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[ISO 9001 certification of a sterilization unit: Transition to the 2015 version].
A Maurin1, A Petit2, P Tilleul3
1Pharmacie à usage intérieur, Unité fonctionnelle de stérilisation, Groupe hospitalo-universitaire La Pitié-Salpêtrière-Charles-Foix, 47-83, boulevard de l'hôpital, 75013 Paris, France.
Annales Pharmaceutiques Francaises
|July 2, 2019
Summary
The sterilization unit successfully transitioned to the ISO 9001:2015 standard, enhancing its quality management system (QMS) and stakeholder engagement. This involved rigorous preparation, risk assessment, and staff involvement for improved operational effectiveness.
Area of Science:
- Healthcare Management
- Quality Assurance
- Hospital Operations
Background:
- The Pitié-Salpêtrière-Charles Foix hospital group's sterilization unit holds ISO 9001 certification.
- Transitioning to newer standards requires strategic planning and adaptation.
Purpose of the Study:
- To detail the preparation process for the ISO 9001:2015 version transition.
- To describe the execution and outcomes of the certification audit.
Main Methods:
- Pharmaceutical team training via the French national organization for standardization (Afnor).
- Utilized SWOT and PESTEL analyses for strategic assessment.
- Implemented a 3-month retro-planning approach with defined deadlines.
Main Results:
- Identified internal/external challenges, stakeholders, risks, and opportunities.
- Strengthened management leadership, communication, and external provider oversight.
- No non-compliance issues were found, though system maturity was noted.
Conclusions:
- The quality management system (QMS) is now more effective with clearer requirements.
- New strengths, weaknesses, and stakeholder needs were identified.
- Successful transition depended on significant pharmaceutical investment and staff involvement.
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