Calibration: Conforming to ISO9001 Requirements

[grnfish]

Hey,

I am currently starting to create documents for my company's quality department (exciting!). From my understanding to meet ISO9001(2015), you need to be able to quantify that you are meeting the specs/requirements implemented by your company through its various processes. Basically, can you prove that the company is doing as they say in their procedures ("promises") and quantify it with documentation?

From this interpretation, a company can set its own "standards" to follow rather than adopting a common standard to become ISO9001 certified. Is this correct?

i.e.
If a company states that an error of +/- 0.01" is justifiably good for acceptable error of a micrometer reading, (which in most context is not), can ISO certification be granted to the company if it can be quantified that they are meeting what they state as acceptable? (Such as a completed calibration form based off a standard traceable to NIST).
Or in order to get ISO certification must the company conform to a widely accepted standard such as ASME B89.1.13 - 2013? (Standard for micrometer calibration).

Based on the open ended generalities of the ISO9001 document it seems that in order to receive ISO9001 certification a company can set their own standards as long as they abide them fulfilling their promise to the consumer.

I am considering this concept as an employee of a company that has just stepped out of the start-up world. Currently no documents exist (such as calibration plans) and I am tasked with creating them. Eventually, all our procedures will be to the appropriate associated standard, in order for the company to be desirable to larger customers (i.e. corporations such as Bosch, BAE, Seaman, etc.). However for the time being, if drafts can be created surrounding our own "standards" we can write them faster and save money by not purchasing 500+ standards at $50+ a pop to become ISO9001 accredited.

Opinions are welcomed.

Zack



TLDR:

For ISO9001 certifications, for calibration procedures can a company create its own "standard" to follow or must they conform to an accepted standard such as ASME?

 

[Michael_M]

You should base your standard on existing data. For example, your Micrometer, what does the manufacture state as the accuracy? In my company, we have multiple manufacturers for multiple types of measuring tools so this makes it a bit harder so we average. For this we just use '+/- 2 readings' rule for most tools so a standard micrometer is 'good' if it calibrates within +/-.0002" (if it can read the .0001) whereas a digital micrometer needs to calibrate within .0001" as it reads to the 5th decimal place. Note on the digital micrometer, it reads to the .00005, but we still say '2 readings'. For most all of the tools, our +/- 2 readings is better than the accuracy of the device from the manufacturer. This does limit us but we are holding some tight tolerances on occasion and this makes everything easier.

We don't allow some tooling types because of this, for example, we do not allow micrometers that cannot read to the 4th decimal.

Since this is all recorded in work instructions, we have not had any issue with ISO 9001/AS9100 requirements.

 

[Michael_M]

If it helps, I am attaching our work instructions for calibrating (internal) tools.

 

[blackholequasar]

TLDR:

For ISO9001 certifications, for calibration procedures can a company create its own "standard" to follow or must they conform to an accepted standard such as ASME?

Hey Zack!

In the past, the companies that I worked for calibrated to the specification of the actual device. Like Michael said, if the caliper/micrometer/etc. states that it operates within ±0.001" then you'd want to calibrate to that specification to ensure that the device was working within parameters. If you are unable to measure to the tolerances listed on the device, I imagine that checking it to the tightest possible variable may be acceptable!

But to be fair, we found it easier to send our instruments out to a calibration service after a while just to have that NIST trace. And also take into consideration that you may be able to quantify a longer calibration time frame based on usage (instead of 6 month/1 year intervals) -- you just have to prove that the tools are still effective based on light use after, let's say, 2 years in service. We had welding machines that we calibrated every 3 years, and that helped keep our costs for calibration down.

 

[Richard Wilde]

A company can create it own procedure for calibrating its instruments. For example, the period between calibration is relevant to the use of the instrument. typically an instrument used frequently will be checked annually as a minimum.

 

[dwperron]

Hey,

I am currently starting to create documents for my company's quality department (exciting!). From my understanding to meet ISO9001(2015), you need to be able to quantify that you are meeting the specs/requirements implemented by your company through its various processes. Basically, can you prove that the company is doing as they say in their procedures ("promises") and quantify it with documentation?

From this interpretation, a company can set its own "standards" to follow rather than adopting a common standard to become ISO9001 certified. Is this correct?

ISO 9001 is very easy on their calibration requirements. First they discuss general principles:
* Determine what you need to measure or monitor
* Choose suitable tools for the tasks
* Maintain the tools so they are fit for purpose
* Document and retain records to show you are doing this

Then they get into the calibration part of the process:
* Find out what measurements are required to be "traceable" (calibrated tools), whether by customers or internal requirements
* Calibrate them, at specified intervals (you specify these), against national standards (like NIST in the US)
* Identify their calibration status
* Protect them from abuse or deterioration
* If they are found out of tolerance take action to see what was affected

That's it. The rest is up to how you implement these steps.
Yes, you can set your own tolerances for your tools, though most people just use the OEM specifications. This simplifies things, as you don't have to worry about using tools with "custom" tolerances on the wrong jobs.

And this all assumes that your customers will be satisfied with ISO 9001 certification. BAE needs compliance with the more stringent AS9100 standard, Bosch automotive products may require your calibrations to be ISO 17025 accredited, some of your products may need to comply with ANSI or ASME standards. that will have their own requirements.

Do your homework, find out what kinds of measurements you will need to make, and come up with a process that works for you.

 

[Eredhel]

There are some common acceptance criteria for mics, calipers, et cetera. I would just find those and use them. Then just send out your measurement standards like gage blocks and mic standards for NIST calibration.