Water Systems Verification and Validation, and ISO 9001

[somashekar]

Re: Water systems and ISO 9001

Ana, I'm still confused here. Why do you think you have water requirements? If you have requirements, then it should be clear what requirements you have, and how you are supposed to verify that quality.

We're all passionate for quality here. But I would hate to send you down a path of doing one thing, when it's not even necessary, or won't even meet your requirements.

I always believe that we share points of view on any OP's subject and question which gives the OP the stuff to balance / filter and take what best suits to their requirement. Most of what is said across here may be known to the OP / new to the OP / information to process to the OP. I do not think we force anyone down a path of doing something just because we do that thing.
Here is a copy of 'Pure water handbook' which I share and perhaps will be of some use to the OP or anyone else.

 

[harry]

Re: Water systems and ISO 9001

I just wanted to check if anybody knows what are the ISO 9001 standards as it applies to water systems; specifically a Millipore Rios 16.

We are a small nanobiotechnology company seeking ISO9001:2008 therefore, we are busy making sure all of our systems are in place and in optimal conditions. Water is the foundation to so many of our processes & procedures that I need to pay close attention to it. I know in pharma water is validated...conversely, a cheap alternative might be to have it verified.

Does it suffice to have the water unit verified or do I have to validate it?
What do auditors & inspectors look for in water systems?

What type of process must we put in place for our water units to meet ISO 9001 standards?

Thanks for sharing your expertise in this matter.

Ana

In a way, I think your post is related to another of your recent post where you asked if the 4Q (IQ, OQ, PQ...) is needed for certification to ISO 9001: 2008.

1. I think you should be clear that ISO 9001 is about a Quality Management System.
2. If you are doing development work for pharmaceutical for example, then, by virtue of requirements of the industry, 4Q will come in.
3. You may integrate these requirements into you QMS processes/procedures.

 

[BradM]

Re: Water systems and ISO 9001

I always believe that we share points of view on any OP's subject and question which gives the OP the stuff to balance / filter and take what best suits to their requirement. Most of what is said across here may be known to the OP / new to the OP / information to process to the OP. I do not think we force anyone down a path of doing something just because we do that thing.
Here is a copy of 'Pure water handbook' which I share and perhaps will be of some use to the OP or anyone else.

No disagreement.

My point is that we're (including the OP) is even sure if there is a requirement. Having WFI is a very expensive process to create, validate, and maintain.

All I am asking is before the OP goes to extraordinary lengths to achieve some status with their water quality/purity, the actual requirements may need to be ascertained.

 

[BradM]

Re: Water systems and ISO 9001

In a way, I think your post is related to another of your recent post where you asked if the 4Q (IQ, OQ, PQ...) is needed for certification to ISO 9001: 2008.

1. I think you should be clear that ISO 9001 is about a Quality Management System.
2. If you are doing development work for pharmaceutical for example, then, by virtue of requirements of the industry, 4Q will come in.
3. You may integrate these requirements into you QMS processes/procedures.

Exactly. All I have seen quoted is 9001. If we're talking about USP and pharmaceutical, then that is another matter. Too, if it is an existing system, it may not be designed to create water pure enough for WFI.

 

[somashekar]

Re: Water systems and ISO 9001

Exactly. All I have seen quoted is 9001. If we're talking about USP and pharmaceutical, then that is another matter. Too, if it is an existing system, it may not be designed to create water pure enough for WFI.

ISO 9001:2008, 1.1 General a) and b) mentions about applicable statutory and regulatory requirements. So will the requirement of water quality fall under this when we talk of USP or other pharmaceutical / biotechnology application ? With the amended text of 1.1 does the ISO 9001 get more broad since it asks for meeting applicable statutory and regulatory requirements ...

 

[somashekar]

Re: Water systems and ISO 9001

Ana, with your Millipore system do you make and use Type III lab grade water or do you further purify to Type II or Type I ? Do you make and store your water also ?
What are your applications ... if you could elaborate to us.