KROMEGA - Traceability

CERTIFIED REFERENCE MATERIALS

Who / What Are The Regulations?
Organisations working within regulated environments such as Pharmaceuticals (FDA/ USP) and Agrochemicals (EPA) are required to provide documented evidence of the calibration/ qualification status of an instrument.

What Is ISO Guide 17034:2016?
ISO Guide 17034:2016 is an international standard which defines the requirements which must be adhered to in order to become an accredited reference material producer.

Who Are UKAS?
UKAS are the United Kingdom Accreditation Service, which is the UK's independent body responsible for the accreditation of organisations to a huge scope of national and international standards.

UKAS is the UK equivalent to ACLASS in the USA, DAkkS in Germany and JAB in Japan along with many other national bodies throughout the world. As such, UKAS work to the international agreement for Certification Bodies, thus certification carries a global stamp of approval.

CRM & The Data Quality Triangle
USP <1058> details the hierachy of Data Quality and works on the theory that "confidence in a higher level relies on completion of lower levels".

How kromega Certified Reference Materials impact on the Data Quality Triangle

kromega products underpin the lowest layer of the triangle and therefore underpin all of your data.

Because of our Accreditation to ISO Guide 34, you can rest assured that our standards provide the vital traceable link to internationally observed standards, without which all calibration is regarded as suspect, thus undermining your data

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Kromega Certified Reference Materals

Kromega CRMs. Fully certified.