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