Reference number
ISO 13485:2016
© ISO 2024
International Standard
ISO 13485:2016
Medical devices — Quality management systems — Requirements for regulatory purposes
Edition 3
2016-03
Preview
недоступно на русском языке
Опубликовано (Версия 3, 2016)
Последний раз этот публикация был пересмотрен в  2020. Поэтому данная версия остается актуальной.

ISO 13485:2016

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What is ISO 13485?

ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices. It outlines specific requirements that help organizations ensure their medical devices meet both customer and regulatory demands for safety and efficacy.

Why is ISO 13485 important?

ISO 13485 is crucial for manufacturers and suppliers of medical devices as it establishes a framework to ensure consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. It aids in meeting rigorous regulatory requirements and managing risk, while ensuring best practices in the manufacture of medical devices. This standard not only facilitates market access across different countries but also enhances trust among stakeholders through demonstrated commitment to safety and quality.

Benefits

  • Risk management enhancement: Provides systematic methods to identify and mitigate risks throughout the product lifecycle, ensuring patient and user safety
  • Regulatory compliance: Helps organizations meet strict regulatory requirements specific to medical device manufacturing, crucial for market access and global trade.
  • Operational efficiency: Streamlines processes to improve overall efficiency and effectiveness, reducing waste and increasing productivity
  • Market access: Facilitates entry into global markets with standardized compliance, enhancing competitive advantage
  •  Enhanced reputation: Builds credibility and trust with stakeholders, including regulators, customers, and end-users, through proven adherence to a globally recognized quality standard

 

FAQ

ISO 13485 is intended for any organization involved in the design, production, installation, and servicing of medical devices and related services. It can also benefit suppliers and external parties that provide product, including quality management system-related services to such organizations.

While ISO 9001 applies to a wide range of industries, ISO 13485 is specifically tailored to the regulatory and safety requirements of the medical device industry. It emphasizes meeting regulatory as well as customer requirements, risk management, and effective process validation more than ISO 9001.

Buy together

Bundle - 10% discount
Medical devices - the basics

This bundle combines essential ISO standards to provide a robust framework for quality management and risk management in the medical device industry.

  • ISO 13485:2016
  • ISO 13485:2016 A practical guide
  • ISO 14971:2019
  • ISO/TR 24971:2020
English | PDF
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Общая информация

  • Текущий статус
     : Опубликовано
    Дата публикации
     : 2016-03
    Этап
    : Подтверждение действия международного стандарта [90.93]
  • Версия
     : 3
  • Технический комитет :
    ISO/TC 210
  • RSS обновления

Жизненный цикл

Цели в области устойчивого развития

Данный стандарт разработан для достижения следующих Цели в области устойчивого развития

3
Хорошее здоровье и благополучие
10
Уменьшение неравенства

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