Have you heard about ISO 33401? Here’s a look at the new reference material standard for certificates, labels, and accompanying documentation.
ISO 33401:2024 – Reference materials — Contents of certificates, labels and accompanying documentation is an international standard intended to compliment ISO 17034:2016 – General requirements for the competence of reference material producers.
Until recently, ISO 33401 was referred to as Guide 31. This guide was created to assist reference material producers (RMPs) in creating clear, concise, and compliant documentation for their reference materials (RMs) and certified reference materials (CRMs). RMs are essential for many fields of measurement, quality assurance, calibration, and validation, and the organizations that use them rely on the information provided to support their results. Guide 31 offers standardization of the requirements for all certificates, labels, and accompanying documentation. Some attributes in section 7.14 RM documents and labels of ISO 17034:2016 have been misinterpreted throughout the years but Guide 31 brought clarity for RMPs to provide the necessary information accurately and efficiently.
Guide 31 was first published by the ISO Committee on Reference Materials (ISO/REMCO) in 1981. This first edition focused on a brief synopsis of the certificate. In 2000, the second edition brought light to the required content of the certificate of a certified reference material (CRM). The third and final edition in 2015 pressed the concepts of a “product information sheet” and a “reference material certificate.” Fast forward to 2024, the ISO/TC 334 group supersedes Guide 31 and publishes the first edition of ISO 33401.
ISO 33401 focused on the requirements from section 7.14 of ISO 17034 and explains the intent for each clause. These clauses are short and simple, but some leave room for broad interpretation. For example, part e. intended use in ISO 17034, leaves a lot of wiggle room to meet compliance. However, section 5.2.6 in ISO 33401 describes the necessary details that need to be included and offers several examples for both RMs and CRMs. Similarly, section 5.2.11 Instructions for handling and use provides various examples that may not have been considered previously and would be helpful for the end users. Section 4 discusses using “product information sheet” for all RMs but only using “reference material certificate” for CRMs. This distinction helps to separate the additional requirements for CRMs. Another beneficial section is 5.3.1 Description of the material for RM certificates. This discusses specifics that should be included in CRM descriptions to ensure appropriate applications, with consideration to the composition, matrix, analytical methods etc.
There are potential risks and misunderstandings surrounding this standard. Given that ISO 33401 was recently published, it’s currently a complimentary document for ISO 17034 and is not mandatory under Global Accreditation Cooperation Incorporated. RMPs can maintain their accreditation without ISO 33401. Additionally, A2LA does not currently audit to ISO 33401. The standard provides insight but also examples for several of the requirements. These examples are just that; examples. And they may not fit every RMP. Lastly, this has great information but RMPs are still responsible for ensuring their final documentation is applicable and appropriate for their materials and field.
ISO 33401 provides clear requirements for RMPs to demonstrate technical competence, consistency, and reliability across their operations. By clarifying requirements for production, characterization, documentation, and quality assurance, the standard supports confidence in reference materials and their appropriate use by users. ISO 33401 helps promote harmonization, traceability, and continual improvement, contributing to the overall quality and credibility of measurement results across various fields.
Want to learn more about ISO 33401? Contact A2LA at info@A2LA.org or give us a call at 301.644.3248. Ready to start your accreditation journey? Request a quote today: A2LA.org/estimate-request.