top of page

What does ISO13485 Medical Certification mean to you

While many electronics manufacturers hold ISO9001 certification very few hold ISO13485 Medical certification.

The ISO9001 Standards focus mainly on Customer satisfaction, general business procedures and continuous improvement. This is why a large percentage of companies from Electronics manufacturers to Coffee shops hold this certification. It is a more generic Quality Assurance model and system which can apply to almost any type of business.

The ISO13485 Standards puts emphasises on meeting regulatory and customer requirements, risk management and maintaining effective processes. This standard is a medical certification and is an extension of ISO9001. Where ISO9001 stops ISO13485 takes over.

The question is what does this Medical Certification do for you if you have no requirements to be medically certified and your products do not require this level of certification? Dealing with a Contract Electronics Manufacturer (CEM) that has these certifications provides confidence that this CEM has fully documented, strict controls over traceability of components as well as all processes in their factory.

Accredited CEM’s will have systems in place that provide:

  • First Article Inspection Systems - These systems provide documented evidence that the process has been executed the way in which the customer requirements state. Our automated First Article Inspection System is a world leading proven system.

  • MRP/ERP Systems that have a traceability element designed into them that allow the CEM to purchase, receive and store raw materials to ensure that exactly was specified by the customer has in fact been purchased and manufactured into the product correctly.

  • Electronic Document Control Systems - The Zones system Circuitwise uses documents and distributes all pictures, drawings and procedures pertaining to the customers product and is available in an electronic format to the production floor and under strict revision control. This ensures that any products manufactured are built at the right revision level using the most up to date drawings and instructions.

  • Systems and equipment in place to ensure that all process windows established for the product are adhered to. What this means is that the CEM should have X-Ray, 3D Inspection and Temperature Profilers to verify 100% that once a process has been established for a given product this ancillary equipment ensures that the process window is contained within specification.

  • Engineering Documentation Systems which is revision controlled and allows for listing of critical, IS critical, and manufacturer specific elements ensuring customer BOM’s are documented correctly. These also have ECO/ECN systems built in with full traceability.

  • Production Control Systems which are ERP integrated which document and control all steps of manufacturing and are fully integrated with all other systems. Personnel and Time Management are built into these systems.

At Circuitwise all of the above systems are in place and are fully integrated to ensure that the right product is manufactured the first time and every subsequent time consistently at the correct revision levels and manufacturing standards.

ISO13485 is more than a documented system that is created and sits on the shelf. It is a methodology and an ideology that is used by all employees and systems to ensure that potential risks are mitigated, highlighted and controlled. These include potential future risks. At Circuitwise we are constantly updating and revising the way things are handled, evolving with experience and refining systems to suit current and future requirements. We employ full-time software gurus which are constantly refining inbuilt software systems to ensure that we have market leading systems to control the manufacturing effort for our customers.

Our systems are so good that we sell them under the Cluso Vision Systems banner to 6 of the top 10 CEM’s all over the world. We are the world leading manufacturer of the Cluso First Article Inspection Systems as well as the Zones Document Control and Distribution System. These systems were designed at Circuitwise many years ago due to an internal requirement and they were not available to purchase externally at that time.

Even though an OEM may not be a medical products manufacturer the benefits in dealing with a CEM that is ISO13485 Medical as well as ISO9001 certified ensures that their products will be manufactured reliably, consistently, documented accurately and all of this with full traceability of the raw material. Our systems and methods at Circuitwise are second to none and are world class.

As a small example of the difference this makes, ask your current CEM “How do you perform and validate First Article Inspection?”. You will be surprised by the answer.

Greg Ross

Circuitwise Electronics Manufacturing

bottom of page