Quality Management System on an ISO 13485 : 2005

ISO 13485 focuses on defining a Quality Management System (QMS) for medical devices and services.  As one would expect devices and services used in the medical community require that they meet stringent customer and regulatory requirements without fail.   The standard also seeks to harmonize how medical suppliersaround the world work in this industry.   Compliancehelp consulting can help you understand this standard then help you with documenting your processes to meet these requirements and regulations.

Like many ISO standards ISO 13485: 2003 has many aspects that are the same as ISO 9001 with a few exceptions. The standards main focus is to help you define a process with the following attributes.

  • Compliance with statutory and regulatory requirements
  • Effective product traceability and recall systems
  • Risk Management approach to product development and product realization
  • Validation of processes and prevention efforts
  • Clear concise documentation to help/assist the end user in the proper use and care of your product.
  • Control of work areas where cleanliness or sterile requirements are required
  • Your company’s ability to produce a consistent medical product or service in a very high quality manner every time.

If you need to meet both ISO 9001 and ISO 13485 to appeal to a wider base of customers Compliancehelp can help you define one “Quality Management System” that meets both ISO 9001 and ISO 13485 Standards.   In fact we can also add in ISO 14001 so you meet environmental requirements at the same time.

NOTE:  Ever wonder why you may need to meet ISO 13485 and be subject to FDA regulations and audits…Well in June 2012 the FDA is starting a pilot program that will allow you to utilize your ISO13485 Certification, Audit results etc.to meet the FDA audit requirements.