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ISO 13485 REVISIONS ISO
Manufacturers, and other economic operators, will need to integrate the quality management system requirements in the applicable European Regulation into the processes provided by EN ISO 13485.
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Consequently, conformity is not entirely achieved by complying only with the requirements specified in EN ISO 13485. It is important to take note that the primary goal of ISO 13485:2016 is not to cover exactly the European quality management system requirements as it is intended to be applicable in jurisdictions all over the world.
ISO 13485 REVISIONS VERIFICATION
In addition, the report offers line-by-line charts laying out the similarities and differences and also discusses key considerations on definitions, training and competence, approvals versus signatures, risk management, and corrective and preventive actions versus improvement processes.EN ISO 13485:2016+A11:2021 amends EN ISO 13485:2016, incorporating corrigenda March 2016, December 20, with a revised European Foreword and European Annexes ZA and ZB.Īnnex ZA addresses the relationship between the EN ISO 13485:2016 and the requirements of Regulation (EU) 2017/745 (MDR) with regards to the general obligations of the manufacturer in Article 10 (covered in Table ZA.1), the quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation (covered in Table ZA.2) and quality management system requirements in Annex XI on conformity assessment based on product conformity verification (covered in table ZA.3).Īnnex ZB addresses the relationship between the EN ISO 13485:2016 and the requirements of Regulation (EU) 2017/746 (IVDR) with regards to the general obligations of the manufacturer in Article 10 (covered in Table ZB.1), the quality management system requirements in Annex IX on conformity assessment based on a quality management system and on assessment of technical documentation (covered in Table ZB.2) and quality management system requirements in Annex XI on conformity assessment based on production quality assurance (covered in table ZB.3).
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This difference may not have been noticed reviewing the requirements in only one direction.” “While there are no incongruities among the requirements for the quality management systems, there may be some verbiage or directed differences. “An example of this is 21 CFR 820 supplier controls compared to ISO 13485:2016 outsourced suppliers and purchasing controls and the need for quality agreements,” the report says. The document also maps 21 CFR 820 to ISO 13485:2016 and vice versa, as AAMI explains that companies should review the alterations in both directions. To help industry prepare for such changes, the AAMI report, which was developed and approved by a working group of industry and FDA experts, documents the relative and systemic differences and similarities between 21 CFR 820 and ISO 13485:2016, noting areas in risk management where ISO 13485:2016 is more prescriptive and explicit than the current quality system regulation, which was first written in 1996. “The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” FDA said. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and modernization of the quality system regulation for medical devices with the specifications of ISO 13485:2016. The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. New Report Compares FDA Quality System Requirements With ISO 13485:2016