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The latest version of ISO 13485 was published in 2016, and the transition from the previous version is ahead. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents and records are needed for an effective Quality Management System (QMS) based on ISO 13485.
This documentation kit is written in simple English. The Documents are written and prepared in MS Word 7 which is well-suited with any window 2003 and the higher versions. A soft copy of an editable IATF 16949 document kit is provided, so the user can edit it and it covers the total documentation package.
ISO 17021 2015 documentation kit contains more than 75 editable MS-Word files. These editable documents address all the elements of certifying body accreditation. Documents with the iso 17021 manual are user compatible, easy to learn, and easy to use.
Personnel Certification is popular to complement the personnel conformity assessment process globally. ISO/IEC 17024:2012 assessment needs proper Person certification documentation which conforms to the requirements of the 2012 version and ANSI Guidelines, regarding the components that must be included in the development and maintenance of the scheme.
ISO 14155 awareness training kit contains more than 100 ppt presentation slides, which are like Awareness of ISO 14155:2020, ISO 14155:2020 requirements, ISO 14155:2020 document control & records, and Step for ISO 14155:2020 certification. These readymade ISO 14155 training ppt package is designed to minimize the time and the cost involved in certification as well as better control over the Clinical investigation of medical devices for human subjects.
