Circuitwise - Quality Systems for PCB Assembly | Sydney | ISO 13485

Circuitwise Electronics Manufacturing, Sydney Australia

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Quality Systems

ISO 13485 logo certifying compliance to  a Medical Device Manufacturing quality system

Your Partner in Reliability

At Circuitwise, we have invested deeply in quality systems that we can proudly claim to be best-in-class globally.

 

Not only are we certified to one of the most exacting quality standards in the world, ISO 13485, but we also export our systems to leading manufacturers around the world in non-competing markets. Developed over 15 years, our quality system is constantly refined to deliver:

 

  • Reliability

  • Traceability

  • Continual improvement

  • Regulatory compliance

 

Underpinning our quality is the experience of our specialist staff with an average employment of over 10 years. Five staff are dedicated to administering the quality system, including two full-time programmers who are constantly improving the system.

 

View our Quality Policy

 

ISO 9001 certificate showing compliance to a total quality management system

Quality Principles

We have robust documentation processes to ensure we deliver exactly what was ordered. However, we are flexible and our robust change control process records all change requests. Every board is built to the IPC-A-610 Class 2 standard, or Class 3 if required.

Our overall quality principles include design for manufacturing (DFM), failure mode and effects analysis (FMEA) and six-sigma (DFSS) concepts. These methods go well beyond SPC charts, first pass yield and DPMO calculations.

We pride ourselves on getting the job done right the first time and helping customer detect any manufacturability problems early. The cost of issues rises exponentially the later it is caught, particularly if products need to repaired or replaced in the field.

Detecting manufacturability problems early saves customer's money

Traceability

Circuitwise labels every board before the start of the process, unless instructed otherwise.

 

The source of every component is linked to the production batch, facilitating design troubleshooting and, in the worst case, product recalls.

 

With the cost of data storage becoming cheaper every day, there is no retention period defined for our internal traceability - it remains forever.

Circuit board assembly showing serial number and barcode (bottom right hand corner)

Continual Improvement

At Circuitwise we are constantly looking for ways to improve our operations.

 

Many of the systems we employ were invented in house, including our world class First Article Inspection System and our smart SMT Reel Storage solution. Both of these in-house solutions are now exported around the world.

Reel Storage.JPG

InvMan-S1 SMT reel storage solution invented by Circuitwise

Regulatory Compliance

All documentation required for regulatory compliance is managed and stored in our system in perpetuity. This includes a full product history, part history and links to original orders, bill of materials and all other relevant information. 

We also institute advanced product quality planning (APQP) and production part approval processes (PPAP) and any other controls as required by the customer.

 

We can issue certificates of compliance as required, satisfying the request of certifiers like Underwriters Laboratories (UL).

A product card linking all relevant quality information

Quality Team

 

The 'quality thinking’ concept is built into all our operational processes and the systems we use.

 

We have formal systems to meet the standards and audits. The engineering team creates a detailed quality plan for the customer's products and the quality team reviews this before manufacturing commences.

Download a copy of our Certificates 
 
An ISO 13485 registration certificate
An ISO 9001 quality certificate of registration