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ISO 13485 Certification & Auditing

Medical device certification to streamline quality

Develop a quality management system focused on trust WITH ISO 13485 certification

ISO 13485 is the internationally recognized quality management systems standard for the medical device industry. The medical device business is grounded in trust. Before a device is used on a patient, it must first win the trust of many stakeholders. From medical staff, hospitals, and healthcare institutions to regulators and often the public themselves. 

A quality management system is integral to this chain of trust. It ensures that your medical products consistently meet customer expectations of quality, safety, and performance.

In some markets, such as the European Union, Canada, and Japan, medical device manufacturers must implement and obtain certification of quality management (QM) system according to ISO 13485. 

The ISO 13485:2016 edition of the standard builds on the ISO 9001:2008 standard includes additional regulatory requirements for the medical device industry. Following the last revision, this third edition of March 1, 2016, incorporates 12 years of technological progress and global regulatory changes. 

In view of the above, manufacturers and service providers in the medical device industry are facing changed and extended requirements. A summary of the key changes:

key aspects of the ISO 13485:2016

  • Responsibility Quality management system (Clause 4)- all processes that are part of a manufacturer’s QMS need to be developed using a risk-based approach. Any software used as part of the quality system should be validated and documented. The validation of all types of computer software used in the QM system is expanded to include software applications outside product realization, including document control and complaints management. The new standard describes Device Master Records (DMR) contents in greater detail and gives examples of mandatory documents.
  • Management Responsibility (Clause 5) - ISO 13485:2016 now demands a definition of the “role” that an organization plays within the scope of the regulatory requirements (e.g., representative, importer, manufacturer, etc.) and, taking a risk-based approach, of the processes related in addition to that. The standard describes the input and output of the regular management review of the QM system’s effectiveness in greater detail. Management representatives now have the additional responsibility of promoting awareness of the significance of regulatory requirements among all organization employees.
  • Resource management (Clause 6) - device manufacturers must define the skills and experience required for personnel involved in the maintenance of the QMS, through ongoing training and mechanisms for assessing the effectiveness of such training. A new clause also addresses contamination control and processes for sterilization.
  • Risk-Based Approach to Product Realization (Clause 7) - this clause specifies the requirements and their risk-based implementation for all product-realization processes. This edition includes special requirements for the validation of software used in monitoring and measuring equipment. The aspect of “usability” has been added to the design and development process. The reasons for the selected sample size in design verification and design validation must be provided and documented in the future. There are now separate subclauses describing the requirements for transferring design and development outputs to production (transfer design) and the contents of the design history file (DHF).
  • Defined Processes for Measurement, Analysis and Improvement (Clause 8) -  the manufacturer must define processes for recording and evaluating production and postproduction data and integrating them into the risk-management process. Notification to the regulatory agencies is addressed by a separate subclause of the standard and has been extended by the addition of adverse event reporting. Regarding the control of nonconforming products, the standard differentiates between corrections and corrective actions for nonconformities identified before and after delivery.

Download the ISO 13485:2016 fact sheet to learn more

THE importance of ISO 13485:2016 to enter international markets

In the EU, the requirements of ISO 13485 have been harmonized with the essential requirements of the EU’s Medical Device Directive (93/42/EEC), the Directive for In Vitro Diagnostic Medical Devices (98/79/EC) and the Directive for Active Implantable Medical Devices (90/385/EEC). Certification to ISO 13485 by an accredited certification body provides a presumption of conformity with the essential requirements of these important directives.

In the U.S., the Food and Drug Administration (FDA) permits device manufacturers to submit ISO 13485 audit reports as a substitute of the evidence of compliance with its quality systems regulations (QSR). Health Canada also requires medical device manufacturers marketing their products in Canada to have their quality management system certified to ISO 13485.

Meeting the ISO 13485 certification requirements can allow your organization to:

  • Improve your process quality and transparency
  • Ensure quality, safety and performance of your medical devices
  • Raise brand reputation and consumer trust and satisfaction
  • Avoid costly product recalls by delivering consistent quality and safety

Our Services to Help You Achieve 13485 Certification

Achieving ISO 13485 certification proves that your medical devices have been manufactured under a certified quality management system. Our auditors have an established history of assessing leading medical device manufacturers with ISO 13485 audits and certification. We know how to assess your operational efficiency. 

TÜV SÜD CERTICIFICATION, TESTING AND AUDITING SERVICES

To help you estimate the individual efforts involved in your implementation of ISO 13485:2016 and prepare for the change in the best possible way, TÜV SÜD will provide you with basic information related to the standard. Our factsheet, which is available for download here, summarizes the information at a glance.

TÜV SÜD offers a complete range of testing, certification, and auditing services to manufacturers of medical devices. Our specialists and experts will be happy to answer any further questions you may have.

Contact Us to Learn More about ISO 13485 Certification

Learn More about the ISO 13485 standard

ISO 13485 Quality Management System for Medical Devices
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ISO 13485 QMS for Medical Devices

Fulfill the requirements of ISO 13485:2016 with expert guidance

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ISO 13485:2016 Revision
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ISO 13485:2016 Revision Fact Sheet

A quick guide to the revised ISO 13485:2016 standard

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ISO 9001 & ISO 13485 – How Do These Standards Relate and Differ?
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ISO 9001 & ISO 13485 – How These Standards Relate and Differ

Discover the similarities and differences between the two standards

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