ISO 13485 | Certification for Medical Devices | NQA

ISO 13485 the International Quality Management Systems for the design and manufacture of medical devices.

Helps you with

Quality Control, Risk Management, Legal Compliance, Traceability and Recall, Process Improvement, Product Improvement, Operational Efficiency

WHAT IS ISO 13485?

ISO 13485 is based on the ISO 9001:2008 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 realisation
  • Validation of processes
  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems.

WHO IS IT 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.

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 recognised standards
  • Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.

THREE STEPS TO CERTIFICATION

  • Application for registration is made by completing the Quote Request Form. This provides information about your organization so we can accurately define the scope of assessment.

  • Assessment to ISO 13485 is undertaken by NQA - 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 management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.

  • Certification is issued by NQA and maintained through a programme of annual surveillance audits and a three yearly recertification audit.

Initial Certification Audit

Stage 1 - 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

Stage 2 - 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.

NEXT STEPS

QMS Training - 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.

Gap Analysis - 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.

Consultancy - We don't provide consultancy but we can help you choose a reputable consultant from the NQA Associate Consultant Register.

Get a Quote - We'll give you a clear indication of the costs of gaining and maintaining certification, contact our sales team directly here.

GET IN TOUCH

We can advise you on how to achieve certification, related training, useful resources and finding a reputable consultant.

Contact our business advisors on 0800 052 2424 or complete our contact us form.

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