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Quality assurance, accreditation, and certification: needs and possibilities
1Frederiksberg Hospital, Department of Clinical Chemistry, Denmark.
Clinical Chemistry
|July 1, 1994
Summary
Achieving laboratory service quality requires a defined quality policy, user needs assessment, and robust measurement systems. External recognition through accreditations like ISO 9000 or EN 45,001 further validates competence.
Area of Science:
- Laboratory Management
- Quality Assurance in Science
Background:
- Demonstrating laboratory service quality is crucial for reliable scientific results.
- Establishing robust internal quality systems is a foundational step.
Purpose of the Study:
- To outline the essential components for achieving demonstrable laboratory quality.
- To explore various external recognition pathways for laboratory competence.
Main Methods:
- Defining internal quality management system requirements, including policy, user needs, measurement procedures, traceability, control materials, and proficiency testing.
- Identifying external quality assessments such as Good Laboratory Practice, ISO 9000, professional accreditation, and governmental accreditation (EN 45,001).
Main Results:
- Internal quality requires a comprehensive set of documented procedures and materials.
- External accreditations provide independent validation of laboratory competence and quality systems.
- Quality manuals are essential documentation for ISO and EN standards.
Conclusions:
- A dual approach of strong internal quality systems and external accreditation is necessary for demonstrable laboratory excellence.
- Adherence to standards like ISO 9000 and EN 45,001 enhances laboratory credibility and service quality.