ISO 17025 Implementation & Quality Manual HELP!!

[Lourna]

Hi,

I have been tasked with implementing a quality system and writing our quality manual based on the ISO 17025 standard. I am looking for some serious help here.

We are subscribing to the Testing part of the standard. My company manufactures Semiconductor and my department provides Reliability and Failure Analysis testing for internal and external customers.

Best Regards,

 

[Hershal]

Lourna,

First, DON'T PANIC!!!!

The Standard looks daunting, but it is not quite a difficult as it seems.

First, do a comparison of the section 4 and 5.2 requirements to any documented quality system you have now (e.g. ISO 9001:2000, TL9000). Find the common elements and refer to them in your lab manual. That will save some time, and more importantly, you use an established base instead of reinventing the wheel.

Then you should be able to see the differences. In the lab manual, identify and address the requirements that are different for ISO/IEC 17025. One of note is Management Review, which in section 4.14 has a very prescriptive menu. You can and should add other parameters for review if appropriate for your business situation.

Now, you get to section 5.3 and following. That is the technical stuff. There are some sections (e.g. 5.10, reporting the results) where the Standard has common elements (5.10.2), test specific (5.10.3), and cal (5.10.4). Common elements of course must be addressed, as (for you) so must test specific elements. If you are not doing any of your own calibration, you can leave off the cal specific stuff.

Couple of points to watch. Your cal providers must be documented as being competent, having measurement capability, and traceability according to section 5.6.2.1.1. The easy way to accomplish that is use a calibration provider that is accredited to 17025 also. The hard way is to get a 17025 checklist and a Metrology professional, go to the cal provider, and audit them. Depending on their scope that could take several days.

Next point is measurement uncertainty (MU). Even as a test lab, you will have to do MU. There is another thread in this section that is better for MU questions.

Should you go for accreditation down the road aways, I also suggest shopping first, instead of centering on one or another of the accrediting bodies.

Hope this helps.

Hershal

 

[Lourna]

Hershal,

Thanks for the advice. I will take a look at the company manual. Currently, the lab doesn't have any quality system at all. The lab has never been apart of any of the company quality system certifications (ISO9000, QS9000, or TS16949). We have been left to fend for ourselves. So, in a way I will be re-inventing the wheel.

Thanks again,

 

[Wes Bucey]

Hershal,

Thanks for the advice. I will take a look at the company manual. Currently, the lab doesn't have any quality system at all. The lab has never been apart of any of the company quality system certifications (ISO9000, QS9000, or TS16949). We have been left to fend for ourselves. So, in a way I will be re-inventing the wheel.

Thanks again,

I suspect you do have a Quality System, just not labeled as such and perhaps not as systemized as 17025. It strikes me that engineers and scientists share one trait in common - they are ORGANIZED! They recognize no discovery is valid unless it can be repeated and so we have variations of the Scientific Method
"The principles and empirical processes of discovery and demonstration considered characteristic of or necessary for scientific investigation, generally involving the observation of phenomena, the formulation of a hypothesis concerning the phenomena, experimentation to demonstrate the truth or falseness of the hypothesis, and a conclusion that validates or modifies the hypothesis"
wherever engineers and scientists work. I am willing to bet your lab folk have written procedures for performing tasks (even though everyone knows the Procedure so well it is tucked away in a drawer under the instrument.) They have forms to write down their observations (no Post-It notes!) They have OTJ training processes to show the "new guy" how to use equipment and complete forms. They have routine maintenance to take care of their equipment and calibration methods to check their instruments against Standards. How close am I to the truth?

 

[RLight]

Dont feel alone

Hello,
Just wanted to let you know that you are not alone in that task. I myself have been given the task of getting a lab set up for 17025. And again the lab I am working on does not have any quality standard(actually the lab isnt even built yet but I am working on it). I do agree with the above statement that there is usally some sort of documentation sitting in a drawer collecting dust. One thing that I did that has been helping a lot with the process is to take the time to write up an audit for the 17025. This helped us to form our quality manual and system to the 17025 from the beginning.
Dont give up!!!
Good Luck
Ryan

 

[Lourna]

Thank you for your support, it is greatly appreciated!! It is a wonderful thing to beable to get valuable advice from so many professionals, I am so glad this forum!!
It is true we do have some procedures, maybe just a handful but we are documenting more everyday.
I will take your advice and construct an audit checklist for the standard and get to work.
I am wide open for any more advice or resources.

 

[ISOCOP]

I am in the same ballpark as you ...however we are a ISO9001-2000 company are we having fun yet.

 

[Ken K]

Lourna,

Click this link ANSI National Accreditation Board | ANAB and download the following documents:


ISO/IEC 17025 Lab Guidance for Documenting and Implementation

17025 Assessor/Client Checklist (Form 48A)

They will both help you understand what is needed for 17025.

EDIT NOTE: The original above link redirrected to the ANAB website. This is an OLD post so the documents may not still be available.

 

[ISOCOP]

Thank you Ken this will also be a big help to me.

 

[Lourna]

Ken,

You are my hero !!

Thanks,