What Mandatory Procedures are Required for the ISO 17034 Accreditation Process?

The general requirements for the proficiency and reliability of reference material producers are outlined in the ISO 17034 standard. Reference materials (RMs) are utilized for method validation, calibration, and quality control at every stage of the measurement process. They are also utilized in interlaboratory comparisons to evaluate laboratory competence and validate methods.

A fundamental criterion for guaranteeing the quality of reference materials (RMs) is for reference material producers (RMPs) to demonstrate their technical and scientific expertise. The requirement for RMs of greater quality is increasing as a result of both increased measurement equipment precision and the need for more precise and trustworthy data in the scientific and technological disciplines. RMPs must not only supply information on their materials in the form of RM documents but also show that they are capable of creating RMs of the appropriate quality.

The creation of CRMs is included, along with all other forms of RMs. There is a comment in the scope that makes it clear that regulatory agencies and accreditation organizations may also utilize ISO 17034:2016 to evaluate the proficiency of RMPs. The overall advantages of ISO 17034 accreditation include trade gains in the market, acknowledgement of expertise in the creation of reference materials, assistance in lowering organizational expenses, and these benefits. It has been demonstrated that accreditation boosts organizational effectiveness and the marketing of RMPs.

An important prerequisite for individuals who create certified reference materials (CRM) is ISO 17034 accreditation, which also serves as proof of both technical and scientific proficiency for RMPs. The need for new RMs of greater quality is growing as a result of enhanced measuring tool precision as well as the need for more accurate and trustworthy data in the scientific and technological disciplines. ISO17034 documentation that is well-written and arranged is required for RMP accreditation. Documentation required for ISO 17034 accreditation must comprise the ISO 17034 manual, ISO 17034 procedures, records, SOPs, formats for different activities, audit checklists, etc. The overall goal of the documents is to support reference material producers in ISO 17034 documents and give assurance to their customers, regulating authorities, accreditation bodies that are associated with them, as well as ISO 17034 consultants that the reference material producers satisfy all the documentation requirements as per the standard.

List of Mandatory Procedures for ISO 17034 Accreditation

Below is the list of mandatory documents of ISO 17034 accreditation procedures that are required to complete the accreditation procedure: 

• Procedure for establishing the quality of materials as a component of the management system
• Procedure for data evaluation
• Procedure for material handling, storage and transportation
• Procedure for preparation of processing procedures
• Procedure for undertaking characterization
• Procedure for identification, labelling and packaging facilities, packing and delivery
• Procedure for production of reference materials
• Procedure for protection of customer’s confidential information and proprietary rights
• Procedure to avoid involvement in any activities that might diminish confidence in its competence, impartiality, judgment or operational integrity
• Procedure for Document and Data Control
• Procedure for review of request, tender and contracts
• Procedure for subcontracting
• Procedure for procurement of services and supplies
• Procedure for Complaint Handling
• Procedure for Control of non–non-conforming work and reference materials
• Procedure for Corrective Action
• Procedure for Control of Records
• Procedure for Internal Audit
• Procedure for Management Review
• Procedure for Personnel and Training
• Procedure for production planning and implementation
• Procedure for production control
• Procedure for accommodation and environment
• Procedure for material processing
• Procedure for measurement method
• Procedure for measuring equipment
• Procedure for protecting the integrity of data
• Procedure for metrological traceability
• Procedure for assessment of homogeneity
• Procedure for assessment of stability
• Procedure for assignment of property values and calculation of uncertainty of measurement

Recognize the Changes in the ISO/IEC 17043:2023 Proficiency Testing Standard as Per the Revised Standard

ISO 17043:2023 Standard

The general requirements for the creation, management, and expertise of proficiency testing scheme providers are outlined in ISO/IEC 17043. These specifications can serve as the basis for more detailed technical specifications for particular domains and are meant to be general for all types of proficiency testing schemes. It is commonly acknowledged that proficiency testing (PT) is a crucial instrument for proving the expertise of conformity assessment bodies. PT can demonstrate expertise and act as a warning sign for hidden or developing issues. The goal of the ISO 17043:2023 documents helps to increase trust in how PT providers conduct their business. It includes specifications for PT providers so they may prove their proficiency and ability to produce reliable assessments of participant performance. The following parties can utilise and comply with ISO 17043 international standard:

• Testing and calibration laboratories
• Legal regulation by governments and regional agreements
• Industrial and professional standards

The proficiency testing (PT) version of the ISO 17043:2023 standard was released in its second edition by the International Organisation for Standardisation (ISO). An expert group comprised of individuals chosen by their respective national standards bodies prepared the revised versions of the standard. A few modifications have been made to the standard’s technical specifications. For all conformity assessment documents to comply with the most recent ISO criteria, there have been numerous adjustments made. In addition, many of the structural criteria of the new standard are more closely aligned with those of ISO/IEC 17025:2017. For PT providers with labs or who provide reference materials, the majority of these changes will be familiar.

On May 8, 2023, the conformity assessment standard ISO/IEC 17043, General Requirements for the Competence of Proficiency Testing Providers, was released. The standard review process started in 2020, and the final voting started in January 2023. The original edition, ISO/IEC 17043:2010, is replaced by this revision, which is the second edition of the standard. By emphasising in the Introduction that PT can be applied to any aspect of conformity assessment, the new document, in a significant way, acknowledges the applications of PT outside of testing and calibration. There are now accredited PT programmes that present difficulties in the areas of inspection, sample, result interpretation, and individual competency. The first version (ISO/IEC 17043:2010), which has been technically amended, has been revoked and replaced by this second edition.    

The Reasons Behind the ISO/IEC 17043 Revisions:

• Add fresh CASCO common elements
• Editorial alterations to illustrative Annexes
• Clarify the PT for inspection and sampling in the technical specifications
• Align with other CASCO standards, including ISO 13528, Statistical Methods, ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, and ISO 17034
• Update the management system’s structure, bibliographies, and other components that are out-of-date
• Modernise the symbols used in statistical calculations

The key changes to ISO/IEC 17043 standard:

• Extending the definition of PT to include inspection and sampling in addition to the presently listed test and calibration as additional forms of conformity assessment activities
• Harmonisation with the new ISO/IEC 17025 standard, including the formal specifications in accordance with the definitions, phrases, and symbols used in statistics in ISO 13528:2016
• Combination of requirements from ISO/CASCO PROC 33
• Including the need that testing, calibration, and the production of PT items adhere to the pertinent requirements of the pertinent ISO conformity assessment standards
• Risk-based thinking is introduced in the updated standard
• Removal of Annex C and revision of Annexes A and B (Informative)