These are conducted by trained and competent auditors in auditing of QMS based a respective standard. The role of baseline assessment is to determine the extent of implementation of management and technical requirements of a given standard. Audit reports are generated and used to plan interventions. The consultants have planning session meetings with the clients to finalize the proposed work plan, select scope tests, and advise on external quality assurance schemes and laboratory infrastructure needs among other key discussions.
The laboratory personnel are trained in relevant quality management system courses. The courses include QMS based on applicable international standards, Internal auditing, Biorisk management based, identification and management of non-conformances, management review, and statistical process control. The Laboratory director undergoes training on selected clauses of the applicable standards to facilitate their roles as lab directors. Trainings are organized for lab staff preferably offsite and are delivered in line with ILAC/CLSI guidelines.
Following audits, pieces of training, and mentorship cycles by a minimum of one mentor to ensure successful knowledge transfer and implementation of the QMS. During the mentorship, some elements of the QMS are implemented directly by consultants and lab staff while others are assigned to staff in the form of a post-mentorship action plan. This enables staff to know the evidence created while implementing the QMS. A minimum of 6 mentorship cycles are required from baseline audit to apply for accreditation. Each mentorship is followed by a report.
Quality assurance: Each mentorship cycle has pre-determined deliverables. All mentorship cycles are supervised through the operations budget. During implementation, traceability of the methods and processes is ensured.
These are conducted by trained and competent auditors in auditing QMS based on the applicable Quality management system standards. The role of this mock assessment is to determine the extent of implementation of management and technical requirements based on ISO standards being implemented following the pieces of training and mentorships. Audit reports are generated and used to plan interventions. Mock audits are rigorous and are conducted by a minimum of 3 auditors.
After evaluating the readiness to apply for accreditation and putting in place measures to sustain the achieved degree of knowledge and skills, a lab is supported to apply to a selected accreditation body. A nominated representative will be selected and guided on the application process. Application fees and assessment fees are met at this stage. These costs will include flight costs, accommodation, and other fees as required by a given accreditation body.
When the accreditation body raises nonconformities from the review of the application including support documentation provided by the applicant, support is offered to have these closed. Similar support is offered to NCs that are raised from the initial assessment.