| BIO/DATA CORPORATION |
An ISO 13485:2003, 9001:2000 Registered Company
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| QUALITY SYSTEM |
Bio/Data's Quality Policy is to produce products and services that meet customer
expectations for performance and provide a maximum level of customer satisfaction.
This policy is implemented to maintain strong customer satisfaction and to reinforce
quality assurance , quality control, and good business practices.
To affirm this commitment, Bio/Data has established a comprehensive quality
assurance system which meets the requirements of the United States Food and Drug
Administration's Quality System Regulation (commonly called the cGMP and detailed
in CFR Title Section 800 to 899) and is registered by BSI North America (British
Standards Institution) to the ISO 9001:2000 and ISO 13485:2003 quality standards.
Our products are manufactured to conform to the EU 98/79EC Directive and the
Canadian SOR/98282 Medical Device Regulations. These quality assurance
regulations and programs permit for worldwide marketing of our products.
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.
Bio/Data Corporation's Quality Assurance System Concentrates on providing:
How does Bio/Data Corporation measure its commitment to Quality and the
realization to its quality goals?
Bio/Data Corporation supports global efforts to standardize test performance and
harmonized interpretive guidelines. With laboratories around the world relying on
Bio/Data Corporation's aggregometers and reagents, lab professionals are able to
provide accurate hemostasis monitoring by running platelet function and activation
tests under the same conditions time after time. As a manufacturer, marketer, and
distributor of hematological medical laboratory products, our Company continuously
works to improve its test systems and customer satisfaction.
Please refer to our Standards page for more information.
expectations for performance and provide a maximum level of customer satisfaction.
This policy is implemented to maintain strong customer satisfaction and to reinforce
quality assurance , quality control, and good business practices.
To affirm this commitment, Bio/Data has established a comprehensive quality
assurance system which meets the requirements of the United States Food and Drug
Administration's Quality System Regulation (commonly called the cGMP and detailed
in CFR Title Section 800 to 899) and is registered by BSI North America (British
Standards Institution) to the ISO 9001:2000 and ISO 13485:2003 quality standards.
Our products are manufactured to conform to the EU 98/79EC Directive and the
Canadian SOR/98282 Medical Device Regulations. These quality assurance
regulations and programs permit for worldwide marketing of our products.
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.
Bio/Data Corporation's Quality Assurance System Concentrates on providing:
- Defect-free products and services to our customers.
- On time delivery.
- Continual improvements to all aspects of our Quality Assurance System,
products, and services.
How does Bio/Data Corporation measure its commitment to Quality and the
realization to its quality goals?
- Timely and periodic review by management of the data generated by the
Quality Assurance Systems. These reviews generate Corrective and
Preventative Actions (CAPA) that improve our systems, products, and services.
- Timely and periodic review of reports detailing the Company's delivery
performance. The Management team develops policies and procedures for
improvement if and when needed.
Bio/Data Corporation supports global efforts to standardize test performance and
harmonized interpretive guidelines. With laboratories around the world relying on
Bio/Data Corporation's aggregometers and reagents, lab professionals are able to
provide accurate hemostasis monitoring by running platelet function and activation
tests under the same conditions time after time. As a manufacturer, marketer, and
distributor of hematological medical laboratory products, our Company continuously
works to improve its test systems and customer satisfaction.
Please refer to our Standards page for more information.
| 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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