Lab Quality System - Developing a Quality System for an Internal Testing Laboratory

S

Sean Manning

#1
Does anyone have any experience of developing a Quality System for an Internal Testing Laboratory.
I'm endeavouring to implement a Quality System without actually implementing ISO9001 or 17025, though I will be using both of them as a resource.
I accept that a certified / accredited Quality System does aid as a driver though I think an effective Internal Auditing System, driven internally will be equally effective.
Based on feedback It would be great to expand on this further and share experiences.
Cheers
Sean
 
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Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
ISO/IEC 17025 is the best choice as a guide for you.....it is specifally for labs.

Internal or external, a test lab has many of the same challenges, some of which are detailed in other threads here.....your test Standards will be one to watch....use standard methods if possible, as you then do not need to be as concerned regarding validating a method to meet customer needs. Also, use an accredited calibration lab for your equipment.

Hershal
 
K

Ken K

#3
I agree with Hershal...all the benefits of an excellent standard without the cost of accreditation :rolleyes:
 
D

Daryl Montie

#4
Agreed on the ISO 17025 as a starting point. Just don't forget that it was written as "General Requirements..." to be applied to various types of labs such as medical, forensics, etc., and not just manufacturing related applications. You are in an enviable position in that you don't have to worry about the Accreditation Bodies and really get to choose what adds value to your lab. Don't be afraid to put big "X"'s through the paragraphs that don't apply.
 
S

Sean Manning

#5
Thanks guys for your feedback.
I have come up with 5 sections utilising ISO 17025 and ISO9001:2000. These are
1. Lab Operations and Services (Core Processes)
The following are Support processes
2. Inforamatioon Management (LIMS & Doc Control)
3. Performance and Improvement
4. Human Resources
5. Finance and Purchasing
I'm developing all documentation within these folders and developing Training tools as an aside to train personnel on howm the system works. The tricky bit is Internal Auditing which I'll probably split between Quality System Audits and process (method) audits.
Further down the road I see the EFQM Excellence model as a means of validating our QMS.
Cheers,
Sean
 
W

wallen - 2008

#6
Hi Sean
what is the level of management support that you enjoy.
I have found that in ireland it is reasonably easy to achieve accreditation from NSAI for ISO 9k. A competent management rep can easily do enough to appease the auditor by basicaly performing a one-man show and stage managing the entire audit. what you achieve is a nice certificate which management display proudly to every customer , but very little else other than a very ineffective QMS, the same mistakes are made time after time, you do your cover up job before the bi-annual visit and everyone is happy .... you get to keep your job. forget motivation and job satisfaction :bonk:
all I can say is ensure you have that all important management support, management with the basic understanding of a quality system and what you are trying to achieve its targets and its restriction- i currently have a operations manager who demands ever more inspection to prevent customer defects but apprars to believe that the true path forward has nothing to do with the QMS that in theory is in place, just begging to be used.
ensure the support and all the other drivers will fall into place
 
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