ISO 9001 CMM Room Temperature Requirements

Greetings All,

I am new to ELSMAR.com, I need a quick answer to this question... Where does it state in ISO requirements about monitoring and recording temperature and humidity for CMM/Inspection labs?

Regards,
Scott

Re: ISO CMM Room Temperature Requirements

Hi Ssccarpiello, welcome to the cove.

If we assume you're talking about ISO 9001, it doesn't directly. BUT it certainly could be required based on this requirement:

ISO 9001:2008 said:

6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
NOTE The term “work environment” relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).

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Re: ISO CMM Room Temperature Requirements

Scott, it doesn't. It will depend upon your requirements per 6.4. Don't add monitoring unless you really need it. Good luck.

Re: ISO CMM Room Temperature Requirements

Thanks for the prompt replies!!!!

It's not something we are looking to add to our requirements, one of our suppliers whom we just did an audit of has there CMM calibrated at 68º per OEM specs, if that machine needs to calibrated at that specific temperature wouldn't the accuracy of that machine be based on that temperature? and if so, would all this fall under 6.4?

Re: ISO CMM Room Temperature Requirements

Yes, it would. In cases where measuring equipment is being used at significantly different temperatures than at calibration, correction factors should be applied. Also, the temperature of the part itself should be considered. Often, especially for close-tolerance parts, it's appropriate to allow "soak time" to allow the part to stabilize at temperature before measuring.

The AS9100 standard (ISO 9001 with additional requirements for aviation, space, and defense) clarifies with this additional requirement:

AS9100 Rev C said:

The organization shall ensure that environmental conditions are suitable for the calibration, inspection, measurement and testing being carried out.

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The Medical Device QMS standard ISO 13485 (also based on ISO 9001) clarifies with these requirements:

ISO 13485 said:

If work environment conditions can have an adverse effect on product quality, the organization shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions

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Of course these aren't specific requirements of ISO 9001, but should be considered for guidance.

Re: ISO CMM Room Temperature Requirements

Howste,

Thanks for the information, It was very helpful in what I was trying to figure out. Should be good to go now...

Regards,
Scott

Depends on which "ISO" standard you were auditing against.

The ISO/IEC 17025:2005 standard (for testing and calibration labs) has specific requirements for environmental conditions (see clauses 5.3 and 5.10.3.1).

If your company is ISO/TS 16949 certified, then (I believe) a lab supplying results to you has to be accredited to 17025.