ISO 9001 and ISO 13485 Quality Management
What is the status of our process ("management system") certifications?
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 report for ISO 9001 from 2023-02-07 (email me if you would like a copy of the entire 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."
- "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."
- "And more..."
ISO 13485 "Medical devices: Quality management systems - Requirements for regulatory purposes"
The certification audit for ISO 13485 is scheduled for August 2023, the processes are already in place. Send me an email if you want to know more about the status of ISO 13485 at Solcept.
Benefit from our quality management systems, click here for the contact page!