ISO 13485 Certified Battery Manufacturing for Medical Applications

Ultralife’s facilities in the USA, UK, Canada, and China manufacture cells, battery packs, and chargers for the medical and healthcare sector.

Each year these facilities are externally audited to the internationally recognized ‘ISO 13485 standard for quality management – medical products’ by a certified body.

The audit indicates that Ultralife has a Quality Management System (QMS) in place that consistently meets customer and regulatory requirements, enabling us to provide safe and effective products in support of medical devices. It also confirms that we facilitate market approval for medical device OEMs. Ultralife has maintained certification to the ISO 13485 standards for many years.

While ISO 13485 incorporates most of the ISO 9001 quality standards within it, to which our facilities are also certified, there are differences. For instance, ISO 9001 encompasses all manufacturing (not just medical), so it primarily aims to achieve customer satisfaction, whereas ISO 13485 places more emphasis on regulatory requirements and documentation (because it is medical focused). Any regulatory documents must be retained with other documentation for at least the lifetime of the medical device or as specified by applicable regulatory requirements (minimum of two years).

Furthermore, ISO 13485 puts more focus on corrective and preventive actions, as well as risk management, than ISO 9001 does. However, both are effectively Business Management Systems that require input from all aspects of the organization, from Top Management to Human Resources, Engineering, and Customer Fulfillment.

As an organization, we are proud to maintain our certifications to both ISO 13485 and ISO 9001, as part of our commitment to delivering safe, reliable, and high-quality products for critical applications.

Whether you are dealing with our headquarters in Newark (USA), Accutronics Ltd in the UK, Southwest Electronic Energy in the USA, Excell Battery in Canada, or Able New Energy in China, you can be assured that you are getting high quality products that have been manufactured in facilities approved by a certified body.