- ISO15189 Compliance (through UKAS certificate)
- IQ/OQ Validation
- USP41 (Update USP36-NF 31)
- European Pharmacopoeia (EP) Chapter 2.1.7 Report
- Test Report
ISO15189 Compliance (through UKAS certificate)
Many medical & pathology laboratories are now required to meet the requirements of ISO 15189. An integral part of compliance is to assess what equipment is used within the laboratory that can have a significant influence on their results. Once this equipment has been identified steps must then be taken to assess the performance of the equipment and ensure that it has been calibrated with references traceable back to National and International standards. Compliance with ISO15189 can be achieved through a UKAS Certificate of Calibration.
Equipment Qualification (EQ) is becoming increasingly important to analytical laboratories. For many laboratories it is no longer sufficient to just do things right: they must also provide documented evidence to demonstrate the integrity of their data and validity of their results.
Therefore it is important to determine:
- The instrument is fit for the purpose intended.
- Instrument is checked on an ongoing basis to ensure it meets your requirements.
European Instruments offer the Regulatory Services Compliance Package to meet this requirement.
This service includes a UKAS certificate of calibration.
USP41 (Update USP36-NF 31)
Demonstrates compliance with the United States Pharmacopeia Chapter 41 and 1251 for weighing equipment.
This is achieved by:
- Calibrating the instrument over the operating range.
- Assess the instruments against defined requirements repeatability.
- Assess the instruments against defined requirements accuracy.
- Calculating the operating range (minimum weight).
European Pharmacopoeia (EP) Chapter 2.1.7 Report
Report Coming Soon…
Functional check of your equipment to verify operation. Tested using references traceable back to International standards, this provides a cost effective solution when a full range calibration is not required.