SGS Unannounced audit in Nov 2016

SGS Unannounced Audit in Nov 2016

Well done to everyone at Europlaz for an excellent result from the SGS unannounced audit this week. SGS is the world’s leading inspection, verification, testing and certification company.

 

The feedback from the two auditors was excellent and we were given no non conformances.

 

Focus of the audit

The audit focused on one product family from a key customer and investigated our quality systems, design and change control, traceability, cleanroom cleaning and monitoring and purchasing controls.

 

There were no non-conformances to report and the auditors were impressed with what they saw. This is a really excellent result and is testament to the changes and proactive approach of the quality department and all at Europlaz.

 

Quality management system (QMS)

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

 

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.

 

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.

 

Strategic 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.