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.

aki is an BS EN ISO 9001:2000 certified company. aki uses a range of procedures and equipment to maximise quality control and ensure continuous improvement.

aki is an ISO 13485 certified company. The ISO 13485 standard specifies a quality management system for 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

Our Quality Management Systems comprising policies and procedures are controlled through Powerway®, an electronic document management software application.
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
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.