ISO 9001:2008 + 4Q Model + USP<1058>

[AnaMariaVR2]

HI:

I want to seek advise on this issue. We are preparing for ISO 9001:2008 and currently there are 2 school of thoughts: the one that believes that we need to incorporate the 4Q model into our standards to become ISO9001 certified and the other group that says, 4Q has nothing to do w/ ISO 9001.

How do you guys see it?

Is there anywhere on the ISO9001:2008 standard language specific or vague that calls for doing DQ/IQ/OQ/PQ (also known as the 4Q model)? Or not at all? I haven't find it.

For those that are not familiar...the 4Q model for equipment qualification stands for: Design Qualification (DQ), Installation Qualification (OQ), Operational Qualification (OQ) and Performance Qualification (PQ).

USP Chapter <1058> talks about:
*validation is used for processes and software and qualification it is used for instruments
*Analytical Instrument Qualification (AIQ) is developed according to the 4Q model & expected to be the foundation and a prerequisite for any other quality elements

Other than that, does anybody knows if there is a mandate to do 4Q within ISO 9001? Do Certifying Bodies audit under ISO 9001 for 4Q????????

I'll be greatly appreciative of any feedback in this matter.
As always, thank you & enjoy the weather wherever you are.

Kind Regards,
Ana Maria

 

[Randy]

OK, here you go....Show me the SHALL reference for 4Q and you'll be answering your question. It's gotta be between 4.1 & 8.5.3

 

[DrM2u]

I want to seek advise on this issue. We are preparing for ISO 9001:2008 and currently there are 2 school of thoughts: the one that believes that we need to incorporate the 4Q model into our standards to become ISO9001 certified and the other group that says, 4Q has nothing to do w/ ISO 9001.

How do you guys see it?

Like Randy indicated, there is no specific requirement for 4Q in the ISO 9001 standard. Therefore the external auditor will not look for compliance with 4Q requirements unless you state that you do so (verbally on in a document) or required by a customer.

The ISO 9001 requirements for process planning in 7.1 and for process validation in 7.5.2 are fairly vague. There is nothing preventing an organization from going beyond the requirements of ISO 9001 and implementing specific methods (like 4Q, AIAG's PPAP, etc) for process planning and verification/validation. It is up to the organization to decide how it will satisfy the requirements.

To be more specific and concise, you are not required by ISO 9001 to implement 4Q but it is not a bad business practice to implement.

 

[AnaMariaVR2]

Randy & DrM2U:

Thanks for your responses.
Now going further more, what are the ISO standards that will specifically apply to this 4Q model?

 

[DrM2u]

IMHO, a slight correction to your statement: 4Q would be specifically required by or applied to compliance with a standard as opposed to a standard being applied to 4Q.

To the best of my knowledge there is not ISO standard that describes, requires or references the 4Q. Other Covers might have more accurate info than I do, so let's home someone will chime in.