SERVICES
ISO 9001: 2015
Quality, Teamwork, Continuous Improvement
The ISO 9001: 2015 is a quality management system intended to support the organization with the aim of controlling and improving the organization. No mandatory procedures but precisely documented information make this standard suitable for your organization
With our years of experience and successful implementations, we can also guide your organization through the implementation of this standard
read more
Lean Management
Eliminate waste
Lean is a management philosophy aimed at achieving maximum value for the customer with as little waste as possible. This is a philosophy that needs to grow in an organization and offers different tools to become a continuously improving organization.
QMS Improvement can help you implement this philosophy, and we also offer in-house Lean Green Belt training.
read more
High Level Structure
Management by structure
Various ISO management systems already use the High Level Structure (HLS), which stands for structure in outline and what is intended as a plug-in model. Due to the correct implementation of the HLS, different standards can be connected well and they can be logically related to each other.
We help you to match the High Level Structure and your business process
read more
ISO 13485: 2016
Quality Management System for Medical Devices
ISO13485: 2016 specifies requirements for a quality management system where an organization must demonstrate that it is capable of providing medical devices and related services that consistently meet customer requirements and applicable legal requirements.
We are happy to help you with the gap analysis, the preparation of a risk analysis and CAPA files for full certification of your organization
read more
Medical Device Regulation
Investigate, prove, validate and check your Medical Device
In Europe, medical device manufacturers must demonstrably comply with current legislation, Council Directive 93/42 / EEC. In the Netherlands, this guideline has been transposed into the guideline for medical devices and the Medical Devices Decree. Since 2012, the European Commission has been working on a new legislation, the European Medical Device Regulation, which entered into force on May 25, 2017.
With a transition time of just 3 years you have no time to lose as an organization to comply with this legislation for Medical Device, let us help you with this.
read more
Good Distribution Practices
For distribution of medical devices
Good Distribution Practice (GDP) is a guideline that imposes legal requirements on the entire medical device distribution chain. By using the GDP guidelines, the quality and safety of medical devices is guaranteed.
In this training you learn the most important topics from the GDP guideline and the link is made between the GDP, ISO 13485: 2016 and the MDR.
Call us
