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ISO 13485 is a Management Systems Standard specifically developed for the manufacture of Medical Devices.

Its primary objective is to facilitate harmonized medical device regulatory requirements.

The standard contains specific requirements for manufacture, installation and servicing and calls for:

  • Implementation of a Quality Management System with several enhancements
  • Risk Management approach to product development and product realisation
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems

What are the benefits of certification?

  • Customer satisfaction - through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements
  • Reduced operating costs - through continual improvement of processes and resulting operational efficiencies
  • Improved stakeholder relationships - including staff, customers and suppliers
  • Legal compliance - by understanding how statutory and regulatory requirements impact the organization and its customers
  • Improved risk management - through greater consistency and traceability of products and use of risk management techniques
  • Proven business credentials - through independent verification against recognized standards
  • Ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector

Who is ISO 13485 applicable to?

ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

How to gain registration?

The process of registration follows three simple steps:

  • Application for registration is made by completing the application questionnaire
  • Assessment to ISO 13485 is undertaken by NQA - the organisation must be able to demonstrate that its quality management system has been fully operative for a minimum of three months and has been subject of a full cycle of internal audits
  • Registration is granted by NQA and maintained by the organisation. Maintenance is confirmed through a programme of annual surveillance visits and a three yearly re-certification audit.
     
Initial Certification Audit
The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows:

Stage 1 -
the purpose of this visit is to confirm the readiness of the organisation for full assessment. The assessor will:

  • confirm that the quality manual conforms to the requirements of ISO 13485
  • confirm its implementation status
  • confirm the scope of certification
  • check legislative compliance
  • produce a report that identifies any non-compliance or potential for non-compliance and agree a corrective action plan if required.
  • produce 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. The assessor will:

  • 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 potential for non-compliance
  • produce a surveillance plan and confirm a date for the first surveillance visit

If the assessor identifies any major non-conformance, the organisation cannot be certified until corrective action is taken and verified.

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