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UNE-EN ISO 9001 standard in clinical laboratories. Practical guide on its implementation (Spanish Version)
AENOR Spanish Association for Standardization and Certification, January 2009, Pages: 162
It develops a series of guidelines that help the professionals in the sector to effectively apply the UNE-EN ISO 9001:2008 standard in clinical laboratories.
Following the order of the sections in the standard, it associates with each requirement a series of decisive questions for the interpretation, development and implementation of every point of the standard:
- Why is it done?
- What should be done?
- How should it be done?
- Who should do it?
- When should it be done?
- What should it be done with?
Likewise, there are other requirements and responsibilities included that do not appear in the standard, but that are defined in different quality management systems implemented in clinical laboratories.
- Quality management system.
- Management responsibility.
- Resource management.
- Product accomplishment.
- Measurement, analysis and improvement.
Ángel Salas García