ISO/IEC 17025 is the globally accepted standard for the competence of testing and calibration laboratories. Laboratories seeking accreditation must demonstrate that their systems, procedures, and practices comply with the requirements of this standard. A major part of this process involves preparing and implementing accurate and well-structured ISO 17025 documents, including the ISO 17025 manual and various ISO 17025 procedures. Proper documentation not only proves technical competence but also ensures the consistency and quality of laboratory operations.
This article explains how to effectively prepare ISO 17025 documentation for successful accreditation.
1. Understand the Purpose of ISO 17025 Documents
Before creating documents, it’s important to understand why they are essential. ISO 17025 documents serve to:
• Define laboratory policies and objectives
• Establish consistent operational procedures
• Demonstrate compliance with ISO/IEC 17025 requirements
• Provide traceability and evidence for internal and external audits
• Guide laboratory personnel in performing their duties effectively
2. Structure of ISO 17025 Documentation System
A typical ISO 17025 documentation system follows a layered or hierarchical approach:
a. ISO 17025 Manual
The ISO 17025 manual is the top-level that describes the quality management system. It outlines how the lab meets the requirements of the standard.
Contents of an ISO 17025 manual may include:
• Scope of testing/calibration services
• Quality policy and objectives
• Organizational structure and responsibilities
• Reference to applicable ISO 17025 procedures
b. ISO 17025 Procedures
Each ISO 17025 procedure describes the method for performing specific management or technical activities. These are more detailed than the manual and explain how tasks are executed in accordance with the standard.
Examples of common ISO 17025 procedures:
• Internal audit procedure
• Document and record control procedure
• Equipment calibration and maintenance procedure
• Personnel training and competency assessment procedure
• Handling customer complaints and nonconformities
c. Work Instructions / SOPs
These documents provide step-by-step instructions for specific tasks or test methods, especially those requiring technical consistency.
d. Forms and Records
Forms are used to capture information and generate records. Records provide evidence that procedures are being followed and that the lab operates in compliance with ISO 17025.
3. Step-by-Step Guide to Preparing ISO 17025 Documents
Step 1: Identify Documentation Requirements
Start by reviewing each clause of ISO/IEC 17025:2017 to identify mandatory and applicable documentation. Focus on both management system and technical clauses.
Step 2: Assign Responsibility
Designate a quality manager or team to lead the documentation process. Engage technical staff to contribute their expertise, especially in developing SOPs and technical procedures.
Step 3: Draft the ISO 17025 Manual
ISO 17025 manual can help organize your documentation system and demonstrate overall compliance. Ensure the manual references supporting procedures and aligns with your lab’s scope and policies.
Step 4: Develop ISO 17025 Procedures
Write each ISO 17025 procedure clearly and consistently. Include the following elements:
• Purpose and scope
• Responsibilities
• Procedure steps
• Related forms and records
• Revision history
Step 5: Design Work Instructions and Forms
Prepare SOPs and test method instructions where necessary. Create forms to document key actions (e.g., calibration, audits, training, environmental conditions).
Step 6: Implement a Document Control System
Control is critical. Ensure:
• All ISO 17025 documents are approved before use
• Each document has a unique ID, version, and approval date
• Obsolete documents are removed from use
• Changes are tracked and reviewed periodically
Step 7: Train Personnel
Train staff on the ISO 17025 procedures relevant to their roles. Maintain training records as part of the documentation system.
Step 8: Review, Monitor, and Improve
Continuously monitor document effectiveness through internal audits and management reviews. Update documents as processes change or improvements are made.
Conclusion
Preparing ISO 17025 documents is a fundamental step toward achieving and maintaining accreditation. A well-organized system—consisting of an ISO 17025 manual, clearly defined ISO 17025 procedures, and supporting records—ensures that your laboratory operates consistently, meets international standards, and delivers reliable test or calibration results.
By following a systematic approach to documentation, laboratories can not only comply with ISO/IEC 17025 but also improve efficiency, reduce errors, and build trust with clients and accreditation bodies.