Hi,

I am currently assigned to creating a Quality Manual + Standard Operating Procedures for an imaging core lab. This lab works with investigational centres in clinical trials. Example services: quality control of x-ray images and phantom scans.

I understand the guidelines for ICH - Good Clinical Practice and FDA's part 11 apply to this organisation.

The question:

- Does anyone has a reference to example Quality Manuals + SOPs (data management, validation, etc.)?
- Are there any other standards that would apply?

Thanks,
Dave.

Hi,

I am currently assigned to creating a Quality Manual + Standard Operating Procedures for an imaging core lab. This lab works with investigational centres in clinical trials. Example services: quality control of x-ray images and phantom scans.

I understand the guidelines for ICH - Good Clinical Practice and FDA's part 11 apply to this organisation.

The question:

- Does anyone has a reference to example Quality Manuals + SOPs (data management, validation, etc.)?
- Are there any other standards that would apply?

Thanks,
Dave.

Dave,

Hartelijk welkom bij The Cove Forums. :bigwave: :bigwave:

Is your post related to ISO 9001:2000(8) certification?

Stijloor.

Hi Stijloor,

"Dank voor het warme onthaal" :D

The question is not particularly related to ISO 9001:2000(8) certification.

However, we may get audited by the trial Sponsor, so to construct our QMS
using ISO 9001:2000(8) would be a starting point.

I am especially interested in the core lab specific quality requirements, and
how these are be translated to the Quality Manual and SOPs in our type of organization. I am new, so any example or guidance would be welcome.

Best regards,
Dave.

:agree1:Hi Stijloor,

"Dank voor het warme onthaal" :D

The question is not particularly related to ISO 9001:2000(8) certification.

However, we may get audited by the trial Sponsor, so to construct our QMS
using ISO 9001:2000(8) would be a starting point.

I am especially interested in the core lab specific quality requirements, and
how these are be translated to the Quality Manual and SOPs in our type of organization. I am new, so any example or guidance would be welcome.

Best regards,
Dave.

Dave,

Graag gedaan! :agree:

Before you get too wrapped up in Quality Manuals and Standard Operating Procedures, consider utilizing the Process Approach. You should look at 4.1 (a) and (b) first. This includes the following activities:

Identify the processes that make up your quality system (use a process matrix)
Determine how these processes interact with one and other (use a process map)

There are more requirements, but these two activities will "get you out of the gate."

Once you and your colleagues agree that the processes are adequately listed and mapped, then you decide what SOP's and other documents are necessary and required to support each of the processes.

Later on, when everyhing is pretty much defined, only then you develop the organization's quality manual.

There are tons of information here at The Cove Forums. It requires some searching and patience, but you'll find what you would need. If not, please let us know. My Fellow Covers and Moderators are ready to help.

Laat maar weten. :agree1:

Stijloor.

(Previously from Etten-Leur)

:thanx: Stijloor,

This sounds like a practical approach to make the first move!
I will give it go.

Groeten uit Den Haag,
Dave.