6 replies to this topic

[PaolaItaly]

Hello to everybody,

I am starting to prepare a SGQ according to ISO 13485, in a company that packs also dietary supplementary; I am thinkin about an unique Manual.

May you give me some advices or examples?

 

Thank you in advance!

[Charles.C]

Hello to everybody,

I am starting to prepare a SGQ according to ISO 13485, in a company that packs also dietary supplementary; I am thinkin about an unique Manual.

May you give me some advices or examples?

 

Thank you in advance!

 

Hi Paola,

 

Welcome to the Forum !

 

Please explain - What is SGQ ?

[PaolaItaly]

Hello, Charles,

 

You're right, sorry, I used an Italian acronym without specifying the meaning; it stands for Italan Sistema di Gestione Qualità.

That means: Quality Managment System.

 

Thank you

[Charles.C]

Hi Paola,

 

thanks yr clarification.

 

I assume you are interested in a FS(Q)MS system.

 

I have zero familiarity with iso38145 but it appears to be a derivative of iso9001 which is intended for medical devices ?

 

iso9001 as used for food did not include haccp hence the development of iso22000 (an iso FSMS system).

 

I would have thought iso/fssc22000 might be more directly appropriate for food related items if mainly interested in iso options ?

 

Unless there is a specific reason for iso38145 ?

[PaolaItaly]

Hi Charles,
you are right ISO 13485 is an ISO 9001 applied to medical devices production.
 
The company works with medical devices (ISO 13485) and dietary supplements too (HACCP - ISO 22000);
I have just started to prepare the documentation for the quality managment system, related to medical devices (so it is based on ISO 13485);
but as ISO 22000 aim is to harmonize the food sector specific standards, and is written with a structure compatible to other management system standards in the likes of ISO 9001 combining HACCP, I would like to know is someone has experience in an integrated system of ISO 13485 and 22000 (or HACCP); above all if someone has prepared an unique manual for both the standards.
 
Kind regards.
natascia

[Charles.C]

Hi Charles,
you are right ISO 13485 is an ISO 9001 applied to medical devices production.
 
The company works with medical devices (ISO 13485) and dietary supplements too (HACCP - ISO 22000);
I have just started to prepare the documentation for the quality managment system, related to medical devices (so it is based on ISO 13485);
but as ISO 22000 aim is to harmonize the food sector specific standards, and is written with a structure compatible to other management system standards in the likes of ISO 9001 combining HACCP, I would like to know is someone has experience in an integrated system of ISO 13485 and 22000 (or HACCP); above all if someone has prepared an unique manual for both the standards.
 
Kind regards.
natascia

 

Hi natascia,

 

The nearest i can find is an integrated manual for  iso 9001:2008, ISO 22000:2005, ISO 27001:2005, BS OHSAS 18001:2007 and ISO 14001:2004 -

 

http://www.ifsqn.com...001/#entry57838

 

+ these documents listing upgrades from iso 9001 to iso 13485 (or maybe iso 13485 includes an appendix with a 9001-13485 cross-matrix ?) -

 

 ex1 - iso13485-vs-iso9001.pdf   150.71KB   92 downloads

 ex2 - Contras-ISO-13485-to-ISO-9001.pdf   47.76KB   68 downloads

 ex3 - ISO-13485-v-ISO-9001-060310.pdf   96.41KB   61 downloads

 ex4 - WP_Differences-and-similarities, iso 9001, iso 13485.pdf   2.47MB   101 downloads

 

[PaolaItaly]

Hi natascia,

 

The nearest i can find is an integrated manual for  iso 9001:2008, ISO 22000:2005, ISO 27001:2005, BS OHSAS 18001:2007 and ISO 14001:2004 -

 

http://www.ifsqn.com...001/#entry57838

 

+ these documents listing upgrades from iso 9001 to iso 13485 (or maybe iso 13485 includes an appendix with a 9001-13485 cross-matrix ?) -

 

ex1 - iso13485-vs-iso9001.pdf

ex2 - Contras-ISO-13485-to-ISO-9001.pdf

ex3 - ISO-13485-v-ISO-9001-060310.pdf

ex4 - WP_Differences-and-similarities, iso 9001, iso 13485.pdf

Thank you very much, Charles. :)