ISO 9001 Certification Support • 12 Expert Days

BIO15PHARMA helps you reach or renew it with 12 working days of expert support, structured over up to 12 months and shaped around how your sector operates.

Who it is for : Executive committees, quality directors and quality managers in regulated industries (pharmaceutical, chemical, cosmetics, biotech, CRO) who want a quality system that runs the business, not paperwork that only serves the audit.

The 12-day programme, over up to 12 months : *Fundamentals (0.5 day): ISO 9001 principles, risk-based thinking and the PDCA cycle *Vision and strategy (1.5 days): align quality with company strategy, map internal and external issues and risks, set quality objectives *Process approach (4 days): map and streamline your processes, deploy the indicators that show performance *Information management (1 day): keep the documents that add value, retire the rest *Continuous improvement and compliance (4 days): non-conformity management, QMS structuring, management review preparation *Mock audit (1 day): a full dry run led by an external consultant, with corrective actions closed before the certification audit

What you get : Ready-to-use tools at every session, a written report and action plan after each one, and skills transfer to your team so the system holds once we step back.

Standards : ISO 9001.