Preparing ISO 15189 documents is an important step for any medical laboratory aiming to earn accreditation. These documents like quality manual, procedures, standard operating procedures (SOPs), and records—serve as the foundation of a lab’s quality management system. Yet, even experienced laboratories can make documentation mistakes that lead to nonconformities or delays during the accreditation process. By understanding these common errors and learning how to avoid them, laboratories can stay compliant, work more efficiently, and confidently demonstrate their technical competence.
1. Lack of Clarity and Consistency in Documentation
One of the most frequent mistakes laboratories make is creating documents that are unclear or inconsistent. Procedures must be written in simple, precise language that ensures uniform understanding among all staff. When instructions are vague or open to interpretation, different employees may follow different methods, which can result in inconsistent testing outcomes and quality issues.
2. Missing Document Control Information
ISO 15189 document should have essential control details such as a document number, revision date, page numbering, approval signature, and distribution list. Laboratories often overlook these elements, leading to confusion about which version of a document is current. Missing or incomplete document control information can result in serious nonconformities during audits.
3. Using Generic or Outdated Templates
Many laboratories rely on generic templates borrowed from other ISO standards, such as ISO 9001 or ISO 17025. Although these may provide a starting point, ISO 15189 has its own unique requirements tailored for medical laboratories. Using outdated or irrelevant templates without customization can create gaps in compliance and weaken the quality management system.
4. Poor Linkage Between Documents
Effective documentation requires logical linkage between the quality manual, procedures, work instructions, and records. A common mistake is failing to reference or cross-link documents, which breaks the traceability chain. Without proper references, auditors may find it difficult to verify that all related documents support each process adequately.
5. Unclear Roles and Responsibilities
ISO 15189 emphasizes defined roles and responsibilities for all laboratory personnel. When procedures or SOPs do not specify who performs, reviews, or approves an activity, accountability becomes unclear. This not only leads to confusion among staff but also makes it difficult to demonstrate compliance during an audit.
6. Inadequate Version Control
Improper version control is another common issue in laboratories. Failing to archive obsolete documents, not updating revision numbers, or not communicating updates to staff can cause the wrong procedures to be used. Proper version control ensures that everyone in the laboratory is following the most recent and approved procedures.
7. Insufficient Review and Verification
Before approval, ISO 15189 documents should undergo a thorough internal review by competent personnel. Laboratories often skip this step, resulting in errors that go unnoticed until an audit. Regular reviews not only ensure accuracy but also help identify improvements in existing procedures.
8. Copying Content Without Validation
Some laboratories make the mistake of copying text directly from online sources or other organizations without verifying its relevance or accuracy. To avoid such issues, it’s always better to rely on professionally developed ISO 15189 document templates created by experts. Global Manager Group offers ready-to-use ISO 15189 documentation kits that are designed by experienced consultants and aligned with the latest standard requirements.
9. Inconsistent Formatting and Terminology
Uniform formatting enhances readability and professionalism. However, many labs use inconsistent numbering, fonts, or section titles across different documents. Similarly, inconsistent terminology—such as mixing “test,” “examination,” or “analysis” inconsistently—can confuse staff and auditors alike. A standard document style guide helps maintain uniformity throughout the system.
10. Misalignment Between Documentation and Practice
Perhaps the most serious mistake is when the documented procedures do not match actual laboratory practices. ISO 15189 auditors closely observe how well the written system reflects real operations. If staff are unaware of or not following documented processes, it signals poor implementation and can result in major nonconformities.
How to Avoid These Errors
To avoid these common pitfalls, laboratories should adopt a structured approach to documentation:
- Use approved, laboratory-specific templates.
- Clearly define document ownership and approval authority.
- Conduct periodic document reviews and internal audits.
- Train staff regularly on document control and updates.
- Implement electronic document management systems for version tracking.
These proactive steps ensure that ISO 15189 documents remain current, consistent, and compliant with accreditation requirements.
Conclusion
ISO 15189 documentation is more than just a paperwork exercise—it’s the framework that demonstrates a laboratory’s commitment to quality, accuracy, and competence. By avoiding common documentation errors, laboratories can reduce audit findings, improve operational efficiency, and strengthen their overall quality management system. Well-prepared and well-maintained ISO 15189 documents not only facilitate accreditation but also foster trust among clients, patients, and regulatory authorities.
