Dec 17 2015

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The quality of medical products starts with the management of company-producers. ISO 13485

1-1024x386The official publication of the new edition of ISO 13485 international standard, that regulates quality management systems in a sector of medical products, is scheduled for the beginning of 2016. Currently, this document is in the FDIS state (Final Draft International Standard)- stage of the final project for the international standard. As for the previous versions of ISO 13485 (2003, 2003/Cor 1:2009), the b2ase remains ISO 9001 (requirements for the quality management system) including the specific requirements for the medical equipment production industry. ISO 13485 is applicable for organizations implementing design, production, installation, maintenance of medical equipment, as well as development and provision of corresponding services. Note that ISO 9001 was significantly updated in September of the current year.

It is worth recalling that in September this year, ISO 9001 has been radically updated.

Permanent link to this article: http://www.register-sic.com/the-quality-of-medical-products-starts-with-the-management-of-company-producers-iso-13485.html

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