WHAT IS ISO 13485?

ISO 13485 is based on the ISO 9001:2000 process model approach and 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 realization
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems.


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.


  • 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.


  • Applicationfor registration is made by completing the Quote Request Form. This provides information about your organization so we can accurately define the scope of assessment.
  • Assessmentto ISO 13485 is undertaken by NACSER – this consists of two mandatory visits that form the Initial Certification Audit (explained below). Please note that you must be able to demonstrate that your quality management system has been fully operative for a minimum of three months and has been subject to a full cycle of internal audits.
  • Certificationis issued by NACSER and maintained through a program of annual surveillance audits and a three yearly recertification audit.



The purpose of this visit is to confirm that your organization is ready for full assessment. Your assessor will:

  • confirm that the quality management system 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 opportunities for improvement and agree a corrective action plan if required
  • produce an assessment plan and confirm a date for the Stage 2 assessment visit


The purpose of this visit is to confirm that the management system fully conforms to the requirements of ISO 9001 in practice. Your assessor will:

  • undertake sample audits of the processes and activities defined in the scope of certification
  • document how the system complies with the standard by using objective evidence
  • report any non-compliances or opportunities for improvement
  • produce a surveillance plan and agree a date for the first annual surveillance visit

If the assessor identifies any major non-conformances, certification cannot be issued until corrective action is taken and verified.


We provide a range of IRCA and CPD accredited training options to suit your needs and budget. These give you the skills to implement, audit and manage an effective quality management system.


We can undertake a gap analysis to help you determine the likely workload and timescale for implementing a quality management system that will achieve ISO 13485 certification. You can use this to plan implementation or brief a consultant.