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ISO 13485

The International Standard for Medical Device Quality Management Systems

ISO 13485 is a global standard for quality management in the medical device industry. It helps businesses involved in the design, production, and servicing of medical devices consistently deliver reliable, high-quality products that meet regulatory requirements.

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Looking for information on getting certified? Head to our ISO 13485 Certification page. If you’re just starting your journey and want to understand the standard itself, you’re in the right place. 

What Is ISO 13485?

ISO 13485 is the internationally recognised Quality Management System (QMS) standard for businesses operating in the medical device sector. It sets out requirements for organisations involved in the design, development, production, storage, distribution, installation, and servicing of medical devices. The standard can support them in consistently meeting customer and applicable regulatory requirements. 

Businesses across the medical device supply chain use ISO 13485 to demonstrate their commitment to product quality, patient safety, and regulatory compliance. Customers, supply chain partners, and regulatory or market-access requirements may specify certification.

The current version of the standard is ISO 13485:2016. ISO 13485 is closely aligned with ISO 9001:2008 and shares many of its quality management principles, while placing additional emphasis on regulatory requirements and risk management specific to the medical device sector.

We also offer online ISO 13485 awareness training to learn how your business can benefit from certification and the steps involved.

What is ISO 13485

What Is a Quality Management System (QMS) for Medical Devices? 

A QMS is a structured way for an organisation to manage the quality of its products and services. It includes the policies, objectives, processes, and documented procedures used to plan and control how work is done, as well as how quality is checked, recorded, and improved. 

For medical devices, a QMS carries extra weight. Because the products involved can directly affect patient health and safety, the management system must also:  

  • Manage risks that could affect the quality or safety of medical devices. 
  • Keep records that allow devices, parts, and materials to be traced where required. 
  • Identify and address the regulatory requirements that apply in each market where the device is supplied. 

ISO 13485 is a widely recognised Management System Standard for medical device quality management. 

Understanding ISO 13485

Who Is ISO 13485 For?

ISO 13485 applies across the medical device supply chain – not just to device manufacturers. It can be used by organisations of any size involved in one or more stages of the product lifecycle, including: 

  • Medical device manufacturers, including contract manufacturers. 
  • Component and raw material suppliers to the medical device industry. 
  • Distributors, importers, and authorised representatives. 
  • Organisations providing installation, servicing, or technical support for devices. 
  • Providers of related services, such as calibration or packaging. 

The standard is designed to be applied proportionately – requirements that are not applicable because of the organisation’s activities or the nature of the medical device need not be included, provided the justification is recorded.  

British Assessment Bureau, part of Amtivo Group, is a UKAS-accredited certification body for ISO 13485:2016. Certification provides independent demonstration that your QMS conforms to the specified certification requirements. 

Who needs ISO 13485

Why ISO 13485 Matters 

Few industries are as tightly regulated as medical devices, and ISO 13485 is recognised in medical device regulation around the world: 

  • EU Medical Device Regulation (MDR) and IVDR: Both regulations require manufacturers to have a Quality Management System. EN ISO 13485 is a harmonised standard under the MDR and IVDR, which means using it can help demonstrate conformity with the specific regulatory requirements it covers and support CE marketing. It does not cover every requirement of the MDR or IVDR.  
  • UK regulation and UKCA/CE marking: In Great Britain, medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). ISO 13485 can support relevant Quality Management System requirements and the conformity assessment process for UKCA marking, or accepted CE marking routes, but it does not demonstrate full regulatory compliance on its own.  
  • US FDA requirements: Since 2nd February 2026, the FDA’s Quality Management System Regulation (QMSR) has incorporated ISO 13485:2016 into 21 CFR Part 820. This means ISO 13485 requirements form an important part of the FDA’s quality system requirements, alongside additional FDA requirements.  
  • Global market access: The Medical Device Single Audit Program (MDSAP) uses ISO 13485 alongside regulatory requirements from participating countries. This allows one regulatory audit to address requirements from several participating regulators. 

It is important to note that ISO 13485 certification is not the same as regulatory approval; devices must still go through the applicable conformity assessment or approval route for each market. However, a certified QMS is a foundational building block that many regulators, notified bodies, and approved bodies expect to see. 

Key Benefits of ISO 13485?

Global-Recognition

Access to regulated markets

Product-quality-assurance

Improved patient safety and product quality

Enhanced-Trust

Strong supplier and customer relationships

Regulatory-compliance

Reduced regulatory risk

Optimised-processes-documentation

Consistent, controlled processes

Effective-risk-management

Traceability controls

Competitive advantage

Competitive advantage

What Are the Key Requirements of ISO 13485? 

ISO 13485:2016 sets out its requirements across five main clauses, numbered 4 to 8. Each clause addresses a different area of the Quality Management System, and together they cover the full scope of how a medical device organisation operates – from leadership and resourcing through to product realisation and improvement. Select a clause to explore it.

Clause 4: Quality Management System

Clause 4 establishes the foundations of the QMS. It requires organisations to define the processes that make up their system, document them, and keep that documentation under control.

This is where some of ISO 13485’s most distinctive requirements sit: a quality manual is mandatory, and a medical device file must be maintained for each device type or family, bringing together product specifications, manufacturing procedures, and labelling requirements in one place.

Clause 5: Management Responsibility

Clause 5 covers the role of management. Leadership must demonstrate commitment to the QMS by:

  • Setting a quality policy
  • Defining roles, responsibilities, and authorities
  • Appointing a management representative

Regular management reviews are required to check the system remains suitable, adequate, and effective – keeping quality a board-level concern rather than a back-office function.

Clause 6: Resource Management

Clause 6 addresses the resources needed to operate the QMS and deliver conforming product. This includes ensuring people are competent through appropriate education, training, and experience, and that infrastructure and the work environment support safe, compliant production. For organisations producing sterile or contamination-sensitive devices, this clause also covers contamination control requirements.

Clause 7: Product Realisation

Clause 7 is the largest clause in the standard and covers the full product lifecycle, including:

  • Design and development controls
  • Purchasing and supplier management
  • Production and service provision
  • Process validation
  • Identification and traceability
  • Control of monitoring and measuring equipment

A defining feature of ISO 13485 is that risk management must be applied throughout product realisation – typically using the approach set out in ISO 14971. Where a requirement in this clause doesn’t apply to an organisation’s role in the supply chain, it can be excluded with justification.

Clause 8: Measurement, Analysis and Improvement

Clause 8 covers how the organisation checks its own performance and acts on what it finds. It includes monitoring of product and processes, complaint handling and feedback, reporting to regulatory authorities where required, internal audits, control of nonconforming product, and corrective and preventive action (CAPA). Rather than the broad ‘continual improvement’ emphasis of ISO 9001, the focus here is on maintaining the ongoing effectiveness of the QMS.

Together, these clauses create a QMS that keeps product safety, regulatory compliance, and traceability at the centre of everything the organisation does.

How ISO 13485 Relates to ISO 9001 

ISO 13485 has a historical relationship with ISO 9001. Organisations familiar with ISO 9001 will recognise a number of common quality management concepts. However, there are important differences: 

  • ISO 13485 retains requirements relating to customer feedback and improvement, while placing greater emphasis on meeting regulatory requirements and maintaining the effectiveness of the QMS 
  • It adds medical device-specific requirements, including risk management, device traceability, sterile device controls, and complaint handling with regulatory reporting. 
  • It requires more extensive documentation, including a quality manual and a medical device file for each device type or family. 
  • Unlike many modern ISO management system standards, ISO 13485:2016 does not follow the Annex SL Harmonised Structure – it retains a clause structure based on ISO 9001:2008. 

Certification to ISO 9001 does not automatically satisfy ISO 13485, and vice versa. But many organisations hold both, and a well-established ISO 9001 system provides a strong starting point for implementing ISO 13485. You can read more on the different purposes of ISO 13485 and ISO 9001 or contact our team for more details. 

ISO 13485 Training 

With our ISO 13485 Awareness Training, you can learn how the standard works and how a medical device QMS applies to your organisation. Training includes: 

  • Understanding the benefits of ISO 13485 and how they are achieved through a QMS. 
  • Risk-based approaches to QMS process control and risk management in product realisation. 
  • The QMS structure of ISO 13485:2016, from planning through to improvement. 

ISO 13485 Standard FAQs

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