ISO 9001:2015 Calibration Procedures

DavidJ.BlackII

Starting to get Involved
Hi all,

So I’ve been reading up more on IATF 16949:2016 (The automotive quality system standard) & ISO 9001:2015 (IATF 16949 states that it is not a standalone but acts in conjunction with ISO 9001:2015), and I was confused about the calibration requirements.

“7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal laboratory
An organization's internal laboratory facility shall have a defined scope that includes its capability to
perform the required inspection, test, or calibration services. This laboratory scope shall be included in
the quality management system documentation. The laboratory shall specify and implement, as a
minimum, requirements for:
a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such as
ASTM, EN, etc.)
; when no national or international standard(s) is available, the organization shall
define and implement a methodology to verify measurement system capability;
) customer requirements, if any;
f)review of the related records.

NOTE Third-party accreditation to ISO/IC 17025 (or equivalent) may be used to demonstrate the
organization's in-house laboratory conformity to this requirement.””


What does the underlined section mean? What’s the difference between ASME and ASTM? How do I know what process to use when calibrating? I’ve seen that there are different standards by different institutes, can I pick and choose what standards I use?
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Hello DavidJ.BlackII,

I cannot cite here what the calibration subject differences are between ASTM and ASME. I expect the differences, if any, would be subtle.

The standard uses the word "etc." with the intent to allow another acceptable standard to be used. As long as no other requirement in the standard is being violated (you still need to have traceability to a recognized standard, for example) I expect you have freedom to choose the standard that best applies to you.
 

DavidJ.BlackII

Starting to get Involved
Hello DavidJ.BlackII,

I cannot cite here what the calibration subject differences are between ASTM and ASME. I expect the differences, if any, would be subtle.

The standard uses the word "etc." with the intent to allow another acceptable standard to be used. As long as no other requirement in the standard is being violated (you still need to have traceability to a recognized standard, for example) I expect you have freedom to choose the standard that best applies to you.

So, does that mean I can cite ASME B89.1.14 as my methodology for calibrating/validating calipers in my lab scope? On the "Foreword" page it says, "This Standard was approved by the American National Standards Institute on February 27, 2018."; Do I have to validate the methods used, or is it being attributed to ASME enough?
 

DavidJ.BlackII

Starting to get Involved
I'm really interested as to whether or not when I include methodology in my scope, can I apply whatever ASME procedure is applicable (gage blocks, calipers, micrometers, thread wires, dial & drop indicators, etc. are all standards under ASME B89.1)? How would I respond if an auditor asked how I knew each process was valid? What do I need to include for the methodology of my scope?
 

Tagin

Trusted Information Resource
I think you need to read it in context with the sentence prior to the bullets:

The laboratory shall specify and implement, as a minimum, requirements for:...d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.);

To me, they are saying that your lab needs to define and implement the minimum requirements it must meet in order to be capable of properly performing the service to whichever standard you are going to use.

So again, to me this is only a common sense thing: In order to calibrate per standard XYZ, my lab must meet some set of minimum requirements (precision, environmental controls, technician qualifications, whatever) in order to properly claim that the calibration services performed in the lab actually met the XYZ standard, and that therefore, the calibrations performed are valid.
 

BradM

Leader
Admin
The section is under "internal laboratory". So if you're going to calibrate equipment/ instruments, you will need to use a validated procedure. One that is already developed (like ASTM) is best. But if you have to calibrate something and there isn't a validated procedure, you need to develop one.
 

dwperron

Trusted Information Resource
What does the underlined section mean? What’s the difference between ASME and ASTM? How do I know what process to use when calibrating? I’ve seen that there are different standards by different institutes, can I pick and choose what standards I use?


Go back a bit further:
" The laboratory shall specify and implement, as a minimum, requirements for: ", and bullet point d) covers calibration procedures.

You need to specify what the requirements are for choosing the calibration procedures that are being used.
In the automotive world you will find a lot of ASTM or ASME procedures that you can review and state that it meets your requirements. However, for a lot of electronics (multimeters, scopes, etc.) there will not be an ASTM or ASME procedure. In these cases you need to set up your requirements so that they "define and implement a methodology to verify measurement system capability " in choosing what makes up an adequate calibration procedure.
 

Enghabashy

Quite Involved in Discussions
Hi all,

So I’ve been reading up more on IATF 16949:2016 (The automotive quality system standard) & ISO 9001:2015 (IATF 16949 states that it is not a standalone but acts in conjunction with ISO 9001:2015), and I was confused about the calibration requirements.

“7.1.5.3 Laboratory requirements
7.1.5.3.1 Internal laboratory
An organization's internal laboratory facility shall have a defined scope that includes its capability to
perform the required inspection, test, or calibration services. This laboratory scope shall be included in
the quality management system documentation. The laboratory shall specify and implement, as a
minimum, requirements for:
a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such as
ASTM, EN, etc.)
; when no national or international standard(s) is available, the organization shall
define and implement a methodology to verify measurement system capability;
) customer requirements, if any;
f)review of the related records.

NOTE Third-party accreditation to ISO/IC 17025 (or equivalent) may be used to demonstrate the
organization's in-house laboratory conformity to this requirement.””


What does the underlined section mean? What’s the difference between ASME and ASTM? How do I know what process to use when calibrating? I’ve seen that there are different standards by different institutes, can I pick and choose what standards I use?

* the inspection & test in Lab. should be done by taking the relevant product standard specs, as DIN EN, BS , ASTM in its reference , as example : you manufacture automotive brake , the EN standard for inspection & testing of Brake could be followed in your Lab. test procedures , with considering all uncertainty calculations also in lab. test reports
 

DavidJ.BlackII

Starting to get Involved
* the inspection & test in Lab. should be done by taking the relevant product standard specs, as DIN EN, BS , ASTM in its reference , as example : you manufacture automotive brake , the EN standard for inspection & testing of Brake could be followed in your Lab. test procedures , with considering all uncertainty calculations also in lab. test reports
How do I confirm that a standard such as ASME is valid in my scope? Like if I cite ASME standard B89.1.14 as my methodology in my lab scope for all calipers of a similar type, how can I prove that it’s an acceptable standard? Would an auditor even ask me to validate my process standards?
 

dwperron

Trusted Information Resource
How do I confirm that a standard such as ASME is valid in my scope? Like if I cite ASME standard B89.1.14 as my methodology in my lab scope for all calipers of a similar type, how can I prove that it’s an acceptable standard? Would an auditor even ask me to validate my process standards?

ASME and ASTM procedures are considered to be "internationally recognized' documents. Procedures from the OEM, GIDEP military procedures, NIST handbooks, etc. are also well accepted by auditors. A caveat is that most auditors will check to see if you perform the procedure as written, using all steps and the equipment called for.
When you write your own procedures you will need to validate them as being effective, and adequate for the equipment you are using them for.
 
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