ISO Abbreviated as (International Organization for Standardization) is a worldwide federation of national standards bodies Formed by More than 160 Countries with one standards body representing each member country.
The Bureau of Indian Standards (BIS) for example, represents India.
Member organizations of ISO collaborate themselves in the development and promotion of international standards for technology, scientific testing processes, working conditions, societal issues, Technical Standards, and more.
A General Assembly of ISO which consists of representatives from ISO members from Countries and elected leaders called principal officers, acts as the decision-making body for ISO. The organization has its headquarters in Geneva, Switzerland, where a central secretariat oversees operations.
ISO 13485 specifies requirements to enhance and ensure the effective performance of medical devices and equipment. This internal standard helps to effectively implement and as well as to maintain the organization’s quality management system. Also, ISO 13485 provides guidance for manufacturers/suppliers to deal with medical device directives, regulations, and responsibilities.
ISO 13485:2016 is a QMS Standard for Medical Devices, has been harmonized with European Medical Devices Directives i.e MDD, AIMDD, and IVDD. The Old Standard EN ISO 13485:2012 is updated as ISO 13485:2016, in the EU Official Journal, with the date of ‘cessation of presumption of conformity’ of EN ISO 13485:2012 stated as 31 March 2019.
Harmonization of the standard allows manufacturers to use their compliance to the standard as evidence of conformity to the requirements of relevant legislation.
The harmonization of EN ISO 13485:2016 is another step towards compliance to the recently published Medical Devices and IVD Regulations, which will supersede the current Directives in 2020 and 2022, respectively.
ISO 13485 Certification demonstrates the quality of the business and its products. It expands your business locally and as well as helps you attract overseas clients. This certification establishes the organization’s commitment to delivering high-quality medical devices. Moreover, the ISO 13485 Certification ensures the organization complies with the standard requirement of ISO 13485.