This article presents to you some of the most common facts about ISO 13485 certification which is the certification for Medical Devices Quality Management.

Organizations in the medical devices industry are required to fulfill a lot of regulations to ensure that their devices are safe for patients and can be used appropriately for the given purpose. The ISO 13485 certification helps organizations to assure that because it is the specific certification for medical device quality management. It is the certification that harmonizes medical device management systems and helps organizations to meet the regulatory compliance requirements imposed by the industry authorities as well as legislation. The ISO 13485 standard clearly defines the requirements for establishing Quality Management System (QMS) in the medical device businesses. Therefore, achieving the certification by any medical device business demonstrates its capabilities to meet all the defined regulatory conditions as well as the customer needs in all their devices or products. This article attempts to answer the few questions or doubts that are most asked about by medical device manufacturers or related businesses about the ISO 13485 certification standard.

7 Facts You Need to Know About the ISO 13485 Certification

Who Needs ISO 13485?

ISO 13485 is the harmonized standard for the medical device industry and thus all organizations that are involved in any way or in any stage of the medical device lifecycle are required to achieve it. Organizations that design, assemble, produce, install, distribute, store, or service medical devices are eligible to get certified. Even the external third-parties or suppliers that provide various related services, components, and technology support to the medical device businesses can also get certified to prove compliance with necessary regulations. Also, all types and sizes of organizations regardless of whether they are public-sector undertakings or privately-owned can get the certification.

Who Issues the ISO 13485 Certificate?

ISO designs all the international standards which include ISO 13485 but is never involved in their certification. So, if a medical device organization or business needs to get certified, it needs to contact an external certification body that issues certificates after audits.

What is the Purpose of Achieving the ISO 13485 Certification?

In simple words, the purpose of getting certified by an organization is to ensure its processes and medical devices comply fully with the applicable regulatory requirements. It helps an organization to get a strong and formal QMS which leads to continuous improvement of the efficiency and quality of devices. The formal QMS also needs the organization to have necessary documentation of the processes and keep records of audits, customer complaints, third-party interaction and so forth. It hence assists in making decisions for improvements based on issues or nonconformities found later in the documents.

Key Areas Focused on ISO 13485 Medical Device Quality Management

The requirements for medical device QMS as defined by the standard mainly focuses on the key areas:

• Product feedback
• Qualifying for tender opportunities
• Risk management
• Continual improvement
• Improvement in reputation

How is Product Feedback different from Customer Satisfaction of ISO 9001?

Customer satisfaction, which is underlined by the ISO 9001 standard, defines the ability of a business to meet or fulfill the expectations and needs of customers. It hence needs the organizations to make records and review the customer complaints which are a major indicator of customer satisfaction.

Product feedback, on the other hand, is necessary for medical device businesses to pursue continual improvement. Gathering feedback on a continuous basis helps in getting valuable insights about the medical devices post-production i.e., during stages of use. Later those insights, an organization can make necessary revisions to the products or update the processes, quality control methods, or risk assessments.

Why Documentation is a Vast Requirement in ISO 13485?

The ISO 13485 standard is meant to help medical device organizations coordinate and regulate their processes and products to meet industrial and legislative compliance. Therefore, organizations need to assemble, create and maintain many documents to give evidence of their compliance with the applicable regulations.

Do You Need the ISO 13485 Certification?

The answer is yes, regardless of if you are a component manufacturer, a service provider or a whole equipment manufacturer. If you want to show your company’s commitment to fulfilling all medical device regulations that apply and make your devices more reliable to the customers, you need to get certified.

Well, these were some of the most relevant facts about the ISO 13485 certification which are not known or clearly comprehended by the medical device businesses. However, we thought to putting these facts out there so that they can focus on the right aspects and get your business certified as soon as possible.

Author's Bio: 

Damon Anderson is the director and professional quality assurance consultant at a reputed ISO consultancy with over 15 years of experience. He is specialized in the ISO 13485 certification and his experience includes analysis of medical device organizations, medical device QMS implementation, auditing and training and recertification.