A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.  A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.


ISO 9001:2015 is the most recognized and implemented quality management system standard in the world.  It specifies the requirements for a QMS that organizations can use to develop their own programs.

Other standards related to quality management systems include the rest of the ISO 9000 family (ISO 9000 and ISO 9004).  The ISO 14000 family (environmental management systems), ISO 13485 (Quality Management Systems for medical devices), ISO 19011 (auditing management systems), and ISO/TS 16949 (quality management systems for automotive-related products). 

Implementing a quality management system affects every aspect of an organization’s performance.   Benefits of a documented quality management system include:

  • Meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business.
  • Meeting the organization’s requirements, which ensures compliance with regulations and provision of products and services in the most cost and resource efficient manner, creating room for expansion, growth, and profit.

These benefits offer additional advantages, such as helping to communicate a readiness to produce consistent results, preventing mistakes, reducing costs, ensuring that processes are defined and controlled, and continually improving the organization’s offerings.

Each element of a quality management system helps achieve the overall goals of meeting the customers and organizations requirements.  Quality management systems should address an organizations unique needs, however, elements that all systems have in common include:

  • Quality Manual
  • Procedures, instructions, and records
  • Data management
  • Internal processes
  • Customer satisfaction from product quality
  • Quality analysis
  • The organization’s quality policy and quality objectives
  • Improvement opportunities


Before establishing a quality management system, your organization must identify and manage various connected, multi-functional processes to help ensure customer satisfaction.  The QMS design should be influenced by the organization’s varying objectives, needs and products and services provided.  This structure is based largely on the Plan-Do-Check-Act (PDCA) cycle and allows for continuous improvement to both the product and the QMS.  The basic steps to implementing a quality management system are as follows:

  • Design & Build – The design and build portions serve to develop the structure of a QMS, it’s processes, and plans for implementation.
  • Deploy – Deployment is best served in a granular fashion by breaking each process down into subprocesses, and educating staff on documentation, education, training tools and metrics.
  • Control & Measure – Control and measurement are two areas of establishing a QMS that are largely accomplished through routine, systematic audits of the quality management system.
  • Review & Improve – Review and improvement detail with how the results of an audit are handled. The goals are to determine the effectiveness and efficiency of each process toward its objectives, to communicate these findings to the employees, and to develop new best practices and processes based on the data collected during the audit.

The history of quality can trace back to centuries when craftsmen began organizing into unions called guilds.  When the Industrial Revolution came, early quality management systems were used as standards that controlled product and process outcomes.  As more people had to work together to produce results and production quantities grew, best practices were needed to ensure quality results.

As a leader in Scientific Equipment Repair and Medical Equipment Calibrations, Scientific Instrument Center works with many corporations, universities, and hospitals providing the highest level of laboratory services. Whether we are providing biosafety cabinet calibration or medical equipment calibration, we keep your equipment performing to industry codes and regulations. Feel free to contact us at (614) 771-4700