Do basic Microscopes require Calibration per FDA and ISO 13485

M

medicalcomp

#1
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.
 
Elsmar Forum Sponsor
G

Gert Sorensen

#2
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

Trusted Information Resource
#3
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!
 
Last edited:

Jim Wynne

Staff member
Admin
#4
Re: microscopes

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

Trusted Information Resource
#5
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
 
Last edited:

AnaMariaVR2

Trusted Information Resource
#6
Re: microscopes

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

medicalcomp

#7
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

Trusted Information Resource
#8
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

Stop X-bar/R Madness!!
Trusted Information Resource
#9
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.)
 
M

MIREGMGR

#10
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.
 
Thread starter Similar threads Forum Replies Date
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A GMDN Registration Basic preliminary Information EU Medical Device Regulations 0
M Basic UDI and technical documentation EU Medical Device Regulations 1
C NB approval - Basic question about Notified Bodies and their role EU Medical Device Regulations 10
B Seven Basic Quality Tools (January 23) [Paid] Training - Internal, External, Online and Distance Learning 1
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Evaluation of Basic Safety during EMC Immunity or Climate Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
J How to measure a Critical Characteristic that is a Basic Dimension Misc. Quality Assurance and Business Systems Related Topics 6
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
L Unacceptable risk for basic safety prior to or after mitigation? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
E Basic Risk based thinking questions Risk Management Principles and Generic Guidelines 5
S Question about a basic additive variance/tolerance example Quality Tools, Improvement and Analysis 2
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0
Marc Basic - How to Start a New Discussion Thread Elsmar Xenforo Forum Software Instructions and Help 1
S Basic Dimension W/O using FCF Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
V Carbon Black (Master Batch) - Basic Requirements Manufacturing and Related Processes 5
G Setting Up a Basic Quality Lab for a small manufacturing company General Measurement Device and Calibration Topics 2
P Basic Minitab Help - It's about Linear Regression Using Minitab Software 1
L Lean Book for Basic Knowledge Lean in Manufacturing and Service Industries 2
L Seeking help in Basic Maintenance Knowledge Manufacturing and Related Processes 4
M "Basic Safety" versus "Essential Performance" IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
M Use of Excel and VBA (visual basic for applications) in quality systems Excel .xls Spreadsheet Templates and Tools 3
P Basic questions about earning TSOA (Technical Standard Order Authorization) and PMA Federal Aviation Administration (FAA) Standards and Requirements 2
J Excel spreadsheet to use Basic and Mini MOST for Line Balancing Document Control Systems, Procedures, Forms and Templates 1
T How to report Basic Dimensions on a Dimensional Report (ISIR) Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
A Basic ISO 13485 Training Material ISO 13485:2016 - Medical Device Quality Management Systems 5
M Basic Dimensions on Machining Prints Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
M Basic International Standards required for a Manufacturing Industry (Optical Media) Other ISO and International Standards and European Regulations 4
L How to set up a basic electronic test equipment calibration laboratory General Measurement Device and Calibration Topics 3
R Rejecting a Part when Dimension Feature is Basic Inspection, Prints (Drawings), Testing, Sampling and Related Topics 3
O Metrology Devices to Measure the Basic Dimensions of Plastic Specimens General Measurement Device and Calibration Topics 6
F ISO 9001:2008 Fundamentals: Basic Questions - Controlled Documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
E How can I measure three true positions? GD&T basic question General Measurement Device and Calibration Topics 5
M SPC, Moving Range Chart and Weighted Graph Basic Questions Statistical Analysis Tools, Techniques and SPC 1
T Basic Document Control Database (Excel/Access) Document Control Systems, Procedures, Forms and Templates 3
V The Purpose of Basic Dimensions on Prints APQP and PPAP 6
N Basic requirements and steps involved to get NADCAP Certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Profile of a Line of a radius of 25mm basic dimension - Question Inspection, Prints (Drawings), Testing, Sampling and Related Topics 6
C Basic Internal Calibration Procedure to check the Accuracy of a Balance Calibration Frequency (Interval) 6
P Basic Food Hygiene Presentation Training - Internal, External, Online and Distance Learning 6
M Training Toolbox for Basic Food Hygiene - Food Safety Food Safety - ISO 22000, HACCP (21 CFR 120) 2
Q Basic questions about AS9100C Quality Standard Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Basic Educational Film - What Quality is all about ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Basic Internal Auditor Training Powerpoint File Internal Auditing 26
S Basic Environmental Aspects Register template wanted Document Control Systems, Procedures, Forms and Templates 1

Similar threads

Top Bottom