ISO 13485:2016 · Medical devices
ISO 13485 Medical devices certification
For medical device manufacturers and suppliers to demonstrate conformity to regulators.
recognised through
and registered with
Overview
What is ISO 13485 certification?
ISO 13485 is the leading international standard for quality management systems for medical devices, covering their design, production, installation and servicing, and related services. Certification demonstrates that an organisation is committed to safe manufacturing practices and high quality in this critical industry. The standard is designed to ensure that medical products meet the highest levels of quality and safety, protecting patient health and supporting compliance with international regulatory requirements.
ISO 13485 certification sets out a range of requirements and procedures that organisations must follow, including process control, testing procedures, risk assessment, component traceability, change management and internal audit. Conforming to ISO 13485 helps strengthen quality management and customer satisfaction, enhances your reputation and opens up wider international trade opportunities in the medical device industry.
Raise the quality of your medical products
The certification that makes your medical products safer and of higher quality. Find out how to achieve it.
Your route to compliance in the medical sector
Achieve safety and compliance in medical device manufacturing, with a straightforward guide to certification.
A key to success in the medical sector
Unlock high quality and customer satisfaction across the medical device industry.
Your path to innovation and quality in healthcare
Use ISO 13485 as a platform for innovation and excellence in the medical sciences.
What does ISO 13485 bring your organisation?
The key benefits organisations gain from implementing the standard and achieving certification.
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Better product quality
ISO 13485 certification helps improve the quality of your medical devices by embedding high-quality manufacturing practices.
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Greater safety
Certification strengthens the safety of medical products and reduces the associated risks, helping to protect public health and safety.
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Meeting regulatory requirements
Certification supports compliance with international and local regulatory requirements for medical devices.
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Increased trust
Certification builds the confidence of customers and business partners in your products and services.
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Access to new markets
Conformity with ISO 13485 opens doors to international trade and increases export opportunities.
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More efficient processes
Certification encourages more efficient processes and less waste, reducing costs and lead times.
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Higher customer satisfaction
Delivered through better-quality products and improved customer service.
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Stronger risk management
Certification strengthens risk management through the assessment and monitoring of potential hazards.
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Competitive advantage
Certification makes your organisation more competitive in the medical device industry.
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Enhanced reputation
Conformity with ISO 13485 builds a positive reputation for your organisation as a reliable supplier committed to quality and safety.
How to get ISO 13485 certified
A clear path from first contact to receiving your certificate, with support afterwards.
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Step 1: Speak to one of our experts
The process begins with a conversation with one of our quality specialists, who will explain the steps involved and the requirements you need to meet to achieve ISO 13485 certification.
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Step 2: Pre-assessment (optional)
You can request an optional pre-assessment audit that shows where your system stands against the requirements of the standard before the certification audit.
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Step 3: Planning and implementation
Your organisation draws up its action plan and puts in place the measures needed to conform to ISO 13485. Your team can attend our open training courses, such as internal-auditor and awareness courses; as a certification body, we do not provide consultancy on building your system, so that our audits remain impartial.
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Step 4: Audit and certification
Team Quality carries out the Stage 1 and Stage 2 certification audits to verify that your system conforms to ISO 13485. Once the process is complete and all requirements are met, you will be awarded certification.
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Step 5: Sustained compliance
After certification, we carry out periodic surveillance audits throughout the certificate's validity, followed by a recertification audit, to confirm that your systems and processes remain conformant and continue to improve.
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ISO 13485 frequently asked questions
What is ISO 13485 certification?
ISO 13485 is an international standard for quality management systems in the medical device industry. Its aim is to ensure the quality and safety of medical device products.
What are the main benefits of ISO 13485 certification?
Benefits include improved quality, greater customer confidence, compliance with regulatory requirements and new export opportunities.
Does every organisation in the medical device industry need this certification?
Not necessarily. ISO 13485 certification is voluntary and depends on each organisation's needs and objectives.
What are the main steps to ISO 13485 certification?
The steps include understanding the standard, assessing your current level of compliance, planning and implementation, audit and certification, and sustained compliance.
How long is ISO 13485 certification valid?
Validity depends on the policy of each certification body, but certificates are typically valid for three years, subject to periodic surveillance audits.
What is the difference between ISO 13485 and ISO 9001?
ISO 13485 is specific to the medical device industry, whereas ISO 9001 applies to a wide range of sectors. ISO 13485 places particular emphasis on safety and quality in medical device manufacturing.
Does ISO 13485 certification require compliance with other standards?
Depending on its needs and specific requirements, your organisation may also need to comply with certain additional standards.
Does my organisation need to be large to achieve ISO 13485 certification?
Not necessarily. Organisations of all sizes can achieve certification, provided they meet the requirements of the standard.
How long does it take to achieve compliance with ISO 13485?
The time required depends on the size and complexity of your organisation and its current level of compliance. The process usually takes a few months.
Can I use ISO 13485 certification to promote my products?
Yes. You can use the certification to promote your products as meeting international quality and safety standards.