from low to medium (eg. 1 to 10)? SPC normally applies to mass production, right?

Besides, thanks for recommending the link. It's really detailed.

What if our quantity is from low to medium (eg. 1 to 10)? SPC normally applies to mass production, right?



Well, 1 to 10 is pretty low. For such a low quantity, you may want to 100% the dimension in question.

But, you can use the same concept as indicated in the link without paper charts, by controlling your checks to within 75% of the tolerance. You can even by using go/no-go gages set at 75% of the tolerance. It will surely permit your products to pass your final inspection process with less problems! It allows for gage and measurement error between shop floor and inspection, and other such variations that contribute to total variation. Remember, only Final Inspection "owns" the total customer tolerance, as they are considered equivalent to the customer dock. The shop floor does not, due to the variations mentioned above! That is why 75% of the tolerance on the shop floor is best.

The concept also illustrates why the setup people need not set up at the mean. In fact, they should set up below the mean for an OD (or above the mean for ID) to allow the tool to wear longer before adjustment - even on low quantities. They really know this, but too many wrong SPC classes try to force them to adjust to the mean. Forget the mean! Do not run to the mean! It is overcontrol. It has no place in precision machining length and diameter control.

Target the tightest tolerance of every finishing tool on the part!

Dear all,

I would like to get some views here :)

My company plans to fabricate precision metal parts for medical industry. We have already obtained ISO9001:2000, is it compulsory to have ISO 13485:2003 as well?

Looking forward for your input! Thanks in advanced. ;)

Hi Esthyl,
In my opinion, you should set the target to certify the ISO 13485 ASAP!
Change Vision!!!!!!!!
ISO 9000 certified -> Metal part company
ISO 13485 certified -> Medical device part companay,
Feel good!!!
Do you agree with me?
DRDDO

Hi Esthyl,
In my opinion, you should set the target to certify the ISO 13485 ASAP!
Change Vision!!!!!!!!
ISO 9000 certified -> Metal part company
ISO 13485 certified -> Medical device part companay,
Feel good!!!
Do you agree with me?
DRDDO

Thanks for your suggestion!

Implementing a new system involves $, time & people, company is trying to save $ in current economic. Furthermore, ISO 13485 is much more complicated than ISO 9001. I am not sure how important is ISO 13485 in medical industry. I am wondering is it possible to fabricate medical device/equipment components without ISO 13485 at this initial stage. From kind Covers' feedback, I understood that it's not compulsory, yet it will be an advantage.

Esthyl,

Please see yhis and if you follow it thien you can say ISO9000/2008 is acceptable.


Thank you for your share

Regards