ISO 13485


ISO 13485 standard was created based on the ISO 9001 standard is an international standard contains specific requirements for medical devices.

As well as competition in the medical device manufacturers who want to take advantage fulfill the legal requirements will have to prove that they are complying with the requirements for quality management systems.

Medical device manufacturers meet current legal requirements, to ensure customer satisfaction, increase efficiency and establish internal quality assurance system to build a legal case can be opened against and feel the need certification.

EN 46001 / ISO 13485 Management System ISO 9000 Quality Management includes additional special requirements for medical device manufacturers, including prompt requirements.

This standard, covers the supply of medical devices and quality management system requirements for an enterprise customer needs consistently applied to medical devices and related services that are required to prove its ability to meet regulatory requirements. The main purpose of this standard is to facilitate harmonized medical device regulatory requirements for quality management systems.

Medical device manufacturers operate in the EU and North American markets can depend on many legal obstacles to overcome. Canada, and some types of medical device manufacturers in many countries of the ISO 13485 standard to establish a quality management system has been made mandatory by law.

ISO 13485: 2016 is the latest version of the standard 13485. ISO 9001: 2015 is based on the model of process and risk approach.

Medical Device Quality System Services for Manufacturers

* General Check-Up (analysis of the current situation)
* Determining the Process
* Determination of Critical Control Points
* Project Manager and determination of the team
* ISO 13485 standard training
* Internal quality auditor training
* Document review
* Review of pre Audit passing

13485 Establishment of Quality Management System

* Standard Received of Education
* Determining
* Study Team and Strategy
* Establishment of Quality Manual
* Support Procedure of Establishing
* Implementation of the System
* Application for Certification
* Certification Audit

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