The latest edition of ISO 13485, the internationally recognised quality management systems standard for the medical device industry, with over 27,000 certificates globally, has been published on March 1, 2016.

ISO 13485:2016 identifies the requirements for a quality management system (QMS) in which an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet both customer and regulatory requirements.

This third edition cancels and replaces the second edition (ISO 13485:2003) and ISO/TR 14969:2004, which have been technically revised. It also incorporates the Technical Corrigendum ISO 13485:2003/Cor.1:2009.

ISO 13485:2016 Changes

Some of the most critical changes in the 2016 version include:

  • Incorporation of risk-based approaches beyond product realisation. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements;
  • Alignment of global regulatory requirements and meet customer and applicable regulatory requirements for safety and performance;
  • Application to organisations throughout the lifecycle and supply chain for medical devices;
  • New requirement related to the protection of confidential health information;
  • Emphasising the requirements for software validation for different software in different clauses of the standard considering the risk approach;
  • Increased focus regarding feedback mechanisms to utilize feedback in risk management processes;
  •  Specific requirements for documentation and validation of processes for sterile medical devices considering control of contamination with microorganism or particulate matter;
  • Adds a requirement that infrastructure prevents product mix-up and ensure orderly handling of the product.
  • Strengthening of supplier control processes and the changes made by them;
  • Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design records and design changes considering the risk of changes;
  • Add design and development transfer and design and development file as two new sub-clauses;
  • Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay and also considering adverse effects;
  • Added requirements for sterile barrier systems

ISO 13485:2016 and ISO 9001:2015

The ISO 13485 standard was updated for two main reasons: to keep up with changes in the industry and to address changes in the underlying ISO 9001 standard. While the old ISO 13485 2003 standard was based on the old ISO 9001 2000 standard, the new one is based on ISO 9001 2008. While some people expected the new ISO 13485 standard to use the latest ISO 9001 2015 standard, ISO TC 210 evidently feels that the older ISO 9001 standard better serves the needs of medical device suppliers, regulators, and customers.

How ISO Consulting Services can help you

Please fill out the Questionnaire or contact us if you need our hands to assist you in developing and establishing your management system in compliance with the requirements of ISO 13485:2016 standard. We also offer a gap assessment service to find out how close you are to your ISO 13485:2016 certificate.

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