To support Yess Pharma GmbH, an international medical device distributor based in Germany, in strengthening its quality management system, regulatory compliance and distribution practices in accordance with ISO 9001:2015 and applicable Good Distribution Practice (GDP) principles.
The assignment focused on establishing consistent processes, improving operational controls and supporting readiness for independent certification assessment.
Year
August 2025 – May 2026
Client & Country
Yess Pharma GmbH-Messkirch, Baden-Württemberg, Germany
Type of Activity
Quality Management Consulting, ISO 9001 Implementation, Good Distribution Practice (GDP), Regulatory Compliance, Certification Readiness.
Activities:
Developed and implemented ISO 9001-aligned quality management processes, policies and procedures.
Integrated applicable GDP principles into procurement, storage, distribution and supplier management processes.
Established documentation, risk management and operational control mechanisms.
Supported internal quality assessments, corrective actions and management review.
Prepared the company for external certification assessment and coordinated audit readiness activities.
Results:
Strengthened the company’s quality management and distribution control framework.
Established documented processes and operational controls aligned with ISO 9001 and applicable GDP principles.
Improved internal audit readiness, regulatory compliance and management oversight.
Supported the successful ISO 9001 certification process with DQS.
