Do basic Microscopes require Calibration per FDA and ISO 13485

medicalcomp · May 5, 2011

We make a medical device. per FDA and ISO 13485, can anyone tell me if we need (are required) to calibrate a basic microscope? It is used to disposition product as the acceptance criteria is a visual attribute noted/or not noted at 10 x. Thank you.

Gert Sorensen · May 5, 2011

Re: microscopes

I do not believe that you should worry about calibration of the microscope. You should however worry about the operators ability to set up the microscope in a correct manner - that is actually a tricky task. You may also want to get into the operators eyesight - is it OK, or do they need glasses/lenses?

AnaMariaVR2 · May 5, 2011

Re: microscopes

It is used to disposition product as the acceptance criteria is a visual attribute noted/or not noted at 10 x.

The answer is yes.
Whatever your "visual attribute" is that you are verifying through the microscope needs a device that if fit for use and compliant with industry standards. Operator training goes hand in hand but operator's eyesight health (is unique & different) on top of using an optical instrument that is not properly maintained will exponentionally increase variability & inconsistency in your acceptance criteria procedure.

The instrument is used to make a decision of pass vs. fail therefore it should be reliable & reproducible. If equipment is not maintained regularly & consistently, this is a big gap in your quality system & someone will easily figure it out & find it. I look at critical steps in a process, then I look at how are these steps controlled & look deeper into those steps and go even deeper until there is a clear logical description & proof that it is followed every single time during production. If I don't see evidence of it, then it is a non-conformance & I flag it.
Basic preventive maintenance & calibration services can be scheduled from an external vendor annually, you get your paper work and then your are set.

The decision is good for your quality system and the quality of your product but a business decision as well.

Good luck!

Jim Wynne · May 5, 2011

Re: microscopes

medicalcomp said:
We make a medical device. per FDA and ISO 13485, can anyone tell me if we need (are required) to calibrate a basic microscope? It is used to disposition product as the acceptance criteria is a visual attribute noted/or not noted at 10 x. Thank you.

I don't know about medical device requirements in this regard (there are two conflicting responses as I write this), but if the microscopic verification involves use of a reticle ( or what an old boss of mine used to call a "radical" :tg:

) in the microscope, I would think that calibration would be necessary.

pkost · May 5, 2011

Re: microscopes

What would happen if the attribute was observed at 11x...it may have passed if at the proper mag; similarly it may be missed if only at 9x mag.

you have to be able to demonstrate that you are getting 10x magnification (or if appropriate >10x) otherwise it could lead to an incorrect pass/fail of your product; which is bad news from the FDA's and other regulatory bodies point of view.

As pointed out, the biggest source of error is likely to be the operator, therefore you should have adequate training and frequent eye tests in place

AnaMariaVR2 · May 5, 2011

Re: microscopes

Any measuring instrument used to verify/accept product must be calibrated and records must be available to support the calibration. :bigwave:

medicalcomp · May 5, 2011

I agree that risk of it being off and acceptance at 9 x could happen. I want it calibrated. Sometimes logic isn't enough when there is push back. But, is there something in a standard I can use? -there is an interesting change of opinion when when you point out something in a standard. It simply isn't questioned (usually). I just haven't found anything.

pkost · May 5, 2011

further to my last post:

ISO 13485 said:
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 documented procedures 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;

The key thing here and I'm sure some calibration expert will jump down my neck for this: the standard does not specify how often you have to calibrate. I would have thought that the variation in a lens and the associated magnification is going to be insignificant over quite a considerable period of time. You should therefore be able to justify a really long calibration period!

edit: the second paragraph about documented procedures is specific to 13485 and not present in 9001

bobdoering · May 5, 2011

pkost said:
The key thing here and I'm sure some calibration expert will jump down my neck for this: the standard does not specify how often you have to calibrate.

That is true. As long as you qualify the microscope with appropriate MSA, you should be fine.

You can also check into this. Edmunds Optics is a great source of information.

You should also PM the microscope (clean lenses, etc.)

MIREGMGR · May 5, 2011

And the FDA's rules:

PART 820 -- QUALITY SYSTEM REGULATION

Subpart G--Production and Process Controls

Sec. 820.72 Inspection, measuring, and test equipment.

(a)Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.

(b)Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented.
(1)Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(2)Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.

Because of the 21CFR820.72(a) requirement for "valid results", you may also need to consider whether the setup-and-use procedure for the microscope needs to be validated per 21CFR820.75.

Do basic Microscopes require Calibration per FDA and ISO 13485

medicalcomp

Gert Sorensen

AnaMariaVR2

Jim Wynne

pkost

AnaMariaVR2

medicalcomp

pkost

bobdoering

Stop X-bar/R Madness!!

MIREGMGR

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