Services Available
| Track and trace the organization’s design input requirements throughout the product development process, ensuring that they have been transitioned into measurable technical requirements. |
| Review product validation protocols and reports, with emphasis on ensuring that customer, other interested party and intended use requirements have been addressed. |
| Ensuring the quality management systems are compliant with ISO 13485:2016 and ISO 9001:2015 customer-related processes. |
| Ensuring that all appropriate customer and other interested party concerns, issues, needs and requirements have been identified. |
Success Stories
Provided process and system assessment, process mapping and recommendations to promote a more effective service and repair operation for an international medical device company.
In viewing suppliers as a “customer” of requirements, Ron was instrumental in establishing product specification limits by demonstrating supplier product and process capability.
Who is the Customer?
We like to think of the customer as the recipient of the finished product or service. While this is true, there are likely other customers as determined through the analysis of interested parties, i.e. suppliers, employees, stockholders, competitors, regulators, neighbors, governments and special interest groups.
What Does the Customer Really Need?
It’s imperative, then, that the requirements of all interested parties are considered during the design stage, to ensure that they are validated. Failure to do so can lead to producing the wrong product or providing the wrong service.
Keep the Customer Involved
The organization needs to ensure that project scope, objectives and goals are understood, clear, measurable and periodically reviewed with all customers, as appropriate, to stay on track.
