ISO 17034:2016 General Requirement for the Competence of Reference Material Producers
As a laboratory scientist or researcher, you often work with reference materials for method calibration, validation, general research, and quality control. The question is: How do you determine if the reference standard you use in lab experiments is completely reliable and able to be trusted?
Reliability in reference material is essential; any fault in the reference material can cause major imbalances and inaccuracies in your experiments. In severe cases, you may even have to start all over, losing a great deal of time, resources, and money.
The standard lays out detailed requirements for the manufacturers of reference materials to ensure their product’s technical competence, consistency, reliability, property value, and traceability. In this case, reference material pertains not just to typical textbooks or source material, but to materials that are more stable and homogeneous than other properties; these are properties that are used during all stages of the measurement process, including:
- Calibration of measurement systems.
- Evaluation of a measurement procedure.
- Assignment of property values.
- Quality control.
Earlier, these requirements were covered in ISO guide 34:2009, but it lacked some crucial procedures and requirements. Therefore, the ISO Committee on Conformity Assessment (CASCO) joined forces with the ISO Committee on Reference Materials (REMCO) to develop the new ISO 17034:2016 accreditation.
The standard consists of a general quality assurance procedure for producers and providers of certified reference materials (CRM). It is also used by accreditation bodies to assess third-party reference material producers (RMPs).
The purpose of this article is to explain all aspects of international standard ISO 17034:2016, how it is different from other standards, such as ISO/IEC 17025 and 9001, and its advantages for certified organizations.
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Basic Requirements of ISO 17034
The general ISO 17034 requirements for reference material producers (RMP) to achieve the accreditation certificate include:
- General Requirements, which include:
- Procedures to review and document the contractual matters of organizations.
- Instructions to safeguard impartiality in producing reference materials and certified reference materials.
- Information on keeping confidential matters.
- Structural Requirements: Specifies the assignment of duties and responsibilities to personnel and ensures effective communication between staff regarding the implementation of RMP standards.
- Resource Requirements: Includes the requirements to judge the competence of organizations’ personnel in manufacturing reference materials. It also contains procedures to ensure the ability of subcontractors (if they are involved with the reference material producer (RMP) in any part of the production, including processing, characterization, homogeneity, storage, or distribution).
- Technical and Production Requirements: Explains the end-to-end requirements for the production of reference materials, ranging from production planning, production control, handling and storage, measurement procedures, data integrity, and meteorological traceability of certified values.
- Management System Requirement: Documents the quality of the policy, control of records, period of internal audits, actions for risks and opportunities, and controlled management of system documents.
The Difference Between ISO 9001, 17025 & 17034 Explained
The International Organization for Standardization (ISO) has developed several standard quality assurance procedures for product manufacturers. Together, the standards ensure that users and customers receive quality and reliable products. Furthermore, it also assists the organizations in improving their quality management systems and the competence of their staff.
In addition to many others, the three most important certifications for standard manufacturers are ISO 9001, ISO 17025, and ISO 17034. These certifications are often combined, conflated, or otherwise closely associated with one another. They are also referred to as three levels of ISO accreditation. Let’s review each in a little more detail.
- ISO 9001 specifies general requirements for a quality management system applicable to any organization irrespective of the products and services it provides.
- It ensures that the organizations comply with the standard regulatory procedures for improved customer satisfaction with the products and services of the organization.
- As long as the organization maintains consistency in its ISO 9001 certified values and activities, it is likely to keep its ISO 9001 certification.
- ISO 17025 is an accreditation standard to ensure the competence of testing and calibration laboratories.
- It examines research and design operations, quotations and contracts, proficiency testing results, manufacturing, and quality control activities during the accreditation process.
- Its certification ensures that the laboratories generate legitimate results based on technical and management system requirements.
- It requires organizations to maintain both consistency and quality in their products and services.
- The ISO 17034 accreditation is created for any manufacturers involved in the production of reference materials.
- It evaluates the methods and procedures used by manufacturers for the certification of certified reference materials (CRM).
- An RMP accreditation assures that international standards are followed in the production, labeling, and determination of material properties, including stability and homogeneity properties.
- Compared to ISO 17025, it has an additional requirement for reliable and traceable manufacturing of products.
Why Is ISO 17034 Important?
ISO 17034 certification shows that a company or manufacturer can provide certified reference materials that have been subjected to metrologically valid procedures.
This standard enables the certified organizations to operate competently and gain consumers’ confidence in their products. Additionally, it offers many other advantages, including:
- Recognition of technical and scientific competence.
- Display of reference material production under a fully accredited system.
- Helps to build credibility and customer trust.
- Offers a competitive market advantage.
- Provides the opportunity for improved organizational outputs and efficiency.
- Improves product quality by ensuring impartiality in the production of reference materials.
- Exhibits the organizations’ expertise in producing reference materials.
- Builds consumer confidence in the safety and quality of reference material.
- Improves the ability of organizations to produce quality and validated results.
How Excedr Helps Labs Obtain Accreditations
An ISO 17034 accreditation enables reference material producers (RMPs) to ensure the quality of their reference standards and measuring instruments. Further, it also scaffolds trust among consumers for the quality and reliability of the reference materials. Obtaining an ISO 17034 certification benefits RMPs by increasing their reputation, credibility, and demonstrating their expertise in producing certified reference standards.
Excedr helps organizations qualify for accreditation requirements by procuring cutting-edge equipment on lease. Our tailored and flexible leasing program allows researchers, founders, and entrepreneurs to outfit their labs with the right equipment needed for accreditation standards.
Through our program, labs can avoid the huge expense of purchasing individual equipment outright and invest more time and money into obtaining accreditation certificates and high-quality results.
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