The International Organization for Standardization (ISO) develops compliance guidelines to ensure quality in the manufacturing industry. Standards set forth by ISO 13485 cover documented quality management systems for medical device manufacturing companies. While ISO 13485 isn't mandatory, the standards it uses are considered the best in the world. Here's what you should know if you're having a manufacturer develop products for your medical facility using these guidelines.

What Are Some Important Details to Know About ISO 13485?

1. Certification Process

Once the scope of the medical device has been defined, manufacturers must conduct a gap analysis to uncover discrepancies between their practices and ISO 13485. If gaps are discovered, a corrective plan must be established to ensure the device meets relevant regulations. 

Next, documentation regarding the device manufacturing process should be compiled, followed up by training staff in the proper processes. At this point, the manufacturer will have three to six months to roll out the new quality management system and apply for certification. Certification will only occur after an external audit to ensure they're following the pertinent standards. 

2. Mandatory Requirements

While there are eight sections total in the ISO 13485, the last five list the mandatory requirements medical device manufacturing companies must follow. Clause 4 provides general and documentation requirements that govern the quality management system. 

Clause 5 relates to accountability of the management team, while clause 6 dictates that certain resources must be available to manufacture the device safely and effectively. Clause 7 covers product realization from the concept stage to the final production, and clause 8 requires the manufacturer to develop a process to monitor the success of the device after release and collect feedback from patients. 

3. 2016 Update

While the ISO first established standards for quality management systems in 1996, the guidelines have undergone several changes over the years. The most recent update occurred in 2016 and included some key adjustments. 

For example, manufacturers can now incorporate risk management procedures into the quality management system process. Clarifications were also provided regarding responsibility for employee training and management roles. Manufacturing monitoring procedures also received new requirements to ensure accurate information collection. 

If you're looking for a medical device manufacturing company that adheres to ISO 13485 guidelines, work with Pacific Integrated Manufacturing in Bonita, CA. With a state-of-the-art facility and over 15 years of experience, they develop quality products that will help patients receive the care they need. They'll incorporate your specifications into the process to ensure the results align with your goals. Visit their website to learn more about their services, or call (619) 921-3464 to request a free quote.