Scope in procedure and content for 7.6 Monitoring and Measuring Equipment

Q

QAMTY

#1
Hi all.

I'm in the phase of implementing an ISO 9001:2008 and have some questions in 7.6, please share your ideas. 7.6 require to comply with

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards exist, the basis
used for calibration or verification shall be recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
and some others...

But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards

 
Elsmar Forum Sponsor

drgnrider

Quite Involved in Discussions
#2
? But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards
Special tests ? no these are not required. You may, however, perform these tests, (or have them performed), to prove a reason for using a calibration interval greater than the manufacturer recommended interval, (typically one year). Neither I, nor my predecessor, ran these tests, but he had enough historical data to make a decent estimate of how the gages are faring using the current intervals.
:2cents:Personally, I would not mention these tests, other than possibly as a side note 'these are tests that can be used to...'; depending how you word them in your procedures then that is what you must do. If they are not in your procedure, they are options that you can use if, and when, you deem necessary.

Competency ? this can be something as simple as someone with experience deeming you competent after training you. Most calibration is using the tool to measure against a known standard and recording the result.
- Before I started as a machinist I had never used a micrometer, I became proficient using them on the shop floor and now I am only using them on known standards, not parts, and recording my results (aka: calibrating). I added to my skills by seeing what was required of calibration and adjusting our calibration procedures accordingly (they were missing some steps).

As for the standard and your procedure - as long as your procedure addresses all the points of the standard, that is the minimum that is required, anything beyond that up to you... you just have to be doing that.

drgnrider
Calibration & ISO Coordinators
 
#3
Hi all.

But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards

[/SIZE][/FONT][/SIZE][/FONT]
If you are going to calibrate something, to do it properly you should know the measurement uncertainty. This why an accredited lab reports this factor. Without it - like checking a caliper against a gauge block - is just verification, NOT calibration. You have to determine whether calibration or verification is needed. It sounds to me that you might need to get some education on calibration before doing much else. To suggest that competency comes from training is putting things around the wrong way - defining competencies comes before taking action - including training - to develop those skills.

So, if YOU don't know if you need to perform any of the analyses such as R & R, linearity, bias, stability etc, then clearly you need to be competent in those things. I'd recommend getting help from someone who IS competent in the subject (some labs also run training)
 
Q

QAMTY

#4
Thanks drgnrider and Andyn


Good comments

Even if I'm not going to be a guru in calibration, at least
I have to know the basics of equipment calibration terms and definitions

Thanks again
 

Big Jim

Super Moderator
#5
Actually, a procedure for calibration isn't required. Gauge R&R isn't required. Measurement uncertainty isn't required.

All are good to do, but is above and beyond ISO 9001.

Any of them could be a customer requirement though.
 

Johnson

Involved In Discussions
#6
Hi all.

I'm in the phase of implementing an ISO 9001:2008 and have some questions in 7.6, please share your ideas. 7.6 require to comply with

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards; where no such standards exist, the basis
used for calibration or verification shall be recorded (see 4.2.4);
b) be adjusted or re-adjusted as necessary;
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.
and some others...

But I have heard that in calibrating the equipment with external suppliers some special tests have to be done,
e.g. R&R graphs, repeatability, reproducibility, etc.
My doubt is:
As I understand, I only have to take care of issues required mentioned on top (ISO requirements), additionally, I need to have the competency to perform the measurements , I only have micrometers and rules.
I have a procedure where I mention everything, but I'm not mentioning, R&R, repeatability, reproducibility,etc.
Do I have to mention that?
I think that these test are to be done only by the supplier of calibration in order to determine the status of a an equipment,

Please shed light on me., what I have to mention in my procedures?

My best regards


Firstly the concept and purpose of calibration and Gage R&R should be clarified. To make it simple (but the statement is not accurate enough):

The calibration is to check the correctness and accuracy of a measuring device compared to it's specification. It uses "master" or "reference standard". Normally done by the third party. Your parts are not used.

But Gage R&R is used to check if one selected measuring device is suitable /capable to measure your parts with defined tolerance. It use your parts and the measuring is done by your inspectors or operators. For example, you should not use a caliper (with resolution of 0.01 mm) to measure the parts with tolerance of 10+/-0.020 mm, you may use micrometers (with resolution of 0.001 mm)

Based on above explaination and look at ISO9001 7.6 again. It could be concluded:
A measuring device need to "be calibrated or verified", but R&R is not mentioned. R&R is required in automotive OEM or ISO/TS16949.
I would suggest you use Gage R&R. It is very simple and usefull since you" only have micrometers and rules.".


Hope it helps !
 
#7
Actually, a procedure for calibration isn't required. Gauge R&R isn't required. Measurement uncertainty isn't required.

All are good to do, but is above and beyond ISO 9001.

Any of them could be a customer requirement though.
"above and beyond" may be your understanding, however, just like many requirements in ISO 9001 - even simple document control, WHAT you do to calibrate equipment to ensure it is "suitable" MAY require an organization to perform these steps. Just be cause ISO/TS 16949 called it out specifically (or by ref. to the MSA manuals etc) may only be because it's not clear enough for those who would "prefer" not to do it.

The control of measuring equipment is often a misunderstood requirement where some most people know a little bit and are too quick to dismiss a number of activities as "not required". Just like many other ISO 9001 requirements don't tell you WHAT has to be done...
 

Big Jim

Super Moderator
#8
AndyN;572604 Just like many other ISO 9001 requirements don't tell you WHAT has to be done...[/QUOTE said:
And thus the comment of these activities are above and beyond the requirements of ISO 9001:2008.

Again, as I said before, they still may be desirable, just not a requirement.
 
#9
And thus the comment of these activities are above and beyond the requirements of ISO 9001:2008.

Again, as I said before, they still may be desirable, just not a requirement.
In all seriousness, could you explain HOW (without reference to any of these established techniques) an organization is going to demonstrate that the equipment they use to measure something - is "suitable"? I'm all ears...:popcorn:
 
Last edited:

Big Jim

Super Moderator
#10
In all seriousness, could you explain HOW (without reference to any of these established techniques) an organization is going to demonstrate that the equipment they use to measure something - is "suitable"? I'm all ears...:popcorn:
By training the users on how to properly use the equipment and to select the right measureing tool.

Much of selecting the right tool is common sense. You don't use a tape measure to measure something that needs to be within 5 thousands of an inch. You select a tool that has suffecient resolution.

Put the popcorn away. You don't need it here.
 
Thread starter Similar threads Forum Replies Date
T Vendor (Supplier) Approval Procedure - Scope of the procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
I IATF Lab Scope Testing Qualification and Competency Documentation IATF 16949 - Automotive Quality Systems Standard 3
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
silentmonkey Are risks in supply chain and development activities within scope of MDD? EU Medical Device Regulations 3
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
G APQP Scope and scale tool APQP and PPAP 2
R NRTL - Scope Question - Off-the-Shelf Plug In IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
O MDSAP Reduction in Scope Other Medical Device Related Standards 0
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
K Restricted Scope of ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 7
C IATF 16949 - Scope or not? IATF 16949 - Automotive Quality Systems Standard 2
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
qualprod To raise a NC beyond the audit scope? Two signatures were missing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D CE Marking Requirements MDD & MDR - new product development covered under same scope EU Medical Device Regulations 1
P Scope of application for IEC 60601-1-11 Medical electrical equipment — Part 1-11 IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
M ISO 27001 ISMS scope for companies with subsidiaries IEC 27001 - Information Security Management Systems (ISMS) 0
T AS9100D - Scope of QMS for New Company - Only Choosing a Function Subset Due to Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
R Scope of ISO 13485 certification ISO 13485:2016 - Medical Device Quality Management Systems 6
D Scope of Facility - Our auditor asked us last week for our "Scope of the Facility" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
L Dying a slow SCOPE death - NEW ISO APG Paper on Scope and Applicability May 2020. AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
W Scope of MRB (Material Review Board) Responsibilities Misc. Quality Assurance and Business Systems Related Topics 5
P ISO 80369-7 standard - Interpreting which Parts should be in scope Other Medical Device Related Standards 7
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Exclusion of 'Design and Development' from scope of certification ISO 13485:2016 - Medical Device Quality Management Systems 9
S ISO 13485 scope of certification - We are a virtual manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 1
F API Spec Q1 Scope - Limiting the scope of certification Oil and Gas Industry Standards and Regulations 3
M How To Define ISMS (information Security Management System) Scope IEC 27001 - Information Security Management Systems (ISMS) 9
qualprod ISO 9001:2015 8.5.1 f - Scope with customer special process requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Determining number of employees within the "Scope" of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Informational Scope of BSI for the MDR – Regulation (EU) 2017/745 on medical devices Medical Device and FDA Regulations and Standards News 0
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
Q Calibration laboratory scope - Include software such as Gagetrak or Mini tab used? General Measurement Device and Calibration Topics 3
A Determining the Scope of the QMS during Stage 1? Registrars and Notified Bodies 11
F Information Technology in IATF 16949 audit scope IATF 16949 - Automotive Quality Systems Standard 12
S MDSAP Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
K MDSAP scope vs ISO 13485 Scope Canada Medical Device Regulations 4
S Regulatory Certification Exam (RAC) - Global Scope ISO 13485:2016 - Medical Device Quality Management Systems 1
P Injection Molding Machine Validation Scope Capability, Accuracy and Stability - Processes, Machines, etc. 6
S ISO 9001:2015 - Scope of Registration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
T Restricting scope of AS9100 certification to a couple of customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
Q AS9120B Clause 8.4.1.1 External Providers Scope of Approval AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Scope change in Japan - Class I disposable medical devices Japan Medical Device Regulations 0

Similar threads

Top Bottom