How to Identify Nonconformities in ISO 17034 Documents

Learn how to detect and prevent nonconformities in ISO 17034 documents through audits, reviews, and effective document control for smooth accreditation.

Maintaining well-structured and accurate documentation is a critical requirement for any Reference Material Producer (RMP) seeking ISO 17034 accreditation. The quality and compliance of your ISO 17034 documents directly influence your organization’s ability to demonstrate technical competence, traceability, and consistency in producing reference materials. However, identifying and resolving nonconformities in ISO 17034 documents is an essential part of maintaining a compliant and effective quality management system.

This article explains how to identify nonconformities in ISO 17034 documents, common areas where they occur, and best practices to prevent them.

Understanding Nonconformities in ISO 17034 Documents

A nonconformity refers to any deviation from the requirements stated in the ISO 17034 standard, your organization’s internal procedures, or other applicable quality management criteria. In simple terms, it means something in your documentation or practice does not meet what’s required.

Nonconformities may arise due to missing procedures, outdated information, inconsistent records, or failure to implement documented processes effectively. Early identification of these issues ensures smoother audits, prevents accreditation delays, and enhances confidence in your quality system.

Common Sources of Nonconformities in ISO 17034 Documentation

Before learning how to identify nonconformities, it’s important to recognize where they most often occur. Some of the most common areas include:

  1. Incomplete Procedures: Missing sections or lack of clarity in procedures related to production, testing, or quality control.
  2. Outdated Manuals: Manuals or SOPs not updated to reflect recent revisions of ISO 17034 or organizational changes.
  3. Improper Record Keeping: Missing calibration records, incomplete traceability data, or unsigned test reports.
  4. Inconsistent Implementation: Procedures documented but not followed in practice, creating gaps between “what is written” and “what is done.”
  5. Uncontrolled Documents: Lack of document version control or distribution logs, leading to confusion over current versions.
  6. Insufficient Training Records: Missing or incomplete training documentation for personnel involved in critical operations.

These are typically highlighted during internal audits or external accreditation assessments.

Steps to Identify Nonconformities in ISO 17034 Documents

  1. Conduct Regular Internal Audits

Internal audits are the primary mechanism to identify documentation nonconformities. Trained auditors should compare the content of ISO 17034 documents against standard requirements and actual practices. Check whether every clause of the standard is addressed and implemented as documented.

  1. Perform Document Review and Cross-Verification

Regularly review manuals, SOPs, and records to ensure they are current, accurate, and aligned with the latest version of the standard. Cross-check whether procedures correspond with on-site operations and laboratory practices.

  1. Use a Nonconformity Checklist

Develop a checklist that includes all key ISO 17034 clauses and associated documentation requirements. This helps systematically assess compliance and makes it easier to detect gaps such as missing records, outdated revisions, or uncontrolled formats.

  1. Compare Against Accreditation Body Findings

If your organization has undergone previous audits, review past audit reports and corrective action records. Many recurring nonconformities can be detected early by analysing historical data and ensuring that corrective actions were effective.

  1. Involve Competent Personnel

Engage qualified quality managers and technical experts in the document review process. Their subject-matter expertise can reveal subtle inconsistencies that might otherwise be overlooked, especially in technical procedures and measurement uncertainty documentation.

  1. Monitor Change Management

Whenever changes occur in reference material production, test methods, or quality systems, ensure that corresponding documents are updated. Uncontrolled or delayed updates are a common source of nonconformities.

  1. Validate Records and Traceability

Verify that all test data, calibration certificates, and reference material characterization records are traceable, signed, and dated. Missing or inconsistent records often trigger major nonconformities during accreditation audits.

Best Practices to Prevent Nonconformities

  • Establish a Document Control Procedure: Ensure that every document has a unique identification number, issue date, revision history, and approval signature.
  • Implement Periodic Reviews: Schedule semi-annual or annual reviews of all ISO 17034 documents to confirm their accuracy.
  • Train Staff on Documentation Compliance: Regular training helps staff understand their responsibilities in maintaining document integrity.
  • Use Controlled Templates: Standardized templates reduce formatting errors and maintain consistency across all documents.
  • Maintain Corrective Action Records: When a nonconformity is identified, record the root cause, action taken, and effectiveness verification.

Conclusion

Identifying nonconformities in ISO 17034 documents is not just an audit requirement — it’s an ongoing process that safeguards the credibility of your quality management system. By conducting regular audits, maintaining robust document control, and engaging skilled personnel, reference material producers can detect issues early and sustain compliance with ISO 17034 requirements. Consistent documentation review and timely corrective actions ensure continuous improvement and long-term accreditation success.

 


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