ISO 15189 Quality Standards

ISO 15189 quality standards spell out both quality management requirements (based on ISO 9001) and technical competence standards (based on ISO/IEC 17205) for medical laboratories.

ISO 15189 quality standards provide an effective quality management and technical competence framework that enables medical laboratories to meet international standards for patient care and laboratory responsibility. The ISO 15189 quality standards, when carefully planned to meet laboratory requirements, can also improve laboratory services, products and business processes.

Medical laboratories can also benefit from the automation of business processes and controls that help obtain or continually maintain ISO 15189 quality standards. Automation also helps with the College of American Pathologists (CAP) inspections. To learn more about automating compliance with ISO 15189 quality standards, please download the following white papers.

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ISO 15189 Quality Standards Checklist

Want an ISO 15189 checklist? Here are some specific ways that MasterControl allows medical laboratories to effectively automate and streamline compliance with ISO 15189 quality standards:

ISO 15189 Quality Standards

MasterControl Solution


Clause 4.2.1 - "Policies, processes, programmes, procedures and instructions shall be documented and communicated to all relevant personnel. The management shall ensure that the documents are understood and implemented."

Clause 4.2.4 - "All personnel shall be instructed on the use and application of the quality manual and all referenced documents, and of the requirements for their implementation. The quality manual shall be kept up to date under the authority and responsibility of an individual appointed to be responsible for quality by the laboratory management."

MasterControl Document Control

Documentation is often the central facet of an effective quality management system. Medical and clinical laboratories need to be able to create documents that will be automatically tracked, routed and controlled (as they are revised) in a secure, centralized system to ensure compliance with ISO 15189 quality standards. MasterControl allows medical and clinical laboratories to create any type of file and secure that file in the MasterControl system. MasterControl's advanced meta-data InfoCards allow any approved employee to quickly search and find essential documentation such as an ISO 15189 quality manual, SOPs, etc. Routing, approvals, escalations and storage procedures are also automated for best results to comply with ISO 15189 quality standards.

Documentation is also often necessary for training purposes in medical and clinical laboratory environments to ensure compliance with ISO 15189 quality standards. MasterControl makes it simple to combine training and documentation management. For example, if a quality manual or an SOP is revised within the document system it can be set to automate the release of training tasks or full-scale training units to employees anytime and from anywhere which will help in meeting ISO 15189 quality standards ultimately.

MasterControl also provides integrated change control management that connects different departments with data and processes under a secure and centralized system. This connectivity vastly improves efficiency through automatic task assignment, routing, scheduling, notification, and escalation of incomplete tasks.

Remember, MasterControl is Web-based, so even suppliers and others outside the company (off-site or traveling employees) who need to participate in change control can do so from virtually anywhere.

Training for ISO 15189 Quality Standards Compliance

Clause 5.1.4(g) - "...ensure that there are sufficient qualified personnel with adequate documented training and experience to meet the needs of the laboratory;"

MasterControl Training Management

One of the main items on any ISO 15189 checklist is managing training processes effectively. MasterControl automates the routing, tracking, and follow-up of training tasks and even grading of online exams. Users are automatically notified about new training tasks. Upon task completion, the verifier is also automatically notified whether the training for ISO 15189 quality standards is complete or not.

MasterControl integrates the training process with the rest of the quality system to ensure ISO 15189 quality standards compliance for a holistic approach to management. If there's any change in a document linked to a required course because of a revised SOP, policy, ISO 15189 quality manual, etc., all affected trainees will immediately receive new training tasks.

MasterControl's advanced analytics and reporting capability includes customizable reports and online charting. The system automatically performs gap analysis for all training tasks making it simple to access real-time data and to adhere to ISO 15189 standards.

Nonconformance Management

Clause 4.12.1- "All operational procedures shall be systematically reviewed by laboratory management at regular intervals, as defined in the quality management system, in order to identify any potential sources of nonconformance or other opportunities for improvement in the quality management system or technical practices. Action plans for improvement shall be developed, documented and implemented, as appropriate."

MasterControl Nonconformance Management

MasterControl's best-practice form and five-step process connect all responsible personnel for effective and timely disposition of a nonconformance. MasterControl offers ensurity of compliant processes with ISO 15189 quality standards with the choice of maintaining a stand-alone nonconformance process for small-scale, localized incidents, or you may connect it to the CAPA process for automatic escalation when the situation warrants it.

MasterControl automates data collection, routing, follow-up, and escalation of nonconformance cases. The electronic "in" box tracks all active tasks for a user and provides tools for staying on top of things. Approvers can also review and sign electronically. All of these things help shorten cycle time.

The system tracks all routing information and data entered into the electronic form, allowing the nonconformance owner to identify bottlenecks and understand the sequence of events during processing.

Audits for ISO 15189 Quality Standards Compliance

Clause 4.14.1 - "In order to verify that operations continue to comply with the requirements of the quality management system, internal audits of all elements of the system, both managerial and technical, shall be conducted at intervals defined by the system itself. The internal audit shall progressively address these elements and emphasize areas critically important to patient care."

MasterControl Audit Management

MasterControl connects the audit process with the rest of the quality system for a holistic approach to quality management. A CAPA form can be launched directly from an audit finding form, greatly streamlining the process.

The MasterControl system also automates the scheduling of all recurring audit-related activities so they won't be overlooked and helps sustain compliance with ISO 15189 quality standards. It allows for the planning and scheduling of tasks well in advance and provides powerful analytics and reporting capabilities, including customizable reports and online charting. Through the reports, managers get a real-time view of the audit process and can be more proactive about improving the quality system.


Clause 4.10.1 - "Procedures for corrective action shall include an investigative process to determine the underlying cause or causes of the problem. These shall, where appropriate, lead to preventive actions. Corrective action shall be appropriate to the magnitude of the problem and commensurate with possible risks."

Clause 4.10.2 - "Laboratory management shall document and implement any changes required to its operational procedures resulting from corrective action investigations."

Clause 4.11.1 - "Needed improvements and potential sources of nonconformities, either technical or concerning the quality management system, shall be identified. If preventive action is required, action plans shall be developed, implemented and monitored to reduce the likelihood of the occurrence of such nonconformities and to take advantage of the opportunities for improvement."

MasterControl CAPA Management

The MasterControl system automates the routing, delivery, escalation, and approval of CAPAs and all related documents. It provides a centralized repository for all CAPA related documentation making search and retrieval easy during inspections and/or audits.

The MasterControl system integrates the CAPA process with the rest of the quality system to ensure ISO 15189 quality standards compliance. For example, the resolution of a CAPA might trigger an SOP change and retraining of employees on a new SOP. This connectivity also means that a CAPA form can be launched directly from another form (i.e., customer complaint, nonconformance) to streamline the process.

The MasterControl system also tracks all routing information and data entered into the electronic CAPA form, allowing the nonconformance owner to identify bottlenecks and understand the sequence of events during processing.

Management Review

Clause 4.15.1 - "In order to ensure their continuing suitability and effectiveness in support of patient care and to introduce any necessary changes or improvements, laboratory management shall review the laboratory's quality management system and all of its medical services, including examination and advisory activities. The results of the review shall be incorporated into a plan that includes goals, objectives and action plans. A typical period for conducting a management review is once every twelve months."

MasterControl Management Review

Management review is as essential element of a quality management system. The MasterControl system can automate review reminders and the release of related documentation which will help in complying with ISO 15189 quality standards.

Easy review of all quality documentation streamlines the College of American Pathologists (CAP) inspections.

Supplier Management

Clause 4.6.4 - "The laboratory shall evaluate suppliers of critical reagents, supplies and services that affect the quality of examinations and shall maintain records of these evaluations and list those approved."

MasterControl Supplier Management

With MasterControl, all supplier status and quality information (such as non-conforming material reports) is automatically contained in a single, easy to access location. In addition to providing an easily maintainable AVL, MasterControl Supplier features a user-friendly interface for accessing all documentation and records related to each supplier.

MasterControl automatically tracks and stores supplier information derived from audits, non-conformance reports, supplier deviations, and CAPAs. This electronically managed information can then be easily compiled for supplier quality ratings according to ISO 15189 quality standards. Furthermore, suppliers can be approved using MasterControl's robust approval workflow technology.

With MasterControl, goods or services can be added to the "approved to supply" list simply by linking the goods/services to a specific supplier in MasterControl. Suppliers, conversely, can be added the same way. If a part is linked to a supplier that is not approved, the link will be disabled until the supplier becomes approved or reapproved. All of this information is easily obtainable via MasterControl's built-in reporting tool which is developed according to ISO 15189 quality standards.

MasterControl's web-based platform makes accessing supplier data easy and efficient which helps in maintaining compliance with ISO 15189 quality standards. Geographically dispersed divisions have the ability to share supplier qualification data with others in the corporation, potentially cutting out costly duplication of effort and speeding time to market.


About MasterControl's Software for ISO 15189 Quality Standards

MasterControl produces software solutions that enable regulated companies to get their products to market faster, while reducing overall costs and increasing internal efficiency. MasterControl securely manages a company's critical information throughout the entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use which helps in sustaining compliance with ISO 15189 quality standards. MasterControl solutions include quality management, document management, product lifecycle management, audit management, training management, document control, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of services based on industry best practices, MasterControl provides our customers with a complete information management solution, according to ISO 15189 quality standards, across the entire enterprise.

More Information on ISO 15189 Quality Standards

To learn more about automating and streamlining compliance with ISO 15189 standards and continuously maintaining ISO 15189 and CAP accreditation, please feel free to contact a MasterControl representative.