Standard

ISO 13485 - Quality Management System

Demonstrate your ability to provide safe medical devices and services that consistently meet customer demands and applicable regulatory requirements.

What is ISO 13485

ISO 13485 is the harmonized standard for Quality management system (QMS) in the medical device industry

ISO 13485 focuses on patient safety by ensuring the consistent quality throughout the entire lifecycle of medical devices, from design and production to disposal.

It outlines the requirements needed for organizations to establish a QMS that demonstrates their capability to consistently and safely deliver medical devices, and related services, to meet customer and regulatory requirements.

ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015. While ISO 13485 is based on the ISO 9001 process model concepts of ‘Plan, Do, Check, Act’, it is designed for medical devices QMS and therefore can’t be replaced by ISO 9001.

Relevant for designers, manufacturers, and distributors of medical devices.

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What are the benefits of being certified to ISO 13485

Adopting ISO 13485 provides an effective solution to meet the comprehensive requirements for a medical devices QMS.

Establishes a practical foundation for manufacturers to address regulations and responsibilities.
Allows manufacturers to demonstrate a commitment to the safety and quality of medical devices.
Boosts manufacturer confidence in maintaining regulatory compliance.
Helps minimize surprises and failures that could harm patient safety and reputation.
Enhances marketability for medical device suppliers and service providers.

Find answers to the most common questions about ISO 13485

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ISO 13485 is a harmonized standard for Quality Management Systems (QMS) specific to the medical device industry. It focuses on patient safety, ensuring consistent quality throughout the lifecycle of medical devices—from design and production to disposal.

The standard outlines the requirements to establish a QMS that consistently and safely delivers medical devices and related services, meeting customer and regulatory requirements.

ISO 13485, though based on ISO 9001, is designed for regulatory compliance. It includes specific requirements and excludes some ISO 9001 elements, making it more prescriptive and requiring stricter documentation. It is relevant for designers, manufacturers, and distributors of medical devices.
Implementing ISO 13485 offers numerous benefits to companies in the medical device industry. It ensures a robust QMS that enhances product quality and patient safety throughout the lifecycle of medical devices.

Compliance with ISO 13485 helps companies meet global regulatory requirements, facilitating market access. It improves process efficiency, reduces risks, and minimizes the likelihood of defects or recalls.

Additionally, certification to ISO 13485 boosts credibility and trust among stakeholders, demonstrating a commitment to consistent quality and continuous improvement. This standard can facilitate the company’s efforts to achieve operational excellence and maintain a competitive edge in the market.
ISO 13485 certification is a formal recognition that a company’s QMS meets the rigorous requirements of the medical device industry. It demonstrates a commitment to maintain high standards for the safety, quality, and consistency of medical devices throughout their lifecycle.

Achieving ISO 13485 certification requires a company to undergo auditing by a recognized certification body. The certification represents a solid basis to meet MedTech regulatory requirements and is pivotal for companies looking to enter or expand in global markets. It enhances customer trust, minimizes the risk of non-compliance, and fosters continuous improvement within the company, ultimately supporting operational excellence and market competitiveness.
Implementing ISO 13485 involves several key steps to establish a compliant Quality Management System (QMS):

• Conduct a gap analysis to compare current processes against ISO 13485 requirements.
• Develop an implementation plan, with timelines, responsibilities, and resources needed.
• Update or create QMS documentation to align with the standard, including procedures, work instructions, and records.
• Train employees on the new QMS processes and their roles.
• Conduct internal audits to ensure compliance and address any issues.
• Finally, undergo a certification audit by a recognized body to achieve ISO 13485 certification.

Continuous monitoring and improvement are essential to maintain compliance and effectiveness.
The requirements outline the necessary components of a medical device company’s QMS. These include the establishment of a documented QMS, with quality policies, objectives, and procedures. A company must demonstrate control over design, development, production, and distribution processes, ensuring that these consistently meet regulatory and customer requirements.

Risk management is crucial to identify, assess, and mitigate risks throughout the product lifecycle. Regular internal audits, management reviews, and corrective actions are required to maintain compliance and drive continuous improvement.

Additionally, the company must ensure traceability, control of non-conforming products, and effective communication with regulatory authorities.

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Why BSI

Our recruitment process is highly selective for the professionals we hire to conduct ISO 13485 audit

Our recruitment process is highly selective for the professionals we hire to conduct ISO 13485 audits.

Our auditors have exceptional industry experience, knowledge of medical devices design and manufacturing processes and related regulatory requirements. They go through rigorous, continual internal training and qualifications to enable trusted QMS assessment.