With the new ISO 13485:2003, developed for the Medical Device industry, ISO 9000:2000 and the current TS 16949 Quality System Standard, companies are not just looking at documenting their process, but focusing on the process approach to activities and their related resources.

Our ISO consulting philosophy states that in order for a client to understand the total benefits of the Quality System, the entire organization needs to be involved. We understand that every organization is unique in its own right and with our focus on the client organization; we are able to tailor a program to their needs so that all efforts fit within the ISO Quality Management Principles (For the full text of the ISO Quality Management Principles go to: http://www.iso.ch/iso/en/ISOOnline.openerpage):

• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier relationships
  

We perform a review of the processes, procedures and work instructions in all functional areas, as required to prepare the documentation necessary to achieve compliance with the correct ISO Standard, as well as provide employee training on the new business/quality system. Management reviews are established and implemented to complete the final phase, which would be an internal audit of the Quality System performed by Brighton prior to the third party ISO registration audit.

Brighton is proud to state that all of our ISO clients have received their certification from the registrar after the FIRST registration audit.