ISO 13485:2016

Certification ISO 13485:2016

Congratulations to all staff at Europlaz who worked hard to make sure the transition to ISO 13485:2016 was a success.

 

What is ISO 13485:2016?

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

 

Europlaz understands that each customer is unique, but the need for a consistent supply of a quality product is universal.

 

Quality management system (QMS)

We use an established quality management system to ensure:

A common sense approach to the management of the organisation
Consistency
Continuous improvement of working practices
We get it right first time
We keep quality high and costs low

 

Every member of the Europlaz team is expected to adhere to the quality management system and to go above and beyond for our customers and the team.

 

The Europlaz Quality System means consistently providing a product that meets or exceeds customer and business requirements and continually improving the effectiveness of its business processes / quality management system (QMS).

 

This is done by providing enhanced customer satisfaction and business performance through the identification, development, implementation and review of a series of quality objectives, for application at all levels of the organisation. Developing an appropriate and increasingly skilled and motivated workforce through a training plan linked to the Business Plan.

 

Meeting the needs and expectations of the QMS

The company is committed to meeting these needs and expectations through an appropriate and relevant QMS, based on the principles of  ISO13485:2016, the European Medical Device Directive 93/42/EEC, the FDA 21 CFR part 820 Quality System Regulations for Medical devices, and the establishment and delivery of related quality objectives.

 

Our Management team regularly and systematically review the company’s strategic objectives and operations to ensure compliance with the QMS, to confirm its on-going suitability and effectiveness and to review the achievement of its objectives.

 

The company communicates its quality policy and objectives to all levels of the organisation and promotes understanding, involvement and commitment amongst all employees.

 

ISO 13485:2016 certificate

You can view Europlaz’s ISO certificate here.

 

To find out more about our quality department visit the quality assurance page.