What is ISO 13485:2016 certification?

People rely on medical devices for their health and safety. If your organization operates in the medical devices field, quality control is vital. ISO 13485 certification shows you can consistently provide medical devices and services that meet customer and regulatory requirements.

ISO 13485 is a standard for medical device organizations, covers all stages, from design to installation and maintenance, and related services.

Central to this standard is a strong emphasis on patient safety and quality control in medical devices. Its main objective is to ensure consistency in the processes for design, development, production, storage, distribution, installation or servicing, and disposal of medical devices. ISO 13485 requires organizations to implement these processes in accordance with relevant regulatory requirements for the markets they aim to enter.

The ISO 13485 certification process

The process of certification involves thorough on-site audits to assess the capability and reliability of your QMS. Our team of experts evaluates the practical application and effectiveness across various areas including design, development, production, and customer care.

The certification process consist of these 4 steps:

  1. Optional preliminary audit: A voluntary site visit and review of quality management documentation to assess readiness for full-scale stage I & II auditing.
  2. ISO 13485 audit: Stage I: Evaluation of certification eligibility based on the results of the audits, quality management documentation analysis, and business assessment.
  3. ISO 13485 audit Stage II: involves checking the quality management system on-site to ensure good practices and efficiency.
  4. Certification: When you meet the requirements, you will receive an official confirmation. This certifies the integrity of your quality management system and complete compliance with the relevant standards.

Kiwa is a well-known accredited Certification Body with facilities worldwide to serve you. We tailor our comprehensive portfolio of services to accommodate your specific circumstances and business requirements. Get in touch to start your certification trajectory via the contact button or by sending an email to medical@kiwa.com.

MDR compliance, and how ISO 13485 can help with it

The ISO 13485 quality standard is part of the medical device manufacturing standards in the European Union. ISO 13485 helps suppliers of medical devices and related services comply with the Medical Devices Regulation (MDR). This European regulation is applicable from 26 May 2021 and facilitates:

  • Additional requirements for market operators;
  • New risk classification and extension of scope;
  • Enhanced transparency for patients
  • Stricter rules for certain products.
  • Access to the European market (CE marking)

Getting ISO 13485 certified with Kiwa

Safety and quality are essential in the medical devices industry. They can make the difference between life and death. Getting your quality management system certified by a third party is crucial to meet regulations and customer expectations.

ISO 13485 certification can help with this, especially with strict requirements in the supply chain. Partnering with Kiwa shows your medical device is compliant, building trust with customers and meeting legal requirements.

What are the benefits of an ISO 13485 certification?

  • Win new business – With the medical devices quality management system, you have an advantage over competitors in procurement processes when certification is a requirement.
  • With ISO 13485, find ways to improve your management processes and meet international standards for improvement.
  • Increase effectiveness by finding ways to improve your processes, which will help you reduce operating, manufacturing, and energy costs.
  • Meet customers’ needs – with a focus on customers, ISO 13485 lets you set out goals for meeting customer needs.
  • Show your dedication to quality with ISO 13485 certification, proving to customers, partners, and employees your commitment to improvement.
  • Improve competitiveness – The standard helps you enter new global markets and supply chains and forge new partnerships.
  • Monitor and improve performance – ISO 13485 helps you analyze your processes and monitor customer opinion.
  • Manage your supply chain with this certification to improve processes and maintain consistent quality. Control your supply chain effectively.

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