ISO 13485:2016 update
What are the changes and how will they affect medical device manufacturers

ISO 13485Summary

ISO 13485 certification can open doors to European business opportunities and help build confidence with clients, investors and employees.

The 2016 update places greater emphasis on risk management and risk-based decision-making for processes outside of product realisation. The focus is on risks associated with safety and performance of medical devices and compliance with regulatory requirements.

The standard can help manufacturers build their reputation, speed up product launches and reduce number of product recalls and costly regulatory sanctions.

What is ISO 13485?

ISO 13485 is an internationally agreed standard that sets out the requirements that help medical device manufacturers develop a quality management system.

It is designed to be used throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It includes areas such as storage, distribution, installation and servicing, and the provision of associated services.

What are the key changes?

The 2016 update places greater emphasis on risk management and risk-based decision making for processes outside the realm of product realisation. The focus is on risks associated with safety and performance of medical devices and compliance with regulatory requirements. The standard also asks organisations to implement more rigorous risk-based controls such as written supplier agreements.

ISO 13485 reflects the increased regulatory requirements for organisations across the medical devices supply chain such as:

  • Greater emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and additional requirements for validation of sterile barrier properties
  • Increased alignment with regulatory requirements, particularly regulatory documentation
  • More focus on post-market activities, including complaint handling and regulatory reporting
  • Broadening of standards application to include organisations that work with medical device manufacturers such as those involved in: Design and development or repair and maintenance of medicaldevices; supply of raw materials, components or subassemblies; performance of services such as contract manufacture, sterilisation, logistics or calibration of measurement equipment; import or distribution of medical devices
  • Additional requirements in the design and development of medical devices and more robust planning for verification, validation, transfer and records maintenance of design and development activities
  • Integration of validation requirements for different software applications, such as QMS software, process control and monitoring and measurement software


How is ISO 13485 organised?


ISO 13485 has eight sections. Sections one to three describe purpose and use while sections four to eight, outlined below, state requirements necessary for compliance.

  1. Systemic requirements
    Defines general requirements for compliance and explains how to:
  • Implement and maintain a QMS for medical devices
  • Prepare a quality manual
  • Quality policy and quality objectives
  • Control QMS documents
  • Maintain document integrity.
  1. Management requirements
    Defines management roles for:
  • Establishment and maintenance of an ISO 13485 QMS
  • Senior management to actively participate in quality planning and ensure quality policy is understood throughout organisation
  • State specific requirements for carrying out periodic management reviews of the QMS
  • How often reviews should take place
  • What to cover and expected outputs
  1. Resource requirements
    Defines requirements for provision of resources such as:
  • Need for adequate space
  • Tools and equipment
  • Environment must suit type of device being made
  • How to train and maintain competent personnel
  • Importance of defining employee job requirements
  • How to keep good training records
  1. Product Realisation requirements
    Includes everything required in order to produce a product such as:
  • Establishing customer requirements
  • Creating, designing and manufacturing
  • Installing and supporting a medical device
  • How to process catalogue orders
  • Validation
  • Equipment maintenance
  • Risk management, risk assessment, risk analysis and risk reduction
  1. Remedial requirements
    Defines remedial processes necessary in order to maintain effectiveness of QMS. Key topics include:
  • Handling adverse events and customer complaints
  • Conducting internal audits
  • Monitoring and measuring processes including nonconforming product
  • Analyzing data
  • Taking corrective and preventive actions

How does ISO 13485 relate to ISO 9001

Although ISO 13485 is a self-contained standard, it is similar in scope and intent to ISO 9001, quality management systems. It includes requirements specific to organisations involved in the life cycle of medical devices, while other elements of ISO 9001 have been removed that are not relevant as regulatory requirements. As with all ISO management system standards, it is designed to be integrated into an organisation’s management system.


What are the business benefits of ISO 13485?


ISO 13485 certification offers medical device manufacturers many important benefits such as:

  • Building customer confidence by demonstrating commitment to quality
  • Increasing marketing and promotional opportunities. Manufacturers can display certification on all marketing materials, which helps build credibility with customers, employees and stakeholders
  • Promoting better communication and harmonisation of regulatory requirements on an international scale. This means: manufacturers and quality experts speak the same language, fewer communication gaps and misunderstandings, fewer deviations, non-conformances and other quality events, fewer regulatory sanctions and significant cost savings
  • Improving customer and supplier relationships by using a widely accepted system of process control leads to improved products and processes. This often leads to more satisfied customers
  • Building your reputation through improved products and processes with fewer recalls and costly regulatory sanctions
  • Increasing speed to market by allowing device manufacturers meet quality system requirements of the European Medical Device Directive (93/42/EEC), In Vitro Medical Device Directive (98/79/EEC) and Active Implantable Medication Device Directive (90/385/EEC) with fewer problems and delays


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