AnaMariaVR2
Trusted Information Resource
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
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