ISO 13485 is a standard related to quality management systems specifically for medical devices. Currently, obtaining ISO 13485 certification is a mandatory requirement for businesses operating in the medical product manufacturing sector. Having this certification enables companies to promote their medical products not only domestically but also internationally. For a deeper understanding of this certification, let’s refer to the following article by Vinaquality.
ISO 13485 is a standard established by the International Organization for Standardization (ISO) in 2003. It focuses on the management system requirements for ensuring the safety of manufactured medical products. This standard is part of the ISO 13485:2003 series issued by ISO.
ISO 13485 outlines the necessary requirements for quality management systems at facilities that produce and sell medical devices and products. Companies must meet customer expectations and comply with current legal regulations to be granted the ISO 13485 certification.
In simpler terms, ISO 13485 is a set of requirements established by the International Organization for Standardization (ISO). This international standard is predominantly recognized in the healthcare industry, where companies strive to obtain certification to confidently market their products.
Versions of the ISO 13485 standard
The concept of what ISO 13485 entails has been clarified. Below are some updated versions of the ISO 13485 standard for better understanding:
ISO 13485:2003
This standard pertains to the management system for the safety of medical products and was first issued by ISO in July 2003 as part of ISO 13485:2003. It corresponds to the national standard TCVN ISO 13485:2004.
ISO 13485:2012
This is the latest version introduced by CEN. The new standard includes a revised preface and appendices ZA, ZB, and ZC. However, the main text of ISO 13485:2012 remains unchanged, identical to ISO 13485:2003.
ISO 13485:2016
This is the most recent version of the standard, released on March 1, 2016, to replace the older ISO 13485:2003. There was a three-year transition period for manufacturers, organizations, and businesses to comply with the new regulations. Consequently, ISO 13485:2003 became invalid after February 28, 2019.
Who is subject to the application of ISO 13485?
Many individuals and organizations are interested in which standards the authorities apply to specific entities. Is there a limit on who can use these standards? Specifically, the subjects that the ISO 13485 Standard applies to include:
The ISO 13485 Standard is applicable to all organizations, regardless of their size or type, as well as their location.
Types of organizations may include factories, companies, production facilities, and distribution centers involved in the manufacturing and business of medical devices and healthcare services (such as medical masks, medical gloves, protective equipment, rapid Covid-19 test kits, etc.).
Any location that is required to implement standards for medical devices falls under this scope.
With respect to quality management systems, organizations must demonstrate their capability to provide medical devices and related services that meet the legal requirements set by authorities and customer expectations.
Organizations required to comply may participate in one or more stages such as design, research, manufacturing, storage, distribution, installation, maintenance of medical devices, and related services.
This also applies to suppliers and other parties providing products and services related to the quality management system of that organization.
Benefits of applying the ISO 13485 Standard
In practice, many businesses and organizations seek approval from the relevant authority regarding their compliance with the ISO 13485 Standard. This holds significant advantages for those organizations, specifically:
Establishing credibility with customers
Many clients view the ISO 13485 standard as evidence of effective control and assurance of the quality of medical products. For organizations and businesses operating in this sector, possessing an ISO 13485 certification demonstrates professionalism, quality, and superior products. This instills trust in customers, prompting them to choose the company’s offerings.
Compliance with legal regulations
Current legal regulations require that businesses involved in the production and sale of medical equipment must implement ISO 13485. Any company that has not yet adopted this standard needs to do so immediately.
Comprehensive management of business processes
The ISO 13485 standard provides authorities with insight into a company’s production and management processes. This understanding enables businesses to identify areas for improvement, allowing them to make necessary changes and operate more effectively than before.
The above provides complete information about ISO 13485. VIS hopes to offer you all the details on this standard. If you need further information about ISO 13485, please contact VIS for the best support!
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