ISO 9001:2008 7.6 (traceable to international or national measurement standards)?

[TJM05]

Hello,
A little background first- I am currently at a machine shop with about 20 employees. We are in the process of ISO 9001 certification. Right now we are completing our gap analysis and getting our ducks in a row. I work for a very "can-do" company, that will bend over backwards to do a procedure on its own rather outsource. As you can imagine, we are having a grand ol' time looking at the "measurements and calibrations [sect. 7.6]" section of the ISO 9001 2008 standard.
My question relates to section 7.6 of 9001:2008 It states in the 3rd paragraph (I think), that when necessary, you need to calibrate and/or verify all of the measuring equipment, have traceability, etc.
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...

2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005

3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?

4) How particular are ISO auditors on this section? What are they looking for?
How do you other quality people meet this standard?

Sorry for the long post and thank you in advance for everything!

 

[alex FEI]

Re: Question on ISO 9001:2008 7.6 (traceability)

Hi guy,

I can say something about the last two question. But I am not sure I can help solve your problem.

"validated" means you must provide evidence for the validity of your calibration procedure.

Calibration and measuring instruments may be sensitive topics for ISO auditors. Because it is easy to make mistakes on this.

So you'd better pay much attention on it.

Alex

Hello,
A little background first- I am currently at a machine shop with about 20 employees. We are in the process of ISO 9001 certification. Right now we are completing our gap analysis and getting our ducks in a row. I work for a very "can-do" company, that will bend over backwards to do a procedure on its own rather outsource. As you can imagine, we are having a grand ol' time looking at the "measurements and calibrations [sect. 7.6]" section of the ISO 9001 2008 standard.
My question relates to section 7.6 of 9001:2008 It states in the 3rd paragraph (I think), that when necessary, you need to calibrate and/or verify all of the measuring equipment, have traceability, etc.
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...

2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005

3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?

4) How particular are ISO auditors on this section? What are they looking for?
How do you other quality people meet this standard?

Sorry for the long post and thank you in advance for everything!

 

[AndyN]

Re: Question on ISO 9001:2008 7.6 (traceability)

Well these are questions as old as the hills..........and many answers have been given here. Did you try a search yet? If you take a look at the bottom of the page, there's usually a listing of threads with similar titles/subjects and someone who is most technically savy with thread links etc. will probably post a couple of them for you to read........

 

[Stijloor]

Re: Question on ISO 9001:2008 7.6 (traceability)

Hello,
A little background first- I am currently at a machine shop with about 20 employees. We are in the process of ISO 9001 certification. Right now we are completing our gap analysis and getting our ducks in a row. I work for a very "can-do" company, that will bend over backwards to do a procedure on its own rather outsource. As you can imagine, we are having a grand ol' time looking at the "measurements and calibrations [sect. 7.6]" section of the ISO 9001 2008 standard.
My question relates to section 7.6 of 9001:2008 It states in the 3rd paragraph (I think), that when necessary, you need to calibrate and/or verify all of the measuring equipment, have traceability, etc.
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...

2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005

3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?

4) How particular are ISO auditors on this section? What are they looking for?
How do you other quality people meet this standard?

Sorry for the long post and thank you in advance for everything!

I did an advanced search for you here at The Cove Forums on: "In-house Calibration." Not all-inclusive perhaps, but a good start.

Here are the results. Some additional explorations are necessary...

Stijloor.

 

[brahmaiah]

Hello,
A little background first- I am currently at a machine shop with about 20 employees. We are in the process of ISO 9001 certification. Right now we are completing our gap analysis and getting our ducks in a row. I work for a very "can-do" company, that will bend over backwards to do a procedure on its own rather outsource. As you can imagine, we are having a grand ol' time looking at the "measurements and calibrations [sect. 7.6]" section of the ISO 9001 2008 standard.
My question relates to section 7.6 of 9001:2008 It states in the 3rd paragraph (I think), that when necessary, you need to calibrate and/or verify all of the measuring equipment, have traceability, etc.
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...

2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005

3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?

4) How particular are ISO auditors on this section? What are they looking for?
How do you other quality people meet this standard?

Sorry for the long post and thank you in advance for everything!

The ISO auditors are very particular about calibration and traceability.
You have to periodically calibrate your measuring and testing equipment by an accredited laboratory. You can carry out in-house calibration if you have similer facilities like an accredited laboratory. You do not need ISO 17025 accreditation for your in-house lab.
V.J.Brahmaiah

 

[TJM05]

Thanks for the information. I have searched for these topics and found some indirect answers, but was not sure how/if they would suffice for my situation. I am sure I will have more questions in the future! Thank God for the Cove!
TJM05

 

[Stijloor]

The ISO auditors are very particular about calibration and traceability.

Correct. This is per 7.6.

You have to periodically calibrate your measuring and testing equipment by an accredited laboratory.

Only, if the calibration can not be performed internally.

You can carry out in house calibration if you have similar facilities like an accredited laboratory.

Not necessarily. The calibration process and facilities must only to be relevant to the organization's measuring/testing devices and their requirements.

You do not need ISO17025 accreditation for your in-house lab.

That is correct if it is only used for internal calibration purposes.

V.J.Brahmaiah

 

[SpongeMouse]

Hello,
A little background first- I am currently at a machine shop with about 20 employees. We are in the process of ISO 9001 certification. Right now we are completing our gap analysis and getting our ducks in a row. I work for a very "can-do" company, that will bend over backwards to do a procedure on its own rather outsource. As you can imagine, we are having a grand ol' time looking at the "measurements and calibrations [sect. 7.6]" section of the ISO 9001 2008 standard.
My question relates to section 7.6 of 9001:2008 It states in the 3rd paragraph (I think), that when necessary, you need to calibrate and/or verify all of the measuring equipment, have traceability, etc.
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...

- other 3rd party calibration institution is ok. and yes, those limits should be traced.

2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005

- mostly, only hand held instrument is calibrated. if the measuring instrument is located on the machine, provide some refrence limits from your hand held.

3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?

- "validated" means is that, it has a record (those instrument) that can be trace from the calibration.
- if in-house, there are institution that caters to calibration training. just a simple calibration training will do, no need for a high level training.

4) How particular are ISO auditors on this section? What are they looking for?

- very particular, especially if you are in the manufacturing sector. those measuring instruments on the machine can give you headache (with some auditors)





How do you other quality people meet this standard?

Sorry for the long post and thank you in advance for everything!

 

[quality is life]

My dear friend
For your kind information I am an ISO 9001:2008 lead auditor with over 100 man/hour experience.
I know its a taugh job to implement the system without using consultants but it would be more efficient so good luck.
regarding your questions:
1) Does that word "traceability" in the standard relate exactly to the NIST's policy on traceability (as found on their website)? I realize it could relate to another institution other than NIST that also has a policy on traceability...
The word traceability relates to - as mentioned in the text of the standard - International (like ISO, etc.) or national standards and as the accredited standard issuing organization in USA is NIST so it relates to NIST. Normally only 1 national organization in each country is accredited for monitoring, updating and issuing standards.

2) For a machine shop with micrometers, calipers, pin gages, thread and ring gages, etc. is it always necessary? (FYI our general tolerances are +/-.005 in most cases though sometimes they get down to +/-.0005
Again please reffer to the text of the standard. If the equipment is used to determine the conformity of the product with the requirements it should be calibrated ar validated. So you dont need to calibrate all the measuring equipments if they are not used for product conformity testing. But keep in mind if the auditor finds an uncalibrated equipment in the working area, he can claim a non conformity as it can be accidentaly used for checking the conformity of the products. Also if the equipment is used for like measuring the dimensions of the dies or other manufacturing tools, they are impacting the product conformity so they should also be calibrated so if you have tool making or maintanance department dont neglect their equipment.

3) If we come up with an in house calibration procedure, I've heard that it needs to be "validated" and the person doing it "trained". What do those terms mean?
Validation simply means compairing against a valid criteria or measure, like validating the calipers by using calibrated measuring block gauges, so you will need one set periodocaly outsourced calibrated nationally/internationally traceable block gauges, a suitable place for validation (clean enough - not aclean room, acceptable temprature (18-25 you can check ISO 17025 for more details), enough lighting, safe protected storage and so on. Based on your equipment the training needed for the validation person is different but normally its a simple 2 to 4 days training course.

4) How particular are ISO auditors on this section? What are they looking for?
ISo auditors follow a CAPDo cycle - you follow PDCA when implementing the system it means they normally start from the checking points and steps and in this way measuring and monitoring equipments play a major role. How can a check point be acceptable without a calibrated or validated measuring equipment?
Be very sensitive to that.
I am ready to implement a free of charge 1 day audit for your company if you prepare transportation means.
Of course I live in LA, CA.

 

[JaneB]

I know its a taugh job to implement the system without using consultants but it would be more efficient so good luck.

I hope your other information is more accurate than this bit, which isn't.

100 hours of experience = barely 2 1/2 weeks all up; I guess in such a limited time, your experience of consultants - efficient or otherwise - was extremely restricted.