ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Document published on: 2016-03-01

  • Read more at http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=59752

EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)

The EN ISO 13485:2016 supersedes EN ISO 13485:2012/AC:2012  EN ISO 13485:2012

As indicated on the European Committee for Standardization, the ISO 13485:2016 became available on 2016-03-02.  The Date of Withdrawal (DOW) of EN ISO 13485:2012 has been amended to be on 2019-03-31 from 2019-09-30.

  • CEN/CLC/TC 3 – Quality management and corresponding general aspects for medical devices is available at http://standards.cen.eu/dyn/www/f?p=204:110:0::::FSP_PROJECT:37957&cs=1B04E3A6EA841FF02235DCA86690F765D

Implementation Dates

  • Date of Ratification (DOR) (1) 2016-01-30
  • Date of Availability (DAV) (2) 2016-03-02
  • Date of Announcement (DOA) (3) 2016-06-30
  • Date of Publication (DOP) (4) 2016-09-30
  • Date of Withdrawal (DOW) (5) 2019-03-31

NOTE:

Date of announcement (DOA) refers to the latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level

Date of publication (DOP) refers to the latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement

ISO Transition Planning Guidance for ISO 13485:2016

It is recommended that:

  • Two years after the publication of ISO 13485:2016 all accredited certifications issued (new certifications or re-certifications) will be to ISO 13485:2016.
  • Three years after publication by ISO of ISO 13485:2016, any existing certification issued to ISO 13485:2003 will not be valid.

The planning guidance is available at http://www.iso.org/iso/white_paper_-_iso_transition_planning_guidance_for_iso_13485-2016.pdf

Other Information

Last Updated: 2016-03-11

Transition Date for EN ISO 13485 Amended to Be 31 March 2019
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