[ISO 9001 certification of a sterilization unit: Transition to the 2015 version].

Objectives: The sterilization unit of Pitié-Salpêtrière-Charles Foix hospital group is ISO 9001 certified on one of its sites. The purpose of this work is to describe how the unit prepared for the transition from the 2008 version to the 2015 version of the standard, as well as the conduct of the audit.

Methods: The pharmaceutical team has received prior training from French national organization for standardization (Afnor) to understand the new requirements and how to apply them to the sterilization unit. SWOT and PESTEL methods were used. A 3-month retro planning has been established. Deadlines were the annual management review and the certification audit. Audits carried out by the Quality and Risk Management Department helped to identify the priorities.

Results: The compliance of the quality management system (QMS) has led to the identification of internal and external challenges, relevant stakeholders and risks and opportunities. Management leadership and communication has been strengthened and control over external providers has improved. The auditor did not identify any non-compliance, but said that the system had to mature regarding the recent application of the new requirements.

Conclusions: The QMS is more effective, new strengths and weaknesses have been identified and requirements of the unit and stakeholders have been better defined. The pharmaceutical investment necessary for this approach has been important. Involvement in the quality approach of all the staff of the unit lies to the success of the project.