The 12 Quality System Essentials (QSEs): QMS Building Blocks


The role of Quality Management Systems (QMS)  in ensuring Patient safety and Customer satisfaction in Clinical and Public Health laboratories in now well understood and embraced.  Quality Management Principles form the foundation of a QMS. The Quality System Essentials have been described by CLSI as 12 important elements that are required to act as building blocks for developing a QMS.

12 Quality System Essentials: Building blocks
12 Quality System Essentials: QMS Building blocks

Compliance to the QMS will be checked by carrying out audits on each or all of these elements on a regular basis.

1. Organization

The Laboratory needs to be able to show a clear organizational structure, indicating who has overall responsibility for laboratory activities and who reports to who. An organogram or organizational chart is an important tool for this. The Lab also needs to show that there is planning and control  in the day to day and periodic tasks to ensure a well-oiled system.

2. Facilities and Safety

Despite the nature of work undertaken e.g. handling infectious material, laboratories should be a safe place  for staff and visitors alike. The physical containment of the laboratory, worker safety and ergonomics are key considerations.  Procedures and standards should ensure a safe, secure, and clean environment.

3. Personnel

Quality System Essentials: Lab staff at work
Quality System Essentials: Personnel

The management of staff within the lab is paramount to an well-functioning lab. Although laboratory processes are becoming more automated, lab staff still make the ultimate decisions about methods and results.

Staff must have the right qualifications for the job, and job descriptions must spell out what is expected of each position.  Training and competency assessment at the beginning of employment and regularly thereafter will ensure staff remain competent  to carry out tasks as expected.

Motivated and engaged staff will perform at their best.

4. Equipment

Quality System Essentials: Laboratory Equipment, Microscopes
Quality System Essentials: Equipment

Decisions on choice of equipment have to be evidence based. The laboratory maintains an inventory of all the equipment and schedules maintenance activities to ensure optimum functionality.

5. Purchasing and Inventory

Quality System Essentials: Laboratory Reagents
Quality System Essentials: Purchasing and Inventory

Laboratory stocks and supplies provide the inputs for laboratory processes.

‘Garbage in, garbage out’.

The quality of supplies is dependent on choosing the right products and the right suppliers. A good inventory management system ensures uninterrupted service as supplies are available when required.

6. Process Control

The laboratory testing process from the pre-analytical, analytical to the post analytical phase is controlled by having checks and balances along the way. Validation and verification of methods as well as Internal Quality Control are some of the measures in place to ensure that the processes deliver the best outcomes for the patient.

7. Information Management

Quality System Essentials: Documents and Records
Quality System Essentials: Information Management

Laboratories receive and produce information that is highly sensitive and confidential. As one of the 12 Quality System Essentials, it is important to have measures in place to ensure that only the right people can access, edit and share that information.

8. Documents and Records

A cornerstone of the QMS, documentation ensures standardization which is paramount to quality management. Policies, procedures and instructional guides will define the QMS and give direction for laboratory and supporting processes. They should be available for staff to use for reference and they should be current.

9. Occurrence Management

An “occurrence” is any error or non-conformance. All deviations from what is expected within a laboratory and affecting laboratory operations should be investigated. They pose a risk of  harm to patients and staff. If root cause analysis is thorough, corrective action will be appropriate to address the error.

10. Assessment

An important element to maintaining a QMS is constantly checking compliance to requirements. This is done through internal audits and external audits by regulatory and accreditation bodies.  Audits are planned and systematic. Participation in External quality Assessment/ Quality Assurance Programs is mandatory for all the tests that the lab performs.

11. Process Improvement

The laboratory should have a way to continuously improve processes. Improvements may be triggered by something having gone wrong with correction resulting in improvement of a process, but the laboratory should also have mechanisms in place to identify opportunities for improvement even before anything goes wrong. This pro-active approach is preferred to a reactive approach for process improvement.

12. Customer Service

The laboratory needs to understand the customers and their needs and use customer feedback for improvement. There should be mechanisms in place to handle Customer feedback and complaints.

Customer satisfaction is the ultimate  goal of  the laboratory!!!


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