Quality Management Systems

We assist you in implementing a Quality Management System based on the following standards:

  • ISO 9001- Quality Management Systems, Requirements.  The 2015 revision is now released- The standard does NOT define the actual quality of your product or service – it helps you achieve consistent results and continually improve the process. Thus, if you can make a good product most of the time, this helps you make it all of the time. It’s just good business practices.
  • ISO 13485- Medical devices, Quality management systems, Requirements for regulatory purposes. This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
  • ISO 14001- Environmental Management Systems, Requirements with Guidance for Use. This standard is based on the ISO 9001 standard and focuses on an organizational’s environmental responsibilities, controls and sustainability.
  • AS9100- Quality Systems-Aerospace-Model for Quality Assurance in Design, Development, Production, Installation and Servicing. This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to meet requirements related to the aerospace industry.

 

These standards can be purchased through the American Society for Quality.