Delivering Quality From Start to Finish

ISO 13485 quality control manufacturing

Quality Control is the foundation of our business


We understand each customer is unique, but the need for consistent supply of a quality product is universal.

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Europlaz uses an established quality management system to ensure

a)    A common sense approach to the management of the organisation
b)    Consistency
c)    Continuous improvement of working practices
d)    We get it right first time
e)    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.

 

quality control medical devices

 

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

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 organization. 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 ISO9001:2008, ISO13485:2003, CMDCAS ISO13485 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.

Executive Management will regularly and systematically review Company 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 will communicate its quality policy and objectives to all levels of the organization, and will promote understanding, involvement and commitment amongst all employees.