Delivering Quality From Start to Finish

ISO 13485 quality control manufacturing

Europlaz Certifications:

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ISO 13485ISO 9001

Europlaz can CE Mark your products and compile your regulatory files

IMPORTANT NOTICE:  SGS have failed to audit Europlaz within the required timeframe so have issued temporary extensions to our certification. This situation will be resolved before September 2015.

The Key Elements of ISO9001: 2008 & ISO13485:2003 are:
•    Establish, document, implement, maintain / continually improve
•    Identify processes; determine sequence & interaction
•    Determine control method to ensure effectiveness
•    Ensure supporting resources & information are available
•    Measure & monitor; to achieve planned results and maintain / continually improve them


To prove we are achieving the required standards we maintain strict quality records, these include:


Supplier Approval / performance Records – Evidence we have reviewed and monitor our Suppliers to establish and maintain a quality and consistent supply of product / materials.
Inspection Records – for demonstrating supplied product / materials and outputs from the manufacturing processes meet the specified criteria.
Training records - for demonstrating staff have been trained and are approved as being competent.
Internal Audit reports / non-conformity Reports – evidence our quality System has been reviewed and any issues identified have been registered and addressed.
Management Review meeting minutes – Evidence senior Management have reviewed the performance of the quality system and have agreed actions for on-going continuous improvement.