ISO 13485 Medical Devices
Safety and quality are non-negotiables in the medical devices industry. Regulatory requirements are increasingly stringent throughout every step of a product’s lifecycle, including service and delivery. More and more, organisations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do.
For more information, download the ISO’s free tips for getting started with ISO 13485, requirements for quality management systems related to medical devices.
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What is ISO 13485?
ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers of medical devices and equipment. The main objective of the standard is to facilitate harmonised quality management system requirements for regulatory purposes within the medical devices sector.
Key Benefits of ISO 13485
- Meet regulatory requirements
- Demonstrate that medical devices are produced safely
- Increase device sales by accessing more markets.
What Further Advantages can I Expect?
- Reduced operating costs
- Improved stakeholder relationships
- Legal compliance
- Improved risk management
- Proven business credentials
- Openings in new markets
- Customer satisfaction
How is ISO 13485 Structured?
ISO 13485 has been based on the requirements of ISO 9001 and has the same structure in terms of clauses. The ISO 13485 standard, medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most export markets. Having certification demonstrates your commitment to meeting your customer requirements.
Who can apply for ISO 13485 certification?
ISO 13485 is applicable to all manufacturers and suppliers of medical devices, components, contract services and distributors of medical devices. For a number of markets ISO 13485 certification is not sufficient on its own and the appropriate local regulatory certification is also required to legally manufacture and sell medical devices.
Requirements of the ISO 13485 standard
The ISO 13485 standard contains specific requirements for manufacture, installation and servicing and requires:
- Risk management approach to product development and product realisation
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems
- Implementation of a quality management system with several enhancements.
What is the Certification Process?
The certification process is in three simple steps:
- Application for certification
- Complete the on line enquiry form and we will get back to you with quotation.
- Initial Certification Audit
The assessment process is based on a 2 stage approach as follows:
Stage 1 – A basis audit to check whether the organisation is in a state of readiness for the stage 2 audit and involves the following:
- Confirm that the quality manual conforms to the requirements of the ISO 13485
- Confirm the scope of certification including any justifiable exclusions
- Check legislative compliance
- Production of a report that identifies any non-compliance or potential for non-compliance and
- Agree a corrective action plan if required.
- Production of an assessment plan and confirm a date for the stage 2 assessment visit.
Stage 2 – the purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 13485 in practice and involves the following:
- Undertake sample audits of the processes and activities defined in the scope of assessment
- Document how the system complies with the standard
- Report any non-compliances or observations
- Produce an audit programme and confirm a month and year for the first surveillance visit