ISO 13485:2016 is an internationally agreed standard that sets out the requirements for a quality management.During a 3-year transition period, the two versions coexisted to allow users to transition to the new 2016 revision of the standard. The TGA published a notification of this transition period on our website on 9 August 2016.Once this transition period ends, the 2016 version will be formally recognised as the only acceptable revision of this standard - the 2003 version will be made obsolete by ISO.If you are relying on compliance with ISO 13485 to demonstrate conformity with the QMS requirements of the Australian conformity assessment procedures:From 1 January 2019, all TGA audits are conducted against the 2016 revision of the standard, as previously announced: Medical device quality management systems: transition to new standardAll TGA issued ISO 13485:2003 QMS Certificates will expire by 1 March 2019 and cannot be extended beyond the end of the transition period.The TGA can only issue ISO 13485:2016 QMS Certificates to manufacturers who we have audited against the new revision of the standard.If you require a TGA audit to ISO13485:2016 for a new QMS Certificate, please contact us via Applications for TGA Conformity AssessmentFrom 1 March 2019, conformity assessment applications must be supported by evidence that a quality management system has been implemented in accordance with the 2016 revision of the standard.For applications lodged prior to the end of the transition period, QMS evidence based on ISO 13485:2003 will be considered as part of the application process.
13485 Standards Full Transition To
This standard has been revised by ISO 13485:2016 Abstract ISO 13485:2003 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 requirements and regulatory requirements applicable to medical devices and related. ISO 13485 is the main Quality Management System (QMS) standard for medical devices, although several countries have their own set of regulations. As an example, the United States plans to harmonize the Food and Drug Administration (FDA) requirements for medical devices with ISO 13485.The 3-year transition period for ISO 13485 (full transition to the 2016 version of the standard) ends on 1 March 2019.BSIs ISO 13485:2016 Internal Quality Systems Auditor competency- based 3-day course teaches a general understanding of the concepts of the ISO 13485:2016 standard and the principles and practices of effective internal audits in accordance with ISO 19011:2018, 'Guidelines on Auditing Management Systems'.
Requirements (EN ISO 9001:2015, IDT ISO 9001:2015, IDT)” and DSTU EN ISO 13485:2018 “Medical devices. The resolution IAF 2015/13 obliges all the conformity assessment bodies, accredited by the National Accreditation Agency of Ukraine and having the activity of ISO 13485 in the accreditation field, to ensure the transition of its clients from the version of DSTU EN ISO 13485:2015 (EN ISO 13485:2012, IDT ISO 13485:2003, IDT) to the new version of ISO 13485:2016 until March 1, 2019.“UNI-CERT” LLC would like to draw your attention to the need of introducing the new ISO 13485:2016 standard in your activity, since all the certificates obtained for the previous version will be invalid from March 1, 2019.Based on the foregoing, we would like to note that the specialists of “UNI-CERT” LLC have already undergone internal training in the following standards: DSTU EN ISO 9001:2018 “Quality management system. 495 as of Decemthe DSTU EN ISO 13485:2015 standard will be effective until July 1, 2019.Earlier the Resolution IAF 2015/13 determined a 3-year transition period (since the publication of ISO 13485:2016) and the transition process to the latest edition of ISO 13485:2016. According to the Order of the State Enterprise “UkrNDNC” No. Requirements for regulatory purposes (EN ISO 13485:2012, IDT ISO 13485:2003, IDT)”.
Information about the date of the seminar will be posted in the Education section. Requirements for regulatory purposes (EN ISO 13485:2016, IDT ISO 13485:2016, IDT)”, as well as prepared and submitted documents to expand the scope of accreditation according to the specified standards.In addition, we plan to conduct training on the above-mentioned amendments in the field of technical regulation.
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