Why ISO 9001 Is the starting point

ISO 9001 certification satisfies our customer requirements. Most large customers have a policy that will only do business with service providers that are ISO certified compliant companies.

The international nature of ISO 9001 has already been identified; and, in fact, ISO 9001 is such a basic and influential standard that it is used as the basis when industry groups want to add specific industry requirements, thus creating their own industry standard. These include ISO 13485 for the medical devices industry.

ISO 9001 is the foundation for implementing many other management standards.

Did You Know?

Australian Standards recommend that Responsible Owners of Medical Equipment, follow the guidelines of the “Management programs for medical equipment”, (AS3551:2012) to ensure performance verification and safety testing is managed throughout the service life of medical equipment.

U-Tech Medical supports this Standard by providing assistance and guidance to adopt the best management program, specifically for the device types in your practice.

Potential Pitfalls

Taking a systematic approach to your equipment costs should highlight other opportunities to control costs.

In many cases, reducing equipment service costs will require you to change the way you do things but be aware of the potential to risk to your core business activities: focus on the benefits of engaging a service provider with certified quality management systems in place.

Then you can start to identify for your organisation where you can gain improvements and what value you now have.

Cutting testing & maintenance costs can lead to long-term weaknesses & risk.

U-Tech Medical is a Biomedical Engineering Services Company and proud to be an ISO9001 Certified Service Provider.