ISO 13485 is the international standard that defines quality management system necessities for organizations that are or may be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device, and design and improvement or provision of associated activities like technical support. ISO 13485:2016 can also be used by dealers or external parties that deliver product and quality management system-related services to such organizations.
ISO 13485 was written to maintenance medical device manufacturers in designing quality management systems that establish and maintain the efficiency of their procedures. It confirms the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Needs of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where clearly stated. Wherever needs are identified as applying to medical devices, they apply equally to associated services as supplied by the organization. The needs may vary based upon the class of medical device – from a wheelchair to a pacemaker.
Benefits of ISO 13485:2016
- ISO 13485 is a quality system standard for organizations that design, develop, produce or service medical devices. All necessities of ISO 13485 are precise to organizations manufacturing medical devices, regardless of the type or size of the organization.
- Supports harmonization of regulatory necessities for the manufacturers of medical devices on a worldwide scale.
- ISO 13485 will benefit clients, suppliers, management, and especially workers
- Rapid and in effect communication, feedback, and acknowledgment on efforts made, results achieved, and work to be done
- Companies that achieve ISO 13485 certification enjoy the benefits of an improved amount of clients who have more reason to trust and purchase products of consistent high quality.
- Constant assessment, development, and re-registration of systems.
- ISO 13485 compliant management systems assume a risk management approach which includes assessment to recognize & approximation risk, uses risk controls and techniques with a view to remove hazardous situations throughout product realization.
- Emphasizes the sanitation & sterility in the production area, which in turn growths effectiveness & improves safety at the workplace.
- ISO 13485 certification is beneficial to medical device companies which export their products to international markets. Some of the additional necessities relate to design controls, procedure controls (including environmental controls), special procedures, traceability, record retention, and regulatory actions, which are more dangerous for the medical device industry.
- Assures the clients that the product complies with all relevant product & service-oriented technical standards & regulations.