My company is going for QS9000 certification,
Can you guy help me by providing some answer to the following question?

1)QS9000 required external calibration laboratories to be Iso 17025 accredited or equivalent. May i know what standard used in japan, UK and USA (eg: NIST/ ANSI)are equivalent to Iso 17025 and is accepted by QS9000 standard?

2)i had this calibration supplier who claim that for calibration to be perform onsite, ISO 9001/ 9002 will be approriate. ISO 17025 is meant for their laboratory (This statement mean that QS9000 does not required external calibration laboratories who perform onsite calibration to be ISO 17025 accredited, Which i don't agree with..) Comments???:confused:

3) Does QS9000 required external calibration lab for equipments such as noise Dosimeter, Gas detector, to be ISO 17025 accredited? (They have no impact on product quality)

4) Is it necessary to place a status label (Reference only) on every instruments which are part of the machine(such as pressure gauge, Voltage/current indicator)? They are part of the machine to produce the product, not product inspection equipment.

That's all for the time being. Thanks

In the US - and under QS-9000 - If you use an outside calibration lab they must be:
Accredited to ISO 17025 (the standard says "Guide 25" -17025 is the new version of that)
or
Approved via the 2pCP program (AIAG approved auditors using ISO Guide 25 as the base)
or
If there is no accredited lab, the OEM can perform the calibration.

The second question is confusing - An in-house lab doing it's own testing for their process does not have to be accredited to 17025. If they are testing their product and sending you the results (certs) their QS-9000 is good enough. If they sent something to another lab for testing, the lab they sent it to would have to be accredited to 17025. If the in-house lab calibrated their own equipment they do not have to be accredited. They must be able to trace the calibration to a national standard. This would mean that their "master" would have to be calibrated and a certificate issued by an accredited calibration lab.

Third - any calibration done by an outside lab must be done by an accredited lab. The type of equipment is not important (it is possible for a non-accredited OEM to calibrate their own equipment IF an accredited lab DOES NOT EXIST.

Fourth - all measurement devices listed on your control plan or used to determine a state of quality should be in your calibration system and labeled. You determine what goes in the system and therefore determine what needs to be calibrated. If the items you list affect the outcome of the product and someone has to rely on the gage being accurate, then I would say calibrate them. If you decide they don't need calibration then a label shows you have addressed it.

Hope this gets you started.

Dave

Originally posted by Knowledge seeker
1)QS9000 required external calibration laboratories to be Iso 17025 accredited or equivalent. May i know what standard used in japan, UK and USA (eg: NIST/ ANSI)are equivalent to Iso 17025 and is accepted by QS9000 standard?ISO 17025 is the International Standard, followed by each of these nations. There is no equivalent recognized by QS9000.

Japan Accreditation Organizations that you may wish to contact are:

Japan Quality Assurance Organization-(JQA) (http://www.jqa.or.jp/index.html)
Japan Accreditation Board-(JAB) (http://www.jab.or.jp/)
Japan Calibration Service System-(JCSS) [Sorry, I have no link for them]

UK Accreditation Organizations that you may wish to contact are:

United Kingdom Accreditation Service-(UKAS) (http://www.ukas.com/)
National Measurement Partnership-(NMP) (http://www.nmpuk.co.uk/)
National Physics Laboratory-(NPL) (http://www.npl.co.uk/)

USA Accreditation Organizations that you may wish to contact are:

National Voluntary Laboratory Accreditation Program-(NVLAP) (http://ts.nist.gov/ts/htdocs/210/214/214.htm)
American Association for Laboratory Accreditation-(A2LA) (http://http://www.a2la2.net)
Laboratory Accreditation Bureau-(LAB) (http://www.l-a-b.com)

And since your profile says that you are from Singapore, your Accreditation Organizations are:
Dead link: http://www.psb.gov.sg - Productivity and Standards Board-(PSB)
Dead link: http://www.sac-sci.org.sg - Singapore Accreditation Council
Dead Link: http://www.np.edu.sg/~tankc/qrc/sislab.htm - Singapore Laboratory Accreditation Scheme-(SINGLAS)

Any of these organizations should be able to put you in contact with an accredited laboratory to do your outside calibrations, therefore meeting the QS9000 requirement.2)i had this calibration supplier who claim that for calibration to be perform onsite, ISO 9001/ 9002 will be approriate. ISO 17025 is meant for their laboratory (This statement mean that QS9000 does not required external calibration laboratories who perform onsite calibration to be ISO 17025 accredited, Which i don't agree with..) Comments???:confused:Your calibration supplier is wrong. In the USA, adding site calibration capability to any portion of your scope actually must be specified on the scope. Any function being calibrated by an outside vendor must be accredited. I am not familiar with the methodology employed by other nations, but I do know that the 17025 Accreditation is required, whether on-site or in the vendor laboratory.3) Does QS9000 required external calibration lab for equipments such as noise Dosimeter, Gas detector, to be ISO 17025 accredited? (They have no impact on product quality)It is my understanding that equipment that does impact product quality is not covered under the accredited calibration clause.4) Is it necessary to place a status label (Reference only) on every instruments which are part of the machine(such as pressure gauge, Voltage/current indicator)? They are part of the machine to produce the product, not product inspection equipment.Are any of the indications provided by the machine instruments used in the final inspection report? If not, then they do not have to be calibrated, although I personally would have some system of calibration set up for them. As far as the label goes, I would say that it would vary from auditor to auditor, as long as there is documentation in place that states that machine instrumentation is understood to be Reference Only.

Ryan

Hi D Scott, i am sorry to confuse by my question What i really mean is that if a commercial Calibration lab is ISO 17025 accredited, its scope of accrediation should have includ onsite calibration perform for its customer..(somehow they have to provide me with calibration uncertainty at the end of the day)

Ryan, i am perfectly agree with you...
i think it is perfectly alright to have a documentation in place which state that machine instrumentation whose indications is not used in the final inspection report is understood to be Reference Only. That could save the hassle of putting those " reference" label.

Thanks alot...:D

An in-house lab doing it's own testing for their process does not have to be accredited to 17025. If they are testing their product and sending you the results (certs) their QS-9000 is good enough. Dave, until yesterday I would have agreed with you but...

After rejection of a certification packet to GM and a heated discussion with those involved, that is no longer the case. As far as GM is concerned, " Registration to QS9000 is not a substitute for lab accreditation." As of yesterday, unless our internal lab gets accredited to ISO 17025, they will not accept test data from us.

Go figure! :mad: :mad: :mad: :mad:

Originally posted by Ken K


Dave, until yesterday I would have agreed with you but...

After rejection of a certification packet to GM and a heated discussion with those involved, that is no longer the case. As far as GM is concerned, " Registration to QS9000 is not a substitute for lab accreditation." As of yesterday, unless our internal lab gets accredited to ISO 17025, they will not accept test data from us.

Go figure!Two things:

A) That really sucks! Accreditation is no walk in the park, and if they require manufacturers to have their internal labs accredited, a Cavalier would cost in the region of $50k. OUCH!

B) Did they show you, in writing, the requirement for manufacturer's internal labs to be accredited? Either in QS9000 (it's not there) or an honest to goodness GM document? Could this be a case of an overzealous assessor?

If this is genuinely the case, we'll all be buying Hondas and Toyotas (I already do, but that's not the point.)!

Ryan

Well, As far as i know it is not a QS9000 requirement for internal lab to be accredited to ISO 17025. The Standard state that internal lab have to comply with ISO 17025 while external commercial lab used by the company have to eaccredited to the standard. If accredited commercial lab is not available, calibration can be done by OEM.
The only exception is when the testing / calibration lab is being appointed by your customer.

I think for internal lab to be accredited to ISO 17025 is more of a customer's Requirement than the QS 9000 requirement.

This could get quite interesting. It seems this is being driven by the Interior Systems Group. It all started with one of GM's recently updated specifications which states;

Testing is to be performed by a laboratory accredited
or audited, by a third party organization recognized by
GM, to ISO17025/IEC Guide 25 or GM GP-10. Include a
Scope of Accreditation or a Scope of Activity with the test
data. Registration to QS9000 is not a substitute for lab
accreditation.

According to the person I talked with, GP-10 was also not a substitute for accreditation. But, we have a signed document from GM ( our GP-10 auditor) dated August 1997 that states that since we have acheived QS9000 compliance (1996), GP-10 would no longer be required. And our GP-10 accreditation was allowed to expired in December 1997.
She didn't want anything to do with the letter and said if we are not ISO17025 accredited, she would not recognize any test data we supply.

So, in my opinion, we have danced with QS for six years for nothing. 10 audits with absolutely nothing to show for it. When we asked our auditor about this last year, we were told it did not pertain to internal labs and we have nothing to worry about. I wonder who's the one that's confused.

Just when I thought it was safe to go back in the water -

Ken, could you give me a little more info on this? - Was this a test you were doing internally on your oun product? Was it part of an original material approval? Was any supporting portion of the test done on the outside?

This is directly contrary to the IASG interpretation and comes as a complete shock. I have not heard it from other sources yet.

If anyone gets any kind of written information on this please post it for us. I would love to see the whole thing refuted but confirmed will do just as well.

In the meantime, I will present a request for clarification to IASG and see if I can get an answer.

Thanks for the "heads-up" Ken.

Dave

Ken, could you give me a little more info on this? - Was this a test you were doing internally on your oun product? Was it part of an original material approval? Was any supporting portion of the test done on the outside? We developed a new material to replace existing material for which we submitted lab packets to GM, Ford and Chrysler. The material was approved by Ford and Chrysler with no problems. GM balked. Don't know why yet, but we are attempting to get this straightened out. All we were really told is this is GM policy which was likely never conveyed to suppliers. I know we never received anything from GM concerning this.

All testing was done in-house. It consisted of a complete material certification. The test samples were included in the packets along with our Lab Scope, QS Certificate and calibration reports on the equipment used for testing.

Will keep you posted on any further developments.

My position is that manufactures should not require to become accredited to 17025. ISO 10012-1 or -2 would be more realistic for other then calibration laboratories. I agree with the concern about the cost of cars and everything else increasing as a result of the added burden of accreditation. Our lab went through the A2LA accreditation process about three years ago and it makes sence for us. I think it would be an overkill the apply the same requirements to manufactures.

Unless the GM Specific Requirements on page 76 of the QS9000 3rd Edition has been updated, supplier test facilities who are currently third party registered to QS are GP-10 accredited which would satisfy the requirements of 3.1 from my earlier post.
:confused:

Dave, do you agree? :frust:

That's the way I understand it too Ken.

I can understand the need for test results from an accredited lab in the case you mentioned because you are developing a NEW material/process. The QS-9000 in-house testing only applies to verify your material/process meets an existing requirement. By implication, the new data would have to come from an accredited lab.

At least that's my guess. I have tried to get more on this but nobody has heard of any changes and so far there is nothing stirring at IASG/AIAG.

I guess in this case we are best just to sit and wait for someone to tell us we need to become accredited. Until then, the current QS should be OK.

See also - QS-9000 4.10.6.1 NOTE: "Accreditation of supplier facilities to ISO/IEC Guide 25 or other national equivalent is not required by, nor does it satisfy, all QS-9000 requirements for a laboratory."

Dave

Thought I'd give a update concerning Gm's stance on internal labs being 17025 accredited. Just finished our second conference call this morning concerning this.

If you read the last sentence on page 76 in the QS manual concerning Evaluation and Accreditation of Supplier Test Facilities, there is, as my boss put it, a "weasel" clause which states;

"Some GM divisions may require laboratory accreditation of supplier laboratory facilities."

That is the stance the GM interiors division is taking. This only applies to laboratories supplying CA (construction approval) data.
This does not apply to DV, PV and CC data. For those QS is acceptable. :mad: :mad:

So.........now comes the fun part. We are dropping QS and adopting TS. According to section 7.6.3.1, internal labs only need to comply with 17025. What GM will say when the customer specifics are released are another thing. :confused:

So until then, we will be in the process of complying with 17025 and not seeking accreditation. For now. :frust:

Page 76 is a GM specific requirement in QS. It was my understanding that 16949 was in addition to specific customer requirements. Unless you get a waiver, aren't you still in the same boat? :confused:

Dave

That really depends on the customer specifics which will be written for the updated TS. Right now, we only need to be 17025 compliant according to TS.

Knowing the GM people we have been dealing with, I expect the same kind of verbage in the TS specifics. :mad: :mad: :mad:

The best part about this whole thing is I'm smiling more than usual. My co-workers just think I'm happy...:D

We're on the mat...sucking air but not out...yet!

After trying to explain to the lady from GM that we will be TS certified and 17025 compliant by years end, the crushing blow came in a single sentence...

"I don't care where the lab data comes from as long as they are accredited to 17025."

There was one bit of humor though...she said she never heard of TS and wondered how it would affect out QS status! LMAO at that one but somehow her concern eludes me.


Dave...I'm gonna have questions...help!:cool:

Let me know how I can help and I will do my best. If you can think of anything I might have that might give you a start or example, send me an e-mail so I have your address.

If the auditor isn't familiar with 16949 and how it fits the overall picture, strange questions come to mind.

Is she just someone on an assignment who "thinks" she knows the requirements? Maybe she has grabbed onto a piece of information and applied it to the wrong situation.

Her crushing statement (if your quote is verbatum) says "as long as THEY ...". This makes me grab on to the possibility she is referring to your outside labs. If she was referring to your internal data you would think she would say "as long as YOU ...".

End result - you are stuck with whatever your customer requires. I stand ready to help out any way I can.

Good luck

Dave

I am waiting for a fax containing a memo GM said it sent to all suppliers in early 2000 concerning internal labs.

According to GM, since they were in the process of updating certain material specifications which would incorporate GMW and ISO test methods, GM was giving internal labs one year to become ISO17025 accredited.

Unfortunately, no one we have discussed this with within our company have any recollection of ever seeing this memo. And I bet most, if not all of you reading this have either.

I'll have more information after I receive it.



1...2...3... :( :frust:

Ok, Ken - Time has passed. What's the scoop?