The ISO 17034 Documentation Package is an essential resource for reference material producers (RMPs) that develop and distribute reference materials for testing, calibration, and research purposes. This package includes all the necessary documentation to help your organization comply with ISO 17034:2016, the international standard that specifies general requirements for the competence and consistent operation of reference material producers.

Comprehensive and well-structured documentation is key to ensuring accurate, reliable, and internationally recognized production of reference materials. From material characterization to metrological traceability, having robust documentation enhances operational efficiency, regulatory compliance, and accreditation success.

Why ISO 17034 Documentation Matters

Proper documentation plays a critical role in maintaining the quality, consistency, and traceability of reference materials. It serves as a structured roadmap for producing, certifying, and managing reference materials while demonstrating compliance with international accreditation requirements.

This package includes:

Key ISO 17034 Documentation Categories

Core ISO 17034 Documentation Requirements

Management System Documentation

To comply with ISO 17034:2016, reference material producers must maintain a structured management system that ensures competence, impartiality, and consistent production of reference materials. Essential documents include:

• Quality Manual – Outlines the RMP’s management system, scope, and policies for producing and certifying reference materials.
• Policies & Standard Operating Procedures (SOPs) – Define laboratory operations, from material characterization to certification.
• Risk and Opportunity Management Procedures – Identifies and mitigates risks affecting reference material quality and traceability.
• Impartiality and Confidentiality Documentation – Ensures the RMP operates independently and protects client and stakeholder information.

Reference Material Production and Certification Documentation

Detailed and well-documented production and certification processes ensure traceability, accuracy, and compliance. This package includes:

• Production Procedures – Step-by-step documentation of the manufacturing and preparation of reference materials.
• Material Characterization Methods – Validated procedures for determining the composition and properties of reference materials.
• Measurement Uncertainty and Traceability Records – Ensures the reliability and consistency of reference material data.
• Homogeneity and Stability Studies – Documents testing protocols for ensuring the uniformity and longevity of reference materials.
• Corrective and Preventive Action Procedures – Guidelines for addressing non-conformities and improving production processes.

Equipment and Resource Management Documentation

• Equipment Calibration and Maintenance Logs – Ensures measurement instruments meet accuracy requirements.
• Metrological Traceability Records – Documents links between measurement results and national/international standards.
• Environmental Condition Monitoring Records – Ensures compliance with laboratory conditions affecting reference material stability.

Legal and Contractual Documentation

• Reference Material Supply Agreements – Contracts outlining terms, conditions, and responsibilities between the RMP and clients.
• Confidentiality and Impartiality Declarations – Ensures staff and management uphold independence in material production and certification.
• Liability and Insurance Documents – Provides proof of coverage for reference material production and certification activities.

Continuous Improvement and Compliance Documentation

ISO 17034:2016 requires RMPs to document continuous improvement, internal audits, and corrective actions. This includes:

• Internal Audit Reports – Demonstrates compliance with ISO 17034 requirements.
• Management Review Reports – Evaluates RMP performance, risks, and improvement opportunities.
• Change Management Documentation – Handles revisions to production procedures, policies, and standards.

Ensure Compliance with ISO 17034:2016 Today!

Achieving ISO 17034:2016 accreditation can be complex, but with the ISO 17034 Documentation Package, your reference material production facility will have everything needed to streamline compliance and ensure internationally recognized reference material production processes.

💡 Get started today and take your reference material production to the next level with a structured, compliant, and efficient management system!