Safety Standards

Safety: Our Top Priority

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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.  

Novanta manufacturing facilities are ISO certified to ISO 9001 and/or ISO 13485. The majority of the ten major manufacturing facilities are certified under the ISO 14001 standard. Additionally, in 2022, three major facilities completed ISO 45001 certification, with the remaining facilities in process.  

Standards we pursue

For all products
For medical products
  • 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 all products
  • ISO 9001
  • ISO 14001
  • ISO 45001
For medical products
  • 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 Code of Federal Regulations Title 21, Part 820 (QSR – Quality System Regulation) in the U.S. and the Medical Device Directive (MDD) and Medical Device Regulation (MDR) in Europe for medical devices. Our facilities strive to meet the highest global standards—we have already achieved ISO 9001, and half of our manufacturing sites have achieved ISO 13485 certification. The Novanta Growth System provides a common set of best practices and tools that enable us to meet high standards.  
 
In 2022, we continued to design guidelines and processes to incorporate environmental sustainability aspects into product requirement documents during the design stages of new product development. Environmental considerations start there and are embedded in all phases of our product life cycles. 

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Risks and Opportunities

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