Safety Standards

Setting High Standards

ISO Efforts

Novanta products are used in highly sensitive and technical contexts, including medical devices and industrial lasers. It is imperative, therefore, that our products meet the highest standards of safety and quality to meet our customers’ needs. We pursue industry-standard ISO certifications, or their respective national versions, such as EN, DIN, and BS, for our facilities and systems across business units.

All Novanta manufacturing facilities are ISO certified to ISO 9001, and many are also certified to ISO 13485. We have also made significant progress in reaching ISO 14001 certification. To date, four of major manufacturing facilities have received the certification for ISO 14001. Three additional facilities are in the process of being certified. In addition, three major facilities also reached ISO 45001 certifications in 2021.

For our overall management, we pursue:
For our medical devices, we pursue the following standards:
  • ISO 9001
  • ISO 14001
  • ISO 45001
  • ISO 13485
  • CE Marking in the EU
  • FDA Approval in the U.S.
  • CFDA in China
  • PMDA in Japan
  • ANVISA in Brazil
For our overall management, we pursue:
  • ISO 9001
  • ISO 14001
  • ISO 45001
For our medical devices, we pursue the following standards:
  • ISO 13485
  • CE Marking in the EU
  • FDA Approval in the U.S.
  • CFDA in China
  • PMDA in Japan
  • ANVISA in Brazil
quote-Cathy-Zhou​
Novanta Suzhou factory has passed ISO 14001 environmental system surveillance audit in 2021. We will keep following ISO 14001 standard, legal requirements, and corporate environmental policy.
Cathy Zhou
Quality Manager

Product Quality and Safety

The quality and safety of our products is of utmost importance to us. We comply with all laws and regulations relating to product safety in each of the countries where we operate, including Title 21 CFRP Part 820 (QSR) in the U.S. and EU MDR in Europe for medical technologies. Our facilities strive to meet the highest global standards—we have already achieved ISO 9001, and we’re on the pathway to achieving ISO 13485 certification, for all of our medical production locations. The Novanta Growth System provides a common set of best practices and tools so that we meet high standards.

In 2021, we designed guidelines and processes to incorporate sustainability criteria into product requirement documents during the design stages of new product development. Sustainability considerations start there and are embedded in all phases of our product life cycles.

Risks and Opportunities

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