Quality manual help required - Small UK testing laboratory

[labgirl]

I work for a small UK testing laboratory and have recently been made quality manager. I have no previous experience of this and have been thrown in at the deep end. We are a UKAS accredited laboratory and have a very basic, very dated quality manual in place. We keep getting minor non-compliances because of the dated manual and missing information. I would like to start form scratch but don't know where to begin. Are there any books, websites or templates available out there that can help me?

Please , pelase help. I really am stuck.

(from a worried perfectionist).

[Hershal]

There may be some resources for you.

UKAS should be able to make available their ISO/IEC 17025 checklist, which you can use as a base for questions to re-write your QM. They also have a very understandable primer (well, as understandable as anyone's) on measurement uncertainty (MU) and you will need to become familiar with MU.

Identify the standards you actually use for testing. As an example, here in the U.S. we typically use ASTM (American Society for Testing and Materials) standards for various tests.

Get with the folks who actually do the given tasks, whether testing or purchasing or whatever. Have them describe what they do step by step. Then you have the base for the re-write, and it will reflect what you actually do.

I like the use of flowcharts personally as they are easy to use.....and after all, the folks need to use the procedures. Remember the KISS (Keep It Short and Simple) rule, otherwise the procedures will likely get ignored.

Setting up the manual so your paragraph numbers coincide to the Standard's number system makes it easy for your assessor and MAY reduce some nit-picky kinds of things.

Once you have all that, go through your system yourself.....try to access client information from a terminal that should not have access.....makes sure equipment is calibrated by an accredited calibration lab.....make sure any sub-contracted labs are accredited.....make sure the management review includes the mandatory topics in Section 4.14, and others beyond that are OK to have so long as the required ones are there.....if proficiency testing or inter-laboratory comparisons (PT/ILC) exists make sure you have them or are enrolled for them, and contact UKAS if you are not sure if any exist for your scope.

These are just a few of the basics, but should get you on the right track.

Let us all know how things go.

Hershal

[The Moose]

Hi Labgirl,

I was in your exact position just over a year ago and managed to bluff my way through my first surveillence audit purely by reading through the IS0 9001:2000 standard and the help of an understanding auditor, however it wasn't until I got some training that I've begun to feel comfortable with what I'm doing.

What I would suggest is to first off all get a hold of the standard and sit down and read it thoroughly, (It's amazing how many people run a qms without ever referring to the standard - myself included during my early days). In addition speak to your certification body and enquire about waht training they provide. The particular courses I attended where based around the ISO 9001:2000 standard:

IS0 9001:2000 Appreciation - I didn't find this particularly useful as I was already in the position and the company had already commited to it.

ISO 9001:2000 Internal auditor - Very useful course and I would say the minimum level that is required for someone expected to maintain an existing system, it provides a good background to the standard and how to maintain and refresh an existing certification

ISO 9001:200 Series /Lead Auditor - The daddy, an extremely beneficial course which gives a thorough understanding of the standard and which enables you to look at your existing system in an entirely new light, I would rate this as essential for people who are going to be involved long term with their QMS or who are looking to completely overhaul, upgrade or replace their standard.

I would recommed that the minimum you attend is the Internal auditor course relevant to your standard which will at least give you the tools to maintain and improve your existing system and to deal with the audit process

Good luck

[e-shoq]

Have a look at our website:

*SEE PROFILE*

The ISO 17025 Quality Manual Template can be used and customized to any size of lab. Feel free to contact us by e-mail if you have any questions.

Best regards,
Todd

[Hershal]

In my earlier reply, I did forget to mention the training......Moose, thanks for your reminder!

The training that Moose suggests (ISO 9001 related) is good. There are NO such training course on a regular basis for accreditation audits that I am aware of.....but not to worry.....the principles are exactly the same.....the only difference is the Standard and therefore what you audit and how you interpret!

Oh, there are sometimes training courses to learn to audit ISO/IEC 17025.....but typically not scheduled.....they are given by the accrediting bodies (ABs) or the Mutual Recognition Arrangements (MRAs).

The core criteria includes confidentiality of customer information - SPECIFICALLY INCLUDING - protection of electronic information and that includes back-up and such things as anit-virus and firewall. This, BTW, is a CRITICAL component of 17025.

TECHNICAL COMPTENCE - as you know since you are already accredited - is the basis of accreditation. Therefore, training and evaluation is a key for the qualification, just as actual demonstration of technical ability is the key to accreditation. I politely recommend you prepare your folks by having them perform their tasks for you, answer your questions and so forth.


I hope this helps.

Hershal

[labgirl]

To Hershal and The Moose,
Thank you for your help and advice. I have discussed training with my company and they have agreed to allow me to do a course. I have also contacted UKAS and requested a checklist from them. Already have their MU document (although I don't pretend to understand it!).
Think its just going to be a matter of getting stuck in and giving it a go. just not enough hours in the day!!
Thank you for your very helpful advice, really appreciate you taking the time to respond.


Todd,
Thanks for the link but company is unlikely to allow me the funds as they don't think there is anything wrong with our current QM. But appreciated none the less.

[Al Rosen]

Take look at this web site http://praxiom.com/ It may help you gain some understanding of the standard.

[labgirl]

Thanks Al - the website was a great help! You are a star!