Top 10 ISO 17025 Documents Required for Lab Accreditation

Laboratories seeking ISO 17025 accreditation must demonstrate both technical competence and a well-documented quality management system. ISO/IEC 17025:2017 is the international standard used by testing and calibration laboratories to ensure they are capable of producing valid results. Documentation plays a critical role in this process, as it not only supports compliance but also promotes consistency, accuracy, and continual improvement.

Below are the top 10 ISO 17025 documents every testing or calibration lab need for successful accreditation, as recommended by professional consultancy services such as Accreditation Consultancy.

1. ISO 17025 Manual

Even though ISO/IEC 17025:2017 does not mandate a formal quality manual, many laboratories continue to use it as a foundational document. The ISO 17025 manual provides a structured overview of the quality management system (QMS), outlining the lab's scope of services, quality policies, procedures, and responsibilities.

Why it matters:

• Acts as a centralized reference document.

• Demonstrates the lab’s understanding of the standard.

• Useful for training and internal communication.

2. Quality Policy and Objectives

These documents define the lab’s mission and strategic goals related to quality. The quality policy expresses the lab's commitment to impartiality, competence, and continual improvement, while the objectives provide measurable targets.

Why it matters:

• Provides direction for the entire organization.

• Required under Clause 8.2 of ISO 17025.

3. Document and Record Control Procedure

This procedure outlines how the lab manages ISO 17025 documents, including creation, approval, distribution, updates, and archiving. It ensures that only the latest and approved documents are in circulation.

Why it matters:

• Prevents the use of outdated or unauthorized documents.

• Ensures traceability and accountability.

4. Standard Operating Procedures (SOPs)

SOPs are essential for ensuring consistent performance of testing and calibration activities. These documents cover methods, sample handling, environmental controls, equipment usage, and more.

Why it matters:

• Ensures consistency and reliability in lab operations.

• Aids in training and performance monitoring.

5. Equipment Calibration and Maintenance Records

These records include calibration schedules, certificates, maintenance logs, and equipment verification data. They demonstrate that lab instruments are functioning correctly and are traceable to national or international standards.

Why it matters:

• Ensures accurate measurement results.

• Critical for compliance with Clause 6.4 (Equipment).

6. Personnel Competence and Training Records

These documents record staff qualifications, training, skills, and experience. ISO 17025 requires laboratories to ensure all personnel are competent to perform assigned tasks.

Why it matters:

• Confirms compliance with Clause 6.2 (Personnel).

• Provides evidence during audits.

7. Internal Audit Procedure and Records

Internal audits evaluate the effectiveness of the lab’s QMS and identify areas for improvement. This procedure outlines the audit schedule, responsibilities, and reporting process.

Why it matters:

• Supports continual improvement.

• Helps labs detect issues before external audits.

8. Management Review Procedure

ISO 17025 requires regular reviews by top management to ensure the QMS remains suitable and effective. The procedure defines review frequency, inputs (e.g., audit results, customer feedback), and outputs (e.g., actions for improvement).

Why it matters:

• Reinforces management accountability.

• Ensures long-term system performance.

9. Corrective and Preventive Action Procedure

This document describes how the lab addresses non-conformities, investigates root causes, and implements corrective or preventive measures. It also includes tracking and verification of effectiveness.

Why it matters:

• Ensures problems are properly resolved.

• Reduces recurrence of issues and strengthens compliance.

10. Customer Feedback and Complaint Handling Procedure

Capturing and resolving customer complaints is crucial for maintaining credibility and improving service quality. This document details how the lab receives, investigates, and responds to complaints.

Why it matters:

• Demonstrates responsiveness and accountability.

• Required for customer satisfaction and continual improvement.

Additional Supporting Documents

In addition to the top 10, labs may also maintain:

Risk Assessment Documents: Required for evaluating potential risks to impartiality or validity of results.

Audit Checklists: Ensure full clause coverage during internal audits.

Blank Forms and Exhibits: For capturing test data, approvals, and observations.

AccreditationConsultancy.com provides complete ISO 17025 document kits, including manuals, procedures, and editable templates to help labs save time and reduce the complexity of compliance.

Conclusion

Documenting your quality system isn’t just a formality—it’s a strategic investment in the consistency, credibility, and success of your lab. From the ISO 17025 manual to SOPs, audit procedures, and calibration records, these essential ISO 17025 documents provide the structure necessary to achieve and maintain accreditation.

Building a compliant documentation system might seem daunting, but with the right resources and templates, your lab can streamline the process and focus on what matters most: delivering valid and reliable results.