ISO 13485 Medical Devices

What is ISO 13485 ?

You can’t buy trust.  Build it through ISO 13485.

Demonstrate your ability to supply medical devices through Quality Management System for Medical

Devices – ISO 13485

ISO 13485 is the quality management system standard for medical devices. This standard applies the ISO 9001 process approach to quality, and replaces ISO 13485:1996 and ISO 13488:1996. ISO 13485:2003 replaces 13485:2016 provides an effective base model for compliance with the EU CE marking Medical Devices Directives requirements. ISO 13485 is also considered to be fully compatible with the FDAQSR. ISO 13485 is an international standard, recognized throughout the world for establishing a business management system specific to the medical device industry. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components. The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. Some of the additional requirements to ISO 9001 requirements relate to

  • Design controls,
  • Risk management,
  • Environmental controls,
  • Special processes (e.g. Software validation),
  • Traceability, record retention, and
  • Regulatory actions (such as vigilance), ISO 13485 has been harmonized against the medical device directives.
  • Medical Devices Directive
  • Active Implantable Medical Devises Directive,
  • In Vitro Diagnostic Directive

This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system.

Formal certification of quality management system, specifically for medical devices, to ISO 13485 proves advantageous, for medical companies which export their products to the global market.

  • In the European Union, the fulfilment of EU Directives (e.g. Active Implantable Medical Devices Directive, Medical Devices Directive and In Vitro Diagnostic Directive) allows the free trade of medical devices.
  • Canada requires that medical device manufacturers marketing their products in Canada must have a quality system certified to ISO 13485 by an accredited certification body.

ISO 13485 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.

Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices.

13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and—pre-eminently—various global regulators. While being certified to 13485 does not fulfil the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.

13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices.

While 13485 states that a manufacturer’s management team is charged with the management of device related risks and the development of risk management plans, 14971 defines a list of steps to be taken by management in order to fulfil risk-related requirements. While it is not mandatory that a manufacturer be 14971 certified in order to attain 13485 certification, being certified to the former standard can ease the attainment of certification to the latter.

Benefits of ISO 13485 Certification

ISO 13485 implementation improves / leads to:-

  • POLICIES & OBJECTIVES set by ‘top management’
  • Conformance to Legal and Regulatory Requirements
  • Recognition by regulators around the world of ISO 13485 as a good basis for addressing medical device design and manufacturing regulatory requirements
  • Controlled consistency of manufactured products
  • Managed productivity and efficiency, controlling costs
  • Competitive advantage and increased marketing and sales opportunities.
  • Improved customer perception of the organization’s image, culture and performance.
  • improved internal and external Communications
  • greater understanding of the organization’s processes
  • clear responsibilities and authorities agreed for all staff
  • improved use of time and resources
  • reduced wastage
  • greater consistency and traceability of products and services
  • Customer Confidence, Satisfaction and TRUST
  • Level of Assurance in Organizational QUALITY
  • Organizational PROFITABILITY
  • Ability to Differentiate Organization for Competitive Advantage
  • Organizational Credibility & Reputation
  • Consultants providing design services to the medical device market.
  • Companies providing services to the medical device market such as sterilization, cleaning, testing, etc.