New issue of ISO 13485 standard

The International Organization for Standardization (ISO) released a new version of ISO 13485 (ISO 13485:2016) on 1 March, 2016. The revision replaces the previous version from 2003 (ISO 13485:2003).
A 3 year transition period to migrate to the new version is granted after the revision has been published.

The new version of standard brings changed structure and some key novelties and changes in the following areas:

  • new requirements in the field of safety management and effectiveness of medical device
  • connection of the system with legal requirements
  • application of requirements throughout the life cycle and supply chain
  • harmonizing the requirements for the validation of software
  • infrastructure requirements for manufacturers of sterile medical devices
  • requirements for development, handling of complaints, reporting to regulatory bodies
  • planning and implementation of corrective and preventive actions,...

Validity and transition period
ISO and accreditation bodies set the rules for the transition to the new standard:
1. During the transition period ISO 13485:2003 and ISO 13485:2016 certificates are considered equivalent.
2. The transition to the new ISO 13485:2016 standard can be conducted at surveillance audit or recertification audit.
3. 36 months after publication of ISO 13485:2016 (i.e. 01 March 2019), any existing certificate issued to ISO 13485:2003 will not be valid.
4. Certificates issued to ISO 13485:2003 will be valid till end of February 2019.

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