Need an ISO 9001/14001/13485 Quality Manual - Many suppliers - Pharma and Med Devices

[eudevice]

hi all,

pls help me in the following topic:
We have an existing manual according to ISO 9001:2000 for our facility. As we produce also pharmaceuticals, the device-business is integrated; this makes sense because we have harmonized processes (ISO 9001/14000/13485). We are/act as manufacturer of several devices worldwide but we do not produce them itself.

Now we would need for registration purpose one Q-manual, which also should include our device manufacturing processes - but they are outsourced and done by several suppliers (they mostly have also Q-manuals).

Does it make sense to
1. prepare 1 big device Q-manual which includes our suppliers (this would be against our philosophy of harmonized processes within the facility; therefore 2 manuals would exist)
2. outline/describe clear interfaces to our external suppliers of the main production steps in our existing manual and cross-reference the supplier docs (this would be less work)
3. ??? solution to be found

if you you know a solution for my problem or have other experience, please write
thaks, Judy

[Gerry Quinn]

Judy,

1) Do you manufacturer pharmacuticals?
2) Do you outsource device manufacturing to contract manufacturers?

[howste]

Your manual is for your organization. It should include the controls that your organization uses to ensure that these outsourced manufacturing processes are properly controlled.

The requirements you impose on the manufacturers are matters of contracts and/or purchasing documents. As part of these documents, you may consider creating a separate "supplier quality manual" that states the requirements and expectations for them.

[Gerry Quinn]

Howste.

Do you have a sample of the supplier quality manual?

[howste]

Originally Posted by Gerry Quinn

Howste.

Do you have a sample of the supplier quality manual?

Here's one example. It's not specific to the medical device industry, but it should give a good idea of types of content though...

[Gerry Quinn]

Hoswte,

That is one extensive manual, Thanks

Gerry

[eudevice]

hi all,
thank you all for your input!

@Gerry: 1) & 2) is correct

@howste: wow - the supplier manual is quita a good idea! I will present this to Mgmt and also thanks for the supplier manual draft

I knew I will find an answer within the cove
Judy

[howste]

I hope it helps. Please let us know what you end up doing...