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ISO 13485 Medical Devices Management Systems

Applicable to all organisations involved in the design, production, installation and servicing of medical devices and related services.

Recently updated to ISO 13485:2016, the new version of the internationally recognised standard offers a framework to realise requirements of a medical devices quality management system and seeks to address the entire lifecycle of a medical device.

Key Benefits

Meet Compliance Requirements

Build confidence and trust with stakeholders by implementing a practical framework to meet your regulatory requirements for a medical device quality management system.

Gain Market Access

Whether you are a manufacturer at any stage of the medical device lifecycle, or a supplier, ISO 13485 gives you international recognition for quality management systems. The framework and principles of ISO 13485 sits at the core of additional regulatory requirements like Medical Devices Single Audit Program (MDSAP).

Drive Business Performance

Align your management system with the strategic direction of your organisation to improve process efficiency while reducing reputational risks.

Improve Patient Safety and Quality

Protect consumer safety through robust risk management embedded within each processes throughout the medical device lifecycle.

What Is It?

This internationally recognized Standard brings a strengthened process approach to quality management allowing for a framework to comply to regulatory requirements.

ISO 13485:2016 medical devices quality management systems specifies the requirements for organizations in any aspect of a medical device lifecycle, including both product and related services.By implementing a structured framework that aligns with the strategic direction of the business, organisations can experience:
  • Increase patient safety and quality, protecting your brand
  • Achieve regulatory compliance requirements
  • Achieve organizational strategic objectives
  • Improve process efficiency and lower costs
  • Gain market access
Quality Management System
Following the requirements of ISO 9001, ISO 13485 follows the structure to implement a quality management system including the requirements to document processes for the highly regulated medical device industry. Expands the terms of the Standard to include areas such as clinical evaluation, software, medical device families, post-market surveillance, Distributors and Importers.
Management Responsibility
Top management sit at the center of the organisation’s success, and are therefore required to establish the quality processes and objectives, as well as conduct reviews to ensure the business is meeting customer expectations.
Resource Management
Only applicable if relevant, implement the right people and infrastructure to foster a positive work environment that sets the organisation up to succeed.
Product Realisation
Only applicable if relevant, the Standard references the requirements the organisation needs to comply with in planning, designing and developing, purchasing and monitoring of the medical device.
Measurement, Analysis and Improvement

Only applicable if relevant, organisations will need to monitor and measure the performance of the business processes, including meeting customer expectations. Internal audits enable opportunities for continuous improvement and corrective action.

Next Steps

Whether you’re new to ISO 13485 or are looking to transfer your certfication, we can assist you.

  • Purchase the ISO 13485 Standard
  • Undertake optional training to build expertise
  • Implement the Standard
  • Contact SAI Global to discuss requirements, timeframes and costs
  • Review and accept proposal to book audit dates
  • Take an optional pre-assessment
  • Perform a gap analysis
  • Undertake a Stage 1 audit
  • Complete a detailed Stage 2 audit
  • Upon successful certification, display the ‘Five Ticks’ StandardsMark™
  • Conduct Surveillance Audits annually
  • Recertify to ISO 13485 every three years
  • Establish a continuous improvement culture
  • Market for brand and promotional benefits
  • Optimise commercial teams
  • Ensure shareholder and stakeholder awareness

Maximise Your Certification to ISO 13485:2016

ISO 13485:2016 offers medical device manufacturers a quality management system that translated into greater consistency, improved quality and less risk.