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Upgrading of QMS from ISO 9001 to ISO 13485 - Quality Manual Revision

T

Tiffany

#1
Dear Mates,

Our Quality Manual(complying to ISO 9001) is currently in Revision Number 6.

If my organization now is decided to upgrade the QMS from ISO 9001 to ISO 13485, the upgrading of the system will change the Quality Manual in compying with ISO 13485 requirements.

Shall we revise this Manual into Revision No.7 OR perhaps we should make it a total new revision (Revision 0)?

Which is the better one?

Tiff :)
 
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Jim Wynne

Staff member
Admin
#2
Re: upgrading of QMS

Dear Mates,

Our Quality Manual(complying to ISO 9001) is currently in Revision Number 6.

If my organization now is decided to upgrade the QMS from ISO 9001 to ISO 13485, the upgrading of the system will change the Quality Manual in compying with ISO 13485 requirements.

Shall we revise this Manual into Revision No.7 OR perhaps we should make it a total new revision (Revision 0)?

Which is the better one?

Tiff :)
Personally, I'd opt for the continuity of using 7 rather than going back to 1, but it's your choice and doesn't really matter so long as change control is maintained.
 

howste

Thaumaturge
Super Moderator
#3
Re: upgrading of QMS

Since it isn't a new manual, it should be revision level 7.

If you completely rewrote the whole manual (started from scratch) it might justify starting over again.
 
T

Tiffany

#4
Re: upgrading of QMS

Jim,

the reason behind is where the structure of the QManual will be restructure as the previous QM is develop since 2000.

Tiff:thanx:
 

Ajit Basrur

Staff member
Admin
#5
Re: upgrading of QMS

Even I would prefer with rev 7, since ISO 13485 is built over the ISO 9001 concepts and merging into one would be more advantageous and not in favor of looking upon as 2 different systems.

Again, as Jim said, its your decision :)
 

SteelMaiden

Super Moderator
Super Moderator
#6
Re: upgrading of QMS

The only thing I would add to this discussion is my oft repeated mantra of: it is your system, make it work for you, don't work for it.
 
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