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ISO 13485 is an international quality management system for medical devices. This article helps you prepare for ISO 13485:2016 Transition.

Medical Device ISO 13485

ISO 13485 is an international quality management system for medical devices. It helps all manufacturers and related organizations of medical devices to demonstrate their ability to meet customers’ needs and regulatory requirements. It also helps organizations to enter international markets easily, enhance operational efficiency and reduce risks.

The new version of ISO 13485:2016 Quality Management System for Medical Devices was published on March 1, 2016. All ISO 13485:2003 certified organizations have a 3-year transition timeline but the validation will end on March 21, 2019. Although there is still more a year for the transition, the ISO/TC 210 requires that, starting from March 2018, all newly issued or renewed ISO 13485 certificates should be audited against its 2016 version.

Major differences between 2003 and 2016 versions

The emphasis in ISO 13485:2016 is very much on managing risk and compliance with regulatory requirements. It has also expanded its scope to include all stakeholder roles. Furthermore, it provides focus of clarification for design and validation activities (including software validation), as well as for improving supplier control.

To align itself with the forthcoming medical device regulations, ISO 13485:2016 also includes improvements to the feedback processes and clauses surrounding identification and traceability. In short, the major differences between 2003 and 2016 versions are:

  • Emphasis upon global Regulatory Requirements
  • New requirement to apply a Risk Based Approach throughout the Quality Management System
  • New requirement to provide clarification for Design, Validation and Verification Activities, including Software Validation
  • New requirement for improved Feedback Processes
  • New requirement for Identification & Traceability
  • Improvements on Supplier Control Processes

Tips for preparing the upgrade to ISO 13485:2016

Prepared by our experts, here are also some tips for you to better prepare for the upgrade to ISO 13485:2016.

  • Be familiar the applicable regulatory requirements of your products and your target market. For example, Pre-market and Post-market regulatory requirements and UDI etc.
  • Utilize various risk assessment tools throughout the Quality Management System (QMS). For example, FMEA and FTA
  • Strengthen the interactions between Quality Management System (QMS), Risk Management System (RMS) and Post Market Surveillance System (PMS)
  • Review current supplier management methodologies and tools
  • Utilize statistical and scientific approaches on data analysis
  • Validate the applicable of critical computer software used in production and service provision

How SGS can help?

SGS can offer a wide range of services to organisations currently certified against the old version of ISO 13485, as they transition to ISO 13485:2016. SGS is also able to provide expert advice to support clients during the transition/ implementation phase, and finally, to conduct certification audits and assessments against the ISO 13485:2016 standard.

In addition, our experts can help you to understand the requirements of the standard and the new focus on risk-based thinking, through attendance at SGS Academy public training courses:

ISO 13485:2016 Medical Devices Quality Management Systems Foundation Course – For Medical Devices Industry

ISO 13485:2016 Medical Devices Quality Management Systems Internal Auditor Course – Complying with Requirements


You may also click here to participate in a 1-minute survey and instantly get a HK$500 training coupon (applicable for online enrolment only).

Free recorded webinar

Learn about key aspects to the implementation of ISO 13485:2016 and impacts to organizations in the medical device industry. Click here to access the recorded version of the free webinar.

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.

About SGS Academy

Transforming people and businesses with worldwide centers of excellence to meet your global and local training needs, SGS Academy offers the very best in professional development training and customized training solutions. Unrivaled experience and expertise, combined with SGS’s unique global reach ensures that clients benefit from consistent training and development at every level of their organization – anywhere in the world.

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