13485

ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) specifically for medical devices. This standard helps manufacturers ensure that their medical devices meet regulatory requirements and adhere to patient and user safety.

The standard is globally recognized and used to achieve compliance with regulatory requirements, including CE marking and approval of medical devices in markets like the USA, Canada, and Japan.

Importance of Compliance

ISO 13485 serves as a quality benchmark for medical device manufacturers, helping companies to ensure the quality and safety of their products.

Compliance with ISO 13485 is often a prerequisite for accessing global markets and is an essential step towards regulatory approval, avoiding potential recalls, and managing product risks.

Key Elements of ISO 13485

– Quality Management System (QMS): The standard requires implementing a robust QMS that encompasses all processes throughout the product lifecycle, from design and development to production and distribution.

– Documentation Requirements: ISO 13485 places a strong emphasis on documentation. All aspects of product development and quality assurance must be thoroughly documented to demonstrate compliance.

– Risk Management: The standard requires the use of risk management during design and production to identify and mitigate potential hazards for patients and users.

– Process Validation: Processes that cannot be fully verified by subsequent inspection or testing must be validated to ensure consistent quality.

Scope of Application

ISO 13485 applies to manufacturers of medical devices, suppliers of components, and contract manufacturers, as well as companies providing services such as storage and distribution of medical devices.

The standard covers both active and non-active devices, from simple aids to complex implants and software as a medical device (SaMD).

Steps for Compliance

1. Establish a Quality Management System: Implement a QMS in accordance with ISO 13485, including quality procedures and policies.
2. Risk Management: Conduct a risk assessment and establish risk management processes throughout the product lifecycle.
3. Documentation and Traceability: Ensure thorough documentation and traceability of all processes, components, and products.
4. Internal Audit: Conduct internal audits to ensure the QMS meets all requirements.
5. Management Review: Perform periodic management reviews to evaluate the effectiveness of the QMS and ensure continuous improvement.
6. External Audit and Certification: Invite an accredited certification body to conduct an audit of your QMS to achieve ISO 13485 certification.

Resources and Guidance

ISO 13485 Document: Access the official ISO 13485 standard here.

Latest Updates and News

Revised Edition of ISO 13485: A revised version of ISO 13485 is expected to be released in 2025. The new edition will focus on better integration with other standards and enhanced regulatory compliance.

Contact Information

For help with QMS 13485 compliance, email us at info@scengineering.dk or use the contact form.