Laboratory Accreditation provides formal recognition of competent laboratories, thus providing a ready means for customers to find reliable testing and calibration services in order to meet their demands. Laboratory Accreditation enhances customer confidence in accepting testing/calibration reports issued by accredited laboratories. The laboratories seeking accreditation are assessed in accordance with ISO/IEC 17025 for testing and calibration laboratories and ISO 15189 for medical laboratories.
National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India (QCI), set up to establish and operate accreditation programme for healthcare organizations. The board while being supported by all stakeholders including industry, consumers, government, has full functional autonomy in its operation.
The Conformitè Europëenne (CE) Mark is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996), the previously published ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a “certificate” for products regulated by the Food and Drug Administration (FDA). A certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
An independent, not-for-profit organization, Joint Commission International (JCI) accredits and certifies health care organizations and programs across the globe. Joint Commission International accreditation and certification is recognized as a global leader for health care quality of care and patient safety.
ISO 9001 is defined as the international standard that specifies requirements for a quality anagement system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.