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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ISO 13485 is a stand-alone QMS standard, based on ISO 9001:2008, which has been superseded by ISO 9001:2015.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.

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.

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    Establishes a practical foundation for manufacturers to address regulations and responsibilities.

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    Allows manufacturers to demonstrate a commitment to the safety and quality of medical devices.

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    Boosts manufacturer confidence in maintaining regulatory compliance.

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    Helps minimize surprises and failures that could harm patient safety and reputation.

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    Enhances marketability for medical device suppliers and service providers.

iso 1345 quality management system
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.

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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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