At Sysmex America, Inc (SAI), we place a high value on our customer relationships.
Strong business partnerships are built on mutual trust and respect, which require
adherence to the highest ethical and legal standards.
Our Regulatory Affairs department manages registrations and listings with the FDA
and licenses with Health Canada. We oversee compliance with all applicable
federal and state regulations as well as regulations applicable to federal programs
and contracts. This includes Health Insurance Portability and Accountability
Act (HIPAA), export control, and Occupational Safety and Health Administration (OSHA),
including issuance of Material Safety Data Sheets (MSDS).
Sysmex America’s Quality Management System policies define our arrangements for
managing operations and activities across all disciplines and at all levels within
the company in accordance with the framework established by FDA Quality System Regulation
(21 CFR Part 820); Canadian Medical Device Regulation (CMDR); and ISO 13485:2003,
ISO 9001:2008, and ISO 14971:2009. Our Quality Manual defines our plans and
protocols for achieving quality assurance and customer satisfaction.
At Sysmex America, Inc., we believe that quality in healthcare is everyone’s responsibility.
To learn more about our regulatory and compliance approach, refer to the information
and links below.
Quality Policy: Our policy is to provide products
and services with unmatched quality, reliability, and advanced technology to achieve
total customer satisfaction and confidence. We meet or exceed customer requirements
and comply with regulatory requirements. Every associate’s conduct reflects
our duty and commitment to quality in all aspects of our business. This policy
is supported through management review, customer feedback, and maintenance of an
effective Quality Management System.
ISO Certifications: Sysmex America, Inc. has
been certified to ISO 9001 since 2003 and ISO 13485 since 2010. Copies
of our ISO certificates appear below.
13485-2003 exp Feb 2016
9001-2008 exp March 2016
HIPAA and Privacy: Sysmex America, Inc. (SAI) has
adopted a Confidentiality & Non-Disclosure Agreement Policy to
comply with the Health Insurance Portability and Accountability Act (HIPAA) of 1996
and HITECH Act . This policy is also designed to ensure we fulfill our
responsibilities for securing the confidentiality and integrity of confidential
medical information (defined in HIPAA as protected health information (PHI), stored
or transmitted electronic protected health information (ePHI) and other sensitive
information) as required by law and will be supported via a formal associate training
Trade Security, US Export Control: Some
Sysmex products are classified as “Dual Use” commodities as defined by US Export
Administration Regulations (EAR), 15 CFR Part 730. These are products that
could potentially be used either commercially or militarily and, as such, are regulated
by the US Department of Commerce. Consequently, we are obligated to demonstrate
proper due diligence and aim to achieve the following Global Sysmex Security Trade
Comply with all US domestic and international import/export laws and regulations
in support of international peace and safety.
Export all Sysmex finished products, items or commodities regulated by these regulations
based upon administrative permission; and restrict export to countries or end-users
who intend to use these commodities for either the development or production of
weapons of mass destruction (WMD).
Prevention of illegal exports either directly or indirectly to a party that is listed
on one of the various Restricted (Black) Lists.
Access to SAI's site is restricted to persons who are not "Denied Persons"
or "Designated Foreign Nationals" as such phrases are defined under US
export laws and regulations. The "List of Denied Persons" is currently
available at www.bis.doc.gov
(The Bureau of Industry and Security) and the "List of Designated Foreign Nationals"
is currently available at www.ustreas.gov/ofac.
SAI Contracted Partners access information and materials on the Sysmex site at their
Specifically, you warrant to Sysmex that:
1. You do not appear on the List of Denied Persons or the List of Designated
Foreign Nationals and in the event that you subsequently appear on either list,
you will immediately cease to use the site.
2. You are not located in, under the control of, or a national or resident
of any country to which the US has embargoed goods.
3. You will not access, download, use or export information, software, products
or services contained on this site in violation of the US export laws or regulations,
or in violation of any applicable local laws or regulations.
4. You will comply at all times with any export laws and regulations applicable
Sysmex America, Inc. (SAI) Corporate Operating Procedure (COP) establishes
the standard methodologies used by Sysmex America, Inc., Sysmex Reagents America,
Inc. (SRA) and Sysmex Canada, Inc. (SCI) for complying with US Export Administration
Regulations (EAR), 15 CFR Part 730.
FDA Establishment Registrations: Manufacturers
of all medical devices are required to register their establishments and list
their devices with the FDA. To view registrations and listings on
the FDA data base, click here.
Health Canada Establishment License: Health Canada
requires entities who import or sell medical devices in Canada to obtain medical
device establishment licenses. In addition, manufacturers are required to
hold product licenses. To view our Medical Devices Active License Listing
(MDALL), click here.