Shamkris Global Group

ISO 17034:2016 Accreditation

General requirements for the competence of reference material producers

What is ISO 17034 Accreditation?

ISO 17034 is an international standard that specifies general requirements for the competence and consistent operation of reference material producers. Reference materials are materials or substances with well-characterized properties used to validate measurement methods, calibrate instruments, and control the quality of measurements.

ISO 17034 outlines requirements for the production of reference materials, including the selection of appropriate materials, characterization of properties, preparation, homogeneity, stability, and documentation. The standard aims to ensure the reliability, accuracy, and traceability of reference materials, which are essential for achieving reliable and comparable measurement results in various fields, including chemistry, biology, environmental science, and engineering.

Key elements addressed in ISO 17034 include:

Management System Requirements: Establishing and maintaining a management system to ensure the competence and impartiality of the reference material producer.

Selection of Material: Criteria for selecting materials suitable for use as reference materials based on their intended application and properties.

Characterization of Properties: Methods for characterizing the properties of reference materials, including measurement uncertainty and traceability to appropriate measurement standards.

Homogeneity and Stability: Ensuring the homogeneity and stability of reference materials over time to maintain their validity and usefulness.

Production Process: Documented procedures for the production, packaging, labeling, and distribution of reference materials.

Quality Control: Implementing quality control measures to monitor and verify the quality and consistency of reference materials.

Documentation and Records: Maintaining comprehensive documentation and records of all activities related to the production and certification of reference materials.

ISO 17034 Accreditation

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Benefits of ISO 17034 Accreditation

Enhanced Credibility

Accreditation to ISO 17034 demonstrates that a reference material producer or laboratory has been independently assessed and found to comply with internationally recognized standards for competence and quality management. This enhances the organization's credibility and reputation, instilling confidence in customers and stakeholders.

Global Recognition

ISO 17034 accreditation is internationally recognized and accepted, facilitating trade and collaboration by ensuring that reference materials meet consistent quality standards across borders. Accredited organizations gain access to global markets and opportunities for international cooperation.

Compliance with Regulatory Requirements

Accreditation to ISO 17034 helps reference material producers and laboratories demonstrate compliance with regulatory requirements and industry standards. It ensures that reference materials used for regulatory purposes meet the necessary quality and traceability criteria, helping organizations avoid regulatory non-compliance issues.

Improved Quality and Consistency

ISO 17034 accreditation promotes the adoption of robust quality management systems and standardized processes for the production, characterization, and distribution of reference materials. This leads to improved quality and consistency of reference materials, resulting in more reliable and accurate measurement results.

Risk Mitigation

Accredited organizations mitigate the risk of producing substandard or unreliable reference materials by adhering to ISO 17034 requirements. Accreditation provides assurance that reference materials are produced using validated methods, calibrated instruments, and rigorous quality control measures, reducing the likelihood of errors and inaccuracies.

Customer Confidence

ISO 17034 accreditation reassures customers and stakeholders that reference materials supplied by accredited organizations are of high quality, reliable, and traceable to international measurement standards. This enhances customer confidence and satisfaction, leading to repeat business and positive word-of-mouth referrals.

Who can apply for ISO 17034 Accreditation?

ISO 17034 accreditation is intended for organizations involved in the production, characterization, and distribution of reference materials. Therefore, the entities eligible to apply for ISO 17034 accreditation include:


Laboratories engaged in the production or preparation of reference materials for internal use or distribution to other laboratories. These laboratories must adhere to ISO 17034 requirements in their reference material production processes.

Research Institutions

Institutions involved in developing and validating measurement methods, as well as producing reference materials for research purposes. These institutions may seek ISO 17034 accreditation to affirm the quality and reliability of their reference materials.

Government Agencies

Government bodies responsible for setting and maintaining national measurement standards, conducting metrological research, or overseeing regulatory compliance. These agencies may apply for ISO 17034 accreditation for their reference material production activities.

Commercial Entities

Commercial entities engaged in manufacturing and distributing reference materials for specific industries or applications, such as pharmaceuticals, environmental analysis, automotive, and aerospace. These entities are eligible for ISO 17034 accreditation to enhance the quality and credibility of their products.

Who can issue ISO 17034 Accreditation ?

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Approved Agency
Approved Agency

Documents Required for ISO 17034 Accreditation

The extent of Documented Information differs as per:

Role of Shamkris and Process of ISO 17034 Accreditation

Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain an accreditation body of success in addition to enhanced performance.

The implementation process is described below:

Time Frame



Day 1

GAP Analysis
Cost Estimates
Application to Accreditation Body

Week 1

Developing Documents

Week 4

Implementing Management System

Week 8

Internal Audit

Week 10

Accreditation Body
N-C Closing

Week 12

Accreditation Body

Year on Year

Yearly Compliance


ISO 17034 accreditation is a formal recognition that a reference material producer or laboratory has demonstrated competence in accordance with international standards for the production, characterization, and distribution of reference materials.

Organizations involved in the production, characterization, and distribution of reference materials are eligible to apply for ISO 17034 accreditation. This includes reference material producers, laboratories, research institutions, government agencies, commercial entities, and proficiency testing providers.

ISO 17034 accreditation offers several benefits, including enhanced credibility, global recognition, compliance with regulatory requirements, improved quality and consistency of reference materials, risk mitigation, customer confidence, facilitated collaboration, and a commitment to continuous improvement.

The ISO 17034 accreditation process typically involves an assessment by an accreditation body to determine compliance with the requirements of the standard. This assessment may include a review of documentation, onsite audits, proficiency testing, and evaluation of quality management systems.

The duration of ISO 17034 accreditation varies depending on factors such as the accreditation body’s policies, the results of the assessment, and any ongoing surveillance or reevaluation requirements. Accreditation is typically valid for a specified period, after which organizations may need to undergo reassessment or renewal.

ISO 17034 accreditation is not mandatory, but it may be required or preferred by customers, regulators, or other stakeholders as a demonstration of competence and quality assurance in reference material production.

Accreditation bodies that offer ISO 17034 accreditation services can be found through directories provided by national accreditation bodies or international organizations such as the International Laboratory Accreditation Cooperation (ILAC).