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ISO 17034

ISO 17034 Documentation Kit

Clause-mapped documentation for reference material producers seeking accreditation — quality manual, 20+ procedures covering production, characterization, homogeneity and stability testing, and a full audit pack.

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What's included

Every file in the kit is an editable Word document (.docx) with inline guidance notes that tell you exactly what to customize for your organization.

  • ✓ Quality Manual (clause-mapped to ISO 17034:2016)
  • ✓ Document and Records Control Procedure
  • ✓ Impartiality and Confidentiality Policy
  • ✓ Personnel Competence and Training Procedure
  • ✓ Premises, Equipment, and Reference Standards Procedure
  • ✓ Reference Material Development and Design Procedure
  • ✓ Material Procurement and Receipt Procedure
  • ✓ Production and Processing Procedure
  • ✓ Homogeneity Testing Procedure
  • ✓ Stability Testing Procedure (Short-Term and Long-Term)
  • ✓ Characterization of Property Values Procedure
  • ✓ Uncertainty of Certified Values Procedure
  • ✓ Selection and Use of Reference Methods Procedure
  • ✓ Subcontractor and Collaborating Laboratory Management Procedure
  • ✓ Certification of Reference Materials Procedure
  • ✓ Reference Material Certificate Template
  • ✓ Packaging, Labeling, and Storage Procedure
  • ✓ Distribution and Transport Procedure
  • ✓ Post-Distribution Monitoring Procedure
  • ✓ Nonconforming Product and Service Procedure
  • ✓ Complaints Procedure
  • ✓ Internal Audit Procedure
  • ✓ Management Review Procedure
  • ✓ Corrective Action and Continual Improvement Procedure
  • ✓ Batch Production Record Template
  • ✓ Homogeneity and Stability Data Summary Form
  • ✓ Internal Audit Checklist (all clauses)
  • ✓ Internal Audit Report Template
  • ✓ Management Review Agenda & Minutes Template
  • ✓ Clause-Coverage Matrix (ISO 17034:2016)

What’s in the kit

The AccreditationKit ISO 17034 Documentation Kit is a clause-mapped documentation package for reference material producers (RMPs) seeking accreditation under ISO 17034:2016. It covers the full production lifecycle — from material design and procurement through characterization, homogeneity and stability testing, certification, and post-distribution monitoring.

Who it’s for

Organizations that produce certified reference materials (CRMs), reference materials (RMs), or in-house reference standards used for calibration, method validation, or quality control — including specialist chemical producers, national metrology institutes, and laboratory supply companies building or formalizing an accredited RM production program.

The customize-and-adopt value proposition

ISO 17034 is highly technical: the homogeneity and stability testing requirements, the statistical treatment of certified values, and the uncertainty budgets for property values are all areas where assessors look closely. The procedures in this kit include worked guidance explaining which statistical approaches are acceptable under the standard, what the assessor expects to see in your batch records, and how to structure your certificate. You adapt the structure to your specific materials; the technical framework is already in place.

Clause coverage

The Clause-Coverage Matrix maps every clause of ISO 17034:2016 to the document(s) that address it, including the normative annexes on homogeneity and stability testing. It is the most technically detailed clause matrix in the AccreditationKit range.


Legal notice. These templates are editable tools that you customize and implement within your organization. Purchase of this kit does not guarantee accreditation. Accreditation is granted solely by recognized accreditation bodies based on their independent assessment of your management system and technical competence. AccreditationKit is not affiliated with, endorsed by, or approved by any accreditation body.

Legal notice. These templates are editable tools that you customize and implement within your organization. Purchase does not guarantee accreditation. Accreditation is granted solely by recognized accreditation bodies based on their independent assessment of your management system and technical competence. AccreditationKit is not affiliated with, endorsed by, or approved by any accreditation body.