A Closer Look on ISO 15189 Medical Laboratory Standard Quality Manual

A comprehensive description of an organization’s quality management system can be found in the quality manual. It is essential to the procedure and acts as the system’s overall manual. The requirements for quality will be spelt out in detail in the manual, which will also outline how the other laboratory records should be organised. A quality manual is required in every laboratory using a quality management system. However, there is a lot of edibility in the preparation, and a laboratory can design the manual so that it is most helpful and appropriate for the situation at hand. The ISO 15189 clause 4.2.4 requires laboratories to have a quality manual, however the style and organisation are not prescribed.

According to the standard a ISO 15189 quality manual is a document that details a company’s quality management system. It’s intended to:  

• Information must be conveyed clearly
• serve as a foundation for fulfilling the needs of quality systems  
• demonstrate management’s dedication to the quality system

All laboratory personnel should receive ISO 15189:2022 awareness training on how to utilise and apply the quality manual, which serves as a crucial roadmap or guide. It is necessary to keep the manual up to date, and updating responsibilities should be allocated. Although ISO 15189 requires laboratories to maintain a quality manual, the style and organisation are not prescribed. A laboratory can create the manual in a way that is most beneficial and appropriate for the purposes of the laboratory and its clients because there is a great deal of flexibility in how to make it.  

A group of experts as well as ISO 15189 consultant is an excellent strategy to take advantage of when creating a high-quality manual. Each facility should carefully consider how to incorporate those who are necessary because the quality manual needs to be customised to the laboratory’s particular demands. Include the laboratory’s policymakers in your efforts. Involving the bench technicians is also crucial to benefit from their knowledge and get their support.  

The quality manual should include policies for each of the twelve essentials of the quality system. Also, describe how all relevant quality processes occur, and make a note of all versions of procedures (SOPs) and where they are located. SOPs, for example, are part of the larger quality system. Although there are frequently too many to include directly in the quality manual, the manual should stipulate that SOPs be produced and advise that they be compiled in the SOP manual.

A quality manual’s objective is to explain information effectively and to serve as a framework or roadmap for satisfying implemented quality management system requirements in the medical laboratories. The manual is the responsibility of laboratory management, and as such, it communicates managerial commitment to quality and the quality management system. The ISO 15189:2022 manual should follow:

• The quality manual serves as the foundation for the entire quality management system, it must be accurate and up to date at all times. To ensure this, the laboratory will need to develop a procedure. The stages below provide advice for creating, maintaining, and implementing a quality handbook.  
• When the quality manual is written and prepared, it must be approved by the head of the laboratory. In some laboratories, approval by another appropriate person, such as the quality manager, might also be required. This approval should be indicated by having official signatures and dates of signing recorded in the manual itself.
• It is necessary to set up an upgrading procedure or system. This system should outline how often the manual will be reviewed, who will be in charge of updating it (often the quality manager), and how modifications will be incorporated and recorded.
• The quality manual will need to be updated regularly even after receiving approval; this approval should be demonstrated by the signatures of the person(s) with the appropriate authority, along with the date of the modification, being noted in the manual.  
• All laboratory staff members should receive training on how to utilise the manual; they also need to be fully aware of the importance of adhering to the guidelines outlined in the quality manual at all times.