Iso 13485 Download
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Iso 13485 Download
Please note, during the pandemic, certain ISO standards, including ISO 13485:2016, are available for free. You cannot download it as a pdf, but the full text is available online. See the updated list of free standards here.
If you want to know more about ISO 13485 and quality management for medical devices, take a look at our online Quality Management for Medical Devices and ISO13485 course. This comprehensive course is specifically tailored to make the requirements of the ISO 13485 as tangible and concrete as possible, so participants can confidently work in an organisation where ISO 13485 requirements apply. It introduces tools and methods on how to work successfully and efficiently within a quality management systems.
Peter Sebelius is a highly esteemed trainer, consultant and entrepreneur in the medical device industry. He is a member of the Joint Working Group that is revising the ISO 13485 and ISO 14971 standards.
Along with all of the free ISO 13485 materials we also offer ISO 13485 document templates, ISO 13485 software, ISO procedure downloads, and ISO 13485 download information that will all help you on the road to certification.
To sustain the campaigns taking care of the impact of COVID-19, the International Organization for Standardization (ISO) has made a few of its standards supporting the assessment of medical devices as well as personal protection equipments used in healthcare setups easily accessible free of charge. ISO 13485 pdf or EN ISO 13485 pdf can be consulted for free.
The Ottobock manufacturing sites are certified according to DIN EN ISO 13485. The current certificates that document the effective introduction and maintenance of QM systems can be downloaded here. The CE declaration of conformity confirms the compliance of the Ottobock products with the statutory requirements under the medical device regulation 2017/745. Relevant documents regarding the Ottobock manufacturing sites can be found on this page.
In the Healthcare & Life Sciences area, the plants operate with ISO 13485 certifications and are compliant with the European Guide to Good Manufacturing Practice. Many of the products in this division have the CE, are registered with FDA in the United States or have registrations for the specific countries where the Group operates.
Why was ISO 13485 recently updated and what are the main improvementsAll ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
The Ottobock manufacturing sites are certified according to DIN EN ISO 13485. The current certificates that document the effective introduction and maintenance of QM systems can be downloaded here. Mobility Solutions GmbH is additionally certified according to DIN EN ISO 14001. The current certificate for the environmental management system can be found here. The CE declaration of conformity confirms the compliance of the Ottobock products with the statutory requirements under the medical devices directive 93/42/EEC. Relevant documents regarding the Ottobock manufacturing sites can be found on this page.
ISO 13485:2016 MD 671656 - Bellshill, Derby, Chessington, Chesterfield, Grimsby, Guildford, Harrow, Kent, Knowsley, Lincoln, Leicester, London, Sheffield, Tameside, Whitechapel, Wolverhampton, Wythenshawe
Standard: ISO13485: 2016Certificate Register No.: SX 1220269-1Validity: This certificate is valid from 22.06.2022 until 21.06.2025First Certification: 2017Download PDF
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a quality mana