The ISO/IEC 17025 Documentation Package is a must-have for testing and calibration laboratories seeking compliance with ISO/IEC 17025:2017, the international standard that defines requirements for the competence, impartiality, and consistent operation of laboratories.

Comprehensive and well-structured documentation is key to ensuring accurate, reliable, and internationally recognized testing and calibration results. From method validation to quality assurance, having robust documentation enhances operational efficiency, regulatory compliance, and accreditation success.

Why ISO/IEC 17025 Documentation Matters

Proper documentation is essential for maintaining the integrity, accuracy, and traceability of your laboratory’s operations. It serves as a structured framework for ensuring consistent testing, calibration, measurement accuracy, and regulatory compliance with national and international accreditation bodies.

This package includes:

Key ISO/IEC 17025 Documentation Categories

Core ISO/IEC 17025 Documentation Requirements

Management System Documentation

To comply with ISO/IEC 17025:2017, laboratories must maintain a structured management system that ensures competence, impartiality, and consistent operations. Essential documents include:

• Quality Manual – Outlines the laboratory’s management system, scope, and policies for ensuring testing and calibration quality.
• Policies & Standard Operating Procedures (SOPs) – Define laboratory operations, from sample handling to reporting results.
• Risk and Opportunity Management Procedures – Identifies and mitigates risks affecting test and calibration results.
• Impartiality and Confidentiality Documentation – Ensures the laboratory operates independently and protects client information.

Testing and Calibration Process Documentation

Detailed and well-documented laboratory processes ensure traceability, accuracy, and compliance. This package includes:

• Test and Calibration Methods – Validated methodologies for conducting accurate tests and calibrations.
• Uncertainty Measurement and Traceability Records – Ensures the reliability of laboratory measurements.
• Corrective and Preventive Action Procedures – Guidelines for addressing non-conformities and improving processes.
• Proficiency Testing and Interlaboratory Comparison Records – Demonstrates laboratory competence through external verification.

Equipment and Resource Management Documentation

• Equipment Calibration and Maintenance Logs – Ensures laboratory instruments meet accuracy requirements.
• Reference Material and Traceability Records – Maintains links between measurement results and national/international standards.
• Environmental Condition Monitoring Records – Ensures compliance with laboratory conditions affecting test and calibration outcomes.

Legal and Contractual Documentation

• Service Agreements with Clients – Defines laboratory responsibilities, confidentiality, and terms of service.
• Confidentiality and Impartiality Declarations – Ensures staff and management uphold independence in laboratory activities.
• Liability and Insurance Documents – Provides proof of coverage for laboratory services.

Continuous Improvement and Compliance Documentation

ISO/IEC 17025:2017 requires laboratories to document continuous improvement, internal audits, and corrective actions. This includes:

• Internal Audit Reports – Demonstrates compliance with ISO/IEC 17025 requirements.
• Management Review Reports – Evaluates laboratory performance, risks, and improvement opportunities.
• Change Management Documentation – Handles revisions to testing procedures, policies, and standards.

Ensure Compliance with ISO/IEC 17025:2017 Today!

Achieving ISO/IEC 17025:2017 accreditation can be complex, but with the ISO/IEC 17025 Documentation Package, your laboratory will have everything needed to streamline compliance and ensure internationally recognized testing and calibration processes.

💡 Get started today and take your laboratory to the next level with a structured, compliant, and efficient management system!