- Setting up Quality Management Systems according to the ISO-13485
- Along with the years and all the different experiences, able to setup a lean set of procedures, workinstructions, templates and forms that fits in your organization
- Auditing of Quality Management Systems on compliancy with the ISO-13485
- As a contractor for a well known Notified Body: DEKRA
- Via Trial Audits to prepare you for areal Notified Body audit
- Knowledge about Software (see CMMI)
- With help of my 15 years software background …
- In case software is becoming more important to your product, embedding the Software Life Cycle for your product development (IEC-62304)
- Performing Internal Audits
- As an external expert performing the mandatory Internal Audit cycle for you
- But also with the external view to you internal processes
- Support in solving NonConformities e.g.:
- Support in setting up a specific process,
- Defining a good set of KPI’s
- Structuring of the Complaint / CAPA’s process
- Training
- Training is a standard part of my work
- Stand alone training is possible
- Some trainings modules are already part of the program of Mikrocentrum
ISO-13485: Services
- Details
- Written by Hans Jonker
- Category: ISO