Achieving ISO 15189 accreditation is a critical milestone for medical laboratories seeking to demonstrate competence in quality management and technical performance. A significant part of this journey involves preparing and controlling the essential documents that provide objective evidence of compliant processes and performance. Proper documentation not only supports accreditation but also promotes consistency, traceability, and continuous improvement in laboratory services.
In this article, we walk through a step-by-step preparation approach to help you organize and create essential documents efficiently and effectively.
1. Understand the ISO 15189 Requirements
Start by reviewing the ISO 15189 standard requirements thoroughly. ISO 15189 specifies requirements for quality and competence in medical laboratories, covering management system documentation and technical areas such as test methods, equipment calibration, and laboratory personnel competence.
Understanding the standard gives you a framework for what documents need to be prepared and how they should align with each clause of the standard.
2. Create a Documentation Structure
A structure ISO 15189 documentation system makes it easy to manage and update the documents in a systematic way. Documentation hierarchy includes:
· Quality Manual – Describes the overall quality management system.
· Procedures – Define how functions such as document control, internal audits, corrective actions, and risk management are conducted.
· Standard Operating Procedures (SOPs) – Provide step-by-step instructions for laboratory tasks.
· Forms and Records – Capture evidence of implementation.
· Supporting Records – Include audit reports, training records, and management review minutes.
This hierarchy not only aligns with ISO 15189 requirements but also ensures clarity and consistency throughout your system.
3. Develop Documents Based on Roles and Processes
When drafting documents, involve subject matter experts from each functional area of the laboratory. For example:
- Clinical staff draft SOPs for pre-examination, examination, and post-examination processes.
- Quality personnel draft procedures for document control, internal auditing, and corrective/preventive actions.
- Technical staff prepare method validation, calibration, and equipment maintenance records.
This cross-functional involvement ensures documents reflect real practice and responsibilities.
4. Follow Good Documentation Practices
Good documents aren’t just writing content, it’s all about control and traceability
· Use clear titles and unique identifiers on all documents.
· Assign version numbers and dates to indicate revision status.
· Include author, reviewer, and approval signatures.
· Maintain a document register to track updates and revisions.
5. Use Templates and Checklists
Using standardized templates for manuals, SOPs, and records can greatly accelerate document preparation. Templates ensure that all required sections are included and formatted consistently.
Checklists help verify completeness before internal review—especially useful for complex areas like risk management, internal audits, and management review documentation.
6. Review, Approve, and Implement
Once draft documents are prepared:
· Conduct internal reviews for accuracy and compliance.
· Get approval from authorized personnel.
· Communicate and implement documents across the laboratory.
Training staff on new or revised documents improves adoption and ensures that procedures are followed as intended.
7. Maintain and Update Documents
ISO 15189 requires that documents be periodically reviewed and kept current. Document control processes should specify review intervals, change processes, and archiving of obsolete versions.
Having a living system for document control ensures ongoing compliance and readiness for external assessment.
Preparing essential documentation for ISO 15189 accreditation may initially seem complex, but a structured and process-based approach makes it both manageable and effective. By understanding standard requirements, developing role-specific documents, applying good documentation practices, and maintaining controlled records, medical laboratories can build a robust quality management system that supports reliable test results and patient safety. For a detailed understanding of “what specific documents are mandatory for ISO 15189 accreditation”, laboratories can refer to our in-depth guide, “Essential Documents Required for ISO 15189 Accreditation,” which explains each document category and its role in achieving and sustaining accreditation.