ISO 17025 Document Review

ISO 17025 document review consists of examining laboratory quality documentation to determine how the requirements of ISO/IEC 17025 are addressed.

The objective is to identify documentation gaps, inconsistencies and areas that may require clarification before accreditation assessments or audits.

Why Is Document Review Important?

Document review is one of the most effective ways to prepare for ISO 17025 audits and accreditation activities.

A laboratory's quality manual, procedures, records and supporting documents provide evidence that requirements are defined and implemented.

Identifying weaknesses early helps reduce the risk of audit findings and supports continual improvement.

Documents Commonly Reviewed

Document review activities often include evaluation of:

• Quality Manual
• Document Control
• Competence and Authorization
• Corrective Actions
• Equipment and Metrology
• Analytical Procedures
• Internal Audits
• Complaint Handling
• Contract Review
• Management Review
• Risks and Opportunities

Typical Findings During Document Review

Common gaps identified during document review include:

• Missing or incomplete procedures
• Insufficient evidence supporting implementation
• Unclear responsibilities and authorities
• Incomplete equipment traceability
• Weak competence documentation
• Outdated or uncontrolled documents

Relationship Between Document Review and Audits

Document review is not an audit, but it is a key preparation activity.

By identifying potential issues before an assessment, laboratories can implement corrective actions and strengthen their documentation framework.

A structured document review contributes significantly to successful audit preparation.

Supporting ISO 17025 Preparation

Document review tools can assist laboratories by evaluating how ISO 17025 requirements are addressed within quality documentation.

Such tools support preparation activities but do not replace audits, accreditation assessments or formal compliance evaluations.

For a broader overview of the standard, visit the ISO 17025 Requirements Guide.

For audit preparation guidance, see the ISO 17025 Audit Guide.

For practical verification points, consult the ISO 17025 Checklist.