Managing all the aspects of a Quality Management System can be difficult. Understanding and meeting customer requirements, getting top management involvement, verifying product/service design and fulfillment processes, and achieving continual improvement are wide range of diverse elements to manage. But what if you have several quality systems to manage?
Integrated Quality System Management or Chaos?
As enterprise environments become more complex, so do the systems needed to ensure the organization delivers what customers need in an effective, efficient, and compliant way. As well as requiring internal quality mechanisms like policies and procedures, Total Quality Management, and understanding customer expectations, businesses also have to comply with a host of other internal and external driven requirements like ISO 9001 and ISO 14001 as well as a legal obligation to meet regulation standards.
If a business operates in an industry where there are elements of concern for consumer health or safety, investor or customer funds, worker safety, medical devices or products, or environmental impact, then there are usually stringent requirements and regulations being placed on them such as:
- EPA and ISO 14001 requirements for environmental requirements
- FDA and ISO 13485 requirements for medical product and devices
- FDA, HACCP, and ISO2200 requirements for food producers
- COBIT and ISO 27001 for Information Technology
- FAA and AS9000 for avionics
- HIPPA and Dept. of Health regulations for health care providers
This is just a brief list of some common requirements placed on businesses; we could probably fill pages with a complete catalog of the standards and regulations being placed on businesses in various fields (and their equivalents outside the U.S.). In many industries there are state and local regulations to adhere to as well.
Complex Requirements Require Integrated Solutions
A large medical device producer, for example, may have environment regulations and standards, FDA and medical regulations and standards, manufacturing and quality standards, as well as HIPPA, IT security, and Finance & Accounting (SOX, GAAP) compliance requirements.
Trying to manage this barrage of requirements with different systems only increases the complexity. The best way to manage all quality and compliance requirements is to have an Integrated Quality Management System that encompasses handling all the applicable standards and regulations through one system.
While the idea of an Integrated Quality Management System may seem daunting, the key is to focus on processes – the common element of all requirements – not on the myriad of regulation sections and paragraphs. An Integrated Quality Management System uses the Deming approach to define and improve processes in the organization, including satisfying varied requirements during process execution – regardless of the source. At the process level, there are common events, records, and activities where the diverse and seemingly disconnected sets of requirements connect, align and overlap, and where they can best be managed by one Quality Management System that deals with all aspects of inputs, activities, and outputs.
The Benefits of Integrated Quality Management Systems
With a company-wide, holistic approach to quality management united under one umbrella and managed at the process level, priority conflicts are reduced or eliminated plus redundant efforts, documents, and records are coordinated and integrated.
The benefit of an integrated quality management system is a lower cost and a better return quality management investment. There is less duplication and more focused efforts on process performance, not just meeting the minimum “letter of the law” requirement for each individual standard or regulation, which is expensive and provides little real benefit other than meeting minimum requirements.
With processes that are well-defined and under control with an Integrated Quality Management System, meeting standard and regulatory requirements become as ordinary as other elements of the process. Plus, with the focus it places on process performance, it becomes an opportunity for innovation and improvement instead of a burden.