How to Prepare ISO 17025 Documents for Accreditation Assessment

Preparing ISO 17025 Documents for an Accreditation Assessments is one of the important steps in achieving laboratory accreditation. Many laboratories face non conformities during assessments due to incomplete, outdated or poorly developed documentation. Accreditation bodies evaluate not only how a laboratory performs its activities, but also how effectively those activities are documented, controlled, and implemented. Well-prepared ISO 17025 documents act as evidence of competence, consistency, and compliance.

This blog explains how laboratories can systematically prepare ISO 17025 documents to ensure a smooth and successful accreditation assessment.

Understanding the Role of Documentation in ISO 17025 Assessment

ISO 17025 is a documentation-driven standard. During an accreditation assessment, assessors rely heavily on documented information to verify that laboratory processes are defined, controlled, and consistently followed. Documents describe “what should be done”, while records demonstrate “what has been done”. Together, they provide objective evidence of conformity.

Proper documentation helps assessors evaluate technical competence, traceability of results, impartiality, risk-based thinking, and management system effectiveness. Without clear and controlled documents, even well-executed laboratory practices may fail to meet assessment expectations.

Categorizing ISO 17025 Documents

Before preparing documents for assessment, it is important to understand their structure. ISO 17025 documents generally fall into three categories.

Management system documents include quality policies, objectives, risk management procedures, internal audit procedures, and management review processes.
Technical and process documents cover test and calibration methods, SOPs, equipment handling procedures, validation records, and uncertainty calculations.
Supporting records include training records, calibration certificates, test reports, audit reports, corrective action records, and customer feedback logs.

Organizing documents under these categories helps laboratories present information clearly during assessment.

Ensuring Effective Document Control

Document control is one of the most commonly assessed areas. Laboratories must ensure that all documents are approved, version-controlled, and accessible at points of use. Obsolete documents should be removed or clearly marked. A master list of documents helps demonstrate control and avoids confusion during assessment.

Poor version control, unsigned documents, or uncontrolled formats often lead to nonconformities, even if the content itself is correct.

Common Documentation Mistakes to Avoid

Many laboratories make similar documentation mistakes before assessment. These include using generic templates that do not match the laboratory’s scope, maintaining outdated procedures, missing records for key activities, and inconsistencies between documented procedures and actual practices.

Another frequent issue is over-documentation. Excessive or unnecessary procedures can complicate implementation and create gaps between documents and practice. Documentation should be adequate, relevant, and practical.

Pre-Assessment Documentation Checklist

Before the accreditation assessment, laboratories should verify that all key documents and records are complete. Approved procedures should be available for all activities within scope. Internal audits and management reviews should be conducted and documented. Risk assessments, corrective actions, and calibration records must be up to date. Training and competency records should clearly demonstrate staff capability.

Conducting a thorough document review well before the assessment helps identify and close gaps proactively.

Role of Internal Audits in Documentation Readiness

Internal audits play a vital role in preparing ISO 17025 documents for assessment. They help verify whether documents are implemented effectively and whether records provide sufficient evidence of compliance. Audit findings related to documentation should be addressed through corrective actions and verified for effectiveness before the accreditation visit.

Handling Document Review During Assessment

During assessment, documents should be organized and easy to retrieve. Assigning a responsible person to manage document requests helps avoid delays and confusion. Laboratories should present only relevant documents and provide clear explanations supported by records.