Organization Chart - Level of Details?

[Sue789]

I am a small UK company (30 staff) over three sites, modifying the QMS for 21 CFR 820 are there any requirements from the FDA what should be included in an organization chart?
I have inherited an organization chart that lists the Director level of the company and flows down to teams e.g.: R & D to hardware and Software teams (this is acceptable to our ISO 13485 auditor) and does not specify all job titles which I am used to?
Thanks for your help in advance,
Sue

[isoalchemist]

Hi Sue,

Technically the FDA does not require an org chart as they don't use the "establish the interrelationship" that ISO 13485 requires they just want "an adequate organizational structure". With that said an Org chart sure makes it easier to show it is adequate.

I'm assuming the Director Level is President, VP, Director and not just the U.S. Director down (not speaking the same English makes it interesting). If not I'd include those. If it passed ISO it should be OK. MHO org charts are just quick guides to ensure all bases are covered and to provide a red flag for things out of the ordinary (Man Rep reporting to Maintenance Super). Leaving them at the Team rather than job title level should be OK.

[Marcelo Antunes]

Technically the FDA does not require an org chart as they don't use the "establish the interrelationship" that ISO 13485 requires they just want "an adequate organizational structure".

ISO 13485 also does not require an org chart, as the relationship mentioned is related to processes and tasks. But that´s the way people keep understanding the requirement :-)

[isoalchemist]

Excellent point Marcelo! We keep getting confused by what the standard requires and what the majority of the auditors require.

[Sue789]

Thanks Gentlemen,

Most interesting comments, Isoalchemist you are correct my organization structure shows the senior leveles of the departments (Vice President etc.)

Marcelo, interesting comment that an organization chart is not a requirement of ISO 13485 and having looked at the standard again well pointed out.

Sue