Calibration - Clause 7.6 of ISO 9001:2000 - Is all this necessary?

[pammesue]

In looking at my procedure for calibration, I have tons of stuff listed as needed on the calibration cert. We dont do any calibration in house.

The whole division used to be aerospace and Im thinking that all these requirements were held over from previous procedures. They may be too stringent for our applications. Are all of these supposed to be required on an ISO 9001:2000 program?

5.3 Calibration performed by outside sources shall be supported by certification of compliance conformance with data attesting to the following:

• Identification of the unit being calibrated
• Identification of the standards used to obtain traceability
• Date of calibration
• Assigned calibration frequency/interval
• Identification of serial numbers in item such as in gage blocks where more than one set of the same type is used at the same time
• Actual calibration values
• Statement as to measurement uncertainty involved in calibrating the item and its cumulative effect (not a mandatory requirement)
• Calibration method
• Notification of out-of-tolerance conditions
• Environmental condition under which results furnished were obtained details of any maintenance such as servicing, adjustment, repairs, or modification
• Signature and title of approving authority
• Certification number

our current certs have what is highlited in red above.
Ive never gotten back anything that was out of tolerance before so Im not sure whether or not it would be on there. We definately dont get before and after readings on items. We do however get them on our temperature controllers. I think it costs more to have this data?

anyhow, any input is appreciated
pammy

 

[AndyN]

Re: Calibration 7.6 of ISO 9001:2000- Is all this necessary?

If you want to run an effective management program for measuring equipment, you need that info. Getting something back 'in tolerance' is historical data, not a predictor of the future period before it goes out of spec. That's why you need the 'as found' and 'as calibrated' info to track wear etc.

If you are calibrating on a (example) annual basis, the equipment might be right on the 'edge' of the spec, still 'in tolerance', but only last a few more weeks before - WHAM - non-conforming product (only you didn't know!)

 

[Doug Tropf]

Re: Calibration 7.6 of ISO 9001:2000- Is all this necessary?

The items you listed seem pretty standard. I would recommend that you have some sort of documented in-house review and approval of the certificate as well.

 

[Coury Ferguson]

Re: Calibration 7.6 of ISO 9001:2000 - Is all this necessary?

In looking at my procedure for calibration, I have tons of stuff listed as needed on the calibration cert. We dont do any calibration in house.

The whole division used to be aerospace and Im thinking that all these requirements were held over from previous procedures. They may be too stringent for our applications. Are all of these supposed to be required on an ISO 9001:2000 program?

5.3 Calibration performed by outside sources shall be supported by certification of compliance conformance with data attesting to the following:

• Identification of the unit being calibrated
• Identification of the standards used to obtain traceability
• Date of calibration
• Assigned calibration frequency/interval
• Identification of serial numbers in item such as in gage blocks where more than one set of the same type is used at the same time
• Actual calibration values
• Statement as to measurement uncertainty involved in calibrating the item and its cumulative effect (not a mandatory requirement)
• Calibration method
• Notification of out-of-tolerance conditions
• Environmental condition under which results furnished were obtained details of any maintenance such as servicing, adjustment, repairs, or modification
• Signature and title of approving authority
• Certification number

our current certs have what is highlited in red above.
Ive never gotten back anything that was out of tolerance before so Im not sure whether or not it would be on there. We definately dont get before and after readings on items. We do however get them on our temperature controllers. I think it costs more to have this data?

anyhow, any input is appreciated
pammy

The requirements that you are citing are from ISO17025, which can be a requirement of your Calibration Supplier. The ISO9001:2000/8 requires:

7.6 Control of monitoring and measuring devices

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Where necessary to ensure valid results, measuring equipment shall

a) be calibrated or verified 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;

b) be adjusted or re-adjusted as necessary;

c) be identified to enable the calibration status to be determined;

d) be safeguarded from adjustments that would invalidate the measurement result;

e) be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

I think you are looking to deep into this requirement of ISO9001:2000. I see no requirements in the paragraph quoted that are similar to your statement. In my opinion.

If you are a Calibration house that seeks or is ISO17025 than that would be required.

 

[AndyN]

Re: Calibration 7.6 of ISO 9001:2000 - Is all this necessary?

The requirements that you are citing are from ISO17025, which can be a requirement of your Calibration Supplier. The ISO9001:2000/8 requires:



I think you are looking to deep into this requirement of ISO9001:2000. I see no requirements in the paragraph quoted that are similar to your statement. In my opinion.

If you are a Calibration house that seeks or is ISO17025 than that would be required.

Coury, let me help here. A calibration supplier is required to report everything listed in the OP's extract from the procedure. They are required to report this information, because to manage the application or implementation of a measuring device effectively, you (as the owner of the item) have to know that information, in one respect or another. It's data provided to the owner for their use, not simply because the standards have requirements or that they differ.

It's not a case of over thinking this - it's a case of effectiveness of controls! Fact!

 

[Coury Ferguson]

Re: Calibration 7.6 of ISO 9001:2000 - Is all this necessary?

Coury, let me help here. A calibration supplier is required to report everything listed in the OP's extract from the procedure. They are required to report this information, because to manage the application or implementation of a measuring device effectively, you (as the owner of the item) have to know that information, in one respect or another. It's data provided to the owner for their use, not simply because the standards have requirements or that they differ.

It's not a case of over thinking this - it's a case of effectiveness of controls! Fact!

I understand that the Calibration Supplier is to have this information, but that doesn't fall under 7.6 (ISO9001) does it? As far as I understand 7.6 (ISO9001) you have to maintain the records, have status, recall and so forth. But please show me in 7.6 where it requires that the Organization is required to have this "specific" information.

If you want to try to fit this in the requirements of ISO9001 I think it would fall under paragraph 7.4 and subs thereof, but not under 7.6 which this post is asking about.

Maybe I am misunderstanding what the post is asking about or even misinterpreting paragraph 7.6. Please enlighten me on 7.6.

 

[AndyN]

You seem to be trying to 'fit' everything into a 'clause', rather than consider what a company must do to manage a process - in this case, the measuring equipment they have. If a calibration supplier gives you 'as found/as calibrated' data, shouldn't you use it? Isn't it there for you to make some decisions? Like can I continue to use this equipment for measurement? How long will it last before it jeopardizes my product integrity and when can I reasonably expect to have to send it for recalibration?


Are you proposing that the ISO 9001 must have something in '7.6' to tell you to ask these questions?

 

[Coury Ferguson]

You seem to be trying to 'fit' everything into a 'clause', rather than consider what a company must do to manage a process - in this case, the measuring equipment they have. If a calibration supplier gives you 'as found/as calibrated' data, shouldn't you use it? Isn't it there for you to make some decisions? Like can I continue to use this equipment for measurement? How long will it last before it jeopardizes my product integrity and when can I reasonably expect to have to send it for recalibration?


Are you proposing that the ISO 9001 must have something in '7.6' to tell you to ask these questions?

What I am saying is that there is no requirement (ISO9001) to have this information in the organization's file or calibration system. The Calibration process is based upon conditions records and how the process is maintained. The post (at least what I see) doesn't state they perform the calibration of the gages (my emphasis in bold). So taking the statement in the post below, they are only responsible for the Calibration requirements of 7.6 NOT ISO17025; that is their supplier's requirements (if they have been assessed and approved to ISO17025). I don't see the requirement from 7.6 of ISO9001 for the poster's organization. I stand my ground here and I would stand my ground with a Registrar that tried to force me to comply with ISO17025 when it has no bearing on my Organization's management system of ISO9001 or even AS9100.

We dont do any calibration in house

 

[AndyN]

What I am saying is that there is no requirement (ISO9001) to have this information in the organization's file or calibration system. The Calibration process is based upon conditions records and how the process is maintained. The post (at least what I see) doesn't state they perform the calibration of the gages (my emphasis in bold). So taking the statement in the post below, they are only responsible for the Calibration requirements of 7.6 NOT ISO17025; that is their supplier's requirements (if they have been assessed and approved to ISO17025). I don't see the requirement from 7.6 of ISO9001 for the poster's organization. I stand my ground here and I would stand my ground with a Registrar that tried to force me to comply with ISO17025 when it has no bearing on my Organization's management system of ISO9001 or even AS9100.

Under ISO 9001, as I'm sure you're aware, the organization has to maintain records of results of calibrations (doesn't matter who does them). If, as the OP suggests, they don't get 'before and after' data, they cannot manage their equipment properly! How can they attempt to answer the questions I posted before.....??

The OP's comment was based on the content of their procedure - which, in my experience is a good basis for the management of the calibration process. Justifying exclusion of the items (in black text) based on 'it's been good in the past' isn't effective management! Calibration, is and always has, provided purely historical data, not what you need to prevent problems in future.

It's also worthy to consider the management system as a whole, rather than by what individual requirements say. When considering effective management of the organization's measuring capability, you have to also consider the requirements of 8.1, 8.2.3, and 8.4 (in particular) don't you? Just as you have to ensure your people are competent to run a 'calibration process' - but it doesn't explicitly say that in 7.6 alone!

BTW - why did you bring into the equation what a CB auditor might push for? The OP didn't mention anything about that dynamic and, as my profile states, I'm not representing the views of one here and neither do I audit for one! These are simply my experience and expertise from managing effective metrology programs, even before 'ISO' came about!

 

[BradM]

Can I play??

First, I would remove all those requirements from any procedure. I'm not sure that I would want to paint myself into a corner on that. I would be more concerned with proceduralizing the vendor evaluation and the management process for the calibrations.

Now, I would not want to venture into what is required and what is not. But... I pretty much require all the mentioned components provided by Pammy as part of good process management.

1. I don't see anything I would consider as irrelevant. In my years of managing calibration activities, I needed every one of those bits of information at one time or another.

2. As found as left data. As the OP mentioned, they never got back anything out of tolerance. That suggests that intervals may can be extended, thus saving some money. But, you really can't make an intelligent decision without having that data.

My opinion... I would not build my approach to clause 7.6 as making sure that a checklist of data/information was on each calibration certificate. I would be much more inclined to focus on qualifying competent laboratories, identifying/ segregating calibrated/non-calibrated equipment, and managing the process to allow the most benefit.

FWIW.. My work I've done in Pharmaceutical/ Aerospace, those components were considered as requirements/ minimum information. Was that a carved in stone Thou Shalt? I don't know. But the certifications needed to have that information on it, or they were looked down upon.