ISO 9001 and ISO 13485 Quality Management

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 2023-08-10 audit report for ISO 13485 provide you a little more information (email me if you would like a copy of the entire 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."

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