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[Guidelines for documentation management mastery according to the EN ISO 22870]
Annales De Biologie Clinique
|June 28, 2012
Summary
This study outlines a structured documentation system for point-of-care testing (POCT) to comply with EN ISO 22870 standards. It enhances document control and auditability for non-laboratory staff, ensuring quality POCT management.
Area of Science:
- Medical Diagnostics
- Quality Management Systems
Context:
- Point-of-care testing (POCT) requires robust documentation for regulatory compliance.
- EN ISO 22870 specifies standards for POCT quality management.
- Effective document control is crucial for non-laboratory staff involved in POCT.
Purpose:
- To propose an organized documentation system for POCT.
- To meet the requirements of the EN ISO 22870 standard.
- To improve document control and auditability of POCT records.
Summary:
- The article suggests provisions for better control of documents used outside the laboratory by non-laboratory personnel.
- It reviews existing POCT records and proposes an organizational structure for easier auditing.
- A model for a POCT quality plan is presented, including a quality manual and specific control measures.
Impact:
- Facilitates compliance with EN ISO 22870 for POCT.
- Improves the quality and reliability of point-of-care testing.
- Enhances the efficiency of POCT documentation management and auditing processes.
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