ISO 13485:2016 is specially established for Medical Devices which specifies requirements for its Quality Management System.

ISO 13485:2016: Defining Standards for the Medical Devices around the World

The trust of a customer on the products is a huge factor in determining the profits or sales of a company or a service provider. Every company claims to provide the best quality products at the best prices. Price is something that you, as a customer can easily compare or verify. But, when it comes to quality, you need to actually buy a product to be sure about it. Thus, when it comes to making a choice among the available brands, a customer would want to go with one that he can trust.

Certifications are one of the best ways to demonstrate your credibility to your customers. There are several national and international organizations that issue different types of certifications after verifying the standards and checking the quality of your products. International Organization for Standards (ISO) is a well-known organization that sets up the standards that various third-party organizations use to access the products before issuing certification. ISO standards are differentiated on the basis of the unique numbers that follow ISO. For instance, ISO 13485:2016 is a set of standards that determine the quality of the medical devices and equipment.

ISO 13485:2016 refers to a standard quality management system for the organizations dealing with the medical devices and related services. It sets standards that need to be met at various stages including production, storage, design, installation, distribution, design and other associated procedures. It can also be used by the external parties and suppliers that are involved in the distribution of medical products. The standards remain the same irrespective of the size of the organization and thus these standards apply equally to every organization dealing with the medical equipment and products. ISO 13485:2016 also allows some exclusion in design and development in case any of the standards are not met or not applicable. The standard has also defined alternative approaches that need to be fulfilled to qualify for the exclusions.

Certification is not just a tool to prove your worth to your customers but it also required for the legal contracts. It also helps a firm in case of any disputes or claims by any customer. A company can also use these certifications to access its own standards and determine the areas where it needs to work on to improve its quality. Thus, certifications are the best means to stay on top of the requirements of the customers as well as the industry standards.

Major change of ISO 13485:2016

  1. The new changes put more emphasis on the need for proper infrastructure to produce high-quality medical devices.
  2. New standards cover the wider range of organizations involved in various stages as the product reaches the end user.
  3. User complaints are given more attention.
  4. Better risk management.

Benefits of ISO 13485:2016

  1. It ensures that your products to comply all the major national and international regulatory requirements.
  2. Makes your products acceptable in the international market.
  3. Gives you the confidence of better risk management during the production of medical devices and products.