How to Prepare ISO 17025 Documents and Procedures for Accreditation

ISO/IEC 17025 is the internationally recognized standard for the competence of testing and calibration laboratories. Laboratories seeking accreditation under ISO 17025 must demonstrate that their management systems, technical procedures, and operational practices meet the standard’s requirements. A critical part of this process is the preparation and implementation of comprehensive ISO 17025 documents, including the ISO 17025 manual, specific ISO 17025 procedures, standard operating procedures (SOPs), and record-keeping systems.

This article provides a detailed, step-by-step guide on how to effectively prepare ISO 17025 documentation for successful accreditation, ensuring consistent quality, technical competence, and continual improvement.

1. Understand the Purpose of ISO 17025 Documents

Before beginning the documentation process, it’s vital to understand the role of ISO 17025 documents. These documents do more than fulfill a standard—they form the backbone of your laboratory’s quality management system (QMS).

The main purposes of ISO 17025 documentation are to:

Define laboratory quality policies, goals, and procedures

Ensure consistency and reproducibility in laboratory operations

Demonstrate compliance with ISO/IEC 17025:2017 requirements

Provide objective evidence during internal and external audits

Serve as guidance for laboratory personnel in performing their duties

Offer traceability for decisions, actions, and results

Without accurate and structured documentation, a laboratory cannot prove its compliance or maintain quality control effectively.

2. Structure of ISO 17025 Documentation System

A well-structured ISO 17025 documentation system follows a hierarchical or layered approach, enabling clarity and consistency throughout the organization. The main components are:

a. ISO 17025 Manual

The ISO 17025 manual is the top-tier document in your quality system. It outlines your lab’s scope, quality policies, and the methods by which your lab meets each clause of ISO/IEC 17025.

Typical contents of an ISO 17025 manual include:

Scope of testing and/or calibration services

Quality policy and measurable quality objectives

Overview of the laboratory’s organizational structure

Roles and responsibilities of key personnel

References to applicable ISO 17025 procedures

The manual serves as a roadmap that ties the quality system together and provides a reference point for auditors and staff.

b. ISO 17025 Procedures

Each ISO 17025 procedure provides a detailed explanation of how specific requirements of the standard are met. These procedures are critical for both technical and management activities.

Common ISO 17025 procedures include:

Internal audit procedure

Document and record control procedure

Control of nonconforming work

Equipment calibration and maintenance procedure

Risk management procedure

Handling customer complaints

Personnel training and competency evaluation procedure

c. Work Instructions / SOPs

Standard Operating Procedures (SOPs) or work instructions describe step-by-step methods for performing specific tests, calibrations, or other technical tasks. These documents ensure repeatability and consistency, especially for complex or critical operations.

d. Forms and Records

Forms are tools for capturing operational data, and completed forms become records that demonstrate compliance. Examples include:

Calibration reports

Training records

Environmental monitoring logs

Test result reports

Internal audit checklists

Maintaining clear, accurate records is crucial for audit readiness and process traceability.

3. Step-by-Step Guide to Preparing ISO 17025 Documents

Creating ISO 17025 documents is a structured process that involves planning, collaboration, and continuous refinement. Follow these steps for effective documentation development:

Step 1: Identify Documentation Requirements

Review ISO/IEC 17025:2017 clause by clause. Identify which clauses require documented information and determine what applies to your laboratory's scope of work. Pay attention to both management system requirements and technical requirements.

Step 2: Assign Roles and Responsibilities

Designate a Quality Manager or ISO 17025 documentation coordinator to lead the effort. Involve relevant technical personnel for drafting test-specific SOPs and procedures. Assign clear responsibilities for writing, reviewing, and approving each document.

Step 3: Draft the ISO 17025 Manual

The ISO 17025 manual should provide an overview of your laboratory’s quality system. Avoid copying the standard verbatim. Instead, describe how your lab meets the standard’s requirements in practice. Include:

Introduction and purpose

Laboratory scope

Quality policy and objectives

Organizational chart

References to procedures and forms

Ensure that each section aligns with the corresponding ISO 17025 clause.

Step 4: Develop ISO 17025 Procedures

For each identified process (e.g., internal audits, equipment calibration), write a standalone ISO 17025 procedure that includes:

Purpose and scope

Roles and responsibilities

Detailed steps and methodologies

Reference to relevant forms or records

Revision history

Use consistent formatting across all procedures for ease of use and understanding.

Step 5: Create Work Instructions and Forms

Develop SOPs or work instructions for technical tasks such as sample handling, equipment setup, or environmental condition monitoring. Prepare associated forms to document key actions and ensure traceability.

Examples of common forms include:

Equipment calibration log

Training evaluation checklist

Corrective action report

Sample receipt log

Step 6: Implement a Document Control System

A reliable document control system is essential for managing and maintaining ISO 17025 documents. Include processes to:

Assign unique identification numbers and revision codes

Approve documents before release

Prevent the use of obsolete versions

Archive historical records

Track changes and maintain revision history

Document control can be manual or software-based, but it must ensure accessibility and traceability.

Step 7: Train Laboratory Personnel

Once documentation is finalized, conduct training sessions for all relevant staff. Ensure they understand how to access, interpret, and apply the ISO 17025 manual, procedures, and SOPs in their daily work. Maintain training records as part of your quality system.

Step 8: Review, Monitor, and Improve

Documentation is not static. Regularly review your ISO 17025 documents through:

Internal audits

Management reviews

Staff feedback

Updates in regulatory or standard requirements

Continual improvement is a core principle of ISO 17025. Update procedures and manuals whenever changes in processes or requirements occur.

Conclusion

Preparing ISO 17025 documents is a foundational step in achieving and maintaining ISO/IEC 17025 accreditation. A properly structured documentation system—consisting of a clear ISO 17025 manual, detailed ISO 17025 procedures, technical SOPs, and supporting records—demonstrates your laboratory’s commitment to quality, competence, and continuous improvement.

By adopting a systematic approach, laboratories can:

Enhance operational efficiency

Ensure consistent, reliable results

Facilitate easier training and onboarding

Meet international recognition criteria

Satisfy auditors and clients alike

Investing time and effort in creating and maintaining robust ISO 17025 documentation ensures that your laboratory is well-prepared for accreditation—and success in the competitive world of testing and calibration.