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Quality System & Standards

Quality System

Bio/Data Corporation'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 Corporation 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 Title 21 CFR Section 820) and is registered by BSI North America (British Standards Institution) to the ISO 9001:2008 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?

Bio/Data Corporation measures its commitment to quality through timely and periodic review of the data generated by the Quality Assurance System. 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.


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

ceThe 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).

Authorized European Representative

emergologo

Molenstraat 15
2513 BH, The Hague
The Netherlands

Phone: +31 (0) 70.345.8570
Fax: +31 (0) 70.346.7299
Website: www.emergogroup.com

ISO Certifications / Registration

isoBio/Data Corporation voluntarily adopted the ISO Quality Management System Standards in 2004, and continues to comply with those Standards. In 2005, the Company's Quality System was registered compliant with ISO 9001:2000 Standards. Products manufactured under a 9001:2000 quality system fulfill customer's needs for quality products, meet regulatory requirements, enhance customer satisfaction and achieve continuous improvement of Company performance.

Shortly after registration to ISO 9001:2000 the Company added ISO's medical device specific Standard as an objective for its Quality Management System and attained 13485:2003 registration in 2006. This Standard requires that a company demonstrate its ability to consistently produce medical devices that meet both customer and regulatory requirements specifically established for medical devices and related services.

BSI Management Systems, the Company's accredited ISO registrar, audits our quality systems. product performance, regulatory status and customer satisfaction annually to verify compliance to the current versions of each Standard.

Bio/Data Corporation's Quality Management Systems are compliant with newly updated 13485:2003.

ISO 13485:2003 Certificate

iso_13485_2003Effective 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

health_canadaBio/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.

South Korea Ministry of Food and Drug Safety GMP Certificate

Bio/Data Corporation has received a Certificate of GMP from the South Korea Ministry of Food and Drug Safety. This certifies that Bio/Data complies with South Korea Good Manufacturing Practices of Medical Devices for its product range of in-vitro diagnostic instruments and reagents.

ANSI-ASQ National Accreditation Board

ansi-asqThe 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

ulUL 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)

clsiBio/Data supports CLSI goals for improving laboratory performance, harmonizing quality standards, and recommends that its customer laboratories adopt CLSI Approved Standards and Guidelines. For more Information, refer to our Reagent Technical Bulletins reference section for applicable Approved Standards and Guidelines.

NASCOLA and CAP

nascola_capBio/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.

college_america_pathologists

BSI British Standards

bsiAs 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.