Certified and now…. it is the challenge for your organization to continuously improve. This is a task of your organization's top management. But there is no objection to getting external assistance. Reasons for getting external assistance can be:
- the lack of capacity to prepare, execute, and report improvement activities;
- the lack of trained and independent internal auditors, two clear requirements from the ISO 13485.
- the need for an external expert to critically review your processes. "What improvements are possible?", "Why is a procedure working in one department and not in another?", "Can it be more efficient?" are questions that can be answered by an objective internal audit.
I will be happy to help you to do perform these routine tasks for you. You can think of:
- planning, executing and reporting of internal audits
- organizing an annual management review
- follow-up on internal and external audit results
- act as a helpdesk for all your quality assurance related questions
Feel free to contact us to find out what we can do for you.