What is Required to Switch from ISO 9001-2000 to ISO 13845

[wrustywrench]

what really is required to go from ISO 9001-2000 to ISO 13485

We have been asked to switch, where do i start. We have a decend,( good) system in place....

 

[D.Scott]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

what really is required to go from ISO 9001-2000 to ISO 13485

We have been asked to switch, where do i start. We have a decend,( good) system in place....

Welcome to the posting side of the Cove.

I would start by getting a copy of ISO 13485 and reviewing it. Do a gap analysis to determine where you are lacking. Once you determine the gaps, set about bringing your current system up to speed. If you already have a good ISO 9001 system you should have a great start.

Good luck.

Dave

 

[Sidney Vianna]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

I would start by getting a copy of ISO 13485 and reviewing it.

That is always the best way to start: reviewing the actual requirements of the standard. Pay close attention to Annex B of the ISO 13485:2003 document because it contains the explanation of differences between the 2 standards.

 

[wrustywrench]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

OK,, I have the standard....I have been comparing the two. To me it doesnt seem much more than the 9001:2000. am I missing something. I am not a expert of this stuff at ALL.

But, We have do have pretty darn good procedures and such, will i need more for the 13485?

You guys are WONDERFUL....thanks

 

[Le Chiffre]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

Here's a suggestion.. why switch? Why not add.

I've maintained my 9001 certificate and added 13485. A single audit can cover both standards and may make sense even if you're changing your business to only deal with medical products. If you like your current system it shouldn't cost any extra to keep the 9001 part and have two certificates on the wall

It may appear like there's a conflict, particularly with 9001's requirement to continually improve and 13485's to just maintain but you can demonstrate each in different parts of the system (e.g. improvement in non-medical device specific areas, status quo with the medical products).

Good luck.

 

[GStough]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

OK,, I have the standard....I have been comparing the two. To me it doesnt seem much more that the 9002-2000. am I missing something. I am not a expert of this stuff at ALL.

But, We have do have pretty darn good procedures and such, will i need more for the 13485?

You guys are WONDERFUL....thanks

In the back of the standard, you should find a section that compares the differences between 9001 and 13485 - it's the Annex B that Sidney mentioned. This will be a big help.

No, you're correct - 13485 covers all of the 9001 standard, with a few additional requirements, which are indicated in italics throughout the standard. If you have good procedure in place currently, you are well on your way already.

 

[GStough]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

Here's a suggestion.. why switch? Why not add.

I've maintained my 9001 certificate and added 13485. A single audit can cover both standards and may make sense even if you're changing your business to only deal with medical products. If you like your current system it shouldn't cost any extra to keep the 9001 part and have two certificates on the wall

It may appear like there's a conflict, particularly with 9001's requirement to continually improve and 13485's to just maintain but you can demonstrate each in different parts of the system (e.g. improvement in non-medical device specific areas, status quo with the medical products).

Good luck.

Good point, Le Chiffre. We are dual-registered to both standards, as well.

 

[Sidney Vianna]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

OK,, I have the standard....I have been comparing the two. To me it doesnt seem much more that the 9002-2000. am I missing something. I am not a expert of this stuff at ALL.

But, We have do have pretty darn good procedures and such, will i need more for the 13485?

Yes, ISO 13485 requires more procedures, compared to ISO 9001. Are you working for a medical device manufacturer or are you a sub-tier supplier to one?

PS, You had a typo: no ISO 9002:2000 exists.

 

[wrustywrench]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

and ,, may i ask , just what would these added procedured be??

( had to ask)....

I have spent the morning reading ALOT...

 

[wrustywrench]

Re: What is Required to Switch to ISO 13845 from ISO 9001-2000

OK,, I have a new branch to throw into the mix... we will be making parts for a large medical supplier. We will not be the final inspection or the sell the items. Will just be doing operations to the piece. Will we need the whole standard, or just have to satisfy parts of it. ??

We will have nothing to do with final packaging, we will have no clean room, but I see the need to proceudre to control shipments to and from their facility.

Will I need much for risk management.....???? I know nuthin about that.

What new procedures are required over 9001