ISO 9001 Quality standards: Calibration

[quammi]

Does anyone have any good websites that outline a calibration system that meets or exceeds ISO 9001? I would like to research it a bit.

Ever Greatful.

[wjbzone]

Don't know any good sites.

Don't forget to calibrate the depth measurement on your calipers. We just got a write-up for that.
Bill

[murphy625]

Originally Posted by quammi Does anyone have any good websites that outline a calibration system that meets or exceeds ISO 9001? I would like to research it a bit. Ever Greatful.

To my knowledge, no one is offering any "free" help with ISO stuff because everyone is making to much money selling it.

ISO is a waste of time and money unless you are doing business with a large customer who requires you to have it.

Like I always tell my customers, I can be ISO certified on every level but if the $9/hr worker on the production line doesn't give a crap about his work, nothing else is going matter.

As for calibration to meet the ISO requirements, I think all you need is traceable standards and a documented schedule of the calibrations.
It really sounds a lot more complex than it is. They do that on purpose because theres money in them thar certifications!!

Murph

[quammi]

well, I was more hoping for an outline of requirements. I have recently been asked to impliment a system for calibration both metric and standard, and frankly i dont know where to begin

Any input is going to be greatly appreciated!! thanks gents!

[miljnor]

Besides making money for the people who set the systems up and the people who regulate them, IS0 9001 is just basically a paper trail for everything that is done. I don't beleive any of the ISO's set down parameters on how to clibrate, they just set down parameters on how to keep track of the calibrations so they are always the same and always documented..

I could be wrong but when I was a desperate young business, thats what I found out through my wasted research.

you might try looking into how gauge manufactures are setup, I think they use a system of tracking and calibration called NIST (but not sure).

[fyffe555]

What's the purpose? ISO 9001 does not dictate how calibration or any other process should be done. There is no 'iso 9001 way' to measure, cut, build or produce anything in any industry.

There's no point in having an 'ISO 9001' process for calibration unless the rest of the company and its method of producing its product is also Certified. ANY calibration process you may have could be ISO 9001 certified as long as you write down what that process is, get it certified and calibrate using only that process. ISO 9001 does not mean that an ISO 9001 certified company produces a better product than a non certified company..

ISO 9001 is a quality management standard that is used by an organisation to document its processes and then measure if that process is followed. The scope of the documentation and it's measure is entirely up to the organisation implementing it but must cover the business process. The organisation seeking ISO 9001 approval has to have an internal auditor who helps implement the changes required and then audits the documented processes and makes sure that is what the company is doing and that the end product is as defined and expected by the process. An external auditor will then test the same and certify if appropriate.

Note at no time does the process improve a product or produce a better or cheaper product - just a consistant product in the same way each time - UNLESS the process explicitly includes a process for improvement or the company elects to make those improvements and then update the process.

Note there's some differences in standards ISO 9001 2000 replaces ISO 9001 1994, 9002 and 9003 and the standards do expect some degree of process or product improvement.

Have a look at http://praxiom.com/iso-9001.htm for a simple example of what 9001 covers.

If your company is not 9001 certified ( and it probably isn't from the question) the find any calibration method that suits. If your company is certified then go see your internal auditor - and then go find any method that suits. then write it up for the auditor.

ISO 9001 is only a money spinner for 'consultants' because the standard is misunderstood.

Andrew

[FranH]

I had seen on ebay ISO outlines for someone desiring to become certified. fyf555 has a good grasp as to its requirements. ( some 17 different protocols). If calibration of instruments, gage blocks etc is what you need there are many metrology labs to do this service. Depending upon usage will dictate calibration cycles. That may be all you need.

We manufacture replacement parts for the gov't directly. We are in parallel with ISO. We have a Process Control Manual as well as a Quality Control Manual and a Continuing Quality Improvement Policy. Most of our parts are Flight Safety, Flight Critical and Safety Critical items for aircraft catapult launching,main bearing helicopter fixtures etc. Navy, Army and Air Force are our customers. Almost all our work is source inspected by a QAR. Some work is ground based support equipment. Our reason for not being ISO at this point is the paper trail involved not only for ISO but the required history of each part we make.

For the past 2 years we have been "adjusting" the above mentioned manuals after each job. Each of our manuals is about 100 pages long. Proud to say that we are down to 1 piece of paper on the floor. Audits by Navy Source Inspection teams and our regular government Quality Assurance Representative has allowed us to make the above catagories of parts. Quality is near 6 sigma ....which isn't bad for a new company. """ISO is a state of mind...whatever you do you put in writing and whatever you have in writing limits what you can do.""" It is the variables that take the time...What IF....is the big question that needs to be covered. That about sums it up for ISO from here.

FranH

[quammi]

very well put.

the company is ISO certified, however we send out everything to be inspected to maintain that level. what I am attempting to do, is make it possible for us to do inspections in-house, and maintain that certification. thus the research, you all have been extremely helpful, please do not hesitate to add anything you feel might help, no matter how obvious. this is by far the best online community on the net

[gmfoster]

Originally Posted by quammi very well put. the company is ISO certified, however we send out everything to be inspected to maintain that level. what I am attempting to do, is make it possible for us to do inspections in-house, and maintain that certification. thus the research, you all have been extremely helpful, please do not hesitate to add anything you feel might help, no matter how obvious. this is by far the best online community on the net

Well the ISO part is really about paperwork as others have said. However you can't eliminate outside calibration. What you can do if you have enough equipment to justify it is to only send out primary calibration standards and then use those to transfer to working instruments. And usually you need to keep the instruments you use to calibrate separate from those you use to inspect or manufacture with. Also many instruments such as electrical can be used on a time basis, while gages and such that see wear on usage need to be on a time/usage basis and a usage log kept.

Another thing that is required in a good system is a method of recall, that is if an instrument fails calibration then the user needs to be notified and make a decision on what effect that out of tolerance condition could have on the items inspected or manufactured with the bad instrument.

The important thing to keep in mind is that you don't want your system to only satisfy the ISO inspectors(a rather easy task if you hire the right ISO group) but you want your calibration system to actually aid and ensure that your product meets it design tolerances and meets the customers requirements.

Garry

[quammi]

Excellent point, Garry! My immediate plan is to isolate calibration equiptment, from manufacting quality tools. I have determined a proper route to link calibration to NIST.. executing everything seems to be the task at hand, and emplimenting as well.
Great Input here! all of this is going to help tremendously!

[Mule2002]

Originally Posted by murphy625 As for calibration to meet the ISO requirements, I think all you need is traceable standards and a documented schedule of the calibrations. It really sounds a lot more complex than it is. They do that on purpose because theres money in them thar certifications!! Murph

Calibration comes under ISO 17025:2004 - you can get most of the accreditation information that you seek at www.a2la.org

It's a ton more than just traceable standards - a ton more.

mule

[ESjaavik]

@fyffe555:
So ISO9001 does not assure you are making a high quality product. But it requires you to document what level of quality, and how you do it. As well as a quality awareness. And your customer can ask to look at your quality handbook so they can see what level of quality you are producing at. It does not in itself assure or assume that the quality is to any high standard.

This is how I have understood it. Is it about right?

Reasoning: Definition of Quality is meeting the customer's expectation. If they look at your handbook and find "this is good enough for us, we don't want to pay for anything better". Then your quality is (for this customer) high enough.