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1. Steering the LIMS acquisition project
1.1 The design and development process, an essential starting point
1.1.1 Process and risk approach, help from ISO 9001
Figure 1 illustrates the process-risk approach that can be implemented in any complex corporate project: the PRDCA.
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Steering the LIMS acquisition project
LIMS qualification
Bibliography
Standards and norms
- Quality management systems – Basic principles and vocabulary. - ISO 9000 - 2015
- Quality management systems – Requirements - ISO 9001 - 2015
- Conformity assessment – Vocabulary and general principles. - ISO/IEC 17000 - 2020
- Safety and resilience – Business continuity management systems – Requirements - ISO 22301 - 2019
- Exigences générales concernant la compétence des laboratoires d'étalonnages...
Regulations
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (2016)
Law no. 2018-493 of June 20, 2018 on the protection of personal data
Directory
Laboratories – Design offices – Schools – Research centers (non-exhaustive list)
French Information Systems Security Agency (ANSSI) https://www.ssi.gouv.fr/
French Data Protection Authority (CNIL) https://www.cnil.fr/fr
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