ISO 13485 certification has several advantages for your organization in the long run. You can follow the instructions for certification in the manual that goes along with the ISO 13485 Standard implementation. Product congruity is important for all businesses, but it’s critical when it comes to the design and production of medical devices. Patient safety, regulatory compliance, and an organization’s ability to prosper in the marketplace are all impacted by predictable product quality. Accepting the pertinent standard guidelines is essential for ensuring the proper level of quality control. ISO 13485, a Quality Management System (QMS) standard created specifically for manufacturers of medical devices, is one of these standard principles.

Why is ISO 13485 Standard important?

A quality management standard specifically designed for the production of medical devices is the ISO 13485 Standard. The standard is dependent on ISO 9001 Certification, but it also has additional requirements that are expressly related to creating, putting in place, and maintaining medical devices. The ISO 13485 Standard specifies:

  • Putting a quality management system in place
  • To deal with item improvement, use risk management
  • Approving actions that adhere to management and legal requirements
  • Creating effective methods for item inspection and traceability

Additionally, ISO 13485 supports businesses that create, market, and oversee medical devices in terms of measure improvement, operational efficiency, and product improvement.

The most recent version of the ISO 13485 Standard, ISO 13485:2016, was released on March 1, 2016. It replaces ISO 13485:2012. The standard is distributed by the International Organization for Standardization (ISO), and the amendments were handled by the ISO Specialized Council 210. In line with ISO 9001:2008; ISO 13485:2016 is been amended. The deadline to upgrade to the most recent version of the ISO 13485 Standard for firms possessing certifications to more established previous versions was February 28, 2019.

Even though the ISO 9001 Standard and ISO 13485 Standard are interdependent, obtaining one certificate does not automatically imply that you are in agreement with the other; both standards must be examined. Although the ISO 9001 and ISO 13485 Standards are quite similar, the ISO 13485 incorporates requirements and terminology that are specific to the market for medical devices. In comparison to ISO 9001, the ISO 13485 Standard provides a more realistic role for a quality representative to top management.

The steps to becoming ISO 13485 Certified

The clauses in the ISO 13485 Standard are helpful for various types of businesses that are a part of the supply chains for pharmaceuticals and medical devices. Offering assistance to medical device producers is especially important for businesses that manufacture medical devices. Several examples of companies using this standard include:

  • Manufacturers of medical products, including sterile and surgical equipment
  • Organizations that provide medical device manufacturers with goods, components, or raw materials
  • Organizations run by quality executives that collaborate with manufacturers of medical devices
  • Organizations that provide various forms of support to the medical device producer

Although few countries mandate certain medical device companies to adhere to the ISO 13485 Standard. Though, certification to the standard is voluntary. For example, medical device manufacturers in Canada are required to obtain ISO 13485 Certification. On the other hand, Japan and Europe provide an elective public standard. The management standard for medical devices depends on ISO 13485 in several countries.

Even if you are not required to obtain ISO 13485 certification, it very well may be advantageous for your business if it falls under one of the categories listed above. Continue reading to learn more about how to complete ISO 13485 Certification if you think it would be a good fit for your company.

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