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 and 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
Benefits of working with Nathan ISO Consultancy
- Network of Overseas Strategic Partners
- Accredited Certification
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- Industry Experienced Audit Team
- Defined & Agreed Project Timescales
- Fixed Cost & Competitive Quotations
- International Accepted Certificates
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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
- 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 form for Nathan ISO Consultancy to send a 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