| BIO/DATA CORPORATION |
An ISO 13485:2003, 9001:2000 Registered Company
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| STANDARDS |
A standard is an agreed, repeatable way of doing something. It is a published document
that contains a technical specification or other precise criteria designed to be used
consistently as a rule, guideline, or definition. Standards help to make life simpler and to
increase the reliability and the effectiveness of many goods and services we use. They are
intended to be inspirational - a summary of good and best practice rather than general
practice. Standards are created by bringing together the experience and expertise of all
interested parties such as the producers, sellers, buyers, users and regulators of a
particular material, product, process or service.
FDA Quality System Regulations - Bio/Data Corporation adheres to the requirements of
the current good manufacturing practices (cGMP) of the Food and Drug Administration
(FDA). These requirements relate directly to the methods used in the quality control of
designing, manufacturing, testing, packaging, labeling, storing, installing, and servicing of
the medical devices offered by the company and intended for in-vitro diagnostic use.
CE Declaration of Conformity - The CE Mark certifies that a product has met the European
Union (EU) health, safety, and environmental requirements which ensure consumer
safety. By completing a conformity assessment process, Bio/Data Corporation is able to
market the Company's hemostasis products throughout the European Union (EU).
ISO Certifications / Registration - For quality systems standards, ISO recognition is
paramount to competing in a global economy. In order to achieve ISO certification, a
Company needs to implement a quality assurance system, educate its personnel, and
demonstrate to an authorized registrar that the quality system functions in accordance with
the Standard. The Company's earned ISO 13485:2003 certification (specifically earmarked
for medical devices) in 2007. This followed the ISO 9001:2000 general-industry
registration that the Company achieved in 2004.
Health Canada Licenses - Bio/Data Corporation has received Class II Medical Device
Licenses from Health Canada for the Company's Platelet Aggregation Profiler Instruments
and its vW Factor Assay® (von Willebrand Factor Assay) and all of its Aggregation
Reagents. These Health Canada licenses recognize that our quality system conforms to
all of their standards.
Health Canada requires medical device manufacturers to use a quality system certificate
as evidence of compliance to the appropriate regulatory quality system requirement. Health
Canada will only accept quality system certificates that have been issued by special third
party auditing organizations called Canadian Medical Devices Conformity Assessment
System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require
importers or distributors of medical devices to have a registered quality system.
The Medical Devices Regulations require class II, III and IV medical devices to be
manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO
13485:2003. There are no regulatory quality system requirements for Class I medical
devices. These quality system requirements came into force on January 1, 2003.
Standards Council of Canada - Accreditation by the Standards Council of Canada
demonstrates that an organization has met the international standard for management
system certification bodies and is able to competently assess and certify management
systems. The organizations are accredited as management system certification bodies
for medical device manufacturers AND are recognized through Canadian Medical Devices
Conformity Assessment System (CMDCAS).
Standardization is the development and application of standards—publications that
establish accepted practices, technical requirements and terminologies for products,
services and systems. Standards help to ensure better, safer and more efficient methods
and products, and are an essential element of technology, innovation and trade.
The Standards Council carries out a variety of functions intended to ensure the effective
and coordinated operation of standardization in Canada. It also represents Canada's
interests on standards-related matters in foreign and international forums.
ANSI-ASQ National Accreditation Board - The ANSI-ASQ National Accreditation Board is
the U.S. Accreditation body for management systems. ANAB accredits certification bodies
(CBs) for many systems, including ISO 9001 quality management systems (QMS). ANAB
is a member of the International Accreditation Forum and a signatory of the IAF multilateral
cooperative arrangements (MLAs) for QMS and EMS. Through the IAF MLAs and the
Multilateral Cooperative Accreditation Arrangement, ANAB cooperates with other
accreditation bodies around the world to provide value to its accredited CBs and their
clients, ensuring that accredited certificates are recognized nationally and internationally.
The global conformity assessment system ensures confidence and reduces risk for
customers engaging in trade worldwide.
Electrical and Laboratory Safety - Bio/Data Corporation's Instruments and powered
accessories meet required, national, Canadian, and International Standards.
Underwriters Laboratories - UL is the trusted source across the globe for product
compliance. Benefiting a range of customers - from manufacturers and retailers to
consumers and regulating bodies - Underwriters Laboratories tested products for public
safety for more than a century. Underwriters Laboratories now offers one of the conformity
assessment industry's broadest portfolios of capabilities and certification marks. UL's
unique mix of local expertise in global markets and deep industry knowledge helps bring
safer products to markets faster than ever before.
Clinical Laboratory Standards Institute (CLSI) - Bio/Data supports CLSI goals for
improving laboratory performance, harmonizing quality standards, and recommends that
its customer laboratories adopt CLSI Approved Guidelines. For more Information, refer to
our Reagent Technical Bulletins reference section for applicable Approved Guidelines.
NASCOLA and CAP - Bio/Data, strives to provide products that help clinical laboratories
meet required performance standards for producing accurate and precise laboratory
results. Bio/Data participates in the same proficiency testing programs that many of our
customers rely on as performance indicators. Proficiency testing programs regularly send
"unknown" samples to participating laboratories that then test the samples and report
results back to the sponsoring organizations. The reported results are graded and
compared. It is this inter-laboratory comparison that laboratories use to evaluate their
performance. NASCOLA (North American Specialized Coagulation Laboratories
Association) and CAP (College of American Pathologists) are the two leading
organizations that offer proficiency testing for hemostasis, coagulation, and platelet
function testing. Bio/Data participates in both programs.
BSI British Standards - As the world’s first national standards organization, BSI British
Standards has a globally recognized reputation for independence, integrity and innovation
in the production of standards and information products that promote and share best
practice. It is a leading provider of standardization and consortia services to the public and
private sectors, serving the interests of a wide range of industry sectors as well as
governments, consumers, employees and society overall, to make sure that British,
European and international standards are useful, relevant and authoritative.
that contains a technical specification or other precise criteria designed to be used
consistently as a rule, guideline, or definition. Standards help to make life simpler and to
increase the reliability and the effectiveness of many goods and services we use. They are
intended to be inspirational - a summary of good and best practice rather than general
practice. Standards are created by bringing together the experience and expertise of all
interested parties such as the producers, sellers, buyers, users and regulators of a
particular material, product, process or service.
FDA Quality System Regulations - Bio/Data Corporation adheres to the requirements of
the current good manufacturing practices (cGMP) of the Food and Drug Administration
(FDA). These requirements relate directly to the methods used in the quality control of
designing, manufacturing, testing, packaging, labeling, storing, installing, and servicing of
the medical devices offered by the company and intended for in-vitro diagnostic use.
CE Declaration of Conformity - The CE Mark certifies that a product has met the European
Union (EU) health, safety, and environmental requirements which ensure consumer
safety. By completing a conformity assessment process, Bio/Data Corporation is able to
market the Company's hemostasis products throughout the European Union (EU).
ISO Certifications / Registration - For quality systems standards, ISO recognition is
paramount to competing in a global economy. In order to achieve ISO certification, a
Company needs to implement a quality assurance system, educate its personnel, and
demonstrate to an authorized registrar that the quality system functions in accordance with
the Standard. The Company's earned ISO 13485:2003 certification (specifically earmarked
for medical devices) in 2007. This followed the ISO 9001:2000 general-industry
registration that the Company achieved in 2004.
- ISO 9001:2000 Certificate
ISO 9001 is by far the world’s most established quality framework, currently being
used by around 897,000 organizations in 170 countries worldwide, and sets the
standard not only for quality management systems, but management systems in
general. It helps all kinds of organizations to succeed through improved customer
satisfaction, staff motivation and continual improvement.
ISO 13485:2003 Certificate
Effective quality management systems are recognised as a key regulatory
consideration for allowing medical device manufacturers to market their products
around the world. ISO 13485 provides a focus for the quality management system
requirements for medical device manufacturers.
Health Canada Licenses - Bio/Data Corporation has received Class II Medical Device
Licenses from Health Canada for the Company's Platelet Aggregation Profiler Instruments
and its vW Factor Assay® (von Willebrand Factor Assay) and all of its Aggregation
Reagents. These Health Canada licenses recognize that our quality system conforms to
all of their standards.
Health Canada requires medical device manufacturers to use a quality system certificate
as evidence of compliance to the appropriate regulatory quality system requirement. Health
Canada will only accept quality system certificates that have been issued by special third
party auditing organizations called Canadian Medical Devices Conformity Assessment
System (CMDCAS) recognized registrars. The Medical Devices Regulations do not require
importers or distributors of medical devices to have a registered quality system.
The Medical Devices Regulations require class II, III and IV medical devices to be
manufactured (class II) or designed and manufactured (class III & IV) under CAN/CSA ISO
13485:2003. There are no regulatory quality system requirements for Class I medical
devices. These quality system requirements came into force on January 1, 2003.
Standards Council of Canada - Accreditation by the Standards Council of Canada
demonstrates that an organization has met the international standard for management
system certification bodies and is able to competently assess and certify management
systems. The organizations are accredited as management system certification bodies
for medical device manufacturers AND are recognized through Canadian Medical Devices
Conformity Assessment System (CMDCAS).
Standardization is the development and application of standards—publications that
establish accepted practices, technical requirements and terminologies for products,
services and systems. Standards help to ensure better, safer and more efficient methods
and products, and are an essential element of technology, innovation and trade.
The Standards Council carries out a variety of functions intended to ensure the effective
and coordinated operation of standardization in Canada. It also represents Canada's
interests on standards-related matters in foreign and international forums.
ANSI-ASQ National Accreditation Board - The ANSI-ASQ National Accreditation Board is
the U.S. Accreditation body for management systems. ANAB accredits certification bodies
(CBs) for many systems, including ISO 9001 quality management systems (QMS). ANAB
is a member of the International Accreditation Forum and a signatory of the IAF multilateral
cooperative arrangements (MLAs) for QMS and EMS. Through the IAF MLAs and the
Multilateral Cooperative Accreditation Arrangement, ANAB cooperates with other
accreditation bodies around the world to provide value to its accredited CBs and their
clients, ensuring that accredited certificates are recognized nationally and internationally.
The global conformity assessment system ensures confidence and reduces risk for
customers engaging in trade worldwide.
Electrical and Laboratory Safety - Bio/Data Corporation's Instruments and powered
accessories meet required, national, Canadian, and International Standards.
Underwriters Laboratories - UL is the trusted source across the globe for product
compliance. Benefiting a range of customers - from manufacturers and retailers to
consumers and regulating bodies - Underwriters Laboratories tested products for public
safety for more than a century. Underwriters Laboratories now offers one of the conformity
assessment industry's broadest portfolios of capabilities and certification marks. UL's
unique mix of local expertise in global markets and deep industry knowledge helps bring
safer products to markets faster than ever before.
Clinical Laboratory Standards Institute (CLSI) - Bio/Data supports CLSI goals for
improving laboratory performance, harmonizing quality standards, and recommends that
its customer laboratories adopt CLSI Approved Guidelines. For more Information, refer to
our Reagent Technical Bulletins reference section for applicable Approved Guidelines.
NASCOLA and CAP - Bio/Data, strives to provide products that help clinical laboratories
meet required performance standards for producing accurate and precise laboratory
results. Bio/Data participates in the same proficiency testing programs that many of our
customers rely on as performance indicators. Proficiency testing programs regularly send
"unknown" samples to participating laboratories that then test the samples and report
results back to the sponsoring organizations. The reported results are graded and
compared. It is this inter-laboratory comparison that laboratories use to evaluate their
performance. NASCOLA (North American Specialized Coagulation Laboratories
Association) and CAP (College of American Pathologists) are the two leading
organizations that offer proficiency testing for hemostasis, coagulation, and platelet
function testing. Bio/Data participates in both programs.
BSI British Standards - As the world’s first national standards organization, BSI British
Standards has a globally recognized reputation for independence, integrity and innovation
in the production of standards and information products that promote and share best
practice. It is a leading provider of standardization and consortia services to the public and
private sectors, serving the interests of a wide range of industry sectors as well as
governments, consumers, employees and society overall, to make sure that British,
European and international standards are useful, relevant and authoritative.
| ISO 13484:2003 FM 509107 |
| An ISO 13485:2003, 9001:2000 Registered Company |
155 Gibraltar Road, PO Box 347, Horsham, PA 19044-0347 USA
(215) 441-4000 Worldwide / (800) 257-3282 USA / (215) 443-8820 Fax Worldwide
Website: www.biodatacorp.com / Email: customer.service@biodatacorp.com
(215) 441-4000 Worldwide / (800) 257-3282 USA / (215) 443-8820 Fax Worldwide
Website: www.biodatacorp.com / Email: customer.service@biodatacorp.com
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| © BIO/DATA CORPORATION 2008. All Rights Reserved. |
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