7.6 Calibration (referencing outsourcing) in the Quality Manual

Crusader

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#1
I'm venturing into new territory. Current employer does not have a lab or controlled area for calibrating in-house. Everything will be sent out.

I guess I'd like to see some examples of how this was documented in a quality manual for ISO 9001.

Anyone?
 
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Michael_M

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#2
I'm venturing into new territory. Current employer does not have a lab or controlled area for calibrating in-house. Everything will be sent out.

I guess I'd like to see some examples of how this was documented in a quality manual for ISO 9001.

Anyone?
this is what we have for external calibration:

3.5 External Calibration and/or Measurements
3.5.1 Qualification
No contracted metrology laboratory is used until it has been qualified, verifying compliance with ANSI/NCSL Z540-1 or ISO 10012-1. ISO certification will qualify any potential laboratory.

3.5.2 Calibration Certificate
A calibration certificate is required in all cases where calibration is performed by an outside source. This certificate will include the following minimum information:

?Date of Calibration,
?Identification of the equipment to which the certificate pertains,
?Before and after measurement values of the equipment, and
?Proof of traceability to NIST (or other natural constant) for the accuracy of equipment used in the calibration.
All outside calibration certificates will be maintained in the Q.A. department.

3.5.3 Calibration Seals
Calibration adjustments, accessible from the outside of the equipment (other than zero/standardize) and access to internal adjustments are made tamper proof. This is accomplished using glyptol or frangible labels. Breaking of these seals voids the calibration.
 

Crusader

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#3
this is what we have for external calibration:

3.5 External Calibration and/or Measurements
3.5.1 Qualification
No contracted metrology laboratory is used until it has been qualified, verifying compliance with ANSI/NCSL Z540-1 or ISO 10012-1. ISO certification will qualify any potential laboratory.

3.5.2 Calibration Certificate
A calibration certificate is required in all cases where calibration is performed by an outside source. This certificate will include the following minimum information:

?Date of Calibration,
?Identification of the equipment to which the certificate pertains,
?Before and after measurement values of the equipment, and
?Proof of traceability to NIST (or other natural constant) for the accuracy of equipment used in the calibration.
All outside calibration certificates will be maintained in the Q.A. department.

3.5.3 Calibration Seals
Calibration adjustments, accessible from the outside of the equipment (other than zero/standardize) and access to internal adjustments are made tamper proof. This is accomplished using glyptol or frangible labels. Breaking of these seals voids the calibration.
And this is all you need in the QA Manual? No other docs to support?
 

insect warfare

QA=Question Authority
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#4
And this is all you need in the QA Manual? No other docs to support?
This is what we state in our manual:

"Calibration of test equipment (new and otherwise) is quoted and outsourced to an ISO 17025 accredited laboratory that specializes in calibration or metrology. The unique identification of items requiring calibration and/or verification, and their calibration frequency, is defined in separate documentation.

Test equipment is protected and safeguarded during handling, maintenance and storage through authorization of duties and/or the use of specified instructions. Employees are prohibited from performing maintenance on test equipment (such as removing components or breaking seals) that would potentially invalidate its measurement result or calibration status.

Golden samples are used (where applicable) to ensure that consistent results are obtained from test equipment, and are promptly replaced when they cannot provide those results.

Where test equipment does not perform to expectations, it will be removed from the area and, depending on its condition, may need calibration. Known good calibrated test equipment will be substituted in its place. Repaired test equipment is re-calibrated and verified before it is re-used.

Qualified calibration technicians will perform calibration activities either on-site or at a laboratory. Calibration certificates are issued, and stickers are placed on the corresponding equipment showing the calibration status, in accordance with their procedures.

The following types of equipment are tagged out to prevent inadvertent use, regardless of its working condition: Past due Calibration, and Defective (or suspect). Defective equipment may be routed to vendors who specialize in equipment repair, unless it is not economically viable to do so, in which case the equipment may be scrapped or its parts re-sold."


We also maintain the necessary records to provide evidence that we are ensuring this amount of control over this particular outsourced process. In short, there's not much to it. Define your required controls, implement them as you would and maintain a history of what's happened.​

Brian :rolleyes:
 

Michael_M

Trusted Information Resource
#5
And this is all you need in the QA Manual? No other docs to support?
I keep a copy (scanned) of the calibration record. For outside processing, that is all I have.

Note, what I have listed is part of our calibration procedure, the quality manual does not state anything specific about outside calibration services.
 

Crusader

Trusted Information Resource
#6
I keep a copy (scanned) of the calibration record. For outside processing, that is all I have.

Note, what I have listed is part of our calibration procedure, the quality manual does not state anything specific about outside calibration services.
okay. understood. :thanks:
 
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