One Company...One Quality System

Increasingly, companies are required to meet requirements from multiple industry trade organizations, regulatory bodies or customers.  Establishing policies and business practices within an organization that comply with a single set of requirements can seem like a daunting activity.   And, integrating multiple requirements from different sources, which may often times have different minimum expectations, into one business management system can feel next to impossible.  Sometimes, the company’s management may make the decision to set up two or more sets of quality system documents to meet all the different requirements.  This results in confusion within the organization as personnel are left trying to discern which policies to apply depending on the priority of the week.

Having a quality management system that is integrated provides many benefits to the organization.  An integrated system ensures the company is consistent in policies and documentation standards.  It creates a common basis for how all work processes are to be carried out and thus provides employees an understanding and set of expectations.  Companies that must operate within many different regulations and standards can implement one quality management system.   ISO-9001 and other related quality management systems provide the framework to include regulatory requirements and/or industry best practices.  The result of an integrated QMS will pay dividends to the organization and its clients. 

 This presentation will include discussion of the featured American Society for Quality case study “Imaging Core Lab Takes Quality Beyond Regulatory Requirements with ISO 9001” which includes the review of an ISO 9001 implementation project managed by the presenter, Gretchen McAuliffe, within a Houston-based FDA regulated company.  The project was highlighted by ASQ as an example of how an integrated management system can work within an organization that must comply with government regulations but wishes to implement a QMS that will be focused on continual improvement, not just compliance.  The presenter will discuss the path to ISO 9001 certification within the GxP environment and how the company achieved certification in just six months.