Quality Processes
Every aspect of Amatek Design's operations are guided by a set of processes that represent man-decades of accumulated knowledge and expertise.
These tried and proven processes embodied in these procedures form the basis of our Quality Management System (QMS), which is at the heart of our Quality Program.
ISO-Compliant Processes and Procedures
Our Quality Management System (QMS) has been developed and implemented to meet the requirements of both:
- ISO 9001:2015 - QMS for organisations providing products and services that must meet customer and applicable statutory and regulatory requirements.
- ISO 13485:2016 - QMS for organisations providing Medical Devices and Software.
More importantly, it addresses every aspect of our operations; from our comprehensive project proposal format that captures all the pertinent information required for a client to make informed decision, through to the document version control system we use to ensure there's traceability throughout a project, to our comprehensive production and test plans that ensure a manufacturer has everything they need to make a product to our specifications.
Continual Process Improvement
Implemented in June 2021, our QMS has undergone two major internal audits and reviews since January 2022.
These have resulted in improvements to our operational procedures and the QMS itself, with our team working towards our first independent quality systems audit in late 2022/early 2023.
Regulatory Compliance
In addition to our Quality System processes, we're also highly experienced in the application of a range of Australian and international standards applicable to electronics hardware and related software development.
Discover more about our Compliance Support services here.