Common Errors That Impact Accuracy in ISO 17025 Documents: A Workflow Perspective

Accuracy in ISO 17025 documents is not just a matter of compliance—it is a direct reflection of the reliability, consistency, and professionalism of a laboratory. Whether a lab performs testing, calibration, or both, the effectiveness of its documentation lifecycle determines the quality of its outputs. Many common documentation errors are not isolated mistakes but symptoms of weaknesses in the workflow itself. By understanding how documentation flows through a laboratory’s operations, organizations can better identify where problems arise and how to eliminate them.

Mapping the Documentation Lifecycle in ISO 17025

In an ISO 17025-compliant laboratory, ISO 17025 documents pass through a structured lifecycle. This lifecycle generally consists of five steps:

1. Creation – Drafting procedures, forms, records, or technical documents
2. Review – Checking for accuracy, completeness, and consistency
3. Approval – Inclusion of signatures or digital authorization
4. Usage – Daily application of documents by laboratory personnel
5. Archiving – Proper maintenance, retention, and controlled storage

Each stage is critical. If one step is weak or poorly managed, documentation accuracy suffers. Most recurring errors occur because laboratories treat documentation as isolated activities instead of integrated workflow processes.

Where Common Errors Arise in the Documentation Lifecycle

1. Errors During Document Creation

This is one of the most vulnerable stages. Mistakes often happen when technical information is entered manually or when staff do not fully understand the processes they are documenting. Common examples include:

• Incorrect test data or formulas
• Misstated measurement units
• Missing method references
• SOPs that do not reflect actual laboratory practice

These errors linger throughout the document lifecycle if they are not detected early.

2. Review-Stage Weaknesses

Many laboratories struggle with inadequate review mechanisms. When reviews are rushed or conducted by untrained personnel, errors remain unnoticed. Typical issues include:

• Overlooking inconsistencies between related documents
• Failing to verify traceability and data accuracy
• Ignoring changes in equipment, standards, or methods

A weak review stage is the root cause of many audit findings.

3. Approval-Stage Issues

Documents may be accurate but still fail compliance requirements if approvals are mishandled. Errors often include:

• Missing signatures
• Incorrect version numbering
• Use of unauthorized or outdated approval formats

These issues reflect poor document control and create confusion during audits.

4. Errors Occurring During Usage

Even well-prepared documents fail if staff do not follow them correctly. Common mistakes include:

• Using outdated printed copies
• Skipping steps in procedures
• Inconsistent recordkeeping
• Modifying formats without authorization

In many cases, these errors reveal gaps in communication or training.

5. Issues in Archiving and Record Retention

Improper storage and retrieval can compromise accuracy. Problems may include:

• Incomplete records stored without supporting data
• Misfiled or missing documentation
• Poor digital archiving practices
• Incorrect retention schedules

When records cannot be retrieved quickly, auditors question their reliability.

Workflow Solutions to Prevent Documentation Errors

Improving accuracy requires improving the system—not just correcting individual issues. A workflow-focused approach offers sustainable results:

1. Implement Workflow Automation

Digital tools can ensure that:

• All documents follow the correct approval sequence
• Automatic version control is maintained
• Users always access the latest approved documents

Automation reduces human error and accelerates document flow.

2. Define Clear Role-Based Responsibilities

Every stage of the document lifecycle should have clearly assigned roles:

• Who drafts each type of document?
• Who reviews and verifies accuracy?
• Who approves and authorizes?
• Who monitors usage?
• Who manages archiving?

Clear ownership leads to accountability and consistent accuracy.

3. Strengthen Process Control

Ongoing monitoring keeps the workflow consistent. This may include:

• Accuracy checks built into routine operations
• Random sampling of technical records
• Monthly document status reviews
• Internal workflow audits

Strong process control ensures that mistakes do not multiply unnoticed.

4. Use Standardized Data Entry Systems

Consistency in formats reduces the chance of misinterpretation. Templates, controlled fields, and structured forms guide employees and prevent inconsistencies.

Conclusion

Accurate ISO 17025 documentation is not the result of individual actions but of a well-designed, well-managed workflow. By improving the entire documentation lifecycle—creation, review, approval, usage, and archiving—laboratories eliminate the root causes of many recurring errors. Ultimately, a strong workflow not only ensures accurate documents but also strengthens overall laboratory performance, audit readiness, and long-term accreditation success.

Accreditation Consultant which has knowledge about all standard of ISO accreditation as well as provide readymade documentation kits for various accreditation standards like ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17021, ISO/IEC 17024, ISO/IEC 17034,