Services
Calibration
We provide calibration services in a number of areas. The measuring equipment used in some of these areas is accredited by NAT (the Hungarian Accreditation Board) and comply with the ISO 17025:2005 standard/norm.
- thermometers
- nanometers and differential pressure meters
- humidity controllers/meters
please click on:
(http://www.nat.hu/okiratok/NAT-2-0250-2008-01RO.pdf) for more details and information.
National or Approved International attributed standards calibration
- linear measurers
- tachometers
- some dynamometers
- timers
- flowmeters
- velocity meters
- conductivity meters
- PH meters
- exposure meters
Our services are provided in our own calibration laboratory as well as at other places wherever our partners require the instruments to be installed.
We calibrate different sorts of machinery, devices and supply systems with disassembly and professional reconstruction if required. If the measurement is undertaken at a previously arranged time it is usually accomodated to a planned maintenance or production stop in order that the calibration task does not interrupt or disturb standard operation.
In cases of field calibrations we provide, deliver and install all the necessary equipment at our clients’ premises
Our primary preference is the calibration of the entire measurement circle but upon demand we will undertake partial assignments such as individual sensor or measuring loop calibration
We can also provide measuring loop precision and adjustment works according to technical potentialities
In cases of laboratory calibrations we provide our clients a return period of up to 3 days and in the event of a field calibration the operation of the measuring loop is suspended for a maximum of eight hours
We perform calibrations that meet the requirements of GxP, HACCP, ISO-9000, QS9000 quality control systems
Our reference instruments are calibrated at regular intervals and possess renewed validations
Qualification
Our most frequently used scopes of qualification services also possess the accreditation of NAT – the Hungarian Accreditation Board.
- temperature distribution tests
- humidity distribution tests
- cleanroom particle counts
Please click on:
(http://www.nat.hu/okiratok/NAT-1-1558-2008-01RO.pdf) for more details and information.
As mentioned earlier, we have provided qualification services for the majority of devices and supply systems used in pharmaceutical production for a considerably long period of time.
These services are full scale including the preparation of examination protocols and the listing of the necessary testing methods. We also collect essential references and allusions to properly define the user requirements and in addition we execute qualification tests and record results on the basis of the complete examination protocol. Upon evaluation we complete a qualification report and with the necessary enclosures we present a ready-made documentation to our clients that is presentable at times of audits.
During documentation elaboration an individual form suitable to editorial and formatting instructions is accomplished and this complies with the requirements of internal procedures and regulations or templates.
In many cases we take part as partners of the manufacturer or distributor in the qualifying operation of the device to be installed. Moreover, we co-operate with our clients as qualification team members and use our professional experience to help them avoid faults and errors encountered in the past during similar processes.
ISO-MÉR
Quality Assurance
and Methodology Ltd.
H-1165
Budapest
Hunyadvár utca 56. II/3.
Tel: +36 1 253-0316
Tel/Fax: +36 1 257-1912
E-mail: isomer@isomer.hu
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