ISO 13458 PDF

ISO Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization (ISO). The ISO standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO provides a practical foundation for . ISO , the Medical Device Quality Management System standard, has been harmonized to the European Medical Devices Directives: MDD, AIMDD.

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Adopting ISO provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. Retrieved 19 October BSI ISO Certification is one component of the comprehensive portfolio of quality management assurance services that we provide.

We have recently updated our suite of ISO courses to reflect the requirements of the new standard, including: If your organization is at all involved in iiso medical device industry, ISO is iao QMS standard you should look at for additional requirements above and beyond ISO Here, as the Chair of the ISO technical committee for quality management and related general aspects for medical devices, Dr Learn everything you need to know about ISOincluding all the requirements and best practices for compliance.

Quality Management System (QMS) ISO Certification | BSI Group

ISO standards by standard number. List of mandatory documents required by ISO For information on 134558 differences between ISO X Find out what cookies we use and 1458 to disable them. Product specific Regulatory Documentation Customer satisfaction Continual improvement The following text provide a summary of the key differences. As a result, ISO 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.


ISO is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.

Archived from the original on The intent isso the standard is to facilitate the harmonisation of quality management system regulations around the world.

Views Read Edit View history. Most of the uso in ISO This standard contributes to the following Sustainable Development Goals: Meeting product regulation requirements is also a key element of this standard, as the aim is to develop safe products which have an effective performance. How this impacts on organizations will be discussed in another article.

ISO Revision and update | BSI Group

This standard will be published in Augustand days after publication it will become mandatory for the industry. The operational phase of this program is scheduled to begin in January Life cycle 1358 standard is reviewed every 5 years 00 Preliminary.

This is reflected in the ISO What are the benefits of being certified to ISO ?

ISO Medical devices — Quality management systems — Requirements for regulatory purposes is an International Organization for Standardization Isk standard published for the first time in ; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Reference to regulatory requirements is mentioned throughout.


This standard is partially in line with ISO The new version has a greater emphasis on risk management uso risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain. InThe Farmacopea de los Estados Unidos Mexicanos United Mexican States Pharmacopoeiamedical industrial sectors and Cofepris are working together for updating NOM Standard, putting special attention on manage of risks during manufacture and regulating by manufacturing lines some of the most jso medical devices manufacturing processes.

While some of these updates are precursors to the ISO By Sandrine Tranchard on 25 September Here is a brief listing of the main additions:. Learning center What is ISO ?

ISO 9001 vs. ISO 13485

ISO does not perform certification. Just like these other standards, ISO includes the entire ISO standard with additional requirements included in blue italics text.

BSI, the business standards company, has become the first certification body to achieve accreditation for the issue of quality management certificates against the requirements of ISO From Wikipedia, the free encyclopedia.