The general requirements for the competency of reference
material producers (RMPs) are outlined in the international standard ISO 17034.
For businesses, labs, and institutions that depend on precise and trustworthy
reference materials (RMs) for quality assurance, calibration, and testing, it
is essential. Credibility of results, consistency in production, and
international acceptance of reference materials are all made possible by the
standard.
What is the ISO 17034 Standard?
The requirements specified by ISO 17034:2016 are what RMPs
must fulfil to prove their technical proficiency and capacity to generate RMs
that satisfy their clients' demands. The production process, the quality
management system, and the technological specifications that affect the RMs'
integrity and quality are all covered by the standard. To create a unified
structure that ensures measurement accuracy and comparability across the globe,
ISO 17034 closely connects with other ISO standards, including ISO/IEC 17025
(testing and calibration laboratories) and ISO 15189 (medical laboratories).
In addition to imparting fundamental knowledge of the ISO
17034:2016 standard, the online ISO 17034 awareness training provides an extensive understanding of the criteria for
reference material manufacturers. Participants who successfully finish this
course will have a thorough understanding of the ISO 17034:2016 standard.
Difference Between ISO 17025 and ISO 17034
ISO 17025-2 vs. ISO 17034-0 With the specific purpose of
offering a framework to reference material producers (RMPs), ISO 17034:2016 is
in line with the necessary details of ISO/IEC 17025:2017, the standard for the competence
of testing and calibration laboratories. Through the use of stability and
homogeneity studies, statistical criteria, manufacturing and transport
requirements, and other subjects, ISO 17034 builds upon the technical
requirements of testing and applies them directly to the production of RMs. ISO
17034 includes traditional ISO 9001 requirements as well as the technical
ISO/IEC 17025 requirements relevant to any testing conducted by an RMP.
The Importance of ISO 17034 Standard for RMPS
·
Ensures Results Are Accurate and Dependable: The validation of testing
procedures, instrument calibration, and laboratory performance evaluation all
depend on reference materials. Reliability and accuracy of tests and
measurements are guaranteed by using RMs generated by ISO 17034. Since
incorrect outcomes can have serious repercussions, this is especially crucial
in industries like medicines, environmental testing, and food safety.
·
Improved the Competence for Reference Material Producers: ISO 17034 gives a framework for RMPs
to establish procedures and maintain technical competence. It supports
producers in displaying their capacity to regularly generate RMs of the highest
quality. Establishing confidence with clients that depend on these products for
their testing and calibration requirements is essential.
·
Promotes Mutual Recognition and International Trade: The requirement for harmonized
standards grows as trade between countries rises. By offering internationally
recognized standards for RM production, ISO 17034 contributes to the removal of
technological barriers. Through mutual recognition, reference materials are
more widely accepted worldwide, promoting trade and collaboration across a
range of industries.
·
Encourages Compliance with Regulations: Certified reference materials (CRMs) are required to
be used in many industries due to strict regulatory requirements. To ensure
that the RMs generated are appropriate for their intended use and adhere to
industry standards, ISO 17034 accreditation aids in RMP compliance with these
requirements. This is particularly important in industries where standard
compliance is required, such as healthcare, environmental protection, and
manufacturing.
·
Encouraged to Continual Improvements: RMPs are encouraged by ISO 17034 to have a quality
management system that consists of ongoing monitoring, reviews, and continuous
improvement. RMPs can detect opportunities for improvement, maintain the
integrity of their processes, and adjust to the changing demands of the market
thanks to this quality-focused approach. Sustaining competitiveness and keeping
ahead with technical changes require constant improvement.
·
To Builds Customers Confidence: A dedication to excellence, reliability, and technical
proficiency is evidenced by ISO 17034 accreditation. Customers are more
confident as a result, knowing that the RMs they buy are made to the greatest
standards. The assurance that these materials provide is vital for labs,
manufacturers, and other users who depend on them to verify their procedures
and uphold superior results.
·
Reduces Risks and Mistakes: RMPs are assisted by ISO 17034 in recognizing and
controlling risks related to RM production. Producers can eliminate errors,
minimize variability, and guarantee material traceability by following the
requirements of the standard. This risk management strategy improves the
overall dependability of RMs and helps avoid expensive errors.
Applications of ISO 17034 Standard
ISO 17034 used across various industries like,
·
Medicines:
Using reliable testing and calibration to guarantee the effectiveness and
purity of medications.
·
Environmental Testing: Keeping a check on contaminants and making sure rules
governing the environment are followed.
·
Food and Beverage: Verifying quality and safety using precise contamination and nutritional
content testing.
·
Healthcare:
Assisting diagnostic labs in delivering precise test findings to patients.
·
Manufacturing:
Using precise measurements and quality control procedures to guarantee product
quality.
