Clinical Laboratory Quality Manual Iso 15189
Keesha Ondieki
This Laboratory quality management system handbook is intended to provide a comprehensive reference on Laboratory quality management system for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents. The handbook is linked to the training toolkit on laboratory quality management system.
As stated before: quality management is about "writing what you do and doing what you write". Most procedures needed to be standardized in SOPs. It is now time to also start describing the quality management system in a quality manual.
The quality manual describes the complete quality management system of the laboratory. It describes the structure of the quality management system, how it is implemented and how it is functioning. It further refers to all SOPs of the laboratory for more in-depth instructions.
It is recommended to read ISO 15189:2007 article 4.2.4 or ISO 15189:2012 article 4.2.2.2 as these provide a clear explanation on the quality manual and its required contents. The WHO Laboratory Quality Management System (LQMS) handbook also contains information on the quality manual which is provided in the right-hand column.
The quality manual always contains an introductory paragraph in which the laboratory management and higher management (e.g. the management of the organization the laboratory is part of) is documented including signatures of all managers. The Quality System Essentials (QSE) framework can provide a logical outline of the quality manual.
Describe for each QSE the global measures in place regarding the management of quality in the laboratory. Details for specific techniques and measures are provided in SOPs to which the quality manual must refer.
A template for a quality manual together with useful appendices is provided HERE. This quality manual template will help you to understand what the content of the quality manual should be. However, the quality manual of each laboratory is unique. If this, or any quality manual template is used, the Laboratory Manager and Quality Officer must adapt the text of the template to the local situation. If this is not done, the meaning of having a quality manual is lost, as a quality manual describing a quality management system other than that of the laboratory itself is not useful, and auditors will pick this up quickly.
The quality manual is part of the document control system. This means that this manual will need to be reviewed periodically (and revised where necessary) and therefore has a version number and is verified and authorized by different staff members before printing and use (following the procedure described in the laboratory's SOP of SOPs/Master SOP). This also means that the quality manual must be both accessible to all staff members and properly stored protected from damaging influences.
This quality manual provides a roadmap of the laboratory quality management system (LQMS) in place for public laboratories in PNG including all the necessary policies and procedures that support a quality management system as specified by the ISO15189 Standard for Medical Laboratories.
The quality management system aims to provide the necessary support processes to enable the laboratory to perform accurate and reliable analytical work that meets customer requirements (refer to Figure below). The laboratory aims for continuous improvement of the system, and prevention of the occurrence of nonconformities (unexpected wrong results or significant deficiencies of practice).
PNG has legislated that all laboratories will eventually be accredited against this ISO standard. Implementation of ISO15189 LQMS is a complex process that takes several years. The WHO Laboratory Quality Stepwise Implementation tool provides a 4 phase roadmap with a staged approach to all of the Quality System Essentials (QSE) described in this manual. The development of the LQM is described in phase 3 .
This manual is organized following the framework developed by the WHO. As most laboratories in PNG are just at the commencement of the LQMS journey, much of the content will not correspond to what is currently in place. The LQM provides detailed guidance for future action. Local laboratory management can steadily work through section by section, determining and giving priority/resources to action plans based on the required elements.
As a starting point, it is recommended that all Laboratory Managers read the LQMS Information sheet and enrol in the free WHO eLearning course on LQMS which focuses on the 5 very important initial challenges (approximately 30 minutes learning for each course): 1. Documents and records, 2. Personnel, 3. Purchasing and Inventory, 4. Equipment and 5. Facilities and Safety. Access is via this page and a certificate is provided upon completion of the five courses. It is possible to leave an individual course midway and then return to complete it. Elements from these courses have been integrated into the text and the assistance of WHO is gratefully acknowledged.
LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads) on and off LinkedIn. Learn more in our Cookie Policy.
In the diverse world of healthcare diagnostics, laboratory accreditation acts as the keystone to ensuring the quality and reliability of laboratory testing services. This guide seeks to unravel the complexities of laboratory accreditation, shedding light on its profound significance in the healthcare industry.
Clinical laboratory accreditation is not merely a certification but a commitment to upholding the highest standards in laboratory testing. This commitment extends across various facets of laboratory operations, encompassing testing processes, personnel competence, equipment calibration, and overall quality management systems.
It also serves as a benchmark for quality and reliability for building trust amongst your clientele, business partners, and patients. By adhering to accreditation requirements, laboratories elevate their credibility, leading to improved patient care and expanded market opportunities.
In a nutshell, accreditations facilitate healthcare diagnostic centers to adhere to accreditation standards to enable them to achieve operational excellence and global recognition and commit to the highest level of quality assurance.
As laboratories embark on the path of accreditation, they set the stage for continuous improvement, ensuring that diagnostic results are accurate and contribute to the broader goal of advancing patient safety and healthcare quality.
The benefits of accreditation ripple across the healthcare landscape. Accredited laboratories not only enhance laboratory operations and delivery but also improve credibility and overall improvement of patient care. Additionally, accreditation opens doors to broader market opportunities, positioning laboratories as leaders in the field.
Accredited laboratories prioritize patient safety by implementing standardized processes and protocols. This minimizes the risk of errors, ensuring that diagnostic results are trustworthy. As a result, committing to such quality guidance directly contributes to improved patient care outcomes.
To seek accreditation, labs must adhere to international standards that make them stand out as a globally recognized entity. This recognition fosters trust among stakeholders, including patients, healthcare providers, regulatory bodies, and insurers. Moreover, the recognition is valuable for international collaborations and research which can be a scalable boon for business.
Many regulatory frameworks in the United States, such as the Clinical Laboratory Improvement Amendments (CLIA), require laboratories to obtain accreditation for certification and reimbursement. Compliance with these regulations is essential for operating within the legal and reimbursement frameworks.
Accreditation standards often include requirements for standardized data formats and structures. This facilitates interoperability between laboratories and healthcare systems, promoting seamless data exchange. Standardized data formats contribute to the efficiency and effectiveness of healthcare information management, enabling continuity of care.
Accreditation is a mark of excellence that enhances the credibility and reputation of a clinical laboratory. Accredited laboratories are perceived as reliable and trustworthy entities, attracting more referrals from healthcare providers and fostering patient confidence.
The accreditation process often involves implementing quality management systems and continuous improvement initiatives. This leads to enhanced operational efficiency within laboratories, streamlining processes, reducing errors, and optimizing resource utilization.
Clinical lab accreditation opens doors to new and broader market opportunities and partnerships. Many healthcare providers, insurers, and organizations prefer to collaborate with accredited laboratories due to the assurance of quality and reliability. This can result in increased business opportunities and partnerships.
The accreditation process includes gap assessments and risk management strategies. Laboratories identify areas for improvement and implement corrective actions to mitigate risks. This commitment to continual improvement ensures that laboratories stay at the forefront of advancements in healthcare diagnostics.
Accreditation instills a sense of pride and accomplishment among laboratory staff. It promotes a professionalism and continuous learning culture, as employees engage in training and development activities to meet accreditation standards.
- A2LA: American Association for Laboratory AccreditationA2LA provides accreditation services across various laboratory disciplines, including calibration, testing, and medical testing. It is based in the United States and is recognized internationally.
- UKAS: United Kingdom Accreditation ServiceUKAS is the national accreditation body for the United Kingdom, providing accreditation services across a wide range of sectors, including laboratories. UKAS accreditation signifies compliance with international standards and enhances the credibility of laboratory results.
- NABL: National Accreditation Board for Testing and Calibration Laboratories (India)NABL is the accreditation body in India that assesses and accredits laboratories based on international standards. It covers various testing and calibration disciplines.