ISO 9001 "Quality Management Systems - Requirements"
We have been ISO 9001 certified since 2017, here you can find the current certificate.
A little more information is provided by these excerpts from the audit reports for ISO 9001 from 2023..24 (email me if you would like a copy of the entire current report):
- Chapter: Reporting
- "Process reliability is appropriately high."
- "Also noteworthy is the fact that Solcept continues to place a significant focus on the personal development of its employees. Approximately 80 hours per year per employee are scheduled for continuing education activities."
- "Document control is professional in terms of its structure and implementation."
- "Overall, the organization demonstrates exemplary process management and is managed in a fact-based and future-oriented manner."
- Chapter: Strategy, Context, Stakeholders, Risks & Opportunities
- "Overall, the management team can be said to be very deliberate and well managed in terms of strategy and leadership."
- Chapter: Suitability of the Management System
- "The management system is decidedly detailed and is constantly being expanded."
- Chapter: Positive Impressions from the Audit
- "The transparency and exemplary document control are impressive."
- "The improvement system and internal reviews/audits are carried out methodically and effectively."
- "Project management is a core competence of Solcept and is conducted very professionally."
- "And more..."
ISO 13485 "Medical Devices: Quality Management Systems - Requirements for Regulatory Purposes"
We have been ISO 13485 certified since 2023, here you can find the current certificate.
Again, these excerpts from the 2023..24 audit reports for ISO 13485 provide you a little more information (email me if you would like a copy of the entire current report):
- Chapter: Reporting
- "The Solcept process documentation is very detailed, which is appreciated by the employees. Process reliability is correspondingly high."
- Chapter: Conformity and Effectiveness of the Management System
- "The management system is very detailed and is constantly being expanded."
- Chapter: Management Accountability
- "Overall, it is possible to speak of a very deliberate and well-managed strategy and leadership style of the management team."
- "During the audit, the working atmosphere appeared very good and also a high level of personal responsibility for one's own work and a high level of loyalty of the employees to the organization could be recognized."
- Chapter: Positive Impressions from the Audit
- "Transparency and exemplary control of documents."
- "The customer-oriented (customer-related) cooperation of the company."
- "Knowledge of the employees in their areas of responsibility."