Certification & Regulations
Dover Motion products conform where necessary to one or more of the certifications and/or regulations listed below.
ISO 13485:2016 is a set of requirements for a quality management system for manufacturing of medical devices. Dover Motion is certified for the manufacturing of non-active, non-implantable finished products. ISO 13485:2016 has differences from ISO 9001 as it relates to the following:
- Understanding of regulatory requirements as a management responsibility such as those enforced by the U. S. Food and Drug Administration (FDA)
- Controls in place to ensure product safety
- Risk management and design control processes in place during product development
- Requirements for effectiveness verification of corrective and preventive actions
ISO 9001: 2015
ISO 9001: 2015 is a set of guidelines outlining a variety of practices that business have to set in place in order to be awarded this Total Quality Management certification. It can be used by any organization, large or small, regardless of its field of activity. This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. Using ISO 9001: 2015 helps ensure that customers get consistent, good quality products and services. An organization must perform internal audits to check how its quality management system is working and may decide to invite an independent certification body to verify that it is in conformity to the standard. Dover Motion has ISO 9001:2015 Certification for the Design and Manufacture of Precision Positioning Products and Motion Systems.
The Restriction of Hazardous Substances (RoHS) Directive limits the usage of hazardous materials in the manufacturing of various types of electronic components. The RoHS Directive is enforced in all the European Union Member States and all products must undergo periodic compliance checks. Dover Motion solders are lead free and product, components or systems can be RoHS compliant if required by our customers.
The Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) Act is a set of European Union Regulations that address the production and usage of chemical substances in manufacturing. REACH is considered one of the most complex pieces of legislation passed by the European Union and all companies operating within their territory are strongly encouraged to comply.
The Underwriters Laboratories (UL) is an independent company that provides safety related certification for companies operating in a variety of fields, including manufacturing. Their goal is to guarantee the safeguard of life and property.
Copy Exactly! (CE!)
Fabrication (Fab), sort, and assembly test facilities follow a Copy Exactly! (CE!) philosophy developed by Intel. Copy Exactly! enables delivery of product from multiple production sites, which operate as a virtual factory that performs consistently and independent of the manufacturing source site. Additional benefits include faster production ramps that improve product availability and improved consistency to quality performance.
The CE marking of a product indicates compliance with European Union legislation. CE marking signifies that the product conforms with all EC directives that apply to it such as safety, health, and environmental considerations. For electrical products typical regulation involves the Low Voltage Directive and the EMC Directive.
Dover Motion is committed to sourcing components and materials from companies that share our values regarding respect for human rights, integrity, and environmental responsibility. Dover Motion is also committed to complying with the OECD Due Diligence Guidance for Responsible Supply Chains of Minerals from Conflict-Affected and High-Risk Areas, which provides guidance to suppliers in establishing policies, due diligence frameworks, and management systems.