Quality

Quality, best practice and customer service are at the heart of the Company, demonstrated by continued investment in the business and its people. With a fully equipped Quality Department and quality control procedures throughout the production process, we aim for 100% customer satisfaction. Employees play a vital role in our success and we are committed to Investors in People and a TQM culture.

As of July 2009 AKI is now certified to the updated BS EN ISO 9001:2008 quality certification. AKI uses a range of procedures and equipment to maximise quality control and ensure continuous improvement.

AKI is an ISO 13485:2012 certified company. The ISO 13485 standard specifies a quality management system for the medical devices industry. Companies that comply with ISO 13485 also meet appropriate ISO 9001 and FDA regulatory requirements. Special system and process requirements for ISO 13485 include the following:

  • Risk management
  • Cleanliness, sterilization and contamination management
  • Customer requirements
  • Clinical evaluations and trials
  • Purchasing traceability and verification controls
  • Requirements for implantable devices
  • Proper communication of advisory notices
  • Labeling and packaging controls
  • Shelf-life and preservation of the product

Processes

  • Statistical Process Control
  • Complete traceability back to raw materials
  • Initial Sample Inspection Reports
  • Process Capability Studies
  • Failure Mode Effects Analysis

Equipment

  • Johansson Topaz 7 Co-ordinate Measuring Machine with full CNC and 3D CAD Interface
  • OGP Smartscope Quest 300
  • Faro Arm Prime
  • Baty R14 Shadowmaster projector
  • QI Analyst SPC programme
  • Light Cabinet with all Standard Light Sources
  • Full Range of Hand Held Measuring Equipment

We set the standards that others follow.

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