An inherent risk when working with medical devices extends beyond general electronics concerns: defects and performance issues are more liable to cause personal injury. Given the possibility, medical manufacturing must strive for a higher standard than the general industry. ISO 13485 certification is the answer: by providing a foundation for exceeding competency goals while carefully accounting for the many variables throughout the manufacturing stages. ISO 13485-certified companies will keep production smoothly rolling while complying with all industry requirements.
Comparing Various QMS ISO Standards |
||
|---|---|---|
| Standard # | Description | Voluntary/Involuntary Standard? |
| ISO 9001 |
|
Voluntary |
| ISO 13485 |
|
Voluntary |
| ISO 14971 |
|
Voluntary |
The Value of ISO 13485-Certified Companies
For understandable reasons of safety when working with medical devices, manufacturers require ISO 13485 certification to establish that their quality management system (QMS) follows industry safety standards. Regarding a QMS, this is not dissimilar to ISO 9001 (indeed, there is some overlap); ISO 13485 specializes in medical device production and focuses less on non-regulatory best business practices. ISO 13485 provides the framework for various medical administrations globally, ensuring that production adheres to customer expectations regarding safety and simplifies alignment with the varying needs of these regulatory bodies. Importantly, ISO 13485 certification alone does not imply medical device manufacturing conformity; it merely acts as the coordinating system.
ISO 13485 begins by overseeing risk management with thorough documentation of each product design and manufacturing lifecycle step. In this sense, even designers who aren’t contracting manufacturers for medical device production can benefit from the processes of an ISO 13485-certified company; the abstract structure of QMS oversight is generally applicable across industries. The certification has a few areas of emphasis:
- Risk management – Limiting the risk introduced is central to establishing product viability and safety. A proper contract manufacturer, by nature, lessens risk by having fully developed QMS and expertise for medical device production that design teams may lack.
- Inspection and traceability – Traceability concerns are at the core of medical devices: manufacturers must quickly determine the effect on their product lines in a recall. Traceability also allows manufacturers to be proactive by checking the contents of materials and components before assembly to assure compliance. Therefore, traceability relies on inspecting relevant materials and post-assembly to gauge safety.
- Documentation – Documentation builds on the requirements of traceability to ensure a history of process steps before, during, and after manufacturing.
The certification process entails having a capable and broad QMS; thus, the first step in implementing ISO 13485 certification is to design a quality manual. Manufacturers can source internally to craft the quality manual from their experienced quality managers (QM) or look for outside consultancy. Neither option is necessarily better: internal QMs may have a narrow plan due to a limited view of manufacturing as an industry, while external consultants can approach QMS with a “one size fits all’ perspective that fails to account for nuance between manufacturers. Once again, there is some wiggle room in how companies achieve and maintain certification, as repeatable results and consistent, reliable methods outweigh the finer details of the operation.
Achieving certification requires application, preassessment, and an assessment of the facility to evaluate the QMS theoretically and empirically. The assessment duration can vary depending on the size (the premises and its personnel) and the scope of the work performed. Post-certification assessment is ongoing, and its frequency will also depend on the abovementioned factors; at least, manufacturers should expect annual post-certification assessment until reassessment. Reassessment will be a “like new” certification process where the judgment of the accredited body disregards prior certification results to ensure the QMS receives full consideration without the inherent bias of ongoing assessment.
The Other Half of ISO 13485
ISO 13485 pairs with ISO 9001 to form a comprehensive QMS, with the latter providing the impetus for continuous improvement and customer satisfaction goals that make the manufacturer’s process more competitive. Like ISO 13485, ISO 9001 also requires certification by assessing the manufacturing practices. The benefits of ISO 9001 include a Plan-Do-Check-Act methodology that permeates organizational culture to reduce risk and amplify efficiency. Additional benefits are numerous:
- Crystallizing business goals – Explicitly defined outcomes and objectives provide a tangible metric for success and can reveal overlooked business opportunities.
- Process alignment – Keeping all employees on the same page regarding company processes enhances productivity, reduces internal costs, and allows for lean business strategies that improve market fitness.
- Expansion opportunities – Since ISO 9001 has global recognition for reaching regulations and standards regardless of the overseeing body, organizations with a fleshed-out QMS have greater maneuverability when dealing with new markets.
Fortunately, the symbiosis between ISO 9001 and ISO 13485 prevents designers from spending excessive time searching for appropriate manufacturers or choosing between compliance and customer focus.
Your Contract Manufacturer’s Commitment to Safety and Standards
ISO 13485-certified companies keep production on track with a coordinating system that places customer safety at the forefront of manufacturing through intense risk management. Non-medical designs can benefit from the successful implementation of ISO 13485 certification owing to improved process control. Here at VSE, we’re a team of engineers committed to building electronics for our customers in the medical industry and beyond. Along with valued manufacturing partners, we’ve been realizing life-changing and life-saving devices for over forty years.
