Saturday, July 13 2024

What are the requirements of the ISO 13485 standard?

The ISO 13485 standard is an international quality management system (QMS) standard specific to medical devices. It is based on the ISO 9001 standard, but it adds specific requirements to medical device requirements, such as:

  • Safety of medical devices
  • Compliance with regulatory requirements
  • Risk management


The ISO 13485 standard is divided into 8 chapters (clauses). The 416 requirements are in chapters 4 to 8. The chapters cover the following areas:

1. Scope

The standard specifies requirements for quality management systems applicable to organizations involved in the design, manufacture, installation, commissioning, maintenance and supply of medical devices.

2. Normative references: This chapter identifies the normative documents that are used by the standard.

3. Terms and definitions: This chapter defines the terms used in the standard, see also the ISO 9000 standard.

4. Quality management system

The organization shall identify its general and documentation requirements.

5. Top management responsibility

Top management shall:

  • Demonstrate leadership and commitment to the QMS
  • Ensure customer focus
  • Determine the quality policy
  • Plan the QMS and quality objectives
  • Ensure the responsibility and authority of the management representative
  • Implement internal and external communication
  • Carry out management reviews


6. Resources

The organization shall:

  • Determine and provide the necessary resources
  • Document requirements for:
    • infrastructure
    • work environment
    • Control contamination


7. Production of the product

The organization shall:

  • Plan the production of the product
  • Determine product requirements
  • Master design and development
  • Select suppliers
  • Control production and service provision
  • Control monitoring and measuring equipment


8. Measurement, analysis and improvement

The organization shall:

  • Plan and apply monitoring, measurement, analysis and improvement processes:
    • Feedback
    • Complaint handling
    • Reporting to regulatory authorities
    • Internal audit
    • Process and product monitoring
  • Control nonconforming products
  • Analyze the data
  • Improve the QMS


Organizations that can demonstrate compliance with these requirements can obtain ISO 13485 certification.

ISO 13485 certification has numerous benefits for organizations involved in the medical device industry, including:

  • improved patient safety
  • reduced risk of product recalls
  • increased market access


ISO 13485 certification is a valuable tool for organizations in the medical device industry that want to improve the safety of their products and their compliance with regulatory requirements.

In addition to the requirements of ISO 13485, medical device industry organizations must also comply with the requirements of applicable regulations, such as the United States Food and Drug Administration (FDA) and Medical Device regulations. Regulation (MDR) of the European Union.