By using a structured seven-step plan we support you in your efforts to implement a quality management system (QMS). As organization you sets the standard by which you will build the QMS. This could either ISO 9001: 2015 or ISO 13485: 2016. The roadmap focuses on the self-activity of the organization to optimize the support of a QMS. The plan has the following steps:
1. Purpose and scope
2. Baseline assessment
3. Processes mapping
4. Processes description and defining quality parameters of in-, through, and outcome's
5. Initiate improvement projects
6. (Internal) audits
7. Continuous adjustment of the processes under scope
What's in it for You?
A properly functioning and implemented QMS according to the chosen standard, whether or not certified.
Add Value MRM's methodology
Our approach of 7-stages is based on experiences and has proven to be effective which means efficient in time, money and resources. Together with your management and your key process owners we design and implement the QMS in your organization. Outcome will be a solid base for an successful (initial) ISO certification.