Understand the ISO 15189 Internal Audit of Quality Management System

ISO 15189 is an international standard for medical laboratories - Requirements for quality and capability, after this referred to as ISO 15189, was first published in 2003 and revised in 2007 and again in 2012. ISO 15189 is not a tool simply to meet accreditation requirements or deliver quick fixes for specific mistakes. Instead, laboratories executing ISO 15189 strive to:

• Make systems that are as failure resistant as possible, will catch errors before they become a problem, and decrease errors by getting things right the first time.
• Identify opportunities for enhancement at all times.
• Contain and empower their staff by including them in the solving of problems and the implementation of solutions.

ISO 15189 inspires full involvement and utilization of the capabilities of all employees at all levels to expand the organization. In a laboratory accredited to ISO 15189, the goal is constant enhancement, and for staff members to know precisely what to do, how to do it, who is in charge of a procedure, and where to find all information essential to perform their jobs. In the United States, accreditation to ISO 15189 is voluntary, as no governmental or regulatory agency needs laboratories or health care providers to conform to ISO 15189.

Internal Audit of ISO 15189 Quality Management System:

ISO 15189 accredited laboratories have to accomplish internal audits of their Quality Management System on a regular basis. Such audits essential to contain the managerial and technical components, as well as pre-examination, examination, and post-examination procedures. These serve to:

• Establish that all activities of the QMS are covered.
• Assure that processes are effective.
• Identify opportunities for enhancement.

ISO 15189 accredited laboratories generally perform internal audits by section, with an entire cycle completed within one year. ISO 15189 Internal Auditor Training develop capability to plan, initiate, and conduct an internal audit of the management system of a medical laboratory in accordance with the requirements of ISO 15189: 2012 standard. Improved frequency of audits may be essential depending on risk and occurrence management outcomes. Internal audit results are one of some inputs for the regular, high-level management review required of ISO 15189 accredited laboratories. Management review meetings offer the opportunity to review problems that affect the laboratory's processes, with, but not limited to, internal audit results, quality metrics, ongoing quality improvement projects, opportunities for enhancement, complaints, and forthcoming new technologies or regulatory changes.

Quality management system conclusions in an ISO 15189 are based on facts and data. This stops personal preferences or a top-down management style from inhibiting procedure and quality enhancement. Constant enhancement is a permanent objective of ISO 15189 standard quality management. This does not mean, for example in anatomic pathology that every possible effort should be made to decrease the frozen section turnaround time by 1 min. The laboratory would find meaningful metrics that are associated with the laboratory's mission. Enhancements may affect any aspect of the quality management system and its procedures. They may contain problems such as saving control tissue for immunohistochemically stains, making the work instructions for lymphoma workups more succinct and accessible, or automating frozen section against final diagnosis associations using the laboratory information system.

Also, in clinical chemistry, constant improvement does not mean making every possible effort to decrease hemoglobin turnaround time by 10 sec. Though, it may mean making efforts to drive down variation and risk, which can help an essential laboratory avoid repeating testing, incorrect results, physician complaints, or even probably having to add a satellite lab with its associated overhead costs. More significantly, constant improvement also refers to the improvement of the quality management system.

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