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! :confused:

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! :confused:

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........

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! :confused:

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 (http://www.google.com/custom?domains=Elsmar.com&q=in-house+calibration&sa=Search&sitesearch=Elsmar.com&client=pub-1385417534940691&forid=1&channel=6124086287&ie=ISO-8859-1&oe=ISO-8859-1&cof=GALT%3A%23008000%3BGL%3A1%3BDIV%3A%23336699%3BVLC%3A663399%3BAH%3Acenter%3BBGC%3AFFFFFF%3BLBGC%3A000099%3BALC%3A000000%3BLC%3A000000%3BT%3A0000FF%3BGFNT%3A0000FF%3BGIMP%3A0000FF%3BLH%3A50%3BLW%3A350%3BL%3Ahttp%3A%2F%2Felsmar.com%2Fpng%2Fheader-G-search.png%3BS%3Ahttp%3A%2F%2FElsmar.com%2FForums%2F%3BFORID%3A1%3B&hl=en). Some additional explorations are necessary...;)

Stijloor.

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! :confused:


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

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! :biglaugh:
TJM05

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

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) :notme:





How do you other quality people meet this standard?

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


:2cents::bigwave:

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.

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.

Dear jane
I dont understand you clearly.
I dont claim that I am so much experienced but for your kind information thats my experience as a lead auditor, but I have worked as an auditor for 3 years and a consultant for 8 years and specificaly in automotive industry I have the same years of experience in process auditing (based on ISO TS 16949).
I just wanted to help my friend who had the question as I really appreciate small factories hard work in the way of certification and quality improvement.
If there is any problem with the answers given please highlight and clarify because such forums are for sharing information not critisising unrelated issues.
I have just mentioned my "little" experience in this field as lead auditor to answer my friend's question about what auditors are searching for regarding item 7.6 of the standard.

I took exception to the specific remark of yours which I quoted. Which said that implementing without using a consultant is 'more efficient'. Did I misunderstand your meaning?

Given that your post included a strong opinion about not using consultants, I don't think it's an unrelated issue.

I don't and didn't in any way denigrate your desire to help.

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.

This is not accurate in my experience! You are basing you comment on your ISO/TS 16949 training, which introduced auditors to this 'CAPDo' concept. Those 'ISO' auditors who have not had exposure to such training (the vast majority) will not necessarily follow such a technique. Indeed, emphasis has been on following the Process Approach (which, incidentally, 'CAPDo' isn't).

thats my experience as a lead auditor, but I have worked as an auditor for 3 years

........experience in this field as lead auditor

Quality is Life....perhaps you could help us all understand your advise here, since many people call their qualifications the same thing 'lead auditor' (for example) but it can mean very different things.

Are you a Lead auditor for a Certification Body (as some of our fellow Covers are) or do you function as a Lead Auditor, leading an internal audit team, or similar.....

Indeed, have you stopped by our 'Introductions' thread (http://elsmar.com/Forums/showthread.php?t=1477) and posted any details about yourself......

Dear Jane
You have been misunderstood which is also my fault in not expressing in right words. As a consultant I do think consultants can help the companies alot but also I understand the limitations of small businesses (especially financial problems) and appreciate their efforts.

Dear Andy
I am a certified lead auditor having an IRCA code trained in Italian IMQ (member of CISQ).
I just told about myself as JaneB blaimed my little experience, that was a misunderstanding which I appologize for.

Also you surely know that process approach is based on Deming PDCA cycle, so auditors following the CAPDo (Check, Act, Plan, Do) are indeed following the process approach but as the goal of auditing is to determine the conformity of the designated QMS with the standard, starting from Check step is the most efficient way - not in my personal opinion but most of CB's I know through attending their audit process as a consultant.

Any ways my dear friends if you like to discuss technical points regarding what I have said I will be happy to hear and learn more, but please stop claiming each others personal background.

Thank you

as the goal of auditing is to determine the conformity of the designated QMS with the standard, starting from Check step is the most efficient way - not in my personal opinion but most of CB's I know through attending their audit process as a consultant.
:topic:
Since you'd like to continue the technical discussions, only one goal of doing audits is to determine the compliance to the standard! There are (many) others........I'm very surprised as both a certified lead auditor and a consultant that you'd not mention these other objectives. Unless I misunderstand your phraseology 'the goal of auditing.....'

BTW - one of the reasons people post details of their background and experience here - for newcomers such as you - is that it's one way we can establish a level of 'competency' with the people we're responding to! It's sincerely not a case of 'my experience is better than yours' - it's there to distinguish the posters credibility amongst the 1,000's of people who post their comments. After all, some would say that experiencing an audit as a Lead Auditor is quite different from watching a Lead Auditor do an audit.......

That way when someone like the OP asks a question, they will be able to get an understanding of the validity of the answers they get.

BTW - it's not clear to me (still) from what you've posted...are you an IRCA Lead Auditor? I'm not sure what you mean by an 'IRCA Code'. Do you audit for CB's? That would help us to establish your credentials and get to know you and your points of view much better, you understand........:agree1:

As a consultant I do think consultants can help the companies alot but also I understand the limitations of small businesses (especially financial problems) and appreciate their efforts.
Glad to hear it. As a consultant, I run a small business myself, and of course I understand both the strengths and the constraints of small business. One of the strengths of a consultant is (or should be) having experience of many different systems and across a whole range of different organisations, of different sizes and types.

Also you surely know that process approach is based on Deming PDCA cycle, so auditors following the CAPDo (Check, Act, Plan, Do) are indeed following the process approach but as the goal of auditing is to determine the conformity of the designated QMS with the standard, starting from Check step is the most efficient way - not in my personal opinion but most of CB's I know through attending their audit process as a consultant.
I disagree with almost everything you say here. Where to start?

As Andy points out, determining conformity is only one purpose of auditing. I'm not going to argue about automtive (outside my sphere) but I've never yet observed or talked with an auditor I admired who referred to it as 'Check Act Plan Do', but rather called it Plan Do Check/Study Act. Nor started with Check...

if you like to discuss technical points regarding what I have said I will be happy to hear and learn more, but please stop claiming each others personal background.
:confused: I don't understand what you mean about 'please stop claiming each others personal background' - this just doesn't make sense. No one's 'personal' background is being claimed. But exploring professional experience and knowledge - a different matter. Mine is publicly available, posted on my company website (http://www.mapwright.com.au/jmb.html)and available via the Cove links. (I mention this only in the context of this discussion, as my participation in the Cove is not based on advertising or wanting to drum up business.)

As Andy has pointed out, there's a reason for exploring background and experience. It's not a matter of being rude about it, or casting aspersions, but to help the person who asked a question (and others) make some kind of informed decision about the competency and experience of the poster, and thus some kind context about how useful, relevant and accurate the information might be.

I can see that you're new to the Cove - please don't take any of this personally. Robust and frank debate is a hallmark of discussions here. If people make statements, or offer opinions, then it's expected that they'll be willing to explain them, if necessary, and the basis for them, and if relevant, the data or experience that they are based on.

These are normal, professional expectations, not least in the world of the quality professional. So don't see it as in any way an attack on you - it isn't. (indeed, the host is very strong on courtesy and helpfulness). You could well find it helpful and enlightening to scan through various other threads, to understand better, and satisfy yourself of the truth of this.

Dear Andy
I do audit for CBs.
For your kind information when you are a member of audit team you dont only watch the lead audirtor do the audit but you audit the section, department and the process that the lead auditor specifies.
The observer auditors watch the audit, you are an observor auditor for like 10 man/days (based on internal regulations of the CB) after the training course and passsing the exam and then you become an auditor.
The lead auditor is the supervisor of the team and the one who is responsible for conducting the opening and closing meetings also the final report based on audit team observations.
IRCA is a British hence internationally accepted organization who certifies ISO auditors and gives hem and international code accepted by the CBs worldwide. It stands for International register of certified Auditors.
for more informaton please visit IRCA.
Regards
Armond

Dear Andy
i forgot to mention that yes you are right, finding improvement opportunities, positive points of strength and many other goals are among the goals of each audit but when you talk about certifications, you basically discuss the conformity with the standard.
Regards

Dear Andy
I do audit for CBs.
For your kind information when you are a member of audit team you dont only watch the lead audirtor do the audit but you audit the section, department and the process that the lead auditor specifies.
The observer auditors watch the audit, you are an observor auditor for like 10 man/days (based on internal regulations of the CB) after the training course and passsing the exam and then you become an auditor.
The lead auditor is the supervisor of the team and the one who is responsible for conducting the opening and closing meetings also the final report based on audit team observations.
IRCA is a British hence internationally accepted organization who certifies ISO auditors and gives hem and international code accepted by the CBs worldwide. It stands for International register of certified Auditors.
for more informaton please visit IRCA.
Regards
Armond

Armond - all this is good stuff, except I already knew all this, having been:-

a CB auditor (IRCA and RAB) since the 1990's..........(one of the reasons for establishing other posters competencies), and;
a trainer of more than 15 years, for the company who wrote the first Lead Auditor course - Excel Partnership, I've also taught 1,000's of people in Lead and Internal auditor courses for ISO 9000, QS-9000, ISO/TS 16949, ISO/IEC 17024, ISO/IEC 17025 as well as written and delivered a combined ISO 9000/14000/OHSAS 18000 auditor course........and too many others to mention!

I guess the problem is that there's no-where at the Cove where you can 'look up' someone's past experience/qualifications/competencies etc. before engaging with them....

Marc, might that be a facility that you could add here?

I guess the problem is that there's no-where at the Cove where you can 'look up' someone's past experience/qualifications/competencies etc. before engaging with them....

Marc, might that be a facility that you could add here?
There's a "biography" section in the user profile that can be used for that purpose.

Dear all
I do accept that all of you are much much much more experienced.
Please lets stop discussing each others background.
As I have mentioned before I just told about my background for the last question as my friend had asked about auditors attitude.
Any ways it was a mistake of mine.
I do appologize.
I will be a listener and learner after this.
Thanks alot for your comments.
Regards

There's a "biography" section in the user profile that can be used for that purpose.

Plus, on each post, at the top:


the Registration Date (at the left, under poster's name) tells you when someone joined & thus how long they've been around
on the right, there's a bunch of useful statistics on how many posts etc