Why Do We Need ISO 17034 for Reference Material Producers?

 

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.