Recently published, UNE-EN ISO 15189: 2023/A11:2024 complements and amends the standard UNE-EN ISO 15189:2023, known worldwide for providing the requirements needed in medical laboratories to comply with a Quality Management System.
Its implementation helps laboratories to:
- Be technically competent
- Obtain valid results
- Incorporate risk management for enhanced patient well-being
Amendment A11 contains a very useful Annex to see how the standard relates to the requirements of Regulation No 765/2008 of the European Parliament and of the Council (9 July 2008), setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93.
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