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ISO 13485

20 Dec 2021

ISO 13485

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About ISO 13485

ISO 13485 is the international standard for medical device quality management systems. The term “medical device” covers a wide range of products, including medical equipment, surgical instruments, in vitro diagnostic products, cosmetics, and patient monitoring systems used in the diagnosis or treatment of disease. ISO 13485 is applicable to both stand-alone organizations and to any organization providing contract manufacturing or other services to medical device manufacturers. ISO 13485 is not the design control standard for medical devices.

ISO 13485:2016 Version

ISO 13485:2016 is the latest version of the standard created by the International Organization for Standardization (ISO). The purpose of revisions to the ISO 13485 standard is to promote a process of continuous improvement. The ISO 13485:2016 standard aims to ensure that medical devices are safe, effective, and of high quality.

Why is ISO 13485 Important for Businesses?

In 2017, over 250,000 medical devices were recalled from hospitals or clinical settings due to failure. Therefore, it is important to have guidelines during the design and manufacturing process of medical devices to avoid any risk to patients or medical workers. ISO 13485 certification gives your customers confidence that their products are safe and of high quality.

Implementing ISO 13485 standards also gives you access to a wider market by demonstrating your commitment to providing safe, high-quality medical devices. If your company is involved in the design, development, manufacture, or provision of services relating to medical devices, ISO 13485 certification helps you demonstrate continuously that your organization meets the regulatory requirements in all applicable markets.

About ISO 13485 Certification

ISO 13485 certification proves that your organization will undergo a rigorous review of its quality management system and continuous improvement policies to meet current and future regulatory requirements. This is the only internationally recognized standard for medical device manufacturers and suppliers across the globe.

What are the Benefits of ISO 13485 Certification?

ISO 13485 certification is an important factor for today’s medical device companies. This standard holds you accountable to high standards of quality management systems and continuous improvement. ISO 13485 certification will benefit your business in the following ways:

  • More Patient Confidence – Quality improvement brings better performance, reduced costs, and increased customer satisfaction, leading to higher market share.
  • Competitive Advantage – Customers choose ISO 13485-certified businesses due to their confidence in the quality and safety of products or services provided.
  • Improved Efficiency – Quality management leads to improved efficiency, reduced cost, less waste, and faster time to market. If your business follows the ISO 13485 standard throughout its development lifecycle, you will see significant improvements.
  • More Sustainable Growth – When your business complies with all applicable regulatory requirements, you can improve your share of local and international markets.
  • Better Customer Relationships – Customers choose businesses that demonstrate transparency, consistency, and responsiveness to their needs. The ISO 13485 standard provides a clear framework for these relationships.

Steps to Achieve ISO 13485 Certification

  1. Conduct a Gap Analysis – Perform a gap analysis to identify issues and areas of concern within your existing quality management system. This will help you focus your effort on the most pressing items, saving time and money.
  2. Conduct Employee Training – ISO 13485 Foundation training should be conducted for all employees within your organization to help them get familiarized with ISO terminology and quality management systems.
  3. Documentation – Prepare all documents, processes, systems, and materials that will be required by external auditors during the ISO 13485 certification process. This includes conducting period internal audits of your QMS and detecting any non-conformities.
  4. Hire a Certification Body – Once you’ve established that your existing quality management system meets the requirements of ISO 13485, hire a third-party certification body to conduct a series of audits to make sure all ISO 13485 requirements are met.
  5. Maintain Certification – After achieving certification, the ISO 13485 standard requires your company to maintain compliance through a defined cycle of continual improvement. The process can be facilitated by an external auditor who will conduct a series of Surveillance audits throughout the validity period of your ISO 13485 certification.

Recertification Audit – After the validity period of your ISO 13485 certification expires, your organization can undergo a recertification audit to extend the validity of the ISO 13485 certificate. The recertification audit will verify that your QMS still meets the requirements of ISO 13485.

IAS – Egypt’s Leading ISO 13485 Certification Body

IAS is an ISO 13485 certification body that offers a wide range of certification services and ISO training courses. Incorporated in 2006, IAS has more than 13 years of experience in auditing and issuing management system certifications as well as product certifications. We can help you achieve and maintain certification to ISO 13485 quickly and cost effectively. IAS has IRCA certified, professionally experienced, real-time lead auditors to carry out the audit and to support the organizations in the achievement of ISO 13485 certification.

Is your organization ready to get ISO 13485 certified? Contact IAS today for a free consultation!

Contact us Today! Mobile: +91-9962590571 E-Mail: info@iasiso.com

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