about iso 13485

  
 

 

About ISO 13485
 

Medical Device Quality Management System Standard

ISO 13485 was published in 2003 that represents the requirements for a comprehensive management system for the design and manufacture of medical devices.  

This standard supersedes earlier documents such as ISO 46001 and ISO 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).

ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained.

Compliance to ISO 13485 is generally seen as the first step in achieving compliance with European regulatory requirements. ISO 13485 Certification is considered to be the preferred method to prove conformity is the certification of the Quality Management System.

How QSI Can Help

QSI can help organizations by providing fundamental Training Services to help interpret the requirements of ISO 13485.  We also offer advanced ISO 13485 training for Auditors and Lead Auditors based on ISO 19011.

With extensive experience with Medical Device Quality Management Systems, our Approach to Certification  services is one where we create positive environment conducive for achieving Management System objectives.

Our Steps for Certification page indicates the process that we undertake for certification to ISO 13485 based on ISO 17021. (the standard that applies to Management System Certification Bodies)

Our Third-Party Certification for ISO 13485 is currently offered on a non-accredited basis. Accredited ISO 13485 Certification Services are currently offered through our partner Certification Bodies.

QSI can support organizations that are currently certified or that have already chosen a Certification Body by providing Assessment Services to either help get them ready for Certification and/or by providing on-going Internal Audits after ISO 13485 Certification has been achieved.

For individual ISO 13485 Auditors, Consultants, Instructors and Technical Experts that wish to become Certified, QSI administers a Personnel Certification Program based on ISO 17024.

If you need additional information on how QSI can help you meet your organizational or personal development and improvement objectives, please free to Contact Us. 
 

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