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.
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
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.
Document required for CLP Certification
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of CLP Certification
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 buyer approval in addition to enhanced performance.
The implementation process is described below:
Step 1
GAP Assessment
• GAP Assessment report as per CLP Certification checklist
Step 3
Training
• Training to Top Management
• Training to Employee's
Step 4
Implementation
• Verification of Documentation as per Checklist
• Internal Audit, Management Review Meeting & N-Closer for Internal Audit
Step 5
Audit Public Verification
• Verification by third party approval by CLP Approval
• Closer of Non-Conformetives
Year on Year
Yearly Compliance
• Support of Monthly & Quarterly Basis
FAQ
Clean Label Project Certification is an independent program that verifies the purity and transparency of consumer products. It involves rigorous testing to ensure products are free from contaminants like heavy metals, pesticides, and toxins, and promotes transparency in ingredient labelling.
Food and beverage manufacturers, dietary supplement companies, health and wellness product producers, personal care product manufacturers, cosmetic companies, and pet food producers can apply for Clean Label Project Certification.
Products eligible for certification include food and beverages, dietary supplements, personal care items, cosmetics, and pet foods. Each product category must meet specific criteria for contaminants and ingredient transparency.
The certification process involves submitting products for rigorous testing to check for contaminants and verify ingredient transparency. Products that meet the Clean Label Project’s standards are awarded certification, and they undergo ongoing monitoring to ensure continued compliance.
The time required for certification can vary depending on the product and the complexity of testing. Typically, the process involves an initial evaluation period followed by product testing, which can take several weeks to complete.
Certification costs can vary based on the type and number of products being tested, as well as the scope of the certification process. Companies should contact Clean Label Project for specific pricing information.
No, certification involves ongoing monitoring and periodic re-evaluation to ensure products continue to meet the Clean Label Project’s standards. Regular testing is required to maintain certification status.
Consumers can look for the Clean Label Project Certification seal on product packaging. Additionally, they can verify certification by visiting the Clean Label Project’s official website, which provides a list of certified products.