ISO 13485

Medical Devices

ISO 13485 is a globally recognised quality standard that identifies the requirements of a quality management system (QMS) for the design, manufacture and installation of medical devices across the world. It helps ensure compliance with medical product and service regulations and demonstrates an organisation’s commitment to quality and customer satisfaction.

medical devices in a lab

ISO 13485 certification

  • Gain ISO 13485 certification with an accredited certification body.
  • Demonstrate compliance with medical regulatory requirements.
  • Develop new markets and apply for tenders that require ISO 13485 certification.
  • Improve customer satisfaction and boost customer retention.
  • Suitable for all sizes of organisations developing, producing and installing medical devices.
  • all types and sizes of organisations – from SMEs and charities to corporates.

What is ISO 13485?​

ISO 13485 is designed to be used by organisations involved in the design, production and installation of medical devices. Certification bodies can also use them to help when auditing organisations. It helps provide the framework for implementing a quality management system to ensure that medical devices are produced and installed to regulatory requirements and the same quality across all organisations.

The ISO 13845 standard is beneficial for many organisations and can be used by suppliers and external parties involved in providing medical device products. There are currently 25,656 valid ISO 13485 certificates across 35,253 sites worldwide, according to The ISO Survey.

ISO 13485 certification for quality management of medical devices provides a framework to help:

  • Ensure consistency in the production and delivery of medical products.
  • Ensure compliance with medical product and service regulations.
  • Increase competitiveness across the organisation and build customer trust.
  • Enable organisations to identify manufacturing and installation faults and improve on them.

What are the benefits of ISO 13485?

Implementing a quality management system for medical devices is beneficial for organisations involved in all stages of the production and implementation of medical devices, from design to installation. The ISO 13485 certification demonstrates the organisation’s commitment to quality. It enables the achievement of customer satisfaction and prevents risks associated with poor quality processes.

ISO 13485 certification allows organisations to:

  • Improve risk management and quality assurance.
  • Meet customer expectations and improve the ability to respond to customer requirements.
  • Increase efficiency and cost savings.
  • Improve ability to win more business through proven business credentials.
  • Help to maintain the quality of the supply chain.
 

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How to become ISO 13485 certified

Achieving ISO 13485 certification involves implementing a quality management system (QMS).

Hundreds of organisations have been certified to a range of ISO standards by Certification Europe, including brands such as Servecentric, Thorntons Recycling and Belfast Met. Certification Europe also provides ISO training to help your organisation define, develop and implement a quality management system.

Our expert ISO assessors will conduct a pre-assessment, including a gap analysis to review your QMS against ISO certification requirements. We operate a comprehensive multi-stage assessment process to audit your QMS and determine if your organisation is compliant with ISO 13485 requirements.

Start your journey to certification

Contact our dedicated ISO support team for a free, no-obligation quotation to start your ISO certification journey. We tailor our quotes to meet your requirements, and we support a range of ISO standards, including ISO 27001, ISO 45001, ISO 14001 and Cyber Essentials.

Learn more about Certification Europe’s accreditations, discover our client testimonials and find out more about how we can certify your management system.

The Certification Journey

The Certification Journey

Stage One

The initial assessment determines if the mandatory requirements of the standard are being met and if the management system is capable of proceeding to Stage 2.

1

Stage Two

The second assessment determines the effectiveness of the system, and seeks to confirm that the management system is implemented and operational.

2

Recommendation for Certification

At this point in the process we review any corrective actions taken to address findings raised at Stage 1 & 2. Certification may be recommended.

3

Certification Review & Decision

The organisations files are reviewed by an independent and impartial panel and the certification decision is made.

4

Certification Achieved

Successful certification is communicated to the client. Certificates are issued.

5

ISO 13485 FAQs

If an organisation is ISO 13485 certified, it has implemented a quality management system in line with ISO 13485 medical device requirements. This means its processes for ensuring the quality, safety and efficiency of medical devices have been assessed and recognised as reaching the ISO 13485 standard.

ISO 13485:2016 is the most up-to-date version of the standard.

The current standard has significant changes from the previous version ISO 13485: 2003 and reflects the evolution of the medical device regulatory environment and the greater need for risk management and risk-based decision-making processes within the medical devices industry.

Requirements of ISO 13485 apply to organisations regardless of their size and type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services supplied by the organisation. The requirements may vary based upon the class of medical device, from a wheelchair to a pacemaker.

The processes required by the ISO 13485 standard that applies to the organisation, but are not performed by the organisation, are the organisation’s responsibility and are accounted for in the organisation’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches to be addressed in the quality management system. It is the organisation’s responsibility to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

Certification to ISO 13485 lasts for three years and is subject to mandatory audits to ensure compliance.

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