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ISO/IEC 17025 Quality Management System

What is a QMS?

A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction. Specifically, laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results, it is also the basis for accreditation from an accreditation body.

A QMS integrates the various internal processes within the organization and intends to provide a process approach for project execution. Process Requirements are the heart of the ISO 17025:2017 standard, describing the activities to ensure that results are based on accepted science and aimed at technical validity. Management System Requirements are those steps taken by the organization to give itself quality management system tools to support the work of its people in the production of technically valid results.

The Concept of Quality Management

A Quality Management System in its basic concept is quite simple. It seeks to,

  • Recognize interested party requirements including Licenses to Trade, guidelines, customer requirements, and the chosen management system standard(s).
  • Ensure that all requirements have been met.
  • Confirm that employees receive applicable training in the quality system requirements.
  • Determine processes, their interaction, inputs and outputs.
  • Produce records or evidence that system requirements have been met.
  • Measure, monitor and report the performance of the QMS.
  • Plan changes to the QMS and take actions to address risks and opportunities as a result of changes.
  • Perform internal audit to analyze the QMS and correct nonconformities.
  • Continually improve the QMS.

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What a Quality Management System is Not

There are many definitions for general quality management systems. Most of them emphasize the use of some type of system that is repeatable, measurable and constantly improving. In an ISO 17025 (or other ISO standards) quality system, this structured way of delivering a better service or product is supported by documented information such as procedures, work instructions, policies and forms. The key is to provide all those who must execute the quality system with documented, understandable and workable instructions which define both expectations, responsibilities and actions to achieve the stated quality goals. Most of the systems include some type of external and internal auditing process which ensures that the system is in compliance with requirements.

At its core, a quality management system is an integrative element, uniting diverse aspects of a company into a unified purpose of delivering products/services in their best form. Rather than be seen as a cost burden, an effective quality management system is viewed as a key component of success. Quality management systems focus on:

  • Being centered on the customer or consumer of the good or service, actively providing that customer with the best value possible.
  • Some type of continuous improvement program, which implies that there is not a “perfect” state, all processes can be continually improved upon.
  • An efficiency imperative that says waste must be reduced and all resources maximized.
  • Top management is to support and provide adequate resources to achieve goals.
  • It aids or facilitates a clear understanding of expectations between all participants.
  • Measurement and accurate data collection are incorporated to support data-driven decision making.
  • Documentation of QMS processes is maintained and controlled.

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